Rheumatology and Therapy最新文献

{"title":"Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.","authors":"Philip J Mease, Joseph F Merola, Yoshiya Tanaka, Laure Gossec, Iain B McInnes, Christopher T Ritchlin, Robert B M Landewé, Akihiko Asahina, Barbara Ink, Andrea Heinrichs, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Laura C Coates","doi":"10.1007/s40744-025-00764-8","DOIUrl":"10.1007/s40744-025-00764-8","url":null,"abstract":"<p><p>This Summary of Research summarises results from the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) studies and their open-label extension, BE VITAL (NCT04009499). These phase 3 studies looked at how well bimekizumab treatment worked in patients with psoriatic arthritis, and the safety of bimekizumab treatment, over the long term. Two patient groups were included in these studies: patients who had not previously been treated with biologic disease-modifying antirheumatic drugs (bDMARD-naïve; BE OPTIMAL) and patients who had a poor response or were intolerant to tumour necrosis factor (TNF) inhibitors (BE COMPLETE). These studies showed that the beneficial effects of bimekizumab treatment on patients' symptoms reported at year 1 of treatment were sustained up to 2 years, regardless of whether patients were bDMARD-naïve or had previously had a poor response or intolerance to TNF inhibitors. Bimekizumab was well tolerated up to 2 years. The data from this study may help clinicians and patients when they are making shared decisions on treatment options for psoriatic arthritis.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"609-612"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246320/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144043857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Matching-Adjusted Indirect Comparison of Guselkumab and Secukinumab in Patients with Psoriatic Arthritis Over 52 Weeks.","authors":"Suzy van Sanden, Agata Schubert, Barkha P Patel, Miriam Zimmermann, Fareen Hassan","doi":"10.1007/s40744-025-00771-9","DOIUrl":"10.1007/s40744-025-00771-9","url":null,"abstract":"<p><strong>Introduction: </strong>Studies evaluating the long-term comparative efficacy between biologic therapies for psoriatic arthritis (PsA) are scarce. Two biologic therapies, guselkumab and secukinumab, were evaluated up to 52 weeks in a mixed patient population (biologic-naïve and biologic-experienced patients).</p><p><strong>Methods: </strong>An unanchored matching-adjusted indirect comparison (MAIC) was conducted to compare guselkumab 100 mg every 8 weeks (Q8W) and every 4 weeks (Q4W) versus secukinumab 150 mg Q4W and 300 mg Q4W on American College of Rheumatology (ACR) and Psoriasis Area and Severity Index (PASI) responses from weeks 4 through 52 using pooled individual patient-level data from guselkumab trials (COSMOS, DISCOVER-1 and -2) and pooled summary-level data from secukinumab trials (FUTURE 2, 3, 4, and 5). For the primary analysis, patients from the guselkumab trials were re-weighted on six clinically relevant baseline characteristics to match those in the secukinumab trials. Additional characteristics were included as a sensitivity analysis. A scenario analysis was conducted in a biologic-naïve patient population only.</p><p><strong>Results: </strong>For the mixed population, both guselkumab doses initially had numerically or significantly lower ACR 20 responses than both secukinumab doses prior to weeks 12-20; however, from weeks 12-24 onward, ACR 20 responses became numerically or significantly higher for guselkumab. For PASI 90 responses, both guselkumab doses showed significantly higher responses than both secukinumab doses at weeks 24 and 52. Notably, at 52 weeks, ACR 20 and PASI 90 responses for both doses of guselkumab were numerically or significantly higher than both doses of secukinumab. Results from the sensitivity and scenario analyses were similar to the primary analysis.</p><p><strong>Conclusions: </strong>While the IL-17A inhibitor secukinumab may demonstrate more rapid and greater efficacy before weeks 12-20, both doses of guselkumab provide similar or greater efficacy on joint and skin outcomes compared to both doses of secukinumab from week 24 onward. This study provides valuable insights for treatment decisions when considering the chronic nature of PsA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"663-677"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246347/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Efficacy and Safety of Single Injections of Hybrid HA in the Treatment of Symptomatic Knee Osteoarthritis: A Case Series.","authors":"Marcin E Domzalski, Klaudia Marchewa","doi":"10.1007/s40744-025-00780-8","DOIUrl":"10.1007/s40744-025-00780-8","url":null,"abstract":"<p><strong>Introduction: </strong>The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.</p><p><strong>Methods: </strong>Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28, 42, 84, and 168 days post-treatment.</p><p><strong>Results: </strong>VAS scores measured at rest and when walking indicate an improvement during follow-up, particularly at 28 and 42 days, compared to baseline. Similarly, the most notable improvement of the WOMAC score was observed within the first 42 days after injection. While decrease in pain and joint function improvement were not as pronounced at the end of follow-up, they were still statistically better than at baseline. Overall patient satisfaction was high.</p><p><strong>Conclusion: </strong>Treatment with a single injection of hybrid HA was demonstrated to be safe and effective in patients with varying degrees of knee OA. Patients with medial knee OA responded better to treatment than patients with patellofemoral OA, which provides information on which types of patients are best suited to this intervention.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT06652893. Retrospectively registered October 10, 2024.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"695-708"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144542083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influence of Rheumatoid Factors on the Efficacy of TNF Inhibitor Therapy in Patients with Rheumatoid Arthritis.","authors":"Atsushi Nagayasu, Yusuke Miyazaki, Koshiro Sonomoto, Satoshi Kubo, Ippei Miyagawa, Ayako Yamaguchi, Hiroaki Tanaka, Yasuyuki Todoroki, Masanobu Ueno, Takafumi Aritomi, Yuya Fujita, Hidenori Sakai, Katsunori Suzuki, Shingo Nakayamada, Yoshiya Tanaka","doi":"10.1007/s40744-025-00769-3","DOIUrl":"10.1007/s40744-025-00769-3","url":null,"abstract":"<p><strong>Introduction: </strong>Although the efficacy of tumor necrosis factor inhibitors (TNFi) is reduced in patients with rheumatoid factor (RF)-high rheumatoid arthritis (RA), certolizumab pegol (CZP), lacking the Fc portion, may not be affected. This study aimed to compare CZP with Fc-containing TNFi and investigate whether RF levels affect the efficacy of CZP in patients with RA.</p><p><strong>Methods: </strong>This multicenter retrospective study involved patients with RA (n = 1010) who received TNFi with concomitant methotrexate (MTX). Patients were categorized by baseline RF quartiles. The primary endpoint was the Simplified Disease Activity Index (SDAI) remission rates at 26 weeks for patients treated with CZP and those receiving Fc-containing TNFi. The secondary endpoint compared the efficacy of CZP and adalimumab (ADA) in each RF quartile using propensity score-based inverse probability of treatment weighting (PS-IPTW).</p><p><strong>Results: </strong>In the overall cohort, the SDAI remission rate was the lowest in Q4 (RF ≥ 136.45 IU/mL). In Q4, multivariable logistic regression analysis showed that only the introduction of CZP was significantly associated with remission at 26 weeks. The Fc-containing TNFi group had significantly lower SDAI remission rates in Q4 compared with Q1-Q3. Conversely, the SDAI remission rates were similar between the two groups treated with CZP. After PS-IPTW adjustment in Q4, CZP-treated patients showed a significantly lower SDAI and higher remission rate (36.6%) compared with the ADA-treated patients (24.5%) (p = 0.0172). No significant differences in SDAI remission rates were observed between the two groups in Q1-Q3.</p><p><strong>Conclusion: </strong>CZP may be more effective than Fc‑containing TNFi in patients with RA and high RF levels.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"641-662"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials.","authors":"Vibeke Strand","doi":"10.1007/s40744-025-00766-6","DOIUrl":"10.1007/s40744-025-00766-6","url":null,"abstract":"<p><p>This summary-of-research article presents the findings of a post hoc analysis comparing immunogenicity across the VOLTAIRE trials program, originally published in BMJ Open. Adalimumab-adbm (Cyltezo^®) is approved by the US Food and Drug Administration as an interchangeable biosimilar to the adalimumab reference product (RP; Humira^®). In this analysis of immunogenicity in patients who participated in VOLTAIRE-RA (NCT021372260), VOLTAIRE-CD (NCT02871635), and VOLTAIRE-PsO (NCT02850965), immune response was assessed in patients of each biosimilar and RP treatment arm at various time points, and further stratified by patient sex. Across VOLTAIRE trials, the incidence of immunogenicity parameters had similar trajectories and were highest in VOLTAIRE-PsO, followed by VOLTAIRE-CD and VOLTAIRE-RA, highlighting the effects of differences in patient populations and background medications on immune response for each indication. The same trend was observed in subgroup analyses by patient sex. These analyses show supporting evidence of the biosimilarity of adalimumab-adbm with adalimumab RP in adult patients with rheumatoid arthritis, Crohn's disease, and plaque psoriasis.Trial Registrations: VOLTAIRE-RA, NCT021372260; VOLTAIRE-CD, NCT02871635; VOLTAIRE-PsO, NCT02850965.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"613-616"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246292/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level.","authors":"Ning Kong, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Lingyun Sun, Dai Lie, Chunyu Tan, Zhijun Li, Zhengyu Xiao, Cibo Huang, Jian Xu, Yan Yan, Hongying Li, Hejian Zou","doi":"10.1007/s40744-025-00765-7","DOIUrl":"10.1007/s40744-025-00765-7","url":null,"abstract":"<p><strong>Introduction: </strong>Ixekizumab, an interleukin 17A inhibitor, improved the Assessment of SpondyloArthritis international Society 40 (ASAS40) response rates irrespective of baseline inflammation in international populations with radiographic axial spondyloarthritis (r-axSpA). We investigated the association of baseline inflammation (measured by serum C-reactive protein [CRP] levels) with ixekizumab efficacy in Chinese patients with r-axSpA.</p><p><strong>Methods: </strong>This was a subgroup analysis of a Chinese phase 3 study. Adults with r-axSpA who were biologic-naïve, or tumor necrosis factor inhibitor-experienced with baseline CRP > 5 mg/l, were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo, for 16 weeks. The following endpoints were analyzed by normal (≤ 5 mg/l) or elevated (> 5 mg/l) baseline CRP levels: ASAS40; Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); ASDAS major improvement (MI; change from baseline ≥ 2.0 or achievement of lowest possible score); Bath Ankylosing Spondylitis Metrology Index (BASMI) linear score; Bath Ankylosing Spondylitis Functional Index (BASFI); Short Form-36 Physical Component Score (SF-36 PCS).</p><p><strong>Results: </strong>A total of 147 patients were randomized. At week 16, the ASAS40 response rate was greater with IXEQ4W versus placebo in the normal (50.0% vs. 15.0%; p < 0.05) and elevated (29.5% vs. 5.7%; p < 0.01) CRP subgroups. Significant improvements in BASDAI50 response rate, ASDAS < 2.1, and ASDAS CII with IXEQ4W versus placebo were observed in both subgroups (normal CRP: p < 0.05, p < 0.01, and p < 0.05, respectively; elevated CRP: p < 0.01, p < 0.001, and p < 0.001, respectively); IXEQ4W significantly improved ASDAS MI in the elevated CRP subgroup (p < 0.001). IXEQ4W significantly improved linear BASMI and BASFI scores in the normal CRP subgroup (p < 0.001 and p < 0.01, respectively), while SF-36 PCS improved in both subgroups (both p < 0.05).</p><p><strong>Conclusions: </strong>Ixekizumab showed efficacy in Chinese patients with r-axSpA, irrespective of baseline CRP levels, consistent with results in international populations with r-axSpA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04285229.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"627-639"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144043854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In-Person and Virtual Clinic Visit Frequency to Rheumatologists for Rheumatoid Arthritis at an Academic Medical Center Before, During, and After COVID Lockdown.","authors":"Yuxuan Jiang, Robert S Rudin, Leah M Santacroce, Jamie E Collins, Jackie Stratton, Hallie Altwies, Daniel H Solomon","doi":"10.1007/s40744-025-00768-4","DOIUrl":"10.1007/s40744-025-00768-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to describe outpatient visit volume in a subspecialty clinic before, during, and after COVID lockdown.</p><p><strong>Methods: </strong>We assessed monthly in-person and virtual visit volume (telephone-only or video) of 257 patients with rheumatoid arthritis (RA) at one academic center before, during, and post COVID lockdown, November 2018 to September 2021. The primary outcome was monthly visit volume to a rheumatologist. Visit volume, visit type (in-person vs. virtual), and annual visit frequency per patient were assessed. Piecewise Poisson regression models were constructed to examine visit volume trends. Predictors of patient's visit volume before and after the lockdown were examined using multivariable linear regression.</p><p><strong>Results: </strong>Median patient age was 58 years; 84% were female; 82% used any disease-modifying anti-rheumatic drug (DMARD), and 62% used a targeted or biologic DMARD. Visit volume was stable 18 months prior to the COVID pandemic [slope 1.00 (95% confidence interval (CI) 0.99-1.01)] and increased at a rate of 2% per month post-lockdown [1.02 (95% CI 1.01-1.03)]. In-person visit volume was greatly reduced during the lockdown, with 61% virtual (51% video, 10% telephone). In the 18 months after lockdown, visit volume rebounded to pre-pandemic levels and continued to increase, with 11% virtual. Older age, serologic status, use of combination DMARDs, and non-steroidal anti-inflammatory drug (NSAID) use predicted greater visit volume during the pre-lockdown period. No variables predicted visit volume post-lockdown.</p><p><strong>Conclusion: </strong>While COVID caused a huge disruption in rheumatology practice, visit volume for RA rebounded in one American academic center, with an increasing slope in visit volume after lockdown.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"617-626"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144030913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prophylaxis of Gout Flares in Patients with Renal Impairment: Dosing Adjustments with Colchicine Oral Solution Informed by a Pharmacokinetic Model.","authors":"Jaymin Shah, Michael H Pillinger, Elaine K Chan, Dmitri Lissin","doi":"10.1007/s40744-025-00772-8","DOIUrl":"10.1007/s40744-025-00772-8","url":null,"abstract":"<p><strong>Introduction: </strong>Patients receiving the standard prophylaxis dose of colchicine for gout flares are at increased risk for developing toxicity if there are pre-existing renal impairment or drug-drug interactions. Guidelines recommend exercising caution, deferring dose adjustment to the clinician's discretion.</p><p><strong>Methods: </strong>Pharmacokinetic study data for colchicine oral solution in healthy subjects was used to build a pharmacokinetic model. Using the derived pharmacokinetic disposition parameters from the best fit model and the derived parameters of clearance in patients with renal impairment, simulation of colchicine plasma levels to target 0.5-3 ng/mL with colchicine oral solution was undertaken for various dose levels in different degrees of renal impairment.</p><p><strong>Results: </strong>With the standard colchicine 0.6 mg daily dose, plasma levels are expected to be therapeutic in patients with mild renal impairment (estimated glomerular filtration rate [eGFR] 60-89 mL/min/1.73 m²). However, with this same 0.6 mg daily dose, patients with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²) and severe renal impairment (eGFR of 15-29 mL/min/1.73 m²) would have excursions up to 10% and 36%, respectively, above the maximum tolerated level. Administering a lower dose such as 0.3 mg daily by splitting the conventional 0.6 mg tablet or by administering 0.6 mg once every-other-day (QOD) in moderate renal impairment would result in plasma colchicine levels in subtherapeutic range (< 0.5 ng/mL) for 20-70% of the dosing interval.</p><p><strong>Conclusion: </strong>Analysis of pharmacokinetic model data confirms that the majority of patients with renal impairment taking colchicine solid dosage formulations will be above or below therapeutic levels, exposing them to potential side effects. However, more precise dosing with colchicine oral solution of 0.48 mg (4 mL) or 0.5 mg tablet available in certain countries for moderate renal impairment and 0.3 mg (2.5 mL) for severe renal impairment are associated with optimal levels and safer for patients with renal impairment. No dosage adjustment is needed for patients with mild renal impairment.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"721-730"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12245748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of Accelerated Rituximab Infusion in Rheumatic Diseases: A Systematic Review.","authors":"Jozélio Freire de Carvalho, Samuel de Oliveira Andrade, Ana Tereza Amoedo Martinez, Thelma Skare, Simone Appenzeller","doi":"10.1007/s40744-025-00773-7","DOIUrl":"10.1007/s40744-025-00773-7","url":null,"abstract":"<p><strong>Objective: </strong>To systematically evaluate the safety and feasibility of rapid rituximab (RTX) infusion protocols in patients with autoimmune rheumatic diseases.</p><p><strong>Methods: </strong>A comprehensive literature review was conducted using PubMed, LILACS, and Scielo databases from 1965 to May 2024 without language restrictions. Studies reporting infusion reactions associated with accelerated RTX protocols (infusion over 90 to 120 min) in rheumatologic conditions were included. Infusion-related adverse events were assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (Grades 1-5). Key variables extracted included patient demographics, underlying diseases, RTX dosage, use of premedication, number of infusions, and frequency and severity of infusion reactions.</p><p><strong>Results: </strong>Seven studies encompassing 538 patients aged 14-78 years were included. The patient cohort covered a spectrum of autoimmune rheumatic conditions, including systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, Sjögren's syndrome, systemic sclerosis, IgG4-related disease, and anti-synthetase syndrome. All studies implemented rapid RTX infusion protocols exclusively for the second and subsequent doses. Premedication with acetaminophen, diphenhydramine, and corticosteroids was routine in most studies. RTX dosage varied between 375 mg/m² and 1000 mg, administered in two infusions spaced two weeks apart. The incidence of infusion reactions ranged from 3 to 15%, predominantly of mild severity (Grades 1 and 2), with only six cases classified as Grade 3. No Grade 4 or 5 reactions were reported. Rapid infusion protocols consistently reduced the total time patients spent in infusion clinics.</p><p><strong>Conclusion: </strong>Rapid infusion of RTX in patients with autoimmune rheumatic diseases appears to be a safe and efficient alternative to standard infusion protocols. The frequency and severity of infusion reactions were comparable to traditional infusion rates, with the added benefit of reduced clinic time. These findings support the broader implementation of rapid infusion protocols in rheumatology. However, larger prospective studies with standardized reporting of adverse events are necessary to validate these results and explore the feasibility of even shorter infusion durations, as seen in oncology.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"601-607"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246283/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144302794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcomes of Patients with SLE Treated with Belimumab, Without Versus With Prior Immunosuppressant Use: a US Claims Database Study.","authors":"Karen H Costenbader, Maral DerSarkissian, Yan Chen, Brendan Rabideau, Karen Worley, Theo Man, Bernard Rubin, S Sam Lim","doi":"10.1007/s40744-025-00774-6","DOIUrl":"10.1007/s40744-025-00774-6","url":null,"abstract":"<p><strong>Introduction: </strong>This study examined the benefit of belimumab as standard treatment in patients with systemic lupus erythematosus (SLE) treated without versus with immunosuppressants (IS) prior to belimumab initiation.</p><p><strong>Methods: </strong>This retrospective cohort study (GSK Study 217537) used healthcare claims from the US Komodo Health Database from January 2015 to October 2023. Eligible adults had ≥ 1 inpatient or ≥ 2 outpatient SLE diagnosis codes, ≥ 1 belimumab claim (January 2017-October 2023; index date) and 24 months continuous data pre-index. Two cohorts were defined: those with ≥ 1 claim for non-IS SLE treatment (antimalarials, oral glucocorticoids [OGC] or biologics; non-IS cohort) or ≥ 1 claim for incident IS (IS cohort) within 12 months pre-index. Cohort comparability was assessed across the 12 months before non-IS/IS treatment, applying inverse probability of treatment weighting (IPTW) to adjust for confounding. Outcomes included OGC use, SLE flare rates and healthcare resource utilisation, compared using Cox, Poisson regression and logit models, respectively.</p><p><strong>Results: </strong>Overall, 2190 and 2533 patients were included in IPTW-adjusted non-IS and IS cohorts, respectively. The non-IS cohort had a median (95% confidence interval [CI]) time to OGC discontinuation of 9.8 (8.2, 12.2) months versus 11.7 (10.5, 13.4) for the IS cohort, and a 30% higher likelihood of OGC discontinuation (hazard ratio [95% CI] 1.30 [1.11, 1.52]). The likelihood of OGC dose reduction and discontinuation or dose reduction alone was similar between cohorts. The non-IS versus IS cohort had a lower incidence rate ratio (IRR [95% CI]) of total (0.94 [0.92, 0.96]) and moderate (0.77 [0.74, 0.80]) SLE flares, with similar odds of SLE-related inpatient stays (odds ratio [95% CI] 1.12 [0.94, 1.34]) and emergency visits (1.02 [0.82, 1.27]).</p><p><strong>Conclusion: </strong>In this large, retrospective, real-word study using IPTW adjustment, initiating belimumab without prior IS use was associated with OGC-sparing benefits and reduced incidence and severity of SLE flares.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"679-694"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}