Background: Vaccines are a crucial component of the global efforts to control the spread of COVID-19. Very little is known about COVID-19 vaccine responses in patients living with autoimmune rheumatic conditions in Africa. We examined the clinical reaction to COVID-19 vaccinations in Ghanaians diagnosed with autoimmune rheumatic disease.
Methods: This was a hospital-based interventional cohort study of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients recruited via regular face-to-face clinic visits. The systemic lupus erythematosus disease activity index Selena modification (SELENA-SLEDAI) and the disease activity score 28-joint count-erythrocyte sedimentation rate (DAS28-ESR) were used to measure changes in disease activity levels.
Results: Thirty-eight (38) patients of which 21 (55.3%) were diagnosed with SLE and 17 (44.7%) with RA contributed data for analyses. Most (89.5%) of the patients were females, with a mean age of 37.4 years. The SLE patients experienced a notable increase in severe flares during weeks three and six, as well as the third and sixth months, followed by subsequent decreases in the twelfth month, while remission levels increased throughout the same period. Among RA patients, high disease activity decreased during weeks three and six, as well as the third, sixth, and twelfth months, with remission levels increasing during the same time. A low dose (≥ 50 < 75 mg) dose of azathioprine was at some point associated with having a severe flare among SLE patients. After both vaccine doses, SLE patients were the majority having experienced both local and systemic reactions, all resolving within 24 h. Approximately 73.7% of the patients were COVID-19 negative at baseline. During post-vaccination visits, this increased to 100% by week six, with no positives thereafter.
Conclusion: This study explores COVID-19 vaccine responses in Ghanaian autoimmune rheumatic disease patients, revealing disease activity levels in RA patients improved after vaccination compared to SLE patients. Our findings identify a potential link between low-dose azathioprine and severe flares in SLE patients, particularly evident in the third-week post-vaccination. Further research is warranted to clarify these findings and guide tailored treatment approaches in this medically significant population during pandemics and vaccination efforts.
{"title":"Clinical disease activity in autoimmune rheumatic patients receiving COVID-19 vaccines.","authors":"Dzifa Dey, Bright Katso, Emmanuella Amoako, Aida Manu, Yaw Bediako","doi":"10.1186/s41927-024-00396-5","DOIUrl":"10.1186/s41927-024-00396-5","url":null,"abstract":"<p><strong>Background: </strong>Vaccines are a crucial component of the global efforts to control the spread of COVID-19. Very little is known about COVID-19 vaccine responses in patients living with autoimmune rheumatic conditions in Africa. We examined the clinical reaction to COVID-19 vaccinations in Ghanaians diagnosed with autoimmune rheumatic disease.</p><p><strong>Methods: </strong>This was a hospital-based interventional cohort study of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients recruited via regular face-to-face clinic visits. The systemic lupus erythematosus disease activity index Selena modification (SELENA-SLEDAI) and the disease activity score 28-joint count-erythrocyte sedimentation rate (DAS28-ESR) were used to measure changes in disease activity levels.</p><p><strong>Results: </strong>Thirty-eight (38) patients of which 21 (55.3%) were diagnosed with SLE and 17 (44.7%) with RA contributed data for analyses. Most (89.5%) of the patients were females, with a mean age of 37.4 years. The SLE patients experienced a notable increase in severe flares during weeks three and six, as well as the third and sixth months, followed by subsequent decreases in the twelfth month, while remission levels increased throughout the same period. Among RA patients, high disease activity decreased during weeks three and six, as well as the third, sixth, and twelfth months, with remission levels increasing during the same time. A low dose (≥ 50 < 75 mg) dose of azathioprine was at some point associated with having a severe flare among SLE patients. After both vaccine doses, SLE patients were the majority having experienced both local and systemic reactions, all resolving within 24 h. Approximately 73.7% of the patients were COVID-19 negative at baseline. During post-vaccination visits, this increased to 100% by week six, with no positives thereafter.</p><p><strong>Conclusion: </strong>This study explores COVID-19 vaccine responses in Ghanaian autoimmune rheumatic disease patients, revealing disease activity levels in RA patients improved after vaccination compared to SLE patients. Our findings identify a potential link between low-dose azathioprine and severe flares in SLE patients, particularly evident in the third-week post-vaccination. Further research is warranted to clarify these findings and guide tailored treatment approaches in this medically significant population during pandemics and vaccination efforts.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"25"},"PeriodicalIF":2.1,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11181637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-07DOI: 10.1186/s41927-024-00394-7
Trang Huyen Tran, Trang Thi Huong Ta, Lan Thi Ngoc Nguyen, Huyen Thi Thanh Vu, Hung Van Nguyen
Background: In recent times, there has been acknowledgment of the prevalence of frailty and pre-frailty among individuals with rheumatoid arthritis (RA). Comprehensive Rheumatologic Assessment of Frailty (CRAF) stands out as a dependable tool grounded in synthesis and clinical judgment. Despite this, a validated Vietnamese rendition of the CRAF is currently unavailable. This study seeks to assess the reliability and validity of the CRAF in a patient with RA in Vietnam.
Methods: A cross-sectional investigation was carried out with 402 patients diagnosed with rheumatoid arthritis, encompassing both inpatients and outpatients at the Centre for Rheumatology at Bach Mai Hospital in Hanoi, Vietnam. CRAF was employed to gauge the extent of frailty. To establish convergent validity, the scores from the CRAF were correlated with those from the Fried phenotype. Discriminant validity was ascertained through the utilization of receiver operating characteristic (ROC) curve analysis. Additionally, a multivariate logistic regression model was applied to evaluate the individual determinants' relative impact on the CRAF.
Results: In testing for convergent validity, a significant correlation was found between CRAF and Fried phenotype (p < 0.001). The discriminatory power of CRAF was higher than those of the Fried phenotype (difference between areas under the ROC curves = 0.947 (95% CI: 0.927-0.967). Variables associated with frailty at the multivariate analysis were comorbitidy, medication intake, BMI, DAS28-CRP, and age (all at p < 0.01).
Conclusion: CRAF exhibited strong validity and accurate discrimination. Incorporating frailty assessment into regular rheumatological practices could signify a significant advancement in the care of rheumatoid arthritis.
{"title":"Adaptation of the comprehensive rheumatologic assessment of frailty (CRAF) as a multidimensional frailty screening tool in patients with rheumatoid arthritis in Vietnam.","authors":"Trang Huyen Tran, Trang Thi Huong Ta, Lan Thi Ngoc Nguyen, Huyen Thi Thanh Vu, Hung Van Nguyen","doi":"10.1186/s41927-024-00394-7","DOIUrl":"10.1186/s41927-024-00394-7","url":null,"abstract":"<p><strong>Background: </strong>In recent times, there has been acknowledgment of the prevalence of frailty and pre-frailty among individuals with rheumatoid arthritis (RA). Comprehensive Rheumatologic Assessment of Frailty (CRAF) stands out as a dependable tool grounded in synthesis and clinical judgment. Despite this, a validated Vietnamese rendition of the CRAF is currently unavailable. This study seeks to assess the reliability and validity of the CRAF in a patient with RA in Vietnam.</p><p><strong>Methods: </strong>A cross-sectional investigation was carried out with 402 patients diagnosed with rheumatoid arthritis, encompassing both inpatients and outpatients at the Centre for Rheumatology at Bach Mai Hospital in Hanoi, Vietnam. CRAF was employed to gauge the extent of frailty. To establish convergent validity, the scores from the CRAF were correlated with those from the Fried phenotype. Discriminant validity was ascertained through the utilization of receiver operating characteristic (ROC) curve analysis. Additionally, a multivariate logistic regression model was applied to evaluate the individual determinants' relative impact on the CRAF.</p><p><strong>Results: </strong>In testing for convergent validity, a significant correlation was found between CRAF and Fried phenotype (p < 0.001). The discriminatory power of CRAF was higher than those of the Fried phenotype (difference between areas under the ROC curves = 0.947 (95% CI: 0.927-0.967). Variables associated with frailty at the multivariate analysis were comorbitidy, medication intake, BMI, DAS28-CRP, and age (all at p < 0.01).</p><p><strong>Conclusion: </strong>CRAF exhibited strong validity and accurate discrimination. Incorporating frailty assessment into regular rheumatological practices could signify a significant advancement in the care of rheumatoid arthritis.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"24"},"PeriodicalIF":2.2,"publicationDate":"2024-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11161963/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141287725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-06DOI: 10.1186/s41927-024-00392-9
Ryuichi Ohta, Chiaki Sano
Background: Early diagnosis and treatment of rheumatoid arthritis (RA) are essential to prevent progressive joint destruction and improve the quality of life (QOL) of patients. This study aimed to identify the factors associated with the duration from symptom onset to seeking initial medical care among older rural patients diagnosed with RA.
Methods: This retrospective cohort study was conducted in Unnan City, Japan, using electronic patient records. Data from patients aged > 65 years, who were admitted to the Unnan City Hospital between April 2016 and March 2021, were analyzed. The primary outcome was the duration from symptom onset to the initial visit to the medical institution. Demographic factors, laboratory data, and data on symptoms were collected and analyzed using statistical tests and regression models.
Results: In total, 221 participants were included in this study. The longer duration from symptom onset to medical care usage was significantly associated with age (adjusted odds ratio [OR]: 1.09, 95% confidence interval [CI]: 1.03-1.15), isolated conditions (adjusted OR: 4.45, 95% CI: 1.85-10.70), and wrist symptoms (adjusted OR: 3.22, 95% CI: 1.44-7.17). Higher education level and alcohol consumption were also associated with the duration from symptom onset to medical care usage.
Conclusions: Older age, isolated conditions, and specific joint symptoms were significant factors influencing delays in seeking medical care among older rural patients with RA. Interventions to improve health literacy, increase social support, and raise awareness of RA symptoms are essential for expediting diagnosis and improving patient QOL. Further research is needed to explore additional psychosocial factors and beliefs that affect health-seeking behaviors in patients with RA.
{"title":"Factors affecting the duration of initial medical care seeking among older rural patients diagnosed with rheumatoid arthritis: a retrospective cohort study.","authors":"Ryuichi Ohta, Chiaki Sano","doi":"10.1186/s41927-024-00392-9","DOIUrl":"10.1186/s41927-024-00392-9","url":null,"abstract":"<p><strong>Background: </strong>Early diagnosis and treatment of rheumatoid arthritis (RA) are essential to prevent progressive joint destruction and improve the quality of life (QOL) of patients. This study aimed to identify the factors associated with the duration from symptom onset to seeking initial medical care among older rural patients diagnosed with RA.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted in Unnan City, Japan, using electronic patient records. Data from patients aged > 65 years, who were admitted to the Unnan City Hospital between April 2016 and March 2021, were analyzed. The primary outcome was the duration from symptom onset to the initial visit to the medical institution. Demographic factors, laboratory data, and data on symptoms were collected and analyzed using statistical tests and regression models.</p><p><strong>Results: </strong>In total, 221 participants were included in this study. The longer duration from symptom onset to medical care usage was significantly associated with age (adjusted odds ratio [OR]: 1.09, 95% confidence interval [CI]: 1.03-1.15), isolated conditions (adjusted OR: 4.45, 95% CI: 1.85-10.70), and wrist symptoms (adjusted OR: 3.22, 95% CI: 1.44-7.17). Higher education level and alcohol consumption were also associated with the duration from symptom onset to medical care usage.</p><p><strong>Conclusions: </strong>Older age, isolated conditions, and specific joint symptoms were significant factors influencing delays in seeking medical care among older rural patients with RA. Interventions to improve health literacy, increase social support, and raise awareness of RA symptoms are essential for expediting diagnosis and improving patient QOL. Further research is needed to explore additional psychosocial factors and beliefs that affect health-seeking behaviors in patients with RA.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"23"},"PeriodicalIF":2.2,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11155024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-05DOI: 10.1186/s41927-023-00355-6
Zahi Touma, Karen H. Costenbader, Ben Hoskin, Christian Atkinson, David Bell, James Pike, Pamela Berry, Chetan S. Karyekar
Limited real-world data exists on clinical outcomes in systemic lupus erythematosus (SLE) patients by SLE Disease Activity Index 2000 (SLEDAI-2 K), hereafter, SLEDAI. We aimed to examine the association between SLEDAI score and clinical, patient-reported and economic outcomes in patients with SLE. Rheumatologists from the United States of America and Europe provided real-world demographic, clinical, and healthcare resource utilization (HCRU) data for SLE patients. Patients provided self-reported outcome data, capturing their general health status using the EuroQol 5-dimension 3-level questionnaire (EQ-5D-3 L), health-related quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) and work productivity using the Work Productivity and Activity Impairment questionnaire (WPAI). Low disease activity was defined as SLEDAI score ≤ 4 and ≤ 7.5 mg/day glucocorticoids; patients not meeting these criteria were considered to have “higher” active disease. Data were compared between patients with low and higher disease activity. Logistic regression estimated a propensity score for SLE based on demographic and clinical characteristics. Propensity score matched analyses compared HCRU, patient-reported outcomes, income loss and treatment satisfaction in patients with low disease activity versus higher active disease. Data from 296 physicians reporting on 730 patients (46 low disease activity, 684 higher active disease), and from 377 patients’ self-reported questionnaires (24 low disease activity, 353 higher active disease) were analyzed. Flaring in the previous 12 months was 2.6-fold more common among patients with higher versus low active disease. Equation 5D-3 L utility index was 0.79 and 0.88 and FACIT-Fatigue scores were 34.78 and 39.79 in low versus higher active disease patients, respectively, indicating better health and less fatigue, among patients with low versus higher active disease. Absenteeism, presenteeism, overall work impairment, and total activity impairment were 47.0-, 2.0-, 2.6- and 1.5-fold greater in patients with higher versus low disease activity. In the previous 12 months there were 28% more healthcare consultations and 3.4-fold more patients hospitalized in patients with higher versus low disease activity. Compared to SLE patients with higher active disease, patients with low disease activity experienced better health status, lower HCRU, less fatigue, and lower work productivity impairment, with work absenteeism being substantially lower in these patients.
{"title":"Patient-reported outcomes and healthcare resource utilization in systemic lupus erythematosus: impact of disease activity","authors":"Zahi Touma, Karen H. Costenbader, Ben Hoskin, Christian Atkinson, David Bell, James Pike, Pamela Berry, Chetan S. Karyekar","doi":"10.1186/s41927-023-00355-6","DOIUrl":"https://doi.org/10.1186/s41927-023-00355-6","url":null,"abstract":"Limited real-world data exists on clinical outcomes in systemic lupus erythematosus (SLE) patients by SLE Disease Activity Index 2000 (SLEDAI-2 K), hereafter, SLEDAI. We aimed to examine the association between SLEDAI score and clinical, patient-reported and economic outcomes in patients with SLE. Rheumatologists from the United States of America and Europe provided real-world demographic, clinical, and healthcare resource utilization (HCRU) data for SLE patients. Patients provided self-reported outcome data, capturing their general health status using the EuroQol 5-dimension 3-level questionnaire (EQ-5D-3 L), health-related quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) and work productivity using the Work Productivity and Activity Impairment questionnaire (WPAI). Low disease activity was defined as SLEDAI score ≤ 4 and ≤ 7.5 mg/day glucocorticoids; patients not meeting these criteria were considered to have “higher” active disease. Data were compared between patients with low and higher disease activity. Logistic regression estimated a propensity score for SLE based on demographic and clinical characteristics. Propensity score matched analyses compared HCRU, patient-reported outcomes, income loss and treatment satisfaction in patients with low disease activity versus higher active disease. Data from 296 physicians reporting on 730 patients (46 low disease activity, 684 higher active disease), and from 377 patients’ self-reported questionnaires (24 low disease activity, 353 higher active disease) were analyzed. Flaring in the previous 12 months was 2.6-fold more common among patients with higher versus low active disease. Equation 5D-3 L utility index was 0.79 and 0.88 and FACIT-Fatigue scores were 34.78 and 39.79 in low versus higher active disease patients, respectively, indicating better health and less fatigue, among patients with low versus higher active disease. Absenteeism, presenteeism, overall work impairment, and total activity impairment were 47.0-, 2.0-, 2.6- and 1.5-fold greater in patients with higher versus low disease activity. In the previous 12 months there were 28% more healthcare consultations and 3.4-fold more patients hospitalized in patients with higher versus low disease activity. Compared to SLE patients with higher active disease, patients with low disease activity experienced better health status, lower HCRU, less fatigue, and lower work productivity impairment, with work absenteeism being substantially lower in these patients.","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"24 1","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141256823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The episodic nature of gout and diagnostic uncertainty in the absence of microcrystal evidence make it particularly difficult to estimate the frequency of gout. Our aim was to review the literature on the epidemiological and diagnostic aspects of gout in sub-Saharan Africa.
Methods: This literature review was conducted using the MEDLINE database (via PUBMED), Google Scholar, and conference abstracts. The selection process was based on reading the titles first, then the abstracts, and then the full texts once the articles had been selected. Studies were included in this review if they presented original findings on the epidemiological and/or diagnostic aspects of gout in sub-Saharan Africa. Two groups of two investigators independently reviewed the studies. The results were analysed descriptively.
Results: The literature search identified 131 articles and 22 conference abstracts. Nineteen articles were included in our review. Twelve studies were retrospective, five were cross-sectional, one was prospective, and one was both retrospective and cross-sectional. The duration of the studies ranged from 1 to 15 years, and the sample size ranged from 15 to 511 patients, for a total of 2557 patients. Gout was quite common, with a maximum frequency of 11.87%. Fourteen articles diagnosed gout via criteria, including 9 studies totaling 1174 patients via the 1977 ACR criteria. Gout tophi were reported in 15 articles involving 464 patients. Of these studies, seven looked for monosodium urate crystals in 317 (43.85%) of 723 patients. Among the 317 patients, monosodium urate crystals were detected in 263 (82.97%) patients. Eleven studies reported mean uricemia values ranging from 452.09 µmol/L to 642.44 µmol/L, with a mean of 510.63 µmol/L.
Conclusions: This review revealed that all the studies conducted in sub-Saharan Africa were intrahospital studies, and the majority were retrospective. Consequently, there is a clear need for population-based studies.
{"title":"Epidemiology and diagnosis of gout in sub-saharan Africa: a scoping review.","authors":"Ayouba Tinni Ismael, Kabore Fulgence, Bayala Yannick Laurent Tchenadoyo, Yameogo Wendyam Nadège, Zabsonre/Tiendrebeogo Wendlassida Stéphanie Joelle, Ouedraogo Aboubakar, Zongo Yamyelle Enselme, Traore Awa, Bonkoungou Marcellin, Ouedraogo Dieu-Donné","doi":"10.1186/s41927-024-00391-w","DOIUrl":"10.1186/s41927-024-00391-w","url":null,"abstract":"<p><strong>Background: </strong>The episodic nature of gout and diagnostic uncertainty in the absence of microcrystal evidence make it particularly difficult to estimate the frequency of gout. Our aim was to review the literature on the epidemiological and diagnostic aspects of gout in sub-Saharan Africa.</p><p><strong>Methods: </strong>This literature review was conducted using the MEDLINE database (via PUBMED), Google Scholar, and conference abstracts. The selection process was based on reading the titles first, then the abstracts, and then the full texts once the articles had been selected. Studies were included in this review if they presented original findings on the epidemiological and/or diagnostic aspects of gout in sub-Saharan Africa. Two groups of two investigators independently reviewed the studies. The results were analysed descriptively.</p><p><strong>Results: </strong>The literature search identified 131 articles and 22 conference abstracts. Nineteen articles were included in our review. Twelve studies were retrospective, five were cross-sectional, one was prospective, and one was both retrospective and cross-sectional. The duration of the studies ranged from 1 to 15 years, and the sample size ranged from 15 to 511 patients, for a total of 2557 patients. Gout was quite common, with a maximum frequency of 11.87%. Fourteen articles diagnosed gout via criteria, including 9 studies totaling 1174 patients via the 1977 ACR criteria. Gout tophi were reported in 15 articles involving 464 patients. Of these studies, seven looked for monosodium urate crystals in 317 (43.85%) of 723 patients. Among the 317 patients, monosodium urate crystals were detected in 263 (82.97%) patients. Eleven studies reported mean uricemia values ranging from 452.09 µmol/L to 642.44 µmol/L, with a mean of 510.63 µmol/L.</p><p><strong>Conclusions: </strong>This review revealed that all the studies conducted in sub-Saharan Africa were intrahospital studies, and the majority were retrospective. Consequently, there is a clear need for population-based studies.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"21"},"PeriodicalIF":2.2,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11112960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141086874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-21DOI: 10.1186/s41927-024-00386-7
Alexis Ogdie, Joseph F Merola, Philip J Mease, Christopher T Ritchlin, Jose U Scher, Kimberly Parnell Lafferty, Daphne Chan, Soumya D Chakravarty, Wayne Langholff, Yanli Wang, Olivia Choi, Yevgeniy Krol, Alice B Gottlieb
Background: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.
Methods: The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.
Discussion: Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.
Trial registration: This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.
{"title":"Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study.","authors":"Alexis Ogdie, Joseph F Merola, Philip J Mease, Christopher T Ritchlin, Jose U Scher, Kimberly Parnell Lafferty, Daphne Chan, Soumya D Chakravarty, Wayne Langholff, Yanli Wang, Olivia Choi, Yevgeniy Krol, Alice B Gottlieb","doi":"10.1186/s41927-024-00386-7","DOIUrl":"10.1186/s41927-024-00386-7","url":null,"abstract":"<p><strong>Background: </strong>Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.</p><p><strong>Methods: </strong>The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.</p><p><strong>Discussion: </strong>Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.</p><p><strong>Trial registration: </strong>This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"20"},"PeriodicalIF":2.2,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11106968/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141074499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-21DOI: 10.1186/s41927-024-00389-4
Jeffrey A Sparks, Philippe Dieudé, Anna-Maria Hoffmann-Vold, Gerd R Burmester, Simon Lf Walsh, Michael Kreuter, Christian Stock, Steven Sambevski, Margarida Alves, Paul Emery
Background: Patients with rheumatoid arthritis (RA) are at risk of developing interstitial lung disease (ILD), which is associated with high mortality. Screening tools based on risk factors are needed to decide which patients with RA should be screened for ILD using high-resolution computed tomography (HRCT). The ANCHOR-RA study is a multi-national cross-sectional study that will develop a multivariable model for prediction of RA-ILD, which can be used to inform screening for RA-ILD in clinical practice.
Methods: Investigators will enrol consecutive patients with RA who have ≥ 2 of the following risk factors for RA-ILD: male; current or previous smoker; age ≥ 60 years at RA diagnosis; high-positive rheumatoid factor and/or anti-cyclic citrullinated peptide (titre > 3 x upper limit of normal); presence or history of certain extra-articular manifestations of RA (vasculitis, Felty's syndrome, secondary Sjögren's syndrome, cutaneous rheumatoid nodules, serositis, and/or scleritis/uveitis); high RA disease activity in the prior 12 months. Patients previously identified as having ILD, or who have had a CT scan in the prior 2 years, will not be eligible. Participants will undergo an HRCT scan at their local site, which will be assessed centrally by two expert radiologists. Data will be collected prospectively on demographic and RA-related characteristics, patient-reported outcomes, comorbidities and pulmonary function. The primary outcomes will be the development of a probability score for RA-ILD, based on a multivariable model incorporating potential risk factors commonly assessed in clinical practice, and an estimate of the prevalence of RA-ILD in the study population. It is planned that 1200 participants will be enrolled at approximately 30 sites in the USA, UK, Germany, France, Italy, Spain.
Discussion: Data from the ANCHOR-RA study will add to the body of evidence to support recommendations for screening for RA-ILD to improve detection of this important complication of RA and enable early intervention.
Trial registration: clinicaltrials.gov NCT05855109 (submission date: 3 May 2023).
背景:类风湿性关节炎(RA)患者有患间质性肺病(ILD)的风险,这种疾病与高死亡率相关。需要基于风险因素的筛查工具来决定哪些类风湿性关节炎患者应使用高分辨率计算机断层扫描(HRCT)进行间质性肺病筛查。ANCHOR-RA研究是一项多国横断面研究,它将建立一个预测RA-ILD的多变量模型,该模型可用于临床实践中的RA-ILD筛查:研究人员将连续招募具有以下 RA-ILD 风险因素中≥ 2 个因素的 RA 患者:男性;目前或曾经吸烟;确诊 RA 时年龄≥ 60 岁;类风湿因子和/或抗环瓜氨酸肽阳性率高(滴度 > 3 x 正常值上限);存在或曾有某些 RA 的关节外表现(血管炎、费尔蒂综合征、继发性斯约格伦综合征、皮肤类风湿结节、血清炎和/或巩膜炎/葡萄膜炎);前 12 个月 RA 疾病活动度高。之前被确认为患有 ILD 的患者或在过去两年中接受过 CT 扫描的患者将不符合条件。参与者将在当地接受 HRCT 扫描,并由两名放射科专家进行集中评估。将前瞻性地收集有关人口统计学和 RA 相关特征、患者报告结果、合并症和肺功能的数据。主要结果将是根据一个多变量模型,结合临床实践中通常评估的潜在风险因素,得出RA-ILD的概率分值,并估计RA-ILD在研究人群中的患病率。计划将在美国、英国、德国、法国、意大利和西班牙的约 30 个地点招募 1200 名参与者:ANCHOR-RA研究的数据将为支持RA-ILD筛查的建议提供更多证据,以提高对RA这一重要并发症的检出率,并实现早期干预。试验注册:clinicaltrials.gov NCT05855109(提交日期:2023年5月3日)。
{"title":"Design of ANCHOR-RA: a multi-national cross-sectional study on screening for interstitial lung disease in patients with rheumatoid arthritis.","authors":"Jeffrey A Sparks, Philippe Dieudé, Anna-Maria Hoffmann-Vold, Gerd R Burmester, Simon Lf Walsh, Michael Kreuter, Christian Stock, Steven Sambevski, Margarida Alves, Paul Emery","doi":"10.1186/s41927-024-00389-4","DOIUrl":"10.1186/s41927-024-00389-4","url":null,"abstract":"<p><strong>Background: </strong>Patients with rheumatoid arthritis (RA) are at risk of developing interstitial lung disease (ILD), which is associated with high mortality. Screening tools based on risk factors are needed to decide which patients with RA should be screened for ILD using high-resolution computed tomography (HRCT). The ANCHOR-RA study is a multi-national cross-sectional study that will develop a multivariable model for prediction of RA-ILD, which can be used to inform screening for RA-ILD in clinical practice.</p><p><strong>Methods: </strong>Investigators will enrol consecutive patients with RA who have ≥ 2 of the following risk factors for RA-ILD: male; current or previous smoker; age ≥ 60 years at RA diagnosis; high-positive rheumatoid factor and/or anti-cyclic citrullinated peptide (titre > 3 x upper limit of normal); presence or history of certain extra-articular manifestations of RA (vasculitis, Felty's syndrome, secondary Sjögren's syndrome, cutaneous rheumatoid nodules, serositis, and/or scleritis/uveitis); high RA disease activity in the prior 12 months. Patients previously identified as having ILD, or who have had a CT scan in the prior 2 years, will not be eligible. Participants will undergo an HRCT scan at their local site, which will be assessed centrally by two expert radiologists. Data will be collected prospectively on demographic and RA-related characteristics, patient-reported outcomes, comorbidities and pulmonary function. The primary outcomes will be the development of a probability score for RA-ILD, based on a multivariable model incorporating potential risk factors commonly assessed in clinical practice, and an estimate of the prevalence of RA-ILD in the study population. It is planned that 1200 participants will be enrolled at approximately 30 sites in the USA, UK, Germany, France, Italy, Spain.</p><p><strong>Discussion: </strong>Data from the ANCHOR-RA study will add to the body of evidence to support recommendations for screening for RA-ILD to improve detection of this important complication of RA and enable early intervention.</p><p><strong>Trial registration: </strong>clinicaltrials.gov NCT05855109 (submission date: 3 May 2023).</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"19"},"PeriodicalIF":2.2,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11107068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141074458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-17DOI: 10.1186/s41927-024-00387-6
Michael Schultze, Elena Garal-Pantaler, Marc Pignot, Roger A Levy, Heike Carnarius, Matthias Schneider, Kerry Gairy
Background: Systemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany.
Methods: Claims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score-matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments.
Results: 2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher.
Conclusions: The application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.
{"title":"Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany.","authors":"Michael Schultze, Elena Garal-Pantaler, Marc Pignot, Roger A Levy, Heike Carnarius, Matthias Schneider, Kerry Gairy","doi":"10.1186/s41927-024-00387-6","DOIUrl":"https://doi.org/10.1186/s41927-024-00387-6","url":null,"abstract":"<p><strong>Background: </strong>Systemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany.</p><p><strong>Methods: </strong>Claims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score-matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments.</p><p><strong>Results: </strong>2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher.</p><p><strong>Conclusions: </strong>The application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"18"},"PeriodicalIF":2.2,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11100138/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140956189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-06DOI: 10.1186/s41927-024-00388-5
Danfeng Xu, Bing Wu
Background: Systemic Lupus Erythematosus (SLE) and Osteoporosis are two prevalent medical conditions. Previous studies have suggested a possible correlation between SLE and osteoporosis, though the underpinning causal relationship remains largely unknown. The current study aimed to elucidate the causal association between SLE and osteoporosis by employing a Mendelian randomization (MR) approach.
Methods: We performed two-sample MR analysis using the inverse variance-weighted (IVW), weighted median, and MR-Egger methods on publicly available summary statistics datasets using a SLE genome-wide association study (GWAS) as an exposure and osteoporosis GWASs in people with East Asia ancestry as outcomes. The pleiotropy and heterogeneity were examined using a variety of techniques, including the MR-Egger intercept, the MR-PRESSO approach, and the Cochran's Q test.
Results: We selected 26 single-nucleotide polymorphisms from a SLE GWAS as instrumental variables for osteoporosis. The IVW (p < 0.05) method results support a potential association between SLE and osteoporosis. MR-Egger intercept (p = 0.82) and MR-PRESSO global test (p = 0.80) did not suggest evidence of horizontal or directional pleiotropy. Cochran's Q test (p = 0.78) showed that there was no heterogeneity between IVs.
Conclusion: The results of MR analysis indicated that SLE is likely associated with an increased risk of osteoporosis incidence. Our findings highlight the need for increased awareness the potential risk of osteoporosis among SLE patients.
{"title":"Association between systemic lupus erythematosus and osteoporosis: a mendelian randomization analysis.","authors":"Danfeng Xu, Bing Wu","doi":"10.1186/s41927-024-00388-5","DOIUrl":"10.1186/s41927-024-00388-5","url":null,"abstract":"<p><strong>Background: </strong>Systemic Lupus Erythematosus (SLE) and Osteoporosis are two prevalent medical conditions. Previous studies have suggested a possible correlation between SLE and osteoporosis, though the underpinning causal relationship remains largely unknown. The current study aimed to elucidate the causal association between SLE and osteoporosis by employing a Mendelian randomization (MR) approach.</p><p><strong>Methods: </strong>We performed two-sample MR analysis using the inverse variance-weighted (IVW), weighted median, and MR-Egger methods on publicly available summary statistics datasets using a SLE genome-wide association study (GWAS) as an exposure and osteoporosis GWASs in people with East Asia ancestry as outcomes. The pleiotropy and heterogeneity were examined using a variety of techniques, including the MR-Egger intercept, the MR-PRESSO approach, and the Cochran's Q test.</p><p><strong>Results: </strong>We selected 26 single-nucleotide polymorphisms from a SLE GWAS as instrumental variables for osteoporosis. The IVW (p < 0.05) method results support a potential association between SLE and osteoporosis. MR-Egger intercept (p = 0.82) and MR-PRESSO global test (p = 0.80) did not suggest evidence of horizontal or directional pleiotropy. Cochran's Q test (p = 0.78) showed that there was no heterogeneity between IVs.</p><p><strong>Conclusion: </strong>The results of MR analysis indicated that SLE is likely associated with an increased risk of osteoporosis incidence. Our findings highlight the need for increased awareness the potential risk of osteoporosis among SLE patients.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"17"},"PeriodicalIF":2.2,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11071324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140853454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-28DOI: 10.1186/s41927-024-00385-8
Cécile-Audrey Durel, Eric Simon Thervet, Dominique Chauveau, Aurélie Schmidt, Benjamin Terrier, Pierre M Bataille
In 2013, rituximab was approved in France for the treatment of ANCA-associated vasculitis (AAV). The aim of the study was to compare the treatment and health events of adult incident patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), included before rituximab approval (over 2010–2012, Group 1) and those included after rituximab approval (over 2014–2017, Group 2). Data were extracted from the French National Health Insurance database (SNDS) including outpatient health care consumption and hospital discharge forms. Comparisons between inclusion periods were performed using Wilcoxon and χ² tests. Kaplan-Meier method was used to model the duration of treatment induction, maintenance, and off-drug periods. Fine and Gray tests were used to compare treatment phase durations. A total of 694 GPA and 283 MPA patients were included in Group 1, while 668 GPA and 463 MPA patients were included in Group 2. Between the two inclusion periods, the proportions of patients treated with rituximab increased in the induction and maintenance phases whereas treatment with azathioprine declined. These proportions remained stable in the case of methotrexate, cyclophosphamide, and glucocorticoid-treated patients. Frequency of first-time hospitalized infections, diabetes and renal failure during the first year after inclusion increased for both groups. This is a retrospective study based on claims data including only 76% of people covered by health insurance in France. The period studied includes the learning phase of using rituximab. This study lacks biological data and precise quantitative analysis for the use of steroids, therefore the criteria for establishing diagnosis and therapeutic choice were unknown. Introduction of rituximab reduced the use of azathioprine without affecting the use of glucocorticoids or cyclophosphamide.
{"title":"Evolution of therapeutic management of patients with ANCA associated vasculitis in France after licensing Rituximab use","authors":"Cécile-Audrey Durel, Eric Simon Thervet, Dominique Chauveau, Aurélie Schmidt, Benjamin Terrier, Pierre M Bataille","doi":"10.1186/s41927-024-00385-8","DOIUrl":"https://doi.org/10.1186/s41927-024-00385-8","url":null,"abstract":"In 2013, rituximab was approved in France for the treatment of ANCA-associated vasculitis (AAV). The aim of the study was to compare the treatment and health events of adult incident patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), included before rituximab approval (over 2010–2012, Group 1) and those included after rituximab approval (over 2014–2017, Group 2). Data were extracted from the French National Health Insurance database (SNDS) including outpatient health care consumption and hospital discharge forms. Comparisons between inclusion periods were performed using Wilcoxon and χ² tests. Kaplan-Meier method was used to model the duration of treatment induction, maintenance, and off-drug periods. Fine and Gray tests were used to compare treatment phase durations. A total of 694 GPA and 283 MPA patients were included in Group 1, while 668 GPA and 463 MPA patients were included in Group 2. Between the two inclusion periods, the proportions of patients treated with rituximab increased in the induction and maintenance phases whereas treatment with azathioprine declined. These proportions remained stable in the case of methotrexate, cyclophosphamide, and glucocorticoid-treated patients. Frequency of first-time hospitalized infections, diabetes and renal failure during the first year after inclusion increased for both groups. This is a retrospective study based on claims data including only 76% of people covered by health insurance in France. The period studied includes the learning phase of using rituximab. This study lacks biological data and precise quantitative analysis for the use of steroids, therefore the criteria for establishing diagnosis and therapeutic choice were unknown. Introduction of rituximab reduced the use of azathioprine without affecting the use of glucocorticoids or cyclophosphamide. ","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"50 1","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140811521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}