Corticosteroid-Sparing Effects of Filgotinib in Moderately to Severely Active Ulcerative Colitis: Data from the Phase 2b/3 SELECTION Study

Edward V. Loftus, Scrossed D.Sign©verine Vermeire, Brian G. Feagan, Franck Olivier Le Brun, Alessandra Oortwijn, Ulrik Moerch, William J. Sandborn, Toshifumi Hibi

Research output: Contribution to journalArticlepeer-review


Background and Aims: Corticosteroid-free remission is an important treatment goal for patients with ulcerative colitis [UC]. The corticosteroid-sparing effects of filgotinib, an oral, Janus kinase 1 preferential inhibitor, were assessed in SELECTION, a placebo-controlled, phase 2b/3 trial in moderately to severely active UC. Methods: These post hoc analyses assessed 1-, 3-, 6-, and 8-month rates of corticosteroid-free clinical remission at Week 58 and change in median daily prednisone-equivalent dose over time. A matching-adjusted indirect comparison [MAIC] of maintenance studies assessed corticosteroid-free remission with filgotinib 200 mg, intravenous vedolizumab, subcutaneous vedolizumab, and oral tofacitinib. Results: The Maintenance Study full analysis set included 199 patients receiving filgotinib 200 mg and 98 receiving placebo. Among patients receiving corticosteroids at Maintenance Study baseline, at Week 58, 30.4%, 29.3%, 27.2%, and 21.7% receiving filgotinib had been in corticosteroid-free remission for≥1, ≥3, ≥6, or ≥8 months, respectively, versus 6.4% receiving placebo across thresholds [p<0.05]. Median daily prednisone-equivalent dose decreased from 17.5 mg/day to 10.0 mg/day with filgotinib treatment during the Maintenance Study. Based upon the MAIC, filgotinib was associated with greater likelihood of corticosteroid-free clinical remission versus intravenous vedolizumab (odds ratio [OR], 15.2; 95% confidence interval [CI], 1.6-139.9; p<0.05]) and similar odds to subcutaneous vedolizumab [OR, 3.8; CI, 0.2-63.8; p=0.36] in biologic-naïve patients, and similar odds to tofacitinib overall [OR, 2.0; 0.4-9.1; p=0.39]. Conclusions: Filgotinib 200 mg demonstrated corticosteroid-sparing effects and maintained corticosteroid-free clinical remission in patients with UC. MAIC results should be interpreted cautiously given the large CIs and differences in study design and patient populations. [ NCT02914522].

Original languageEnglish (US)
Pages (from-to)211-220
Number of pages10
JournalJournal of Crohn's and Colitis
Issue number2
StatePublished - Feb 1 2023


  • Filgotinib
  • corticosteroids
  • ulcerative colitis

ASJC Scopus subject areas

  • General Medicine


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