Efficacy and safety of filgotinib for the treatment of perianal fistulising Crohn’s disease [DIVERGENCE 2]: A Phase 2, randomised, placebo-controlled trial
J Crohns Colitis 2024;18:864–74 doi: 10.1093/ecco-jcc/jjae003
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.