United European gastroenterology journal, 5 1 2025 Filgotinib Is an Effective and Safe Treatment Option for Difficult-To-Treat Ulcerative Colitis: Real-World Evidence of the Dutch Initiative on Crohn and Colitis (ICC) Registry. Naber MR, van der Meulen AE, Voorneveld PW, Veltkamp SHC, van Bodegraven AA, Bodelier A, Mujagic Z, Pierik M, Verleye LMM, Duijvestein M, Bouwknegt DG, Visschedijk MC, Srivastava N, West RL, Oldenburg B, Löwenberg M, van Schaik FDM, Dutch ICC Registry
Background
Filgotinib is a preferential Janus kinase 1 (JAK-1) inhibitor registered for the treatment of ulcerative colitis (UC). Real-world effectiveness of filgotinib, especially for difficult-to-treat (DTT, failure of ≥ 2 prior advanced therapies) patients, has been scarcely reported.
Objective
This study aimed to assess the effectiveness and safety of filgotinib for UC patients in routine care.
Methods
The Dutch ICC registry enrolled UC patients initiating filgotinib and prospectively evaluated outcomes up to 52 weeks. The primary outcome was corticosteroid-free clinical remission (CSFR, Simple Clinical Colitis Activity Index [SCCAI] ≤ 2 without steroid use) at week 52. Secondary outcomes included clinical remission (SCCAI ≤ 2), biochemical remission (C-reactive protein serum concentration < 5 mg/L and/or faecal calprotectin level < 250 μg/g), treatment persistence and safety.
Results
A total of 96 UC patients were included. At 52 weeks, 39.5% (34/76) of patients with disease activity at baseline were in CSFR. Out of the patients that met the criteria for DTT disease (n = 68; 71%), 36.4% achieved CSFR. Treatment persistence at 52 weeks was 71.4% (CI 56.5-90.3) and 53.4% (CI 42.6-67.0) for non-DTT and DTT patients, respectively. The main reasons for discontinuation of filgotinib were primary non-response (n = 21, 54%) or secondary loss of response (n = 8, 23%). No severe infections were documented. Most reported adverse events included headache (n = 5), nausea (n = 3) and hypercholesterolemia (n = 3).
Conclusion
Filgotinib is an effective and well-tolerated treatment option for UC, including DTT disease. No new safety signals were found.
