Rheumatology and Therapy最新文献

{"title":"Correction: Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub‑analysis of the ProDERM Study.","authors":"Rohit Aggarwal, Joachim Schessl, Zsuzsanna Bata-Csörgő, Mazen M Dimachkie, Zoltan Griger, Sergey Moiseev, Chester V Oddis, Elena Schiopu, Jiri Vencovský, Elisabeth Clodi, Todd Levine, Christina Charles-Schoeman","doi":"10.1007/s40744-026-00873-y","DOIUrl":"10.1007/s40744-026-00873-y","url":null,"abstract":"","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1379-1380"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759935","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":"Real-World Steroid Burden, Treatment Patterns, and Rheumatologists' Perceptions on Advanced Therapy in Giant Cell Arteritis.","authors":"Anisha B Dua, Aditi Kadakia, Patrick Zueger, Simran Marwaha, Nathaniel Zerad, Arathi Setty, William Jones, Valerie Devauchelle-Pensec","doi":"10.1007/s40744-026-00880-z","DOIUrl":"10.1007/s40744-026-00880-z","url":null,"abstract":"<p><strong>Introduction: </strong>Glucocorticoids (GC) are the mainstay of treatment for giant cell arteritis (GCA), but long-term use can cause significant adverse events.</p><p><strong>Methods: </strong>Rheumatologists from European Union-5 (EU-5) countries (France, Germany, Italy, Spain, and the United Kingdom) and the United States who manage patients with GCA were invited to participate in a cross-sectional retrospective survey (Adelphi Real-World GCA Disease Specific Programmes) between May and October 2024. Rheumatologists completed the surveys based on their experiences managing patients with GCA, including patients' demographic and clinical characteristics, treatment histories, and rates of GC-related adverse events; rheumatologists also shared their opinions on advanced therapies and management strategies. Patients for whom their rheumatologists provided information were invited to self-report their treatment experiences and preferences.</p><p><strong>Results: </strong>In total, 196 rheumatologists reported on 846 patient cases, of whom 221 (26.1%) patients self-reported their experiences. Among all 846 patients, 63% were female, with a mean age of 71 years and a median of 15.2 months since GCA diagnosis; ≥ 99% received GCs within the last 12 months. For patients diagnosed with GCA < 12, 12-24, and > 24 months ago, median cumulative GC doses over the last 12 months were 4343, 5200, and 2196 mg, respectively. Despite most rheumatologists intending to stop GCs by 24 months, 80% of patients were receiving an average of 8.4 mg/day at 24- < 36 months, with 75% receiving 5.3 mg/day at ≥ 48 months. Most rheumatologists (≥ 90%) agreed that advanced therapies should be given early in GCA treatment, yet only 48% reported prescribing an advanced therapy at any point after diagnosis. Both patients and rheumatologists reported GC-related adverse events, most commonly weight gain, fatigue, and fluid retention.</p><p><strong>Conclusions: </strong>Despite aiming to taper patients off GCs by 24 months, most patients remained on GCs for ≥ 48 months. Reports of GC-related adverse events highlight the need for early and effective steroid-sparing intervention with advanced therapies.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1341-1355"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851393","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":"Subcutaneous Belimumab Demonstrates Consistent Steady-State Pharmacokinetics and is Well Tolerated in Paediatric Patients with SLE in China: An Open-Label Study.","authors":"Caifeng Li, Junmei Zhang, Meiping Lu, Haiguo Yu, Li Sun, Qihua Feng, Zhihui Li, Jane Chen, Tiantian Liu, Junyi Wu, Xuan Zhou, Haomin Qiu","doi":"10.1007/s40744-026-00878-7","DOIUrl":"10.1007/s40744-026-00878-7","url":null,"abstract":"<p><strong>Introduction: </strong>This study assessed pharmacokinetics and safety of subcutaneous (SC) belimumab in Chinese paediatric patients with systemic lupus erythematosus (cSLE) who previously received intravenous (IV) belimumab; only the IV form is approved for cSLE in China.</p><p><strong>Methods: </strong>This single-arm, open-label, 12-week bridging study (GSK Study 217091) characterised belimumab 200 mg SC exposure in Chinese paediatric patients (5-17 years) with cSLE who completed the 48-week IV belimumab Phase 4 trial (GSK Study 213560). Safety and tolerability of SC belimumab on-treatment and in a 16-week follow-up period were also assessed. Patients were categorised based on weight; data were summarised using descriptive statistics.</p><p><strong>Results: </strong>Overall, 16 patients were enrolled (≥ 15- < 30 kg, n = 1; ≥ 30- < 50 kg, n = 5; ≥ 50 kg, n = 10) with a mean age of 12.9 years. The geometric mean approximate C_max (3 days post-administration) after the first and last dose were 92.44, 63.41 and 68.87 μg/mL, and 28.01, 85.11 and 88.61 μg/mL for the three weight groups, respectively. The geometric mean C_trough at steady state were, 20.44, 71.57 and 85.55 μg/mL for the ≥ 15- < 30 kg, ≥ 30- < 50 kg and ≥ 50 kg weight groups, respectively. Thirteen patients (81%) reported ≥ 1 AE. No SAEs, severe AEs, AESIs, AEs resulting in belimumab discontinuation, deaths, or local injection site reactions were reported.</p><p><strong>Conclusion: </strong>SC belimumab demonstrated expected steady-state exposure and tolerability in Chinese paediatric patients with SLE, supporting its use in this patient population.</p><p><strong>Trial registration: </strong>GSK Study 217091; NCT05917288.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1325-1340"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623809/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148698012","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":"Fertility and Birth Outcomes in Rheumatoid Arthritis: A Narrative Review.","authors":"Noel L Ermer, Lisa R Sammaritano, Caroline H Siegel","doi":"10.1007/s40744-026-00877-8","DOIUrl":"10.1007/s40744-026-00877-8","url":null,"abstract":"<p><p>Rheumatoid arthritis (RA) is a systemic rheumatic disease that often impacts women of childbearing age. Women and men with RA experience higher rates of subfertility compared to the general population. Disease activity, treatment, psychosocial concerns, and sexual dysfunction contribute to subfertility, delayed childbearing, and reduced family size in the RA population. Assisted reproductive technology (ART) procedures are safe and effective options for patients who experience subfertility or are interested in preserving future fertility while continuing pregnancy-incompatible medications. Women with RA also experience increased risk of various adverse pregnancy outcomes compared to the general population, including preterm delivery and having small-for-gestational-age infants. Achieving well-controlled disease on pregnancy-compatible medications prior to conception optimizes maternal and neonatal outcomes. For patients with childbearing potential taking teratogenic medication, contraception is important; there are no RA-specific contraindications to the use of hormonal birth control. Sexual and reproductive health care for women and men with RA requires a multidisciplinary, patient-centered approach. Future studies are needed to elucidate mechanisms of impaired fertility and adverse pregnancy outcomes in RA, to investigate the safety of non-tumor necrosis factor inhibitor biologic disease‑modifying antirheumatic drugs (non-TNFi bDMARDs) during pregnancy and lactation, and to illuminate patient perspectives and priorities regarding their reproductive health across the lifespan.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1203-1221"},"PeriodicalIF":3.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148797499","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 and Economic Burden Among People with Knee Osteoarthritis and Obesity in the United States: A Retrospective Analysis.","authors":"David Schapiro, Magaly Perez-Nieves, Sylvia Gonsahn-Bollie, Kendra Terrell, Ahong Huang, Wenyang Mao, Alexandra Meeks, Pedram Azimzadeh, Julia Fraseur","doi":"10.1007/s40744-026-00856-z","DOIUrl":"10.1007/s40744-026-00856-z","url":null,"abstract":"<p><strong>Introduction: </strong>Obesity and knee osteoarthritis (KOA) are prevalent conditions that significantly impact public health and healthcare costs. We aimed to quantify the economic burden and explore the relationship between obesity and KOA pain.</p><p><strong>Methods: </strong>This study used Optum's de-identified Market Clarity Data from October 1, 2015, to March 31, 2024. Adults (≥ 45 years) with moderate-to-severe osteoarthritis (MTS-OA) knee pain (index date: first-observed claim with a KOA diagnosis between October 1, 2016, and March 31, 2023), with continuous enrollment in commercial, Medicare, or Medicaid healthcare plans for 1 year before and after post index, were included. The presence of KOA pain was identified using a previously validated algorithm. Adjusted annualized all-cause and KOA-related healthcare resource utilization and costs were assessed in the first year after index date, stratified by body mass index (BMI) categories: normal (≥ 18.5 to < 25 kg/m²), overweight (≥ 25 to < 30 kg/m²), Class 1 obesity (≥ 30 to < 35 kg/m²), Class 2 obesity (≥ 35 to < 40 kg/m²), and Class 3 obesity (≥ 40 kg/m²). Models were adjusted for age, race, sex, payor type, baseline Charlson Comorbidity Index score, and baseline cost. Adjusted costs were winsorized at 1%.</p><p><strong>Results: </strong>The prevalence of obesity-related complications was high, particularly among those with a BMI ≥ 35 kg/m². Adjusted total healthcare costs (mean [standard deviation]) SD]) were the highest in individuals with Class 3 ($37,698 [$34,239])) and Class 2 ($33,676 [$29,627]) obesity) compared with those in individuals with normal BMI ($32,402 [$32,290]). Similar trends were observed with pharmacy and medical costs (Class 3: $15,040 [$41,754] and $25,493 [$16,927]; Class 2: $11,088 [$33,879] and $24,075 [$15,540]; normal BMI: $9327 [$32,165] and $23,821 [$17,474]). KOA-specific pharmacy, medical, and total costs followed a similar pattern.</p><p><strong>Conclusions: </strong>In people with MTS-OA knee pain, this descriptive analysis revealed higher observed average overall and disease-specific healthcare expenditure in Class 2 and 3 obesity than in other BMI categories.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1091-1105"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148034426","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":"Fatigue in Sjögren's Disease - Integrating Biomedical and Psychosocial Aspects: A Narrative Review.","authors":"Xinyao Zhou, Jinzhou Chen, Pascal Cathebras, Martin Killian","doi":"10.1007/s40744-026-00865-y","DOIUrl":"10.1007/s40744-026-00865-y","url":null,"abstract":"<p><p>Fatigue is a prevalent and disabling symptom in Sjögren's disease (SjD), yet its pathogenesis remains poorly understood and inadequately managed. This narrative review addresses a critical gap in knowledge by conceptualizing SjD-related fatigue as a bidimensional phenomenon driven by both biomedical and psychosocial mechanisms, and framed within the model of persistent somatic symptoms (PSS). In this narrative review, findings from immunology, neuroendocrinology, psychology, and clinical research were synthesized to examine predisposing, triggering, and maintaining factors contributing to SjD-related fatigue. Particular attention was given to studies exploring immune dysregulation, neuroimmune signaling, autonomic imbalance, and psychological traits. Findings indicate that biomedical contributors-such as pro-inflammatory cytokine (e.g., interleukin [IL]-1β, IL-36α), neuroendocrine dysfunction, dysbiosis, and genetic predispositions-interact with psychosocial vulnerabilities, including early-life adversity, personality profiles, maladaptive coping strategies, and mood disorders. These interactions foster self-reinforcing loops of symptom persistence. Notably, current treatments targeting isolated domains yield limited success. Nonetheless, integrated strategies-ranging from biologics and cytokine modulators to exercise, cognitive behavioral therapy, and neuro-modulatory interventions-have demonstrated promise, particularly when aligned with the PSS framework. This narrative review underscores the need for a paradigm shift in fatigue management, advocating for multidimensional assessment and personalized, multimodal interventions. By illuminating the duality of SjD-related fatigue, this narrative review provides a roadmap for more effective diagnosis, research, and patient-centered care.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"951-984"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148194966","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":"Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis.","authors":"Jozélio Freire de Carvalho, Elizabeth Hautz, Ricard Cervera","doi":"10.1007/s40744-026-00858-x","DOIUrl":"10.1007/s40744-026-00858-x","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with primary antiphospholipid syndrome (PAPS) remain at significant risk of recurrent thrombosis despite long-term anticoagulation. Hydroxychloroquine (HCQ) has demonstrated antithrombotic and immunomodulatory effects in systemic lupus erythematosus and experimental models of antiphospholipid syndrome, but its role in thrombotic PAPS remains incompletely defined. This study aimed to systematically review and quantitatively synthesize the available clinical evidence evaluating hydroxychloroquine as adjunctive therapy for secondary thrombosis prevention in non-pregnant patients with primary antiphospholipid syndrome.</p><p><strong>Methods: </strong>A systematic search of PubMed/MEDLINE, EMBASE, Web of Science, and Scopus was conducted from inception through March 2026, following PRISMA 2020 guidelines. Eligible studies included adult patients with thrombotic PAPS comparing HCQ plus standard antithrombotic therapy versus standard therapy alone. Obstetric APS, systemic lupus erythematosus-associated APS, and primary prevention studies were excluded. The primary outcome was recurrent arterial or venous thrombosis. A qualitative synthesis was performed, followed by an exploratory random-effects meta-analysis using time-to-event or incidence-based effect estimates.</p><p><strong>Results: </strong>Three studies met the inclusion criteria, comprising 164 patients with thrombotic PAPS (82 receiving HCQ and 82 controls), with a cumulative follow-up of approximately 380 patient-years. Across studies, adjunctive HCQ therapy was consistently associated with lower rates of recurrent thrombosis. Absolute risk reductions ranged from 30 to 100%, depending on study design and follow-up duration. The pooled analysis demonstrated a relative risk reduction of approximately 65-70%, corresponding to a summary effect estimate equivalent to a hazard ratio of ~ 0.33, favoring HCQ. No increase in major bleeding or serious adverse events was reported.</p><p><strong>Conclusions: </strong>In non-pregnant patients with thrombotic primary antiphospholipid syndrome, adjunctive hydroxychloroquine therapy was associated with a substantial reduction in recurrent thrombotic events when added to standard anticoagulation. Although based on limited evidence and small studies, the consistency and magnitude of the observed effect support further adequately powered randomized trials and suggest that HCQ may represent a rational adjunctive strategy in selected high-risk PAPS patients.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"985-995"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147864370","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":"Psychological Aspects of Rheumatic Diseases: Psychorheumatology in Clinical Practice.","authors":"Domniki M Karagianni, Christina G Katsiari, Konstantinos Bonotis, Lazaros I Sakkas","doi":"10.1007/s40744-026-00868-9","DOIUrl":"10.1007/s40744-026-00868-9","url":null,"abstract":"<p><p>Rheumatic diseases (RDs) significantly impact patients' physical, psychological, and social well-being, yet psychological dimensions remain inadequately addressed in routine clinical practice. In this commentary, we examine psychological manifestations and mental health comorbidities in RDs, such as systemic lupus erythematosus, systemic sclerosis, Sjögren's disease, vasculitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, osteoarthritis, and fibromyalgia. Patients demonstrate high rates of depression (up to 90% lifetime prevalence), anxiety (18-65%), sleep disturbances (19-90%), chronic fatigue (31-89%), and alexithymia (25-59%). The prevalence of anxiety and depression is nearly double in RDs compared to the general population, whereas health-related quality of life is inferior to that in chronic conditions. These manifestations are bidirectionally linked to disease activity, pain intensity, and functional impairment. We propose the utilization of psychorheumatology, integrating psychological assessment, targeted interventions, and coordinated care between rheumatologists and mental health professionals.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"885-898"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148309321","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":"Longitudinal Trajectories and Predictors of Health-Related Quality of Life in Systemic Lupus Erythematosus: A 2-Year Longitudinal Cohort Study.","authors":"Wan-Yun Hsu, Ching-Yi Lai, Li-Yun Tsai, I-Chieh Chen, Jun-Peng Chen, Kai-Ting Chen, Chung-Mao Kao, Yen-Ju Chen, Kuo-Tung Tang, Wei-Ting Hung, Wen-Nan Huang, Yi-Ming Chen","doi":"10.1007/s40744-026-00864-z","DOIUrl":"10.1007/s40744-026-00864-z","url":null,"abstract":"<p><strong>Introduction: </strong>Health-related quality of life (HRQoL) is a critical patient-reported outcome in systemic lupus erythematosus (SLE). We aimed to evaluate longitudinal trajectories of HRQoL and identify associated clinical and demographic determinants.</p><p><strong>Methods: </strong>This longitudinal cohort study included 1005 patients with SLE from the Asia Pacific Lupus Collaboration. HRQoL was assessed using the Short Form-36 (SF-36) at baseline, 12, and 24 months. Disease activity and organ damage were recorded using validated composite indices (SLEDAI-2 K and SLICC damage index). Generalized estimating equations (GEE) analyzed longitudinal trajectories of Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.</p><p><strong>Results: </strong>Among 915 women (91.0%) with median age 35.2 years, both PCS and MCS scores remained stable over 24 months (PCS: p = 0.822; MCS: p = 0.819). Age ≥ 50 years was associated with lower PCS (β =  - 5.80, p = 3.85 × 10 ^-9) but higher MCS (β = 2.09, p = 0.032). Male sex predicted higher MCS (β = 3.50, p = 2.70 × 10^-5). Higher SLEDAI-2 K was associated with lower PCS and MCS (both p < 0.05). SLICC damage index negatively affected PCS (β =  - 1.87, p < 0.001) and MCS (β =  - 0.75, p = 0.006). Musculoskeletal and cardiovascular damage had the strongest associations with reduced PCS, while no organ-specific damage remained significantly associated with MCS after adjustment.</p><p><strong>Conclusions: </strong>HRQoL in SLE remained stable over 2 years. Disease activity and cumulative organ damage were the primary determinants. Organ-specific damage differentially influenced physical but not mental health domains, underscoring the need for domain-tailored assessment and management strategies.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1125-1139"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407827/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148227853","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 Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level: A Pooled Analysis of Phase III Trials.","authors":"Raj Sengupta, Pedro M Machado, Philippe Goupille, Martin Rudwaleit, Mohamed Sheesh, Khai Jing Ng, Marcus Ngantcha, Yan Yan, Hagen Russ, Gabriel Doridot, Yu Xue, Denis Poddubnyy, Xenofon Baraliakos, Victoria Navarro-Compán","doi":"10.1007/s40744-026-00862-1","DOIUrl":"10.1007/s40744-026-00862-1","url":null,"abstract":"<p><strong>Introduction: </strong>C-reactive protein (CRP) predicts radiographic progression in radiographic axial spondyloarthritis (r-axSpA). Normal CRP levels have been associated with reduced response to tumor necrosis factor inhibitor treatment. Ixekizumab (IXE) has demonstrated effectiveness in smaller patient groups stratified by CRP at baseline. This pooled analysis aims to demonstrate efficacy stratified by CRP across a broader population.</p><p><strong>Methods: </strong>This post hoc analysis pooled biologic-naïve patients with r-axSpA from two phase III trials: COAST-V (N = 168) and NCT04285229 (N = 130), with participants receiving IXE 80 mg every 4 weeks or placebo for up to 52 weeks. Analyses evaluated outcomes in patients stratified by CRP at baseline (≤ 5 mg/L or > 5 mg/L). A second analysis subgrouped patients based on magnetic resonance imaging (MRI)-detected inflammation in the spine or sacroiliac joints (SIJ).</p><p><strong>Results: </strong>Baseline characteristics were comparable between normal (N = 105 [35.2%]) and elevated CRP (N = 193 [64.8%]) groups, except for corticosteroid use, MRI-SPARCC spine and SIJ total scores, and ASDAS. Across groups, 67.8-81.8% of patients had MRI inflammation. By week 52, IXE demonstrated improvements in ASAS40 (61.2% [normal CRP], 63.0% [elevated CRP]), ASDAS LDA/ID (69.4% [normal CRP], 58.8% [elevated CRP]), and BASDAI50 (55.1% [normal CRP], 63.0% [elevated CRP]) compared with placebo. Similar improvements were observed across CRP groups for patients with MRI evidence of inflammation at weeks 16 and 52.</p><p><strong>Conclusion: </strong>Patients with r-axSpA and normal CRP at baseline have a similar disease burden to those with elevated CRP. IXE provides significant clinical benefits across key outcome measures regardless of CRP level.</p><p><strong>Clinical trial registration numbers: </strong>NCT02696785 and NCT04285229.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1107-1124"},"PeriodicalIF":3.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13407819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144465","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}