Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn’s Disease

In the phase 2 CELEST study, positive efficacy results were obtained with Janus kinase 1 inhibitor upadacitinib for adult patients moderate to severe Crohn’s disease. We present health-related quality of life and work productivity improvement from CELEST. (NCT02365649) was a double-blind study where randomized 1:1:1:1:1:1 in 16-week induction period placebo or 3 mg twice daily (BID), 6 BID, 12 24 once (QD). Patients completing re-randomized 1:1:1 receive QD 36 weeks BID (after amendment). Inflammatory Bowel Disease Questionnaire (IBDQ), European Quality Life-5 Dimensions visual analog scale (EQ-5D VAS), Work Productivity Activity Impairment (WPAI) questionnaire outcomes assessed at baseline Weeks 8, 16, 52. At Week significant percentage (P ≤ 0.05) receiving 6-mg dose higher achieved IBDQ response (IBDQ score change ≥ 16 points; 49%–57% vs. 24% placebo) remission, except 170; 26%–39% 11% placebo). Greater improvements total score, EQ-5D VAS, activity impairment 0.1) versus also observed. Larger VAS observed 8 placebo, all dosages maintained greater 52 IBDQ, WPAI endpoints, particular 12-mg group. Improvements sustained ClinicalTrials.gov identifier, NCT02365649.