Dafna D Gladman, Philip J Mease, Laure Gossec, M Elaine Husni, Alice B Gottlieb, Barbara Ink, Rajan Bajracharya, Jason Coarse, Nikos Lyris, Jérémy Lambert, William Tillett
{"title":"Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies.","authors":"Dafna D Gladman, Philip J Mease, Laure Gossec, M Elaine Husni, Alice B Gottlieb, Barbara Ink, Rajan Bajracharya, Jason Coarse, Nikos Lyris, Jérémy Lambert, William Tillett","doi":"10.3899/jrheum.2024-0923","DOIUrl":"10.3899/jrheum.2024-0923","url":null,"abstract":"<p><strong>Objective: </strong>To assess the longer-term effect of bimekizumab up to 1 year on patient-reported symptoms, health-related quality of life (HRQOL), and work productivity in patients with active PsA who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR).</p><p><strong>Methods: </strong>BE OPTIMAL (ClinicalTrials.gov: NCT03895203; bDMARD-naïve patients) and BE COMPLETE (NCT03896581; TNFi-IR patients) are phase III studies of subcutaneous bimekizumab 160 mg every 4 weeks. Both studies were double-blind and placebo-controlled to 16 weeks. Patients who completed week 52 of BE OPTIMAL or week 16 of BE COMPLETE were eligible for the open-label extension, BE VITAL (NCT04009499), during which all patients received bimekizumab. Patient-reported pain, fatigue, physical function, HRQOL, and work productivity are reported to week 52 or 40 (52/40) using individual study data for bimekizumab and placebo treatment arms.</p><p><strong>Results: </strong>Bimekizumab-randomized patients demonstrated sustained mean improvements from baseline in patient-reported outcomes to week 52/40, including pain (visual analog scale [0-100 mm]: bDMARD-naïve -30.5; TNFi-IR -31.8), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue scale [0-52]: bDMARD-naïve 5.3; TNFi-IR 6.0), physical function (Health Assessment Questionnaire-Disability Index [0-3]: bDMARD-naïve -0.34; TNFi-IR -0.39), and HRQOL (36-item Short Form Health Survey, physical component summary: bDMARD-naïve 8.1; TNFi-IR 8.4); placebo patients who switched to bimekizumab at week 16 demonstrated comparable levels of improvement from week 16 to week 52/40. Improvements in overall work impairment were sustained among bimekizumab-randomized patients to week 52. Similar trends were observed for absenteeism, presenteeism, and activity impairment.</p><p><strong>Conclusion: </strong>Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms, HRQOL, and work productivity up to 1 year in bDMARD-naïve and TNFi-IR patients with active PsA.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"466-478"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marco Sebastiani, Gemma Lepri, Claudia Iannone, Emanuele Bozzalla Cassione, Giuliana Guggino, Andrea Lo Monaco, Roberta Foti, Marco Fornaro, Maria Sole Chimenti, Angelo Fassio, Simona Truglia, Francesca Cozzini, Antonio Carletto, Alessandro Giollo, Addolorata Corrado, Chiara Bazzani, Serena Guiducci, Ennio Favalli, Serena Bugatti, Florenzo Iannone, Roberto Caporali, Andreina Manfredi
{"title":"Nintedanib in Rheumatoid Arthritis-Related Interstitial Lung Disease: Real-World Safety Profile and Risk of Side Effects and Discontinuation.","authors":"Marco Sebastiani, Gemma Lepri, Claudia Iannone, Emanuele Bozzalla Cassione, Giuliana Guggino, Andrea Lo Monaco, Roberta Foti, Marco Fornaro, Maria Sole Chimenti, Angelo Fassio, Simona Truglia, Francesca Cozzini, Antonio Carletto, Alessandro Giollo, Addolorata Corrado, Chiara Bazzani, Serena Guiducci, Ennio Favalli, Serena Bugatti, Florenzo Iannone, Roberto Caporali, Andreina Manfredi","doi":"10.3899/jrheum.2024-0976","DOIUrl":"10.3899/jrheum.2024-0976","url":null,"abstract":"<p><strong>Objective: </strong>Some concerns remain about the safety of nintedanib in patients with rheumatoid arthritis-related interstitial lung disease (RA-ILD), such as in the presence of comorbidities or in combination with biologic, targeted synthetic, and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs). In this multicenter study, we retrospectively evaluated the safety of nintedanib in a real-world population of patients with RA-ILD from the Italian Group for the Study of Early Arthritis (GISEA) registry and the possible role of comorbidities and DMARDs on drug safety and withdrawal. Our secondary aim was to investigate the causes of nintedanib discontinuation.</p><p><strong>Methods: </strong>Sixty-five patients treated with nintedanib in accordance with the current therapeutic indications were enrolled in the study. Nintedanib was prescribed in combination with DMARDs and/or steroids in 62 patients (95.4%).</p><p><strong>Results: </strong>The 12-month retention rate of nintedanib was 76.7% and the drug was effective in about 80% of patients with ≥ 6 months of follow-up. Adverse events (AEs) were recorded in 36 subjects (55.3%), and these were mainly gastroenteric. Thirty-one subjects required a reduction of the nintedanib dose; among them, a transient or permanent reduction of the daily dose of nintedanib allowed the continuation of the treatment in 22, whereas 15 (23.1%) withdrew from the drug. All reductions and discontinuations were owing to treatment-related AEs. Comorbidities were significantly associated with side effects in multivariate analysis, whereas AEs due to nintedanib were the main cause of discontinuation.</p><p><strong>Conclusion: </strong>Combination therapy with DMARDs did not reduce the safety and effectiveness of nintedanib, and AEs were the main cause of drug withdrawal or dose reduction, mainly owing to comorbidities.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"420-425"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142840056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sahil Koppikar, Bindee Kuriya, Jacob A Udell, Bing Yu, Anna Chu, Douglas S Lee, Jessica Widdifield, Lihi Eder
{"title":"Risk of Heart Failure in Patients With Immune-Mediated Inflammatory Diseases: A Population-Based Study.","authors":"Sahil Koppikar, Bindee Kuriya, Jacob A Udell, Bing Yu, Anna Chu, Douglas S Lee, Jessica Widdifield, Lihi Eder","doi":"10.3899/jrheum.2024-0866","DOIUrl":"10.3899/jrheum.2024-0866","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the risk of heart failure (HF) in patients with immune-mediated inflammatory diseases (IMIDs) compared to the general population with and without diabetes mellitus (DM).</p><p><strong>Methods: </strong>A population-based cohort study was conducted in patients with rheumatoid arthritis (RA), radiographic axial spondyloarthritis (r-axSpA), psoriatic arthritis, and psoriasis (PsO) in Ontario from 2011 until 2019. The study outcome was first hospitalization for HF. Incidence rates of HF were calculated for each cohort. Hazard ratios (HRs) for HF were calculated using Cox proportional hazard models. The etiology of HF was descriptively classified into mutually exclusive groups based on comorbidities during HF hospitalization.</p><p><strong>Results: </strong>A total of 243,061 patients with IMID, 748,517 with DM, and 8,278,934 non-IMID, non-DM controls were analyzed. The crude incidence rate for HF in IMID was 2.70 per 1000 person-years, with the highest rate in RA and lowest in r-axSpA. The risk of being hospitalized for HF was higher in IMID compared with non-IMID comparators (HR 1.34, 95% CI 1.30-1.38). This risk was highest among patients with RA (HR 1.61, 95% CI 1.54-1.68) and lowest in PsO (HR 1.09, 95% CI 1.03-1.15). In comparison, the risk of HF hospitalization in patients with DM was higher (HR 2.19, 95% CI 2.16-2.21). The most common antecedent comorbidity associated with HF in all patients with IMID was ischemic heart disease. In patients with IMID without DM, atrial fibrillation had a similar effect as ischemic heart disease.</p><p><strong>Conclusion: </strong>The risk of HF hospitalization is increased in patients with IMID compared to the general population.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"489-497"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gyorgy Abel, M Qasim Ansari, Melissa R Snyder, Anne E Tebo, Mark H Wener, Stanley J Naides
{"title":"Historical Perspective on Antinuclear Antibody Testing.","authors":"Gyorgy Abel, M Qasim Ansari, Melissa R Snyder, Anne E Tebo, Mark H Wener, Stanley J Naides","doi":"10.3899/jrheum.2023-1121","DOIUrl":"10.3899/jrheum.2023-1121","url":null,"abstract":"<p><p>Serum factors binding to cell nuclei were first described in the 1940s, and the antibodies responsible for the binding to self (autoantibodies) were discovered in the late 1950s. Routine standardized testing using a cell line (HEp-2) started in the 1980s and continues to evolve. In addition to the classic immunofluorescence assay (IFA), various immunochemical techniques have been developed for the measurement of antinuclear antibodies (ANAs). The complexity of ANA IFA pattern reading and the varying sensitivities, specificities, and overall clinical performance of the alternative methods have often generated controversies and sometimes even confusion among healthcare providers and laboratorians. A better understanding of the historical roots of ANA testing can aid in understanding these controversies and assist with selecting the best-performing methods. In this review, we present historic and contemporary ANA testing methods, highlighting the pros and cons of each. We also provide an overview of the current practice of ANA testing based on several recent large laboratory surveys. For optimal patient care, it is critical that clinicians and laboratorians using ANA testing understand the performance and limitations of the methods used by their institutions, as well as the meaning of the test results. Recently published surveys and standardization efforts initiated by several stakeholder scientific organizations will likely lead to new ANA diagnostic guidelines, to be followed by an improvement in testing practices, management, and outcomes for patients with autoimmune disorders.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"412-419"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dr. Solomon et al reply.","authors":"Tia Solomon, Anne Powell, John Findeisen","doi":"10.3899/jrheum.2025-0166","DOIUrl":"10.3899/jrheum.2025-0166","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"526"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura C Plantinga, Eric T Roberts, Courtney Hoge, Brad D Pearce, C Barrett Bowling
{"title":"Indicators of Functional Disability by Receipt of Disability Benefits Among Individuals With Systemic Lupus Erythematosus.","authors":"Laura C Plantinga, Eric T Roberts, Courtney Hoge, Brad D Pearce, C Barrett Bowling","doi":"10.3899/jrheum.2024-0961","DOIUrl":"10.3899/jrheum.2024-0961","url":null,"abstract":"<p><strong>Objective: </strong>We estimated the prevalence of potential functional disability among those with systemic lupus erythematosus (SLE), by receipt of disability benefits.</p><p><strong>Methods: </strong>Participants (N = 443, mean age 46.2 years, 91.7% women, 82.6% Black) were recruited from a population-based SLE cohort. Indicators of potential disability included functioning impairments (Short Physical Performance Battery score ≤ 10; age-corrected National Institutes of Health Toolbox Cognition Battery composite score for fluid cognition < 77.5 [1.5 SD below the mean]); activity limitations (physical functioning <i>T</i>-scores < 35 [1.5 SD below the mean]); at least some difficulty performing ≥ 1 of the instrumental activities of daily living (IADLs) or basic activities of daily living (BADLs); and participation restrictions (any vs no reported effect of health on ability to work; restricted community mobility). We performed multivariable logistic regression models predicting potential disability indicators by self-reported receipt of disability benefits and then obtained adjusted prevalence estimates using postestimation margins.</p><p><strong>Results: </strong>Those who reported receiving disability benefits (45.6%) vs not (54.4%) were more likely to have impairments in functioning (physical performance [71.3% vs 50%, <i>P</i> < 0.001]; fluid cognition [35.4% vs 19.2%, <i>P</i> = 0.01]), limitations in activities (self-reported physical limitations [26.7% vs 7.5%, <i>P</i> < 0.001]; IADLs [73.1% vs 42.9%, <i>P</i> < 0.001]; BADLs [60.6% vs 30.8%, <i>P</i> < 0.001]), and restrictions in participation (work [77.8% vs 60.6%, <i>P</i> = 0.09]; community mobility [43.1% vs 22%, <i>P</i> < 0.001]). These associations were not changed with adjustment for personal and SLE factors.</p><p><strong>Conclusion: </strong>Receipt of disability benefits may be an incomplete marker of functioning. A substantial proportion of those not receiving benefits have impairments, limitations, and restrictions that should be addressed.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"479-488"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12045728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mucosa-Associated Lymphoid Tissue Lymphoma as a Rare Mimicker of Relapsing Polychondritis.","authors":"Norihisa Tada, Nao Oguro, Nobuyuki Yajima","doi":"10.3899/jrheum.2024-0837","DOIUrl":"10.3899/jrheum.2024-0837","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"513-514"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lija James, Philip S Helliwell, Elizabeth M A Hensor, Philip G Conaghan, Paul Emery, Laura C Coates
{"title":"Tight Control and Radiological Progression: The Radiographic Outcomes of the TICOPA Study.","authors":"Lija James, Philip S Helliwell, Elizabeth M A Hensor, Philip G Conaghan, Paul Emery, Laura C Coates","doi":"10.3899/jrheum.2024-1035","DOIUrl":"10.3899/jrheum.2024-1035","url":null,"abstract":"<p><strong>Objective: </strong>The Tight Control of Psoriatic Arthritis (TICOPA) study was the first to undertake the treat-to-target approach in psoriatic arthritis (PsA). Our aim was to further investigate the radiographic changes in the TICOPA study.</p><p><strong>Methods: </strong>The TICOPA trial recruited patients with early treatment-naïve PsA. Plain radiographs of the hands and feet were taken at weeks 0 and 48. Clinical outcomes were recorded by a blinded assessor every 12 weeks. In post hoc analysis, bootstrapped quantile regression, adjusting for baseline values and minimization factors, was used to compare radiographic scores (modified Sharp/van der Heijde [mSvdH]), defined according to treatment arm or disease activity states.</p><p><strong>Results: </strong>Paired baseline and week 48 radiographs were available for 169/206 (82%) at week 48 (84 tight control [TC] arm, 85 standard care [StdC] arm). There was no difference in change in total mSvdH score seen with TC compared to StdC (median [IQR] 0.0 [-2.0 to 0.5] vs 0.0 [-2.0 to 0.0]; difference 0.0 [95% CI 0.0-0.0]). Median total mSvdH score change was lower in those achieving minimal disease activity, Disease Activity in Psoriatic Arthritis remission, and very low disease activity. The number of people with radiographic progression (an increase in total erosion score of ≥ 2 at week 48) was numerically lower in the TC group (5/84 [5.9%] vs 12/85 [14.1%]). Patients with radiographical progression presented with polyarticular disease and high C-reactive protein, and had poorer clinical outcomes at weeks 12 and 24.</p><p><strong>Conclusion: </strong>These data confirm the benefit of achieving low disease activity states on subsequent radiographic outcomes but did not show a significant impact related to a TC management approach.</p>","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"460-465"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lija James, Philip S Helliwell, Elizabeth M A Hensor, Philip G Conaghan, Paul Emery, Laura C Coates
{"title":"Tight Control and Radiological Progression: The Radiographic Outcomes of the TICOPA Study.","authors":"Lija James, Philip S Helliwell, Elizabeth M A Hensor, Philip G Conaghan, Paul Emery, Laura C Coates","doi":"10.3899/jrheum.2024-1035.C1","DOIUrl":"10.3899/jrheum.2024-1035.C1","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"527"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Practical Issues Relating to the Use of Antifibrotic Therapy in Patients With Interstitial Lung Disease and Rheumatoid Arthritis.","authors":"Clive A Kelly, Muddassir Shaikh","doi":"10.3899/jrheum.2025-0103","DOIUrl":"10.3899/jrheum.2025-0103","url":null,"abstract":"","PeriodicalId":50064,"journal":{"name":"Journal of Rheumatology","volume":" ","pages":"405-407"},"PeriodicalIF":3.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143765468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}