Background and aims: Normalized quality of life represents a crucial long-term treatment goal in Crohn’s disease (CD). We evaluated the effect of risankizumab (RZB) versus ustekinumab (UST) on achieving clinically meaningful improvements in patient-reported outcomes (PROs) in the phase 3b head-to-head SEQUENCE study. Methods: Adults with moderate-to-severe CD who have failed prior anti-tumor necrosis factor therapy were randomized 1:1 to recommended induction and maintenance doses of RZB or UST. The proportion of patients who achieved Inflammatory Bowel Disease Questionnaire (IBDQ) response, IBDQ remission, and improvements in 36-item Short-Form Health Survey (SF-36v2) physical and mental component summary (PCS and MCS, respectively) scores was evaluated at weeks 24 and 48. The proportion of patients experiencing improvement in select symptoms of the IBDQ was reported. Results: Analysis included 520 patients (RZB: N=255; UST: N=265). At week 24, greater proportions (all P ≤.01) of RZB- versus UST-treated patients achieved IBDQ response (75.3% vs 64.2%), IBDQ remission (52.5% vs 30.9%), and improvements in SF-36v2 PCS (65.9% vs 53.2%). At 24 weeks, lower proportions (all P ≤.05) of RZB- versus UST-treated patients experienced fatigue (51.4% vs 69.1%), difficulty sleeping (37.7% vs 54.3%), depression (34.1% vs 42.6%), anxiety (34.1% vs 49.8%), and bowel urgency (27.1% vs 40.0%) “all of the time to some of the time.” Improvements were sustained through week 48. Conclusions: RZB was more effective than UST in achieving sustained clinically meaningful PRO improvements including IBDQ response and remission, and in reducing frequency of select symptoms of the IBDQ through week 48 among patients with moderate-to-severe CD.
Loftus et al. (Tue,) studied this question.