ABSTRACT 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.
Naber et al. (Fri,) studied this question.