Symptom Resolution and Meaningful Improvement in Quality of Life With Risankizumab in Patients With Ulcerative Colitis: Post Hoc Analysis of the Randomized INSPIRE and COMMAND Studies.

Abstract

Introduction: Patients with ulcerative colitis (UC) experience disruptive symptoms that can impair quality of life (QoL). This study examined the effect of risankizumab (RZB) induction and maintenance treatment on symptom resolution and health-related QoL (HRQoL) outcomes.

Methods: For the 12-week induction, patients were randomized to intravenous (IV) RZB 1200 mg (RZB1200) or placebo (PBO). For the 52-week maintenance, clinical responders to induction were re-randomized to subcutaneous (SC) RZB 180 mg (RZB180), RZB 360 mg (RZB360), or PBO (RZB withdrawal). This post hoc analysis assessed individual and comprehensive resolution of UC-related symptoms and clinically meaningful within-person changes (MWPCs) for HRQoL outcomes.

Results: RZB improved symptomatic outcomes compared with PBO at week 4 (nominal P ≤ .001; abdominal pain, bowel urgency, fecal incontinence [nominal P ≤ .01]) through the 12-week induction (P ≤ .001; abdominal pain [P ≤ .01]; fecal incontinence, sleep interruption [nominal P ≤ .001]). Greater improvements were achieved with RZB compared with PBO (RZB withdrawal) for symptomatic outcomes through the 52-week maintenance. More patients treated with RZB achieved comprehensive symptom resolution (complete resolution of all six UC-related symptoms) compared with PBO at week 12 of induction (RZB1200, 21.8%; PBO, 9.5% [nominal P ≤ .001]) and week 52 of maintenance (RZB180, 23.5%; RZB360, 19.4%; PBO [RZB withdrawal], 14.2%; nominal P ≤ .05 and P = .1358, respectively). RZB compared with PBO improved MWPCs across HRQoL outcomes at week 12 of induction (nominal P ≤ .001; work time missed [nominal P = .0033]). At week 52 of maintenance, RZB180 compared with PBO (RZB withdrawal) improved MWPCs across HRQoL outcomes (nominal P ≤ .001; overall work impairment [nominal P ≤ .01], work time missed [nominal P = .3324], impairment while working [nominal P ≤ .05]) and more patients treated with RZB360 achieved MWPCs for the Ulcerative Colitis Symptom Questionnaire (UCSQ), Inflammatory Bowel Disease Questionnaire (IBDQ), and the 36-Item Short-Form Survey physical component summary (SF-36 PCS; all nominal P ≤ .05).

Conclusion: RZB treatment improved UC-related symptoms and HRQoL outcomes compared with PBO in patients with UC.

Clinical trials: NCT03398148; NCT03398135.