Rapid and Sustained Symptom Relief in Patients With Ulcerative Colitis Treated With Filgotinib: Data From the Phase 2b/3 SELECTION Trial

Patients with ulcerative colitis (UC) regard rapid onset of action among the most important aspects of their treatment. We used partial Mayo Clinic Score (pMCS) and the component patient-reported subscores to assess rapidity and sustainability of response to filgotinib, a once-daily, oral Janus kinase 1 preferential inhibitor, in adults with moderately to severely active UC in the phase 2b/3 SELECTION trial. The association between early symptomatic improvements and health-related quality of life (HRQoL) outcomes was also assessed.In these post hoc analyses of the double-blind, randomized, placebo-controlled 58-week SELECTION trial (NCT02914522), rectal bleeding (RB) and stool frequency (SF) diary data were evaluated on days 1-15, and pMCS remission and response at multiple time points including weeks 10 and 58. HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) at weeks 10 and 58.Filgotinib 200 mg relative to placebo improved RB and SF within 7 days (P < 0.05). By week 2, greater proportions of filgotinib 200 mg- than placebo-treated patients achieved pMCS remission (biologic-naive, 15.1% vs 8.0%, P = 0.0410; biologic-experienced, 10.3% vs 4.2%, P = 0.0274). A similar treatment effect was observed at week 58 (P < 0.0001). Day 7 RB and SF subscores were associated with MCS response at weeks 10 and 58. Patients in pMCS remission at weeks 10 and 58 had greater improvements in IBDQ score than those not in pMCS remission.CONCLUSIONS: Filgotinib 200 mg daily resulted in rapid and sustained improvements in both UC symptoms and HRQoL.