The phase 2B/3 SELECTION study found that the JAK1 inhibitor filgotinib was effective and well-tolerated as maintenance treatment for patients with moderately to severely active ulcerative colitis who had achieved a clinical response to induction treatment with this drug1.
Filgotinib is being investigated for several inflammatory conditions, including ulcerative colitis. The SELECTION maintenance study evaluated maintenance treatment with filgotinib in 664 patients with moderately to severely active ulcerative colitis who achieved clinical remission or Mayo Clinic Score response after 10 weeks of induction with filgotinib 100 mg or 200 mg or placebo. Approximately 40% of patients were biologic experienced. Patients randomized to filgotinib induction were re-randomized to their induction filgotinib dose or placebo. Patients randomized to placebo during induction continued placebo maintenance. Mandatory steroid tapering was required.
The primary endpoint was endoscopic/rectal bleeding/stool frequency (EBS) remission at week 58, defined by Mayo endoscopic subscore ≤1, rectal bleeding subscore=0, and ≥1-point decrease in stool frequency subscore (SFS) from baseline and SFS ≤1. A significantly higher proportion of patients on filgotinib achieved EBS remission compared with placebo:
In addition, significantly higher proportions of patients achieved key secondary endpoints, including 6-month corticosteroid-free clinical remission and histologic remission, with filgotinib 200 mg versus placebo:
Overall, the incidences of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar across treatment arms. Serious infection and herpes zoster infection were infrequent across groups, and no opportunistic infections occurred. There were also no venous thromboses, including pulmonary embolism, among filgotinib-treated patients.
The current analysis of the SELECTION study showed that filgotinib was effective as maintenance treatment for patients with moderately to severely active ulcerative colitis who had achieved a clinical response to induction treatment with filgotinib. In addition, filgotinib 200 mg met all key secondary endpoints including endoscopic, histologic, and 6-month corticosteroid-free remission.
1. Peyrin-Biroulet L. Efficacy and safety of filgotinib as maintenance therapy for patients with moderately to severely active ulcerative colitis: results from the phase 2B/3 SELECTION study. UEG Week E-congress 2020, abstract LB20.