Efficacy and safety of filgotinib for the treatment of perianal fistulising Crohn’s disease [DIVERGENCE 2]: A Phase 2, randomised, placebo-controlled trial

Filgotinib (FIL) 200mg was associated with numerical reductions in the number of draining perianal fistulas based on combined clinical and MRI findings compared with placebo. Reinisch et al. reported a numerically higher proportion of patients achieving the primary endpoint of a combined fistula response and/or remission at Week 24 with FIL 200mg compared with placebo.

Both FIL doses were associated with numerical improvements in median time to clinical fistula response and/or remission, and mean change from baseline to Week 24 in PDAI score compared with placebo. TEAE rates were similar between treatment groups; TESAEs were highest in the FIL 200mg group.