Filgotinib seems promising for perianal fistulising Crohn’s disease

Filgotinib was associated with numerically higher response rates than placebo in participants with perianal fistulising Crohn’s disease (PFCD). In addition, the agent was well tolerated in this participant population. Further studies are warranted to confirm the encouraging results of the current, phase 2 DIVERGENCE 2 study, which was underpowered due to low enrollment during the COVID-19 pandemic.

Dr Walter Reinisch (Medical University of Vienna, Austria) explained that infliximab is the only agent with demonstrated efficacy for participants with PFCD in randomised, placebo-controlled trials [1].  The current, double-blind, placebo-controlled, phase 2 DIVERGENCE 2 trial (NCT03077412) investigated the efficacy and safety of filgotinib in participants with PFCD. Filgotinib is a once-daily, oral JAK inhibitor, approved for the treatment of active UC. Participants with PFCD, who failed at least 1 prior therapy, were randomised to 100 mg filgotinib (n=25), 200 mg filgotinib (n=17), or placebo (n=15). The primary endpoint was combined fistula response^a at week 24.

The primary endpoint displayed higher proportion of response for participants in the filgotinib 200 mg arm over placebo (47.1% vs 25%). The combined fistula response in the filgotinib 100 mg arm was 29.2% (see Figure). In addition, the median time to fistula response was shorter in the filgotinib 200 mg arm compared with the placebo arm (15.0 vs 35.5 days), although not significantly different.

Figure: Combined fistula response at week 24 [1]



 

 

 

 

 

 

Dr Reinisch added that filgotinib was in general well tolerated in this participant population. The proportion of treatment-related adverse events was slightly higher in the filgotinib 200 mg arm than in the placebo arm (82.4% vs 73.3%). Also, the proportion of infections was higher in participants receiving 200 mg filgotinib than in participants receiving placebo (64.7% vs 53.3%), but not significant.

“Since limited treatment options are available, PFCD is still a challenging condition that reduces patients’ quality of life. Although the study was underpowered due to limited enrollments during the COVID-19 pandemic, the promising results of this study warrant further investigation of filgotinib in patients with PFCD,” concluded Dr Reinisch.

a. Combined fistula response is defined as the reduction of ≥1 from baseline in the number of draining external perianal fistula openings and absence of fluid collection of >1 cm on MRI.

1. Reinisch W, et al. Efficacy and safety of filgotinib for the treatment of perianal fistulizing Crohn’s Disease: Results from the phase 2 DIVERGENCE 2 study. OP18, ECCO 2022, 16–19 February.

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Posted on 12 April 20228 April 2024