Risankizumab Outperformed Ustekinumab on Patient-Reported Outcomes in Crohn’s Disease

Risankizumab (RZB) was associated with greater improvements in quality of life and symptom burden than ustekinumab (UST) among patients with moderate-to-severe Crohn’s disease (CD) who previously failed antitumor necrosis factor therapy, according to results from the phase 3b SEQUENCE study.

The head-to-head trial evaluated patient-reported outcomes (PROs) in adults with moderate-to-severe CD randomized 1:1 to receive recommended induction and maintenance regimens of either risankizumab or ustekinumab. Investigators assessed improvements in Inflammatory Bowel Disease Questionnaire (IBDQ) response and remission rates, as well as changes in Short-Form Health Survey (SF-36v2) physical and mental health scores.

The analysis included 520 patients, with 255 receiving risankizumab and 265 receiving ustekinumab.

At week 24, risankizumab demonstrated superior outcomes across multiple measures. A greater proportion of patients receiving risankizumab achieved IBDQ response compared with ustekinumab (75.3% vs 64.2%). IBDQ remission rates were also higher with risankizumab (52.5% vs 30.9%). Improvements in SF-36v2 physical component summary scores occurred in 65.9% of risankizumab-treated patients compared with 53.2% of those treated with ustekinumab. All differences were statistically significant (P ≤ .01).

The study also evaluated individual symptoms captured within the IBDQ. At week 24, fewer patients treated with risankizumab reported persistent 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%) compared with ustekinumab-treated patients. All symptom differences reached statistical significance (P ≤ .05).

The investigators concluded that “RZB was more effective than UST in achieving sustained clinically meaningful PRO improvements including IBDQ response and remission.” They further reported that risankizumab was more effective “in reducing frequency of select symptoms of the IBDQ through week 48.”

<Reference
Loftus EV Jr, Joshi N, Sands BE, et al. Improvement in health-related quality of life in patients with moderate to severe crohn's disease treated with risankizumab versus ustekinumab in the phase 3B SEQUENCE study. Am J Gastroenterol. Published online May 5, 2026. doi:10.14309/ajg.0000000000004044