Efficacy of Filgotinib for Treating Chronic Antibiotic‐Dependent Pouchitis: A Pilot Study

ABSTRACT Background and Aims Ileal pouch anal anastomosis is a standard reconstruction procedure during restorative proctocolectomy for ulcerative colitis; however, pouchitis is a major postoperative complication, especially chronic pouchitis. A treatment strategy for chronic pouchitis has not yet been established. We conducted a prospective study to evaluate the efficacy of filgotinib for treating chronic antibiotic‐dependent pouchitis. Methods A single‐centre, single‐arm, open‐label, exploratory prospective cohort study was conducted. Patients were treated with 200 mg of filgotinib once daily. The total follow‐up period was 54 weeks. The primary endpoint was clinical remission at 54 weeks of treatment, which was defined as remission maintained without the use of antibiotics or corticosteroids. Clinical remission was defined as a modified pouchitis disease activity index (mPDAI) of ≤ 4 with a reduction of at least 2 points from baseline. Secondary endpoints included changes in the mPDAI from baseline to week 8. Results Ten patients were treated with filgotinib. Five patients experienced clinical remission during the 8‐week treatment period. The median (range) baseline mPDAI score was 8 (6–9), comprising a clinical subscore of 4 (2–5) and an endoscopic subscore of 4 (4–5). At 54 weeks, 20% of patients were in sustained clinical remission without antibiotic use. No filgotinib‐related adverse events were observed. Conclusions After 8 weeks of filgotinib treatment, 50% of patients with chronic antibiotic‐dependent pouchitis achieved a clinical response. The long‐term remission rate at 54 weeks without antibiotic use was 20%.