Macaluso Fabio Salvatore, Grova Mauro, Bossa Fabrizio, Carparelli Sonia, Pugliese Daniela, Cuccia Giuseppe, Cappello Maria, Muscarella Stefano, Saibeni Simone, Bezzio Cristina, Armuzzi Alessandro, Gravina Antonietta Gerarda, Pellegrino Raffaele, Andrea Caprioli Flavio, Sorge Andrea, Soriano Alessandra, Ribaldone Davide Giuseppe, Festa Stefano, Variola Angela, Ferracane Concetta, Onali Sara, Fantini Massimo Claudio, Orlando Ambrogio
IBD Unit, "Villa Sofia-Cervello" Hospital, Viale Strasburgo 233, Palermo 90146, Italy.
Digestive Endoscopy Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy.
Therap Adv Gastroenterol. 2025 Aug 25;18:17562848251367559. doi: 10.1177/17562848251367559. eCollection 2025.
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).
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.
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.
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.
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%; = 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%; = 0.01).
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.
托法替布（TOFA）在多种风湿性疾病中的疗效引发了人们对其治疗与溃疡性结肠炎（UC）相关的脊柱关节炎（SpA）潜在益处的兴趣。
RETUCAS（托法替布对溃疡性结肠炎相关脊柱关节病的真实世界有效性研究）是首个旨在评估TOFA在UC相关SpA中有效性的研究。
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。使用标准化的风湿病评分评估有效性。
纳入基线时患有UC且确诊为活动性轴向或外周SpA的患者。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）降低⩾1.1个单位，或外周SpA的疾病活动评分28 - CRP降低>0.6个单位，且未使用皮质类固醇。
共纳入44例患者：轴向SpA：9.1%；外周SpA：70.4%；轴向和外周混合型SpA：20.5%。除两名患者外，所有患者此前均接受过生物疗法，其中半数以上患者对两种或更多种生物制剂治疗无效。在第8周，52.3%的患者实现了SFJR，外周SpA患者与轴向或混合型SpA患者之间存在显著差异（67.7%对15.4%；P = 0.001）。在第52周，总体上59.1%的患者维持了SFJR，外周SpA的结果再次优于轴向/混合型SpA（71.0%对30.8%；P = 0.01）。
这是首个专门设计用于评估炎症性肠病相关SpA的前瞻性研究。在患有UC和难治性SpA的患者中——其中许多人此前对多种生物疗法均无效——TOFA显示出有效性，尤其是在外周SpA患者中。
