SKYRIZI Demonstrates Clinical Superiority Over STELARA in Treatment-Resistant Crohn's Disease: SEQUENCE Trial Outcomes

Trial Design and Patient Population

The Phase 3 SEQUENCE study represents a direct comparative analysis of two prominent biologic therapies in inflammatory bowel disease management. The research enrolled adult patients with moderately to severely active Crohn’s disease who had experienced treatment failure with one or more anti-TNF therapies. Participants received either risankizumab (SKYRIZI) via intravenous administration at weeks 0, 4, and 8, followed by subcutaneous maintenance dosing of 360 mg every 8 weeks starting at week 12, or ustekinumab (STELARA) delivered as an initial IV dose at week 0 and 90 mg subcutaneous injections every 8 weeks thereafter.

Primary Efficacy Outcomes

The trial’s efficacy assessment centered on two sequential primary endpoints. SKYRIZI achieved clinical remission non-inferiority at week 24, measured using the Crohn’s Disease Activity Index (CDAI). More notably, risankizumab demonstrated superior endoscopic remission compared to ustekinumab at the week 48 assessment point. These findings underscore a meaningful advancement in disease control for patients who have previously exhausted anti-TNF treatment options.

Secondary Efficacy Measures and Clinical Benefits

Beyond the primary endpoints, SKYRIZI consistently outperformed STELARA across all ranked secondary outcome measures. The analysis revealed superiority in achieving clinical remission at week 48, with additionally higher rates of endoscopic response documented at both week 24 and week 48. Particularly significant was SKYRIZI’s enhanced performance in steroid-free remission markers—both endoscopic and clinical—at week 48 timepoints.

Safety and Tolerability Profile

Evaluation of adverse events confirmed that risankizumab’s safety characteristics remained consistent with its established safety profile observed in prior clinical investigations. The comparative analysis identified no novel safety signals or previously unknown risks during the study period, providing reassurance regarding the therapeutic window of SKYRIZI in this patient population.

Clinical Implications

According to AbbVie’s medical leadership, these comparative trial results contribute to the evolving understanding of treatment optimization strategies in inflammatory bowel disease. The data position SKYRIZI as a differentiated therapeutic option for patients with anti-TNF refractory Crohn’s disease, potentially reshaping clinical decision-making algorithms for treatment sequencing in this challenging patient subset.