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

• Published in: Journal of Crohn's and colitis 2023-03, Vol.17 (2), p.211-220
• Main Authors: Loftus, Edward V, Vermeire, Séverine, Feagan, Brian G, Le Brun, Franck-Olivier, Oortwijn, Alessandra, Moerch, Ulrik, Sandborn, William J, Hibi, Toshifumi
• Format: Article
• Language: English
• Subjects: Adrenal Cortex Hormones - therapeutic use; Colitis, Ulcerative - drug therapy; Humans; Janus Kinase Inhibitors - therapeutic use; Original; Prednisone - therapeutic use; Pyridines - therapeutic use; Triazoles - therapeutic use
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjac122

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. 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. 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