Real-world Effectiveness of Tofacitinib on Ulcerative Colitis-Associated Spondyloarthropathy: a multicenter prospective study from the Italian Group for the Study of Inflammatory Bowel Diseases (IG-IBD).
Fabio Salvatore Macaluso, Mauro Grova, Fabrizio Bossa, Sonia Carparelli, Daniela Pugliese, Giuseppe Cuccia, Maria Cappello, Stefano Muscarella, Simone Saibeni, Cristina Bezzio, Alessandro Armuzzi, Antonietta Gerarda Gravina, Raffaele Pellegrino, Flavio Andrea Caprioli, Andrea Sorge, Alessandra Soriano, Davide Giuseppe Ribaldone, Stefano Festa, Angela Variola, Concetta Ferracane, Sara Onali, Massimo Claudio Fantini, Ambrogio Orlando
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Abstract
Background: The efficacy of tofacitinib (TOFA) in various rheumatic diseases has generated interest in its potential benefits for treating spondyloarthritis (SpA) associated with ulcerative colitis (UC).
Objectives: RETUCAS (Real-world Effectiveness of Tofacitinib on Ulcerative Colitis-Associated Spondyloarthropathy) is the first study designed to evaluate the effectiveness of TOFA in UC-associated SpA.
Design: This was a prospective, multicentre, single-arm, observational study promoted by the Italian Group for the Study of Inflammatory Bowel Disease. Effectiveness was assessed using standardized rheumatologic scores.
Methods: Patients with UC and a confirmed diagnosis of active axial or peripheral SpA at baseline were enrolled. The primary endpoint was steroid-free joint response (SFJR) at weeks 8 and 52, defined as a decrease of ⩾1.1 units in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (CRP) for axial SpA, or a decrease of >0.6 units in Disease Activity Score 28-CRP for peripheral SpA, without the use of corticosteroids.
Results: A total of 44 patients were enrolled: axial SpA: 9.1%; peripheral SpA: 70.4%; mixed axial and peripheral SpA: 20.5% All but two patients had previous exposure to biologic therapies, with more than half having failed two or more biologics. At week 8, SFJR was achieved in 52.3% of patients, with a significant difference between those with peripheral SpA and those with axial or mixed forms (67.7% vs 15.4%; p = 0.001). At week 52, SFJR was maintained in 59.1% of patients overall, again with better outcomes in peripheral SpA compared to axial/mixed SpA (71.0% vs 30.8%; p = 0.01).
Conclusion: This is the first prospective study specifically designed to assess Inflammatory Bowel Diseases-associated SpA. In patients with UC and refractory SpA-many of whom had previously failed multiple biologic therapies-TOFA demonstrated effectiveness, particularly in those with peripheral SpA.
背景：托法替尼（tofacitinib， TOFA）治疗各种风湿性疾病的疗效引起了人们对其治疗伴有溃疡性结肠炎（UC）的脊椎关节炎（SpA）的潜在益处的兴趣。目的：RETUCAS（托法替尼对溃疡性结肠炎相关脊椎关节病的实际疗效）是第一个旨在评估TOFA在uc相关SpA中的有效性的研究。设计：这是一项由意大利炎症性肠病研究小组推动的前瞻性、多中心、单臂、观察性研究。使用标准化风湿病学评分评估疗效。方法：纳入基线时确诊为活动轴性或外周性SpA的UC患者。主要终点是第8周和第52周的无类固醇关节反应（SFJR），定义为轴向SpA的强直性脊柱炎疾病活动评分- c反应蛋白（CRP）减少小于1.1个单位，或外周SpA的疾病活动评分28-CRP减少小于0.6个单位，不使用皮质类固醇。结果：共入组44例患者：轴向SpA: 9.1%；外围SpA: 70.4%；除两名患者外，所有患者既往均接受过生物治疗，其中一半以上患者两种或两种以上生物药物治疗失败。在第8周，52.3%的患者实现SFJR，外周型SpA与轴向型或混合型SpA之间存在显著差异（67.7% vs 15.4%; p = 0.001）。在第52周，总体上59.1%的患者维持SFJR，与轴向/混合SpA相比，外周SpA的结果更好（71.0% vs 30.8%; p = 0.01）。结论：这是第一个专门用于评估炎症性肠病相关SpA的前瞻性研究。对于UC和难治性SpA患者（其中许多人之前多次生物治疗失败），tofa显示出有效性，特别是对于周围性SpA患者。
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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