Filgotinib for ulcerative colitis holds up in real world

The oral Janus kinase (JAK) 1 preferential inhibitor filgotinib appears to be safe and effective in the treatment of Asian patients with ulcerative colitis, according to real-world data.

The multicentre retrospective study included 238 ulcerative colitis patients in Japan who were treated with filgotinib. The primary outcome was clinical remission (partial Mayo score ≤1 with a rectal bleeding score of 0, or Simple Clinical Colitis Activity Index (SCCAI) ≤2 with a blood-in-stool score of 0). Clinical response, corticosteroid-free remission, and endoscopic improvement, and adverse events were also evaluated. Outcome assessments were performed at 10, 26, and 58 weeks based on patients with available follow-up.

More than half of the patients (54 percent) had prior exposure to biologics/JAK inhibitors. At baseline, the median partial Mayo score was 5 while the median SCCAI was 4. In per-protocol analysis, clinical remission rates were 47.0 percent at 10 weeks, 55.8 percent at 26 weeks, and 64.6 percent at 58 weeks.

There were 39 percent of patients who discontinued therapy. At a median follow-up of 28 weeks, the clinical remission rate was 39.9 percent, the clinical response rate was 54.7 percent, the corticosteroid-free remission rate was 36.5 percent, and the endoscopic improvement rate was 43.5 percent. These rates did not significantly differ between biologic/JAK inhibitor-naïve and -experienced patients.

In terms of safety, three patients (1.3 percent) contracted herpes zoster infection. There were no cases of thrombosis or death documented.