Efficacy and safety of filgotinib for ulcerative colitis: A real-world multicenter retrospective study in Japan

Area of Science:

• Gastroenterology
• Pharmacology
• Clinical Medicine

Background:

• Filgotinib, a selective Janus kinase (JAK) 1 inhibitor, is approved for moderate to severe ulcerative colitis (UC).
• Limited real-world data exist on the short- and long-term efficacy and safety of filgotinib in UC patients.

Purpose of the Study:

• To evaluate the real-world clinical efficacy and safety of filgotinib in patients with ulcerative colitis (UC).
• To assess outcomes such as clinical remission, response, corticosteroid-free remission, and endoscopic improvement.

Main Methods:

• Multicenter, retrospective study of 238 UC patients initiating filgotinib (March 2022 - September 2023).
• Primary outcome: clinical remission (defined by partial Mayo score or SCCAI).
• Secondary outcomes and adverse events assessed at 10, 26, and 58 weeks.

Main Results:

• Clinical remission rates at 10, 26, and 58 weeks were 47%, 55.8%, and 64.6% respectively (per-protocol).
• At median 28-week follow-up, overall clinical remission was 39.9% and clinical response was 54.7%.
• Favorable outcomes were observed in both biologic/JAK inhibitor-naïve and experienced patients; herpes zoster occurred in 1.3%, with no thrombosis or deaths.

Conclusions:

• Real-world data indicate favorable clinical efficacy and safety profiles for filgotinib in ulcerative colitis (UC) management.
• Filgotinib demonstrates promising outcomes in a diverse UC patient population, including those with prior advanced therapy exposure.