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PMC11278349_p16
|
PMC11278349
|
sec[2]/p[1]
|
3. Results
| 3.96875 |
biomedical
|
Study
|
[
0.9970703125,
0.0025005340576171875,
0.00028324127197265625
] |
[
0.9990234375,
0.0004875659942626953,
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A total of 85 participants (26 females and 59 males) were included ( Table 1 ). The mean ± SD age for the females was 37.0 ± 12.4 years, and for the males, it was 49.4 ± 16.4 years. Common co-morbidities included systemic hypertension (15.5%) and diabetes mellitus (14.3%). A significant history of smoking was reported by 42.5% of the males, and biomass fuel use was reported by 26.9% of the females. Intermittent/persistent symptoms (cough, sputum, exertional dyspnea, and dyspnea at rest) were reported by 26.9% of the females and 32.2% of the males, resulting in an overall prevalence of 30.6% ( p = 0.626).
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278349_p17
|
PMC11278349
|
sec[2]/p[2]
|
3. Results
| 4.132813 |
biomedical
|
Study
|
[
0.99853515625,
0.001178741455078125,
0.00021970272064208984
] |
[
0.99853515625,
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0.0006585121154785156,
0.00014352798461914062
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A comparison of the radiographical abnormality scores assessed by reader 1 and reader 2 showed minimal differences. The agreement between the two readers for classifying the CXR as normal and abnormal was high, as evidenced by the Cohen’s Kappa score of 0.933 (95% CI: 0.841 to 1.0), and for classifying the radiological patterns of the CXR findings (cavity, fibrosis, and consolidation), the Cohen’s Kappa score was 0.901 (95% CI: 0.792 to 1.0). For classifying the CXR severity scoring, the Cohen’s Kappa score was 0.841 (95% confidence interval (CI): 0.726 to 0.955). The Bland–Altman analysis revealed a low bias of 0.094, with 95% limits of agreement from −1.580 to 1.768 .
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999999 |
PMC11278349_p18
|
PMC11278349
|
sec[2]/p[3]
|
3. Results
| 4.121094 |
biomedical
|
Study
|
[
0.9990234375,
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[
0.99951171875,
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Among the 66 individuals who underwent spirometry assessment, 27.3% of the females and 30.2% of the males exhibited restrictive spirometry patterns ( Table 2 ). The mean age was significantly higher in the individuals with abnormal X-ray findings (48.00 ± 16.36 years) than those with normal findings (40.27 ± 15.05 years) ( p = 0.043). In the 6MWT, the participants with abnormal X-ray findings had a slightly lower mean percentage of predicted distance walked (85.07 ± 12.27%) compared to those with normal X-ray findings (90.96 ± 6.18%) ( p = 0.023). The FEV 1 /FVC ratio post-bronchodilator therapy was significantly different between the normal and abnormal X-ray groups ( p = 0.021), with a slightly lower mean value observed in the abnormal group (0.77 ± 0.14) compared to the normal group (0.82 ± 0.09). Obstructive patterns were significantly more prevalent in the abnormal X-ray group ( p = 0.003), with no significant difference in restrictive patterns. SPO2 changes during the 6MWT significantly differed between the normal and abnormal X-ray groups ( p = 0.004). The majority with abnormal DLCO scores had abnormal X-rays.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278349_p19
|
PMC11278349
|
sec[2]/p[4]
|
3. Results
| 4.082031 |
biomedical
|
Study
|
[
0.9990234375,
0.0007038116455078125,
0.00021517276763916016
] |
[
0.99951171875,
0.00021016597747802734,
0.000324249267578125,
0.00009149312973022461
] |
We observed that 26 patients had a normal chest-Xray and then further analyzed the demographic and pulmonary function test characteristics of these patients. The patients were further classified under low FVC, low FEV 1 , and low DLCO scores. In subjects with low FVC, they also had low TLC, DLCO, FEV 1 , and PEF scores. There was a female predominance in subjects with a low FEV 1 , as well as associated reductions in other spirometric parameters, and DLCO was observed. In subjects with low DLCO, in addition to reduced spirometric parameters, smoking was significantly higher ( Table 3 ).
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278349_p20
|
PMC11278349
|
sec[2]/p[5]
|
3. Results
| 4.082031 |
biomedical
|
Study
|
[
0.99951171875,
0.0003314018249511719,
0.00019633769989013672
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[
0.99951171875,
0.0002689361572265625,
0.0003299713134765625,
0.00006639957427978516
] |
A general linear model to analyze the association between the lung function parameters (percentage of predicted FEV 1 , percentage of predicted FVC, percentage of predicted FEV 1 /FVC, percentage of predicted FEF25-75, and post-FEV 1 /FVC) and CXR severity scoring showed that with increases in CXR severity scoring, lung functions followed a decreasing trend, which is statistically significant.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278349_p21
|
PMC11278349
|
sec[2]/p[6]
|
3. Results
| 4.195313 |
biomedical
|
Study
|
[
0.9990234375,
0.0005803108215332031,
0.00019860267639160156
] |
[
0.9990234375,
0.0003261566162109375,
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0.00011789798736572266
] |
Multiple linear regression analysis ( Table 4 ) revealed the relationships between the various factors and the pulmonary function parameters (FVC, FEV 1 , FEF25-75, FEV 1 /FVC, and DLCO). After adjusting for smoking, hypertension, diabetes mellitus, drop in saturation in the 6MWT, and time elapsed after treatment (in months), the degree of radiologic abnormalities as represented by the CXR severity scoring was independently associated with percentage predicted values of FVC (a 2.5% decrease for each unit increase in CXR severity scoring; 95% CI: −4.9 to −0.16; p < 0.05); FEV 1 (a 4.45% decrease for each unit increase in CXR severity scoring; 95% CI: −6.75 to −2.14; p < 0.001); FEF25-75%—small airway involvement (a 5.59% decrease for each unit increase in CXR severity scoring; 95% CI: −9.24 to 1.95; p < 0.01), and FEV 1 /FVC ratio (a 0.029% decrease for each unit increase in CXR severity scoring; 95% CI: −0.42 to −0.012; p < 0.001). We also observed that after adjusting for smoking, hypertension, diabetes mellitus, and time elapsed after treatment (in months), the drop in saturation in the 6MWT was independently associated with the CXR severity scoring (a 0.85 drop in saturation with each unit increase in CXR severity score; 95% CI: 0.45 to 1.25; p < 0.001). After adjusting for smoking, diabetes mellitus, drop in saturation in the 6MWT, time elapsed after treatment (in months), and degree of radiologic abnormalities, it was observed that patients with the presence of hypertension had a low post-bronchodilator FEV 1 /FVC ratio, suggesting potential airflow limitation.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278349_p22
|
PMC11278349
|
sec[2]/p[7]
|
3. Results
| 4.113281 |
biomedical
|
Study
|
[
0.99951171875,
0.00035071372985839844,
0.00019824504852294922
] |
[
0.9990234375,
0.00019812583923339844,
0.0006756782531738281,
0.00007420778274536133
] |
Figure 4 presents a forest plot depicting the odds ratio from the multivariate logistic regression model of low FEV 1 (≤80) , low FVC (≤80) , and low DLCO (≤80) with other variables . The findings indicate that higher CXR severity scores were significantly associated with reduced lung function, as demonstrated by the lower FEV 1 ( p = 0.027, OR = 2.39, 95% CI: 1.22–5.96) and FVC ( p = 0.032, OR = 2.04, 95% CI: 1.15–4.34). The lower diffusing capacity of the lungs for carbon monoxide seen in post-tubercular patients showed preponderance to the female gender ( p = 0.021, OR = 4.61, 95% CI: 1.33 to 18.41). No significant associations were found between the Spo2 drop in the 6MWT and any of the lung function parameters (FVC and FEV 1 ).
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278349_p23
|
PMC11278349
|
sec[3]/p[0]
|
4. Discussion
| 4.269531 |
biomedical
|
Study
|
[
0.9990234375,
0.0009341239929199219,
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] |
[
0.99853515625,
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] |
The results of our study shed light on the long-term effects after completion of successful medical treatment for TB and highlight the significance of continued monitoring and management of lung health in post-TB patients. The prevalence of abnormalities in lung function observed in our cohort is striking, emphasizing the need for comprehensive care beyond the completion of TB treatment. Nearly 70% of the enrolled patients displayed abnormal CXRs, with fibrosis being a prominent feature in almost half of these cases. One of the key findings of our study is the association between the CXR severity scoring and lung function abnormalities. With every unit increase in severity scoring, there was a 4.4% reduction in the percentage of predicted FEV 1 , a 2.5% reduction in the percentage of predicted FVC, a 5.5% reduction in the percentage of predicted FEF25-75 (suggesting maximal impact on small airways), and a 0.85% drop in the oxygen saturation in the 6MWT. When radiological abnormalities were present after successful completion of TB treatment, we observed greater odds of 1.79 and 2.94 for low FVC and low FEV 1 , respectively. These findings indicate the enduring impact of TB on lung tissue, leading to structural abnormalities that affect lung function. Spirometry revealed that almost 70% of the patients exhibited abnormal results. What makes these findings even more intriguing is the diverse range of patterns observed, including obstructive and restrictive patterns. In addition, 62.2% of the patients, of whom 80% were females, had abnormal DLCO, suggesting significant impairment of their diffusing capacity. Further, nearly 60% had a drop in saturation (1–4%) in the 6MWT, demonstrating diverse lung involvement in post-TB sequelae presentations, complicating the long-term consequences.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999999 |
PMC11278349_p24
|
PMC11278349
|
sec[3]/p[1]
|
4. Discussion
| 4.085938 |
biomedical
|
Study
|
[
0.99951171875,
0.0004820823669433594,
0.00018012523651123047
] |
[
0.99951171875,
0.0001989603042602539,
0.00044417381286621094,
0.00008660554885864258
] |
In our study, we observed that patients with abnormal CXRs experienced lower lung function as measured by spirometry, and this correlation was directly proportional to the severity of lung involvement seen in the CXRs. The link between abnormal CXRs and significant airflow limitation supports the notion that structural lesions, such as fibrosis and bronchiectasis, play a crucial role in compromising lung function. Unlike our study, Saldana et al. found that there was a 2.92% decrease in the percentage of predicted FEV 1 , with every unit increase in the CXR severity score . Even though we used the same CXR severity scoring, our study found greater reduction in the FEV 1 (a 4.45% decrease). This could be due to differences in demographics, comorbidities, proportion of smokers and pack-years, MDR-TB patients, and HIV-infected individuals, and time elapsed between the end of treatment and inclusion in the study.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278349_p25
|
PMC11278349
|
sec[3]/p[2]
|
4. Discussion
| 4.121094 |
biomedical
|
Study
|
[
0.9990234375,
0.0004906654357910156,
0.0004277229309082031
] |
[
0.78466796875,
0.0010671615600585938,
0.214111328125,
0.0003814697265625
] |
Limited studies on DLCO in post-tuberculous patients have reported a decrease in DLCO levels. A study in Brazil with 36 patients found a mean DLCO ranging from 74.1% to 78.8%, while an Indian study revealed that 69% had reduced DLCO of mild to severe grade but did not show female predilection, unlike our study . Interestingly, a female gender predilection for low DLCO was observed in a study of 292 patients, with 116 females having a low DLCO compared to 80 males . Biomass exposure in low- and middle-income countries and late presentation may contribute to the observed gender susceptibility for greater pulmonary diffusion impairment . Late presentation in post-tuberculous patients could be influenced by various factors, including social norms, anemia, malnutrition, and limited access to healthcare for women . Additionally, though not evaluated in tuberculosis, sex steroids may play a role in greater interstitial involvement and delayed healing, leading to greater diffusion defects among women, as observed in previous studies that have evaluated other interstitial and chronic lung diseases . Overall, more research is needed to better understand impaired DLCO in post-tuberculous patients and the influence of gender-related factors.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278349_p26
|
PMC11278349
|
sec[3]/p[3]
|
4. Discussion
| 4.097656 |
biomedical
|
Study
|
[
0.99951171875,
0.00043392181396484375,
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] |
[
0.99951171875,
0.00022864341735839844,
0.00022602081298828125,
0.00006592273712158203
] |
There was reduction in the exercise capacity of patients, especially those with CXR abnormalities, as measured by oxygen desaturation during the 6MWT and a decreased percentage of predicted distance during the 6MWT, which is similar to the findings of other studies conducted for the evaluation of exercise capacity in post-TB patients . We are the first study in south-east Asian countries, to the best of our knowledge, to quantify the severity of post-tuberculosis sequelae (in terms of CXR severity scoring), and the drop in saturation in the 6MWT demonstrated a 0.85 increase in CXR severity scoring with every unit drop in SPO2 in the 6MWT.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278349_p27
|
PMC11278349
|
sec[3]/p[4]
|
4. Discussion
| 3.982422 |
biomedical
|
Review
|
[
0.99853515625,
0.0008792877197265625,
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[
0.472900390625,
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So far, three systematic reviews and meta-analyses have been carried out for the evaluation of post-TB sequelae . Most of the studies have evaluated only spirometric abnormalities, with many reporting only descriptive statistics. It is noteworthy that our study’s findings align with previous research, which has also reported a wide range of prevalence rates (41–100%) for abnormal lung function in post-TB patients . Variations in demographics, comorbidities, and lung involvement severity, and differences in defining severity contribute to this variability. These factors underscore the complexity of post-TB sequelae and highlight the need for individualized patient care and tailored follow-up protocols, and the critical lack of research on identifying the risk factors for post-tubercular sequelae and additional management to prevent such life-long detrimental lung deficit. Despite confirming the profound, lifelong impact post-chemotherapy, there is a lack of guidance from the WHO and National TB programs regarding patient management. The understanding of pathogenesis and therapeutic approaches to reduce sequelae remains insufficient.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278349_p28
|
PMC11278349
|
sec[3]/p[5]
|
4. Discussion
| 3.792969 |
biomedical
|
Review
|
[
0.998046875,
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] |
[
0.0304718017578125,
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] |
Thalidomide’s potential in mitigating lung damage by reducing TNF-alpha and suppressing lung fibrosis pathways is noteworthy . Its role in idiopathic pulmonary fibrosis highlights its significance, suggesting clinical trials for thalidomide or other anti-fibrotic agents alongside anti-tubercular treatment. There is an urgent need for clinical trials on the co-prescription of thalidomide or other anti-fibrotic agents along with anti-tubercular treatment, as well as the identification of newer therapeutic agents to reduce post-TB sequelae.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278349_p29
|
PMC11278349
|
sec[3]/p[6]
|
4. Discussion
| 4.070313 |
biomedical
|
Study
|
[
0.99951171875,
0.00037980079650878906,
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] |
[
0.99951171875,
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0.00008577108383178711
] |
Our study provides valuable insights into the prevalence and implications of altered lung function following successful pulmonary TB treatment. It is important to acknowledge its strengths and limitations. To the best of our knowledge, it is the first study in south-east Asia to use advanced regression techniques to quantify the association between CXR and spirometric abnormality, and a holistic assessment of lung functions was performed using spirometry, DLCO, and the 6MWT. However, the relatively small sample size, lack of CT scans, and lack of long-term follow-up remain its limitations and warrant further investigation to fully comprehend the trajectory of lung function decline in post-TB patients. Information was not available on the pre-treatment chest X-ray findings for the majority of the patients, and lung function before treatment for tuberculosis was not available for all patients.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278349_p30
|
PMC11278349
|
sec[4]/p[0]
|
5. Conclusions
| 4.039063 |
biomedical
|
Study
|
[
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[
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] |
Our study emphasizes that successful medical treatment for pulmonary TB does not guarantee the complete restoration of lung health. Post-TB sequelae can present as a spectrum of obstructive and restrictive lung diseases, with structural abnormalities and comorbidities playing significant roles in lung function alterations. The findings underscore the need for ongoing monitoring, individualized care, and the adoption of holistic approaches that address both the respiratory and comorbidity aspects of post-TB patients. By doing so, we can optimize the long-term outcomes and quality of life for individuals who have triumphed over TB.
|
[
"Nidhi Bansal",
"Sumalatha Arunachala",
"Mohammed Kaleem Ullah",
"Shreedhar Kulkarni",
"Sukanya Ravindran",
"Rekha Vaddarahalli ShankaraSetty",
"Sowmya Malamardi",
"Sindaghatta Krishnarao Chaya",
"Komarla Sundararaja Lokesh",
"Ashwaghosha Parthasarathi",
"Bellipady Shyam Prasad Shetty",
"Prashanth Chikkahonnaiah",
"Prashant Vishwanath",
"Jayaraj Biligere Siddaiah",
"Padukudru Anand Mahesh"
] |
https://doi.org/10.3390/jcm13144115
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p0
|
PMC11278361
|
sec[0]/p[0]
|
1. Introduction
| 3.992188 |
biomedical
|
Review
|
[
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] |
[
0.159912109375,
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Glaucoma is a disease characterized by retinal ganglion cell (RGC) damage, optic nerve degeneration, and subsequent progressive vision loss. It is the leading cause of irreversible vision loss worldwide . Primary open-angle glaucoma (POAG) is the most common form of the disease, with an estimated 68.56 million people affected worldwide . Risk factors for development of POAG include older age, family history of disease, elevated intraocular pressure (IOP), and African ancestry .
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p1
|
PMC11278361
|
sec[0]/p[1]
|
1. Introduction
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biomedical
|
Study
|
[
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[
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] |
In the last decade, it has been suggested that POAG may be associated with cognitive impairment, as both pathologies are age-related neurodegenerative processes. Several common risk factors and associated pathophysiologic mechanisms are shared between dementia and POAG, including intracranial pressure changes and associated increased IOP, optic nerve and RGC degeneration, cerebrospinal fluid circulatory failure and sequestration, and the presence of both amyloid-β and tau proteins, known for their role in Alzheimer’s disease (AD) .
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278361_p2
|
PMC11278361
|
sec[0]/p[2]
|
1. Introduction
| 4.167969 |
biomedical
|
Review
|
[
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[
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The association between POAG and cognitive impairment comes in lieu of a paradigm shift in POAG—from the view of POAG as a primary disease of the eye to a recognition of POAG as an ocular manifestation of overarching systemic dysregulation . Factors beyond elevated IOP likely contribute to the pathogenesis of vision loss in POAG, as controlling IOP—while partially effective at slowing disease progression—fails to prevent continued visual deterioration in up to 37% of POAG patients . Furthermore, there is evidence that POAG is associated with lesions in the central visual pathway, including the lateral geniculate body and the primary visual cortex, and that several POAG risk loci are shared with other neurodegenerative disorders . This has sparked interest in uncovering other targets for treatment for POAG patients, such as neuroprotective agents .
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p3
|
PMC11278361
|
sec[0]/p[3]
|
1. Introduction
| 4.132813 |
biomedical
|
Review
|
[
0.998046875,
0.0009226799011230469,
0.0009388923645019531
] |
[
0.266357421875,
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It remains unclear to what extent neurodegeneration in POAG extends to other neurological functions beyond vision, such as cognition. Studies have found that the prevalence of POAG was increased in patients with AD, and that patients with POAG are more likely to develop dementia . This relationship has also been shown to be specific for POAG as opposed to primary angle-closure glaucoma (PACG), and normal-tension glaucoma (NTG) as opposed to high-tension glaucoma (HTG) . In contrast, other studies have found minimal association between POAG status and risk of dementia or cognitive decline, or have been limited by small sample size or by the confounding of glaucomatous vision loss impacting cognitive assessment scores . The association between POAG and cognitive decline remains particularly unclear and understudied in individuals of African ancestry, who demonstrate the highest incidence and most severe progression of POAG . The predictive value of cognitive screening for dementia or AD in POAG patients has similarly remained undefined, leaving the clinical utility of such testing unclear.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278361_p4
|
PMC11278361
|
sec[0]/p[4]
|
1. Introduction
| 4.101563 |
biomedical
|
Study
|
[
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] |
[
0.99951171875,
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] |
Here, we investigated the association between POAG and cognitive impairment in African ancestry individuals, with the goal of determining whether POAG cases experience greater cognitive decline compared to healthy controls. Within the Primary Open-Angle African American Glaucoma Genetics (POAAGG) study cohort, we compared case and control scores on the Telephone-Montreal Cognitive Assessment (T-MoCA), a validated cognitive screening tool designed for those with visual impairment. We also evaluated whether prior MoCA scores from these same subjects were predictive of severe cognitive decline or a dementia diagnosis over a period of seven years . In a topic that lacks longitudinal analyses of a historically understudied African ancestry population, the aim of this study was to determine if MoCA scores can serve as a biomarker for further cognitive decline and risk of dementia among POAG patients.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278361_p5
|
PMC11278361
|
sec[1]/sec[0]/p[0]
|
2.1. Study Population
| 4.089844 |
biomedical
|
Study
|
[
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[
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] |
Subjects for this study were recruited from the larger POAAGG study. Eligibility criteria for the POAAGG study include self-identification as Black (either African American, African descent, or African Caribbean) and an age of 35 years or older. Exclusion criteria include a history of glaucoma, iritis, uveitis, iridocyclitis, age-related macular degeneration (AMD), and advanced proliferative diabetic retinopathy. Subjects were recruited during regularly scheduled visits to the Ophthalmology Department at the University of Pennsylvania, as well as several nearby ophthalmology clinics and outreach events. Fellowship-trained glaucoma specialists or ophthalmologists categorized subjects as case, control, or suspect based on detailed clinical criteria . Briefly, cases were defined as having an open iridocorneal angle and characteristic optic nerve defects with corresponding visual field loss, and controls exhibited no confounding ocular conditions. An extensive description of the POAAGG study design, baseline demographics, complete eligibility criteria, and phenotyping methods is found elsewhere . All subjects provided informed consent prior to involvement. The study adhered to the principles of the Declaration of Helsinki and was approved by the University of Pennsylvania Institutional Review Board (IRB).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278361_p6
|
PMC11278361
|
sec[1]/sec[1]/p[0]
|
2.2. Prior Cognitive Assessment
| 4.089844 |
biomedical
|
Study
|
[
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] |
[
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] |
We previously assessed and reported the cognitive function of 137 POAAGG subjects between June 2016 and August 2017 using the Montreal Cognitive Assessment (MoCA), a test developed to screen for mild cognitive impairment (MCI) . The MoCA has previously been validated and shown to be sensitive and specific for the detection of MCI, with higher sensitivity for MCI than the Mini Mental Status Exam (MMSE) . MoCA administration takes less than 15 min and assesses patients in seven domains of cognitive function: visuospatial/executive function, naming, attention, language, abstraction, delayed recall (which is further classified by a memory index score, MIS), and orientation. MoCA total score and sub-scores of each domain range from 0 to 30 points, with a lower score indicating worse cognitive function. The details, results, and conclusions of this sampling have been previously described .
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278361_p7
|
PMC11278361
|
sec[1]/sec[2]/p[0]
|
2.3. T-MoCA Assessment
| 4.117188 |
biomedical
|
Study
|
[
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] |
[
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0.00008213520050048828
] |
In this study, we re-approached POAAGG cases and controls who had completed a prior MoCA assessment (described above). Between June and November 2023, we called 137 subjects and invited each individual to undergo the T-MoCA. The T-MoCA is adapted for administration by voice only, by removing the visuospatial/executive function and naming sections of the test, which require visual abilities, but keeping five sub-domains: attention, language, abstraction, delayed recall (including MIS), and orientation. T-MoCA total score and sub-scores for each domain range from 0 to 22 points, with a lower score indicating worse cognitive function. T-MoCA is validated against in-person administration of the full MoCA, and T-MoCA and MoCA scores are significantly correlated and have similar sensitivity for detecting cognitive impairment identified through an extensive in-person cognitive evaluation . We chose to use the T-MoCA, rather than the full MoCA that was previously used, to increase our reach of subjects, who can complete the assessment from the comfort of their homes, as well as to reduce the confounding effect of visual impairment between the case and control groups. Of the 137 subjects approached several times, 33 (13 POAG cases and 20 controls) participated in this study. A total of 21 declined to participate, 16 were reported deceased, and 67 could not be reached (did not answer phone, did not have updated contact information, etc.). One investigator (TS), masked to diagnostic status (case or control) and other ophthalmic testing data, administered the T-MoCA to all 33 subjects.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p8
|
PMC11278361
|
sec[1]/sec[3]/p[0]
|
2.4. Demographic and Phenotypic Information
| 3.910156 |
biomedical
|
Study
|
[
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Demographic information, including age, sex, medical history, and social history, were obtained during standardized interviews during enrollment and augmented using electronic medical records. Each subject also underwent a thorough ophthalmological assessment to allow collection of ocular phenotypic information, including retinal nerve fiber layer (RNFL) thickness measurements from Optical Coherence Tomography (OCT). No additional OCT testing was conducted at the time of T-MoCA administration. Dementia history was verbally obtained during T-MoCA administration.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278361_p9
|
PMC11278361
|
sec[1]/sec[4]/p[0]
|
2.5. Statistical Analysis
| 4.027344 |
biomedical
|
Study
|
[
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[
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] |
Comparison between POAG cases and controls in their baseline characteristics and T-MoCA scores were performed using two-sample t -test for means, and a chi-squared test or Fisher’s exact test for proportions. Associations between baseline factors with total T-MoCA score were evaluated using generalized linear models. Spearman correlation coefficients (R) were calculated to assess correlation between RNFL thickness and T-MoCA scores and correlation between change of RNFL thickness and change of T-MoCA scores. All statistical analyses were conducted using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA), and two-sided p < 0.05 was considered statistically significant.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p10
|
PMC11278361
|
sec[2]/sec[0]/p[0]
|
3.1. Population Characteristics
| 3.734375 |
biomedical
|
Study
|
[
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[
0.9990234375,
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0.0001475811004638672
] |
The T-MoCA test was administered to 13 POAG cases and 20 healthy controls. The mean age ± SD was similar between cases (74.2 ± 10.4 years) and controls (73.9 ± 12.9 years) ( p = 0.94). Cases and controls were similar in other demographic and clinical characteristics ( Table 1 ).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278361_p11
|
PMC11278361
|
sec[2]/sec[1]/p[0]
|
3.2. Demographic Characteristics Are Not Associated with T-MoCA Score Changes
| 4.019531 |
biomedical
|
Study
|
[
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[
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In the univariate analysis, the mean T-MoCA total score was 15.46 in cases and 16.70 in controls (mean difference = −1.24, 95% CI = −3.96, 1.48, p = 0.36). No demographic characteristics were significantly associated with T-MoCA score ( Table 2 ).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278361_p12
|
PMC11278361
|
sec[2]/sec[2]/p[0]
|
3.3. POAG Status Is Associated with Short-Term Memory Decline
| 4.101563 |
biomedical
|
Study
|
[
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[
0.99951171875,
0.00021564960479736328,
0.0002491474151611328,
0.00006496906280517578
] |
When comparing T-MoCA subsection domain scores between POAG cases and controls, there was a borderline significant difference between cases and controls in the delayed recall domain (mean difference = −1.09, 95% CI = −2.20, 0.01, p = 0.052) and a significant difference in its sub-domain, the memory index score (mean difference = −3.02, 95% CI = −5.60, −0.44, p = 0.02). There were no significant differences between cases and controls for the remaining subsection domain scores ( Table 3 ).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p13
|
PMC11278361
|
sec[2]/sec[3]/p[0]
|
3.4. POAG Status Is Associated with Dementia
| 3.869141 |
biomedical
|
Study
|
[
0.99169921875,
0.0078125,
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] |
[
0.998046875,
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] |
On chart review, during the seven-year follow-up after the initial MoCA assessment at baseline, 5 (7.14%) of 70 POAG cases and 0 of 67 controls developed dementia ( p = 0.058, Table 4 ).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278361_p14
|
PMC11278361
|
sec[2]/sec[4]/p[0]
|
3.5. POAG Status Is Not Associated with Increased Rate of Cognitive Decline over Time
| 3.154297 |
biomedical
|
Study
|
[
0.99853515625,
0.0005598068237304688,
0.0009860992431640625
] |
[
0.9990234375,
0.0008301734924316406,
0.00024175643920898438,
0.00010019540786743164
] |
We compared the cognitive score difference between cases and controls in 2016–2017 (assessed by MoCA) and in 2023 (assessed by T-MoCA) for each of the sections assessed in T-MoCA. We observed no difference in these subsection scores between 2016–2017 and 2023 between cases and controls ( Table 5 ).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p15
|
PMC11278361
|
sec[2]/sec[5]/p[0]
|
3.6. Cognitive Decline in POAG Is Not Associated with Disease Severity
| 3.433594 |
biomedical
|
Study
|
[
0.9990234375,
0.0005512237548828125,
0.0006346702575683594
] |
[
0.9990234375,
0.0004858970642089844,
0.00021183490753173828,
0.00008058547973632812
] |
No significant association was found between RNFL thickness and T-MoCA score. Additionally, no significant association was observed between the change in RNFL thickness from 2016–2017 to 2023 and the change in each subject’s subsection score compared the mean subsection score ( Table 6 ).
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278361_p16
|
PMC11278361
|
sec[3]/p[0]
|
4. Discussion
| 4.128906 |
biomedical
|
Study
|
[
0.99951171875,
0.000347137451171875,
0.00029349327087402344
] |
[
0.99951171875,
0.0001577138900756836,
0.000308990478515625,
0.00006526708602905273
] |
This study sought to define the association between POAG status and cognitive decline in the present and over time in an African ancestry cohort. We found no significant difference in total T-MoCA score between cases and controls. However, there was a significant difference between cases and controls in the delayed recall subsection and its subclassification, the MIS. This section asked subjects to remember a list of five unrelated words, and to recall the list at the conclusion of the T-MoCA. Subjects were graded on the number of words correctly recalled and the use of hints. This result may suggest that certain cognitive abilities, such as the short-term memory tested in this section, may become impaired in POAG. While, to our knowledge, no other studies have directly examined the link between POAG and short-term memory loss, several studies have found an association between POAG and other forms of cognitive decline . Our novel results, therefore, suggest that T-MoCA may serve as a tool for assessing short-term memory loss as a sign of early cognitive decline in the POAG population.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278361_p17
|
PMC11278361
|
sec[3]/p[1]
|
4. Discussion
| 4.058594 |
biomedical
|
Study
|
[
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] |
[
0.99951171875,
0.00022423267364501953,
0.0002684593200683594,
0.00005692243576049805
] |
We further found a borderline significant difference between cases and controls in the diagnosis of dementia over the seven-year span of this study. These results are of particular interest given the work of Julayanont et al., which suggests that the MIS may serve as a predictor of conversion from MCI to AD . Indeed, if low MIS score serves as a positive predictor for dementia, and if POAG status is associated with both a lower MIS score and a higher incidence of dementia, these results point towards a novel idea: in a POAG population, T-MoCA or MIS testing may be used to assess the risk of dementia and the relative indications for seeking neuroprotective treatment. To our knowledge, we are the first to report this novel finding.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p18
|
PMC11278361
|
sec[3]/p[2]
|
4. Discussion
| 3.789063 |
biomedical
|
Study
|
[
0.99951171875,
0.0001329183578491211,
0.00027108192443847656
] |
[
0.9833984375,
0.004467010498046875,
0.0119171142578125,
0.00019466876983642578
] |
Our results are also of interest given the association of glaucoma with AMD, and of AMD with dementia. Both POAG and AMD are neurodegenerative diseases that occur in the elderly and have a strong genetic component. These diseases have also previously been associated with each other, and both have independently been linked to cognitive decline . This might suggest that there is a background driver of neurodegeneration shared among POAG, AMD, and dementia . More research is needed on this topic.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278361_p19
|
PMC11278361
|
sec[3]/p[3]
|
4. Discussion
| 4.09375 |
biomedical
|
Study
|
[
0.99951171875,
0.0002963542938232422,
0.00024056434631347656
] |
[
0.9990234375,
0.0002353191375732422,
0.0006380081176757812,
0.00006496906280517578
] |
Over time, there was no increased score disparity between cases and controls in each of the subsections tested on T-MoCA. Similarly, no significant association was seen between worsening disease severity (as measured by RNFL thickness) and worsening cognitive decline over seven years. In the literature, the relationship between RNFL thickness and cognitive abilities is similarly unclear . There are several possible explanations for our results amidst this uncertainty. It is possible that neurodegeneration in POAG may not extend past the visual tract or globally affect neural pathways that moderate cognition. Alternatively, T-MoCA may not be a sensitive enough test to detect subtle differences in cognitive function in POAG. It is also possible that additional factors may affect cognitive decline in POAG, and that better-powered studies may be needed to define this observation.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p20
|
PMC11278361
|
sec[3]/p[4]
|
4. Discussion
| 4.011719 |
biomedical
|
Study
|
[
0.99951171875,
0.00028967857360839844,
0.00022733211517333984
] |
[
0.99951171875,
0.0002429485321044922,
0.0003268718719482422,
0.0000699758529663086
] |
This study has several limitations. This study consisted of an entirely African ancestry cohort. While POAG is more common and severe among African ancestry individuals, this population has been severely under-represented in POAG research, contributing to premature vision loss and subsequent economic and health outcomes. Therefore, there is a critical need for studies of open-angle glaucoma in this population. However, these results may not be applicable to other populations or reflect an association between POAG and cognitive function that is applicable to all patients . Additionally, this study was limited by its small sample size and the inability to follow up with a substantial portion of the original cohort. Similarly, visual field data were not used as markers of disease progression due to the lack of high-quality data for all subjects of this small cohort study.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278361_p21
|
PMC11278361
|
sec[4]/p[0]
|
5. Conclusions
| 3.925781 |
biomedical
|
Study
|
[
0.99951171875,
0.0001933574676513672,
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] |
[
0.99853515625,
0.0007066726684570312,
0.00091552734375,
0.00008177757263183594
] |
In conclusion, findings from this study suggest that there may be an association between POAG and worsening short-term memory and the development of dementia. Future studies are needed to further elucidate the relationship and clinical utility of cognitive testing in POAG.
|
[
"Tzuriel Sapir",
"Patrick Augello",
"Roy Lee",
"Makayla McCoskey",
"Rebecca Salowe",
"Victoria Addis",
"Prithvi Sankar",
"Gui-Shuang Ying",
"Joan M. O’Brien"
] |
https://doi.org/10.3390/jcm13144140
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278373_p0
|
PMC11278373
|
sec[0]/p[0]
|
1. Introduction
| 3.736328 |
biomedical
|
Other
|
[
0.99658203125,
0.002559661865234375,
0.000640869140625
] |
[
0.090576171875,
0.88671875,
0.020904541015625,
0.0019931793212890625
] |
Cartilage defects of the talus represent a diagnostic and therapeutic challenge as they predispose patients to further cartilage damage and progression to osteoarthritis. Therefore, optimising the pre-operative assessment of those patients by implementing a reliable diagnostic tool to accurately quantify the amount of cartilage damage that is present and predict post-operative outcomes is essential.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278373_p1
|
PMC11278373
|
sec[0]/p[1]
|
1. Introduction
| 4.042969 |
biomedical
|
Review
|
[
0.994140625,
0.0031147003173828125,
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] |
[
0.021881103515625,
0.001163482666015625,
0.9765625,
0.00030422210693359375
] |
The treatment options for those cartilage defects vary depending on the size and stability of the lesion . Bone marrow stimulation (BMS) demonstrates an 85% success rate for lesions smaller than 15 mm or shallower than 7 mm . It is worth noting that, following bone marrow stimulation, fibrocartilage forms which predominantly consist of Type 1 collagen, are thus less durable compared to normal hyaline (Type 2 collagen) cartilage. As a result, a recent systematic review of level 4 evidence has demonstrated that, despite the fact that the mid-term (i.e., average 48-month follow-up) clinical results following BMS for the treatment of primary OCDs are satisfactory, radiological deterioration is more often than not documented . With a satisfactory complication profile and a mid-term reoperation rate of 6.0%, BMS remains the standard of care treatment after failed conservative treatment for the above groups of patients .
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278373_p2
|
PMC11278373
|
sec[0]/p[2]
|
1. Introduction
| 4.058594 |
biomedical
|
Review
|
[
0.99560546875,
0.00289154052734375,
0.0012884140014648438
] |
[
0.04864501953125,
0.0305938720703125,
0.91943359375,
0.0012760162353515625
] |
Following the original radiographic classification of OCDs from Bernt and Harty in 1959, which was based on the integrity of the osteochondral fragment, additional MRI-based systems were proposed. Nevertheless, the need for developing a reliable and clinically relevant system remains. The Area Measurement and Depth and Underlying Structures (AMADEUS) scoring system is currently used for the pre-operative assessment of osteochondral defects in the knee. It is a comprehensive three-part classification system that rates (1) the cartilage defect area; (2) the depth of the lesion; and (3) the underlying structures with the associated bone marrow oedema and osseous defects. Not only does it allow for a reliable assessment of the severity of the defects, but also it is clinically applicable in daily practise .
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278373_p3
|
PMC11278373
|
sec[0]/p[3]
|
1. Introduction
| 4.078125 |
biomedical
|
Study
|
[
0.99658203125,
0.0032978057861328125,
0.00023794174194335938
] |
[
0.998046875,
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0.0004425048828125,
0.0003407001495361328
] |
We wish to highlight the importance of utilising an easily applicable MRI-based diagnostic tool which could facilitate interdisciplinary communication between orthopaedic surgeons and clinical radiologists, thus supporting decision making and communication with patients as well. The purpose of this study was to determine the intra- and inter-observer variability of a tool that was originally designed for knee pathology (i.e., the AMADEUS grading system) in adult patients undergoing arthroscopic bone marrow stimulation for talar OCDs. In addition, we sought to assess the potential correlation between pre-operative self-reported outcomes and AMADEUS scores.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278373_p4
|
PMC11278373
|
sec[1]/p[0]
|
2. Materials and Methods
| 1.47168 |
biomedical
|
Other
|
[
0.97314453125,
0.0026397705078125,
0.0239715576171875
] |
[
0.416259765625,
0.57763671875,
0.00440216064453125,
0.0016584396362304688
] |
The study was registered locally at our institution and Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were followed .
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p5
|
PMC11278373
|
sec[1]/p[1]
|
2. Materials and Methods
| 3.988281 |
biomedical
|
Study
|
[
0.85791015625,
0.140625,
0.0013132095336914062
] |
[
0.96875,
0.022796630859375,
0.0013523101806640625,
0.007259368896484375
] |
We included adult male and female patients diagnosed with symptomatic uncontained (i.e., shoulder) talar OCDs measuring <150 mm 2 which were subsequently treated with BMS. To define an osteochondral lesion, its largest diameters on the coronal, sagittal and axial planes were considered . For a patient to qualify for inclusion, a minimum post-operative follow-up of 9 months was required with the corresponding self-administered questionnaire being filled in. Ankles with bipolar osteochondral lesions or osteoarthritis were excluded. Also, patients with associated ankle pathology undergoing concomitant procedures such as lateral ankle ligament stabilisation that could affect clinical outcomes were ruled out.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278373_p6
|
PMC11278373
|
sec[1]/p[2]
|
2. Materials and Methods
| 4.070313 |
biomedical
|
Study
|
[
0.97998046875,
0.019775390625,
0.0004050731658935547
] |
[
0.990234375,
0.007457733154296875,
0.0010700225830078125,
0.00140380859375
] |
Each patient underwent a pre-operative 3 T or 1.5 T MR examination with the appropriate sequences . The MR images were subsequently transferred to the local hospital picture archiving and communication system (PACS). Five independent assessors (two senior radiologists and three orthopaedic doctors) evaluated the pre-operative MRI scans with the AMADEUS scoring system . As per this tool, three metrics are used to describe a focal chondral or an osteochondral lesion. To be more exact, the points for the three metrics and the addendum add up to give a total score of 100 (best score) to 0 (worst score). The three metrics are as follows: (1) Description of the defect area in one plane multiplied by the diameter in the other plane. (2) Description of the defect morphology/depth. (3) Description of the condition of the underlying structures (subchondral bone; A, B or C) and bone marrow oedema-like lesions (BME; E) as an addendum.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p7
|
PMC11278373
|
sec[1]/sec[0]/p[0]
|
2.1. Outcome Assessment
| 4.128906 |
biomedical
|
Study
|
[
0.99853515625,
0.0011777877807617188,
0.00035309791564941406
] |
[
0.9990234375,
0.0003941059112548828,
0.0003371238708496094,
0.00011032819747924805
] |
The primary outcome of the study was to assess the inter- and intra-observer variability of the AMADEUS scoring system for osteochondral lesions of the talus. To achieve this objective, each of the assessors evaluated the scans twice (two weeks apart) and the average reliability was subsequently calculated . To elaborate, the intra-/inter-observer variability was then calculated by means of the intra-class correlation coefficients (ICC) and Kappa (κ) statistics, respectively . The following classification was implemented: Intra-class correlation (ICC) < 0.5 denoted poor reliability; 0.5 < ICC < 0.75 showed moderate reliability; 0.75 < ICC < 0.9 indicated good reliability; ICC > 0.9 showed excellent reliability.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p8
|
PMC11278373
|
sec[1]/sec[0]/p[1]
|
2.1. Outcome Assessment
| 4.054688 |
biomedical
|
Study
|
[
0.9990234375,
0.0005388259887695312,
0.0003790855407714844
] |
[
0.99853515625,
0.0008196830749511719,
0.0005216598510742188,
0.00007021427154541016
] |
For the inter-observer reliability evaluation, the opinions provided by different assessors for each case were compared and the overall agreement was then calculated according to the Landis and Koch grading system . The κ values were classified as follows: κ < 0.2 denoted slight agreement; 0.2 < κ < 0.4 showed fair agreement; 0.4 < κ < 0.6 indicated moderate agreement; 0.6 < κ < 0.8 showed substantial agreement; κ > 0.8 showed perfect agreement.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p9
|
PMC11278373
|
sec[1]/sec[0]/p[2]
|
2.1. Outcome Assessment
| 2.71875 |
biomedical
|
Study
|
[
0.9736328125,
0.024383544921875,
0.0018796920776367188
] |
[
0.99169921875,
0.007022857666015625,
0.0004878044128417969,
0.001018524169921875
] |
The secondary outcome included the assessment of the statistical correlation between the pre-operative clinical scores and the mean AMADEUS scores. The clinical outcome data were collected from an electronic database maintained at our institution. If any additional information was required, the participants were contacted, and the missing data were gathered.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278373_p10
|
PMC11278373
|
sec[1]/sec[1]/p[0]
|
2.2. Statistics
| 3.851563 |
biomedical
|
Study
|
[
0.9990234375,
0.0003533363342285156,
0.0004220008850097656
] |
[
0.9990234375,
0.0008778572082519531,
0.00014328956604003906,
0.00005161762237548828
] |
First of all, the sample size was calculated according to published guidelines for reliability studies . With an expected reliability of 0.8, a confidence level of 95% CI and a power of 80%, a minimum number of 14 patients was calculated based upon the primary outcome of the current study. Of note, a p value of <0.05 indicated statistical significance.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999999 |
PMC11278373_p11
|
PMC11278373
|
sec[1]/sec[1]/p[1]
|
2.2. Statistics
| 3.697266 |
biomedical
|
Study
|
[
0.99853515625,
0.0009713172912597656,
0.00039315223693847656
] |
[
0.99853515625,
0.000949859619140625,
0.00019466876983642578,
0.00012540817260742188
] |
The original percentage AMADEUS scores were transformed to the AMADEUS grade ranging from I to IV (I = best grade, IV = worst grade) and the pre-operative Manchester–Oxford Foot Questionnaire (MOxFQ) outcomes were compared with parametric statistical tests using the SPSS 27 software (SPSS, Chicago, IL, USA). In addition, the pre-operative mean MOxFQ scores of the available AMADEUS stages were compared to each other.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p12
|
PMC11278373
|
sec[1]/sec[1]/p[2]
|
2.2. Statistics
| 4.015625 |
biomedical
|
Study
|
[
0.99951171875,
0.0003554821014404297,
0.00036597251892089844
] |
[
0.9990234375,
0.0007219314575195312,
0.0002574920654296875,
0.00005710124969482422
] |
The linear correlation between the mean AMADEUS scores and pre-operative MOxFQ scores was assessed by means of the Pearson correlation coefficient and classified as shown below , with a p value of less than 0.05 demonstrating statistical significance: Correlation < 0.20: very weak; Correlation 0.20–0.39: weak; Correlation 0.40–0.59: moderate; Correlation 0.60–0.79: strong; Correlation > 0.80: very strong.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999999 |
PMC11278373_p13
|
PMC11278373
|
sec[2]/sec[0]/p[0]
|
3.1. Demographics
| 2.308594 |
biomedical
|
Study
|
[
0.99365234375,
0.004825592041015625,
0.00164031982421875
] |
[
0.994140625,
0.0047607421875,
0.0003707408905029297,
0.000591278076171875
] |
A total of 15 patients were recruited according to our pre-defined selection criteria. The mean age of the participants was 43.2 years (SD = 14.3), with four of the participants being females and ten males ( Table 1 ).
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278373_p14
|
PMC11278373
|
sec[2]/sec[1]/sec[0]/p[0]
|
3.2.1. Intra-Class Correlation
| 4.082031 |
biomedical
|
Study
|
[
0.9990234375,
0.000736236572265625,
0.00023257732391357422
] |
[
0.9990234375,
0.00044536590576171875,
0.00030231475830078125,
0.00009715557098388672
] |
The normality test revealed the normal distribution and the mean ICC was found to be 0.8226 (95% CI 0.71 to 0.94). It should be noted that no statistical significance was noted when the ICC data were compared between the radiologists and the orthopaedic surgeons (mean difference was −0.1; 95% CI −0.353 to 0.146; p = 0.277).
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278373_p15
|
PMC11278373
|
sec[2]/sec[1]/sec[1]/p[0]
|
3.2.2. Percentage Agreement and Inter-Class Correlation
| 3.863281 |
biomedical
|
Study
|
[
0.9990234375,
0.0005474090576171875,
0.00035119056701660156
] |
[
0.9990234375,
0.00066375732421875,
0.0002987384796142578,
0.00009107589721679688
] |
The percentage agreement between the MRI scan assessors was 56.67%. After adjusting for chance, the κ value was found to be 0.42 (95% CI [0.25, 0.59]).
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278373_p16
|
PMC11278373
|
sec[2]/sec[2]/p[0]
|
3.3. Secondary Outcome Assessment
| 3.832031 |
biomedical
|
Study
|
[
0.99853515625,
0.00038933753967285156,
0.0008587837219238281
] |
[
0.99951171875,
0.00037097930908203125,
0.00022161006927490234,
0.0000514984130859375
] |
The correlation between the pre-operative MOxFQ and mean AMADEUS scores was found to be r = −0.618, p = 0.014.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278373_p17
|
PMC11278373
|
sec[3]/p[0]
|
4. Discussion
| 4.140625 |
biomedical
|
Study
|
[
0.99853515625,
0.0010938644409179688,
0.0002244710922241211
] |
[
0.99853515625,
0.00035452842712402344,
0.0008611679077148438,
0.00017786026000976562
] |
In this paper, we assessed the inter- and intra-observer variability of the AMADEUS grading system, which was originally designed for knee osteochondral lesions, for OCDs of the talar shoulder. To minimise heterogeneity in this report, only uncontained (shoulder) lesions (that is, the absence of a peripheral cartilage border on one side with the loss of the medial or lateral articular buttress) were considered, as there is evidence to suggest that the presence of contained (non-shoulder) lesions exerts a positive impact on clinical results in patients with talar OCDs . Of note, only lesions measuring less than 150 mm 2 were included, as clinical outcomes worsen significantly if BMS is implemented for defects beyond this critical defect area . We showed that there is satisfactory reliability and moderate agreement when using the above MRI-based tool for talar OCDs. Those findings remained robust when we accounted for the subspeciality of the assessors (i.e., radiologists vs. orthopaedic surgeons). Of note, a strong negative correlation between the pre-operative MOxFH and mean AMADEUS scores was documented. In other words, there was a positive linear correlation between the pre-operative clinical and radiological outcomes.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p18
|
PMC11278373
|
sec[3]/sec[0]/p[0]
|
4.1. Selecting the Appropriate Diagnostic Imaging Tool Pre-Operatively
| 4.023438 |
biomedical
|
Review
|
[
0.99560546875,
0.0030231475830078125,
0.001300811767578125
] |
[
0.032073974609375,
0.0276336669921875,
0.939453125,
0.0010433197021484375
] |
Despite the fact that CT arthrography demonstrates satisfactory sensitivity and specificity, that is, 99% and 81% , respectively, it cannot detect chondromalacia. By contrast, MRI can reliably assess the stability of the osteochondral fragment and evaluate all cartilage layers (that is, the surface, the cartilage substance and the subchondral bone) . To be more exact, MRI has a sensitivity and specificity of 96% for diagnosing OCDs and is currently considered to be the most appropriate advanced imaging method for this condition. Consequently, CT arthrography is only recommended if in the presence of contraindications for MRI scans and when further diagnostic information is required .
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278373_p19
|
PMC11278373
|
sec[3]/sec[1]/p[0]
|
4.2. AMADEUS and Other MRI-Based Scoring Systems
| 4.105469 |
biomedical
|
Study
|
[
0.9990234375,
0.0006251335144042969,
0.00023305416107177734
] |
[
0.99853515625,
0.0002543926239013672,
0.0011739730834960938,
0.00011110305786132812
] |
Many MRI-based classification systems have been presented over the last few decades; however, their clinical relevance is either questionable or has yet to be determined. A commonly used classification system is that reported by Hepple et al. , which accounts for the presence of subchondral oedema . In this study, we selected the AMADEUS tool due to the fact that the recent literature stemming from knee surgery has shown that it allows for the reliable severity encoding, scoring and grading of osteochondral defects. Furthermore, it is easy to use in the clinical setting as there are clear diagrams and instructions to explain the descriptors. In addition, no familiarity with the talus is specifically required. We highlight that, unlike the previously reported classification systems, the AMADEUS tool considers all the fragment instability signs in a native MRI scan, which include signal changes around the OCD, subchondral changes and focal cartilage defects, all of which can affect treatment . In addition, accounting for bone marrow oedema lesions in the talar dome is of clinical importance as the cartilage condition of the osteochondral fragment may be predicted . To our knowledge, there is no other scoring system in the literature demonstrating higher reliability and inter-observer variability when compared to the AMADEUS tool for talar OCDs.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p20
|
PMC11278373
|
sec[3]/sec[2]/p[0]
|
4.3. Prognostic Factors for the Operative Treatment of OCDs of the Talus
| 2.921875 |
biomedical
|
Study
|
[
0.9951171875,
0.00323486328125,
0.0018911361694335938
] |
[
0.88916015625,
0.10552978515625,
0.0033740997314453125,
0.0016803741455078125
] |
We wish to draw the reader’s attention to the fact that there are several other clinical factors that can potentially affect post-operative results substantially. For example, other positive factors could be contained and anterolateral lesions . Conversely, negative indicators include medial talar lesions , older age (>33–40 years old) and higher BMI, a longer duration of symptoms, an association with a traumatic event and the presence of osteophytes . For the above reasons, we claim that an investigation of the correlation between the AMADEUS scores and the post-operative outcomes could have been inappropriate and it was avoided in the current paper.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278373_p21
|
PMC11278373
|
sec[3]/sec[3]/p[0]
|
4.4. Study Limitations and Implications for Future Research
| 4.15625 |
biomedical
|
Study
|
[
0.99658203125,
0.003070831298828125,
0.00025343894958496094
] |
[
0.99560546875,
0.0008902549743652344,
0.003246307373046875,
0.00043392181396484375
] |
We recognise that this paper has a few limitations. First, the sample size was small to allow for robust conclusions on the self-reported post-operative clinical outcomes. This was because stringent inclusion criteria were implemented to achieve homogeneity in the results and due to the fact that the power calculation was based upon the reliability assessment of the AMADEUS tool. Second, we only investigated patients treated with bone marrow stimulation for small osteochondral defects of the talus. Therefore, more original studies are needed to assess the correlation between the AMADEUS scoring system and clinical outcomes in patients with large defects managed with different surgical techniques (e.g., AMIC, ACI, OATS). Third, we have been unable to perform a correlation analysis to compare the pre-operative scores with the arthroscopic findings, which would have improved the credibility of our study. Fourth, the presence of loose fragments in the ankle joint is an important parameter potentially affecting clinical outcomes in OCDs. Therefore, we advocate that future authors could incorporate it into a modified AMADEUS scoring system. Likewise, the lesion-containment factor and the underlying pathology could be considered, as these parameters do affect treatment outcomes. Last but not least, we claim that the implementation of a reliable MRI-based diagnostic tool in future foot and ankle clinical practise is of the utmost importance for the frequently encountered clinical problem of osteochondral lesions of the talus.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999994 |
PMC11278373_p22
|
PMC11278373
|
sec[4]/p[0]
|
5. Conclusions
| 4.054688 |
biomedical
|
Study
|
[
0.99609375,
0.0034694671630859375,
0.0002675056457519531
] |
[
0.99169921875,
0.00299835205078125,
0.00464630126953125,
0.0005135536193847656
] |
In conclusion, we advocate that the AMADEUS tool demonstrates satisfactory reliability and moderate inter-observer variability and therefore it could be incorporated into the pre-operative assessment of patients who are due to undergo bone marrow stimulation for small osteochondral defects of the shoulder of the talus measuring <150 mm 2 . Furthermore, there was a strong correlation between the pre-operative clinical and radiological outcomes, which reflects the clinical usefulness of this tool for talar dome lesions. However, we wish to highlight the fact that further research on this topic is needed to reach more robust clinical conclusions spanning the whole spectrum of the osteochondral defects of the talus.
|
[
"Konstantinos Tsikopoulos",
"Jenn Wong",
"Moustafa Mahmoud",
"Vasileios Lampridis",
"Perry Liu",
"Radoslaw Rippel",
"Alisdair Felstead"
] |
https://doi.org/10.3390/jpm14070749
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p0
|
PMC11278385
|
sec[0]/p[0]
|
1. Introduction
| 4.289063 |
biomedical
|
Review
|
[
0.99462890625,
0.0035800933837890625,
0.0015859603881835938
] |
[
0.0225372314453125,
0.0023555755615234375,
0.974609375,
0.0006866455078125
] |
Psoriatic arthritis (PsA) is complex disease characterized by a combination of musculoskeletal manifestations, such as peripheral and axial involvement, dactylitis, and enthesitis, along with various extra-articular abnormalities . PsA affects 24% of individuals with psoriasis (PsO) , yet it can go undiagnosed in up to 30% of these cases . Subclinical enthesitis is detectable in up to 36% of PsO patients , while synovitis is detected in 50.7–85.0% of these patients across various studies . Although PsO typically precedes the onset of arthritis, 15% of patients exhibit both PsO and joint symptoms simultaneously, and 20% develop PsA before skin involvement . The diverse clinical manifestations of PsA make its diagnosis particularly challenging. Early diagnosis and treatment, however, are fundamental to prevent joint damage, as they are linked to improved long-term outcomes and better patient-reported outcomes . Early treatment in a prodromal phase in patients with PsO experiencing arthralgia could also help prevent the onset of PsA .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278385_p1
|
PMC11278385
|
sec[0]/p[1]
|
1. Introduction
| 2.251953 |
biomedical
|
Other
|
[
0.99169921875,
0.007110595703125,
0.0014171600341796875
] |
[
0.00893402099609375,
0.978515625,
0.01006317138671875,
0.0025615692138671875
] |
PsA patients, moreover, often present with several comorbidities that need careful consideration during the management of the disease, such as cardiovascular disease and metabolic disorders .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p2
|
PMC11278385
|
sec[0]/p[2]
|
1. Introduction
| 4.277344 |
biomedical
|
Study
|
[
0.9990234375,
0.0006251335144042969,
0.00022673606872558594
] |
[
0.5498046875,
0.035369873046875,
0.4130859375,
0.00177764892578125
] |
Interleukin 17 (IL-17) plays a key role in the pathogenesis of PsA, contributing to inflammation, especially in the skin and entheses. Specifically, IL-17A, through its interaction with its receptor, triggers proinflammatory effects in neutrophils and macrophages. These proinflammatory effects also involve keratinocytes and endothelial cells. At the level of endothelial cells, IL-17A may increase procoagulant activity, thus contributing to endothelial dysfunction and increasing the risk of cardiovascular comorbidities . Ixekizumab, a monoclonal antibody directed against IL-17A, prevents its binding to the IL-17 receptor , and it is approved by the European Medicines Agency for the treatment of PsA, plaque PsO, and axial spondyloarthritis .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p3
|
PMC11278385
|
sec[0]/p[3]
|
1. Introduction
| 3.224609 |
biomedical
|
Other
|
[
0.99853515625,
0.0007519721984863281,
0.0006184577941894531
] |
[
0.2342529296875,
0.53759765625,
0.225341796875,
0.002933502197265625
] |
The early use of IL-17 inhibitors in PsO patients at high risk for PsA has been shown to reduce joint pain and subclinical inflammation, suggesting potential for PsA interception strategies .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p4
|
PMC11278385
|
sec[0]/p[4]
|
1. Introduction
| 4.140625 |
biomedical
|
Study
|
[
0.9970703125,
0.0026378631591796875,
0.0002465248107910156
] |
[
0.98876953125,
0.0064544677734375,
0.004497528076171875,
0.0003771781921386719
] |
In patients diagnosed with PsA, however, the phase 3 randomized controlled SPIRIT-P1 and SPIRIT-P3 trials showed that ixekizumab effectively reduces disease activity and radiographic progression, as well as in improving patients’ function and quality of life in biologic-naïve individuals . In the SPIRIT-H2H, Ixekizumab demonstrated greater efficacy than adalimumab in achieving concurrent improvements of joint and skin involvement among biologic-naïve PsA patients . Additionally, in the SPIRIT-P2 study, ixekizumab improved signs, symptoms, and patient-reported outcomes, even in patients previously treated with tumor necrosis factor inhibitors (TNF-i) , maintaining a favorable safety profile .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p5
|
PMC11278385
|
sec[0]/p[5]
|
1. Introduction
| 3.857422 |
biomedical
|
Study
|
[
0.9990234375,
0.0007262229919433594,
0.0002777576446533203
] |
[
0.65185546875,
0.08355712890625,
0.263671875,
0.0011167526245117188
] |
There are increasing amounts of data regarding the real-world efficacy and safety of patients with PsO who are treated with ixekizumab , and currently, interest in real-world data regarding its efficacy and safety profile in PsA is increasing . Indeed, real-world studies offer additional clinical insights into the disease in a heterogenous context such as the clinical setting, when patients comorbidities and contextual factors can impact the management of the disease and its outcome as well as the drug retention rate (DRR) .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p6
|
PMC11278385
|
sec[0]/p[6]
|
1. Introduction
| 3.933594 |
biomedical
|
Study
|
[
0.99560546875,
0.003742218017578125,
0.0004093647003173828
] |
[
0.99755859375,
0.001667022705078125,
0.00026488304138183594,
0.00028967857360839844
] |
The objective of this study is to examine the DRR of ixekizumab in a real-world monocentric cohort of PsA patients and to assess the predictors of drug discontinuation.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278385_p7
|
PMC11278385
|
sec[1]/p[0]
|
2. Materials and Methods
| 3.773438 |
biomedical
|
Study
|
[
0.994140625,
0.005645751953125,
0.0003502368927001953
] |
[
0.9970703125,
0.0018033981323242188,
0.00037169456481933594,
0.0005669593811035156
] |
This is an observational, retrospective, non-profit study, involving consecutive adult patients (≥18 years) affected by PsA, and follow-ups were performed at the Academic Rheumatology Centre of Clinical and Biological Sciences Department of Turin University—Turin, Mauriziano Hospital, Italy, in patients who underwent treatment with ixekizumab from October 2019 to February 2023.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p8
|
PMC11278385
|
sec[1]/p[1]
|
2. Materials and Methods
| 2.917969 |
biomedical
|
Study
|
[
0.98876953125,
0.00992584228515625,
0.0011806488037109375
] |
[
0.9853515625,
0.01369476318359375,
0.0004010200500488281,
0.000659942626953125
] |
Inclusion criteria encompassed (i) adult age; (ii) fulfilment of CASPAR classification criteria for PsA ; and (iii) availability of complete data records. Exclusion criteria were: (i) less than two follow-up visits and (ii) inability to provide informed consent.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999994 |
PMC11278385_p9
|
PMC11278385
|
sec[1]/p[2]
|
2. Materials and Methods
| 3.943359 |
biomedical
|
Study
|
[
0.95947265625,
0.04010009765625,
0.0004935264587402344
] |
[
0.99072265625,
0.006374359130859375,
0.0010099411010742188,
0.0019683837890625
] |
Clinical and laboratory data were extracted from patients’ medical records. Specifically, we collected the following information: sociodemographic data, smoking habits, body mass index, the presence of Human Leukocyte Antigen B27 (HLA-B27), comorbidities, phenotypes of PsA, disease duration, previous and concomitant therapies, occurrence of adverse events (AEs) and infections, any withdrawal of ixekizumab, and the cause for discontinuation.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p10
|
PMC11278385
|
sec[1]/p[3]
|
2. Materials and Methods
| 1.915039 |
biomedical
|
Study
|
[
0.9912109375,
0.0021514892578125,
0.006626129150390625
] |
[
0.96044921875,
0.034912109375,
0.0035190582275390625,
0.001033782958984375
] |
Considering the retrospective study design, no specific sample size was estimated for this study.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999999 |
PMC11278385_p11
|
PMC11278385
|
sec[1]/p[4]
|
2. Materials and Methods
| 1.277344 |
biomedical
|
Other
|
[
0.9736328125,
0.00824737548828125,
0.0180206298828125
] |
[
0.11602783203125,
0.876953125,
0.0023593902587890625,
0.0046844482421875
] |
The local Institutional Ethics Boards approved the study , and informed consent was obtained from all participating patients.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278385_p12
|
PMC11278385
|
sec[1]/sec[0]/p[0]
|
Statistics
| 4.164063 |
biomedical
|
Study
|
[
0.9990234375,
0.0009889602661132812,
0.0001800060272216797
] |
[
0.9990234375,
0.0004277229309082031,
0.0005960464477539062,
0.00014138221740722656
] |
Firstly, descriptive statistics were provided. Dichotomic variables were expressed as percentage whereas continuous variables as mean ± standard deviation (SD) or median and range interquartile range (IQR) according to their distribution. Kaplan–Meier curves were built to evaluate the cumulative DRR of ixekizumab with the event being drug discontinuation due to inefficacy and/or AEs. Furthermore, Kaplan–Meier curves were performed to evaluate the influence of patient clinical characteristics on the DRR of ixekizumab. Survival curves were thus compared by using the log-rank test. To exploratively assess possible baseline predictors of drug discontinuation, age- and male sex-adjusted multivariate regression logistic models were exploited. The purposeful selection process of covariates started by a univariate analysis of each variable and their clinical relevance. At the end of this multistep process of deleting and refitting, age- and sex-adjusted multivariate models were built, providing odds ratio (OR) estimations of significant associations between clinical features and drug discontinuation. Disease duration ≤ 2 years (lacking specific definition of early PsA ), HLA-B27, the presence of comorbidities and obesity, axial involvement and concomitant active skin disease, previous therapies with either conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) or biological Disease-Modifying Antirheumatic Drugs (bDMARDs), were selected as possible characteristics impacting the drug discontinuation considering univariate analyses but also their clinical relevance according to available literature . Different age- and male sex-adjusted multivariate regression logistic models were also built, taking into account the number of patients discontinuing the drug in this cohort.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p13
|
PMC11278385
|
sec[1]/sec[0]/p[1]
|
Statistics
| 3.304688 |
biomedical
|
Study
|
[
0.99853515625,
0.0011968612670898438,
0.0004551410675048828
] |
[
0.99755859375,
0.0014982223510742188,
0.0005626678466796875,
0.00019299983978271484
] |
Correlation analyses were also estimated among the cumulative number of previous bDMARDs/targeted synthetic Disease-Modifying Antirheumatic Drugs (tsDMARDs) and clinical features.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278385_p14
|
PMC11278385
|
sec[1]/sec[0]/p[2]
|
Statistics
| 2.082031 |
biomedical
|
Study
|
[
0.99462890625,
0.000675201416015625,
0.004878997802734375
] |
[
0.689453125,
0.3076171875,
0.0016412734985351562,
0.001163482666015625
] |
The statistical significance was set at p < 0.05 and all p -values were two-sided. The Statistics Package for Social Sciences (SPSS for Windows, version 22.0, SPSS Inc., Chicago, IL, USA) was used to exploit both regression and correlation analyses, and GraphPad for Windows (version 8.0, San Diego, CA, USA) was used for the assessment of DRR.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p15
|
PMC11278385
|
sec[2]/p[0]
|
3. Results
| 2.474609 |
biomedical
|
Study
|
[
0.96826171875,
0.0294647216796875,
0.0021686553955078125
] |
[
0.9892578125,
0.007732391357421875,
0.0008640289306640625,
0.0022945404052734375
] |
Eighty patients with PsA were included in the study and followed up on for a median of 12 (IQR 23.2) months. The baseline clinical features of the whole patient cohort are summarized in Table 1 .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278385_p16
|
PMC11278385
|
sec[2]/p[1]
|
3. Results
| 2.099609 |
biomedical
|
Study
|
[
0.98388671875,
0.014312744140625,
0.0017223358154296875
] |
[
0.96923828125,
0.02587890625,
0.000812530517578125,
0.00428009033203125
] |
At the first observation, the mean age was 50.1 ± 11.8 years. Twenty-four (30.0%) of the patients were male, twenty-seven (33.8%) were obese, and twenty-two (27.5%) were smokers.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p17
|
PMC11278385
|
sec[2]/p[2]
|
3. Results
| 3.035156 |
biomedical
|
Study
|
[
0.9697265625,
0.0296173095703125,
0.0007104873657226562
] |
[
0.974609375,
0.0178070068359375,
0.0013980865478515625,
0.006092071533203125
] |
Forty-six (57.5%) patients presented comorbidities, and the main comorbidities were high blood pressure (n. 36, 45.0%), type 2 diabetes (n. 17, 21.3%), fatty liver disease (n. 17, 21.3%), cardiovascular disease (n. 16, 20.0%), dyslipidemia (n. 12, 15.0%), and kidney disease (n. 5, 6.3%).
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p18
|
PMC11278385
|
sec[2]/p[3]
|
3. Results
| 3.599609 |
biomedical
|
Study
|
[
0.96533203125,
0.034393310546875,
0.0004813671112060547
] |
[
0.97998046875,
0.01082611083984375,
0.0012903213500976562,
0.00786590576171875
] |
The median disease duration was 4 (IQR 9) years. All patients presented peripheral joint involvement; in addition, 25 (31.3%) displayed axial and 35 (43.8%) enthesis involvement. Sixty-eight (85%) showed skin involvement, and nineteen (23.8%) psoriatic onychopathy.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999994 |
PMC11278385_p19
|
PMC11278385
|
sec[2]/p[4]
|
3. Results
| 3.011719 |
biomedical
|
Other
|
[
0.7392578125,
0.2578125,
0.0029087066650390625
] |
[
0.1881103515625,
0.78662109375,
0.0018138885498046875,
0.0235137939453125
] |
All patients received ixekizumab at a dose of 160 mg by subcutaneous injection at baseline, followed by 80 mg every four weeks thereafter.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p20
|
PMC11278385
|
sec[2]/p[5]
|
3. Results
| 4.089844 |
biomedical
|
Study
|
[
0.91064453125,
0.08843994140625,
0.00109100341796875
] |
[
0.97705078125,
0.0178070068359375,
0.00145721435546875,
0.0039215087890625
] |
Sixty-five (81.3%) patients had received csDMARDs before ixekizumab, with the majority (n. 61, 76.3%) receiving methotrexate. Forty-six (57.5%) patients had received at least one TNFi, four (5%) received one interleukin 12/23 inhibitor (IL-12/23i), nine (11.3%) received a tsDMARDs, and twelve (15%) had already been treated with an IL-17i medication. Among patients previously treated with secukinumab, five (41.7%) discontinued ixekizumab during follow-up, of whom three (25%) ended the treatment because of ineffectiveness. Fifty-six (70.1%) had experienced a failure with at least one bDMARD/tsDMARD and nine (11.3%) to three or more bDMARDs/tsDMARDs before ixekizumab.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p21
|
PMC11278385
|
sec[2]/p[6]
|
3. Results
| 3.824219 |
biomedical
|
Study
|
[
0.6416015625,
0.355224609375,
0.0033111572265625
] |
[
0.7666015625,
0.2105712890625,
0.0032958984375,
0.019744873046875
] |
Forty-three (53.8%) patients were on ixekizumab at the last follow-up visit. Among those who discontinued the treatment, 25 (31.3%) did so due to inefficacy, with 9 (11.3%) experiencing primary inefficacy and 10 (12.5%) experiencing secondary inefficacy, while 12 (15%) discontinued treatment due to AEs ( Table 1 ).
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p22
|
PMC11278385
|
sec[2]/sec[0]/p[0]
|
3.1. Drug Retention Rate
| 3.953125 |
biomedical
|
Study
|
[
0.9892578125,
0.01025390625,
0.0005249977111816406
] |
[
0.99365234375,
0.005130767822265625,
0.00046825408935546875,
0.0005540847778320312
] |
Ixekizumab was administered in our cohort for a median of 12 (IQR 23.2) months. Taking follow-up into account, the cumulative 38 month DRR of ixekizumab was estimated to be 43.8%, considering the discontinuation for both inefficacy and side effects, whereas in 62.6%, the interruption was only due to inefficacy .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p23
|
PMC11278385
|
sec[2]/sec[0]/p[1]
|
3.1. Drug Retention Rate
| 3.703125 |
biomedical
|
Study
|
[
0.9990234375,
0.0007066726684570312,
0.00031304359436035156
] |
[
0.9990234375,
0.0006990432739257812,
0.00026416778564453125,
0.00009399652481079102
] |
After stratifying the results, it was evident that the DRR of ixekizumab was unaffected by concomitant comorbidities ( p = 0.993), obesity ( p = 0.665), and smoking habit ( p = 0.884) .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278385_p24
|
PMC11278385
|
sec[2]/sec[0]/p[2]
|
3.1. Drug Retention Rate
| 4.09375 |
biomedical
|
Study
|
[
0.99853515625,
0.0012645721435546875,
0.00024271011352539062
] |
[
0.9990234375,
0.0005307197570800781,
0.00033974647521972656,
0.0001137852668762207
] |
Despite a positive trend noted in patients with a disease duration ≤ 2 years ( p = 0.071), the DRR did not appear to be significantly influenced by the disease duration. DRR was not significantly different ( p = 0.062) between patients with axial and peripheral involvement ( p = 0.131), despite a numerically higher proportion of patients with peripheral involvement persisted on treatment in the long term. Skin involvement did not influence the DRR of ixekizumab ( p = 0.460) .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p25
|
PMC11278385
|
sec[2]/sec[0]/p[3]
|
3.1. Drug Retention Rate
| 4.105469 |
biomedical
|
Study
|
[
0.9990234375,
0.0008473396301269531,
0.00026726722717285156
] |
[
0.9990234375,
0.0002913475036621094,
0.0003681182861328125,
0.00007808208465576172
] |
In addition, the DRR did not seem to be influenced by previous therapies, including csDMARDs ( p = 0.504), methotrexate ( p = 0.396), bDMARDs ( p = 0.474), and previous TNFi ( p = 0.247) . The number of previous bDMARDs/tsDMARDs was found to be correlated with patients’ age (r = 0.310, p = 0.005) and disease duration (r = 0.265, p value 0.018), while it did not appear to affect the duration (r = 0.106, p = 0.349) or discontinuation (r = 0.042, p = 0.896) of ixekizumab therapy.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p26
|
PMC11278385
|
sec[2]/sec[0]/p[4]
|
3.1. Drug Retention Rate
| 4.109375 |
biomedical
|
Study
|
[
0.99658203125,
0.00334930419921875,
0.00026035308837890625
] |
[
0.99853515625,
0.0008153915405273438,
0.0005574226379394531,
0.0002435445785522461
] |
When conducting multivariate explorative analyses to evaluate the possible predictive role of selected baseline clinical variables in the likelihood of ixekizumab discontinuation, none of these variables reached statistical significance ( Table 2 ). Disease duration and the presence of HLA-B27 were not found to be predictive of ixekizumab discontinuation. Similarly, patient clinical characteristics (i.e., comorbidities, obesity, axial disease, and skin involvement) did not appear to influence drug discontinuation. In addition, the prior therapies with csDMARDs and bDMARDs were not identified as predictors of ixekizumab discontinuation.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p27
|
PMC11278385
|
sec[2]/sec[1]/p[0]
|
3.2. Adverse Events
| 4.0625 |
biomedical
|
Study
|
[
0.7900390625,
0.2083740234375,
0.0013837814331054688
] |
[
0.8837890625,
0.09539794921875,
0.003276824951171875,
0.01739501953125
] |
The most frequent AEs leading to the discontinuation of ixekizumab ( Table S1 ) were skin reactions, including localized reactions at the injection site (four cases, 5.0%) or diffuse skin reactions (three cases, 3.75%). Three (3.75%) patients discontinued the treatment due to diarrhea, and one of these was thereafter diagnosed with microscopic colitis. This patient had previously presented with diarrhea and gastrointestinal intolerance to csDMARDs. Another patient received a concomitant diagnosis of lung malignancy just after the initiation of therapy, despite prior screening. Only one patient had to discontinue ixekizumab due to an infection (i.e., persistent oral candidiasis). Eight (10%) patients experienced SARS-CoV-2 infection, which was not severe in all cases. A single case of localized Herpes Zoster and 1 pyelonephritis was reported.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p28
|
PMC11278385
|
sec[3]/p[0]
|
4. Discussion
| 1.832031 |
biomedical
|
Other
|
[
0.99365234375,
0.0015001296997070312,
0.004665374755859375
] |
[
0.421630859375,
0.443115234375,
0.1318359375,
0.003482818603515625
] |
The majority of real-world data in the literature focus on patients with PsO, while fewer studies concentrate on those affected by PsA .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p29
|
PMC11278385
|
sec[3]/p[1]
|
4. Discussion
| 3.830078 |
biomedical
|
Study
|
[
0.99658203125,
0.002773284912109375,
0.0004949569702148438
] |
[
0.9970703125,
0.0020961761474609375,
0.0003864765167236328,
0.0002560615539550781
] |
In this study, we showed that ixekizumab entails a good DRR in a real-life PsA cohort, with a good safety profile.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p30
|
PMC11278385
|
sec[3]/p[2]
|
4. Discussion
| 4.15625 |
biomedical
|
Study
|
[
0.9990234375,
0.0006375312805175781,
0.00018799304962158203
] |
[
0.99755859375,
0.0003306865692138672,
0.0018472671508789062,
0.00011932849884033203
] |
Taking into account the complete follow-up period of our cohort, a 38-month cumulative DRR was seen in 43.8%, where discontinuation was due to both inefficacy and AEs, whereas in 62.6%, interruption was due to inefficacy only. These findings are consistent with previous real-life data in PsA patients treated with ixekizumab. Recently, Braña et al. observed a 12-month DRR of 65% in a retrospective monocentric cohort of 72 patients ; similarly, an analysis of administrative claims databases from the USA highlighted that 52.8% of patients maintained ixekizumab therapy for a 12 months follow-up period . Glintborg et al., drawing from data across five Nordic biologics registries, outlined a 12-month DRR of 57–65% for 361 treatment courses . Joven et al. instead highlighted a drug persistence rate of 68.5% at two years . In a monocenter cohort study conducted in the UK involving spondyloarthritis patients undergoing therapy with the IL-17i ixekizumab and secukinumab, drug survival rates were found to be 69% at 12 months and 60% at 24 months . Takami et al. reported a 10-year DRR of 50% for ixekizumab in a long-term follow-up study .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p31
|
PMC11278385
|
sec[3]/p[3]
|
4. Discussion
| 3.125 |
biomedical
|
Study
|
[
0.9990234375,
0.0003688335418701172,
0.0008068084716796875
] |
[
0.7861328125,
0.1077880859375,
0.1051025390625,
0.0011053085327148438
] |
In the literature, the DRR of ixekizumab has been found to be comparable to that of other biologics, with the exception of a higher DRR compared to infliximab .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p32
|
PMC11278385
|
sec[3]/p[4]
|
4. Discussion
| 4.011719 |
biomedical
|
Study
|
[
0.9990234375,
0.0005779266357421875,
0.00022852420806884766
] |
[
0.99951171875,
0.00027680397033691406,
0.00023686885833740234,
0.0000749826431274414
] |
Our PsA patient cohort exhibited a high rate of obesity and several comorbidities, primarily cardio-metabolic, which aligns with previous research findings . Nevertheless, when analyzing factors that may influence the DRR of ixekizumab, it became evident that obesity had no significant effect, as previously noted in the literature . Similarly, in our study, the presence of comorbidities and smoking habits, as previously documented by Braña et al., did not show any significant influence on the DRR of ixekizumab .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p33
|
PMC11278385
|
sec[3]/p[5]
|
4. Discussion
| 3.603516 |
biomedical
|
Study
|
[
0.9990234375,
0.0008931159973144531,
0.0002624988555908203
] |
[
0.9970703125,
0.0020847320556640625,
0.0007038116455078125,
0.00024330615997314453
] |
All our patients presented with peripheral involvement. Interestingly, axial involvement appeared to influence the DRR with a negative, albeit non-significant, trend, whereas this was not observed when considering skin involvement. It is necessary, nevertheless, to confirm this trend on larger cohorts, as the evaluation of these factors is crucial when tailoring PsA patients’ treatment, given their different phenotypes and multiple comorbidities .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278385_p34
|
PMC11278385
|
sec[3]/p[6]
|
4. Discussion
| 2.958984 |
biomedical
|
Study
|
[
0.99853515625,
0.0005927085876464844,
0.0007147789001464844
] |
[
0.99755859375,
0.0012788772583007812,
0.0010042190551757812,
0.00013005733489990234
] |
Moreover, we highlighted a positive, but not statistically significant, trend for a higher DRR in patients with a disease duration shorter than 2 years. Braña et al. noted, however, that disease duration did not influence drug persistence .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |
PMC11278385_p35
|
PMC11278385
|
sec[3]/p[7]
|
4. Discussion
| 4.101563 |
biomedical
|
Study
|
[
0.9990234375,
0.0007138252258300781,
0.00020813941955566406
] |
[
0.9990234375,
0.0003056526184082031,
0.0007085800170898438,
0.0000947117805480957
] |
The majority of our patients (70.1%) had encountered prior treatment failure with at least one bDMARD/tsDMARD, and 30.1% had experienced multiple treatment failures. Moreover, 15% had already been treated with an IL-17i. However, prior treatments with csDMARDs, including methotrexate, bDMARD/tsDMARD, or even a number of previous bDMARD/tsDMARD treatments, did not exert a significant impact on the DRR. Similarly, in the PRO-STIP study, it was observed that the number of previous DMARDs did not affect the drug persistence . Braña et al. noted that previous therapies with bDMARDs did not influence drug persistence, whereas the prior use of methotrexate, in contrast with our study, was linked to a higher ixekizumab discontinuation . Weddell et al. reported additionally comparable drug survival rates in PsA patients treated with IL-17 inhibitors, regardless of whether they were bDMARD-naïve or had prior exposure to bDMARDs .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999995 |
PMC11278385_p36
|
PMC11278385
|
sec[3]/p[8]
|
4. Discussion
| 2.046875 |
biomedical
|
Study
|
[
0.9912109375,
0.00327301025390625,
0.005634307861328125
] |
[
0.98974609375,
0.00830841064453125,
0.0015497207641601562,
0.0004830360412597656
] |
These characteristics were analyzed to create multivariate analyses aimed at identifying factors that might affect DRR. However, it seems that even when using these models, they do not appear to predict improved DRR.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999996 |
PMC11278385_p37
|
PMC11278385
|
sec[3]/p[9]
|
4. Discussion
| 3.369141 |
biomedical
|
Study
|
[
0.97900390625,
0.01983642578125,
0.0010919570922851562
] |
[
0.97119140625,
0.025848388671875,
0.0011129379272460938,
0.0016355514526367188
] |
In our cohort of patients characterized with multiple comorbidities, many of whom had experienced treatment failure with second-line therapies, ixekizumab furthermore exhibited a favorable safety profile.
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999998 |
PMC11278385_p38
|
PMC11278385
|
sec[3]/p[10]
|
4. Discussion
| 3.511719 |
biomedical
|
Study
|
[
0.884765625,
0.1131591796875,
0.0019969940185546875
] |
[
0.90087890625,
0.0928955078125,
0.0023365020751953125,
0.0038204193115234375
] |
The discontinuation due to AEs occurred in 15.0% of patients, a higher percentage compared to the literature . However, it is important to note that the AEs were not severe. Indeed, the most common AEs that resulted in the discontinuation of treatment were localized or diffuse skin reactions, which, however, were not severe and were in line with the expectations, as they had been already previously described in previous randomized controlled trials and real life data (SPIRIT-P1, SPIRIT-P2, SPIRIT-P3, and SPIRIT-H2H) .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999993 |
PMC11278385_p39
|
PMC11278385
|
sec[3]/p[11]
|
4. Discussion
| 4.105469 |
biomedical
|
Study
|
[
0.9990234375,
0.0005974769592285156,
0.00019061565399169922
] |
[
0.9990234375,
0.00026869773864746094,
0.0007233619689941406,
0.00009715557098388672
] |
Notably, our study revealed no severe infections. Similarly, Bastard et al. described serious infections in only 2.9% of the 344 patients treated with ixekizumab . No severe infections were detected even among patients who were tested positive for SARS-CoV-2. Also, this finding aligns with the existing literature, which does not exhibit an increased risk of SARS-CoV-2-associated hospitalization or mortality in patients undergoing treatment with IL-17i . Only one patient had to discontinue treatment due to an infectious disease, specifically persistent oral candidiasis. Chronic fungal diseases were also described in the study of Weddell et al. . Localized candida infections were reported in a low proportion of patients treated with ixekizumab, likely related to the function of IL-17A in defense against these pathogens . An analysis of administrative claims in the USA revealed that the risk of serious infection in patients treated with IL-17i appears to be similar to that in patients treated with TNFi .
|
[
"Elisa Bellis",
"Piero Ruscitti",
"Denise Donzella",
"Gloria Crepaldi",
"Valeria Data",
"Marinella Gammino",
"Mariele Gatto",
"Valeria Guardo",
"Claudia Lomater",
"Elena Marucco",
"Marta Saracco",
"Annamaria Iagnocco"
] |
https://doi.org/10.3390/jpm14070716
|
N/A
|
https://creativecommons.org/licenses/by/4.0/
|
en
| 0.999997 |