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. 2025 Aug 25:18:17562848251367559.
doi: 10.1177/17562848251367559. eCollection 2025.

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  1 , Mauro Grova  2 , Fabrizio Bossa  3 , Sonia Carparelli  3 , Daniela Pugliese  4   5 , Giuseppe Cuccia  4   5 , Maria Cappello  6 , Stefano Muscarella  6 , Simone Saibeni  7 , Cristina Bezzio  8   9 , Alessandro Armuzzi  8   9 , Antonietta Gerarda Gravina  10 , Raffaele Pellegrino  10 , Flavio Andrea Caprioli  11   12 , Andrea Sorge  11   12 , Alessandra Soriano  13 , Davide Giuseppe Ribaldone  14 , Stefano Festa  15 , Angela Variola  16 , Concetta Ferracane  17 , Sara Onali  18   19 , Massimo Claudio Fantini  18   19 , Ambrogio Orlando  20
Affiliations

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 et al. Therap Adv Gastroenterol. .

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.

Keywords: arthritis; extraintestinal manifestations; tofacitinib.

Plain language summary

Tofacitinib helps control joint symptoms in people with ulcerative colitis: Results from a real-world Italian study People with ulcerative colitis (UC) often experience joint inflammation, a condition known as spondyloarthritis (SpA). This study looked at whether a medication called tofacitinib, already used for UC and some joint diseases, could also help manage joint problems linked to UC. Researchers across multiple centers in Italy followed 44 patients with UC and active joint symptoms (either in the spine, limbs, or both) who started taking tofacitinib. They checked whether the patients’ joint symptoms improved without needing steroids after 8 weeks and again after 1 year. After 8 weeks, about half of the patients showed improvement without using steroids. The results were more positive in patients with joint problems in the limbs (called peripheral SpA) compared to those with spinal involvement (axial SpA). After 1 year, around 6 in 10 patients had improved, again with better results seen in peripheral SpA. This is the first study focused specifically on UC-related joint inflammation using rheumatology-specific tools. It suggests that tofacitinib can be effective for joint symptoms, especially in the limbs, in patients with UC who have not responded to other treatments.

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Figures

{“content”: “Study flow diagram.”}
Figure 1.
Study flow diagram.
Bar graph showing SFJR rates at 8 and 52 weeks in UC-associated SpA patients on tofacitinib, with percentages at each time point.
Figure 2.
SFJR rates at weeks 8 and 52 in patients with UC-associated SpA treated with tofacitinib. Bars represent the percentage of patients achieving SFJR. SFJR, steroid-free joint remission; SpA, spondyloarthritis; UC, ulcerative colitis.
The image shows a line chart comparing MSDAS-CRP and DAS28-CRP scores over different time points in a clinical study of patients with
Figure 3.
Mean values of ASDAS-CRP and DAS28-CRP at baseline, week 8, and week 52 in patients with UC-associated SpA treated with tofacitinib. Values represent disease activity scores for axial and peripheral SpA, respectively. ASDAS, Ankylosing Spondylitis Disease Activity Score; CRP, C-reactive protein; DAS28, Disease Activity Score 28; SpA, spondyloarthritis; UC, ulcerative colitis.
See this image and copyright information in PMC

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