AbbVie’s SKYRIZI® Achieves All Primary and Secondary Endpoints in Head-to-Head Phase 3 SEQUENCE Study Versus Ustekinumab for Moderate to Severe Crohn’s Disease

Recently, AbbVie announced that the Phase 3 SEQUENCE study of SKYRIZI® (risankizumab) versus Stelara® (ustekinumab) for the treatment of moderate to severe Crohn's disease met all primary and secondary endpoints.

SEQUENCE Clinical Trial Evaluates the Efficacy of Risankizumab vs. Ustekinumab in Adult Patients with Moderate to Severe Crohn's Disease and a History of Failure to One or More Anti-Tumor Necrosis Factor (TNF) Therapies Over 48 Weeks. In the Risankizumab group, an induction dose of 600 mg was administered intravenously at weeks 0, 4, and 8, followed by 360 mg subcutaneously every 8 weeks starting from week 12; in the Ustekinumab group, intravenous dosing at week 0 was followed by 90 mg subcutaneously every 8 weeks. The efficacy of the two groups was compared through week 48 in patients with moderate to severe active Crohn's disease who had failed one or more anti-TNF therapies.

The study results met the first primary endpoint, clinical remission at week 24 (defined as CDAI<150 according to the Crohn's Disease Activity Index [CDAI]), with risankizumab being non-inferior to ustekinumab (non-inferiority margin of 10%); the remission rate was 59% in the risankizumab group and 40% in the ustekinumab group.

The study results achieved the second primary endpoint, which was endoscopic remission at week 48 (SES-CD ≤ 4, with a reduction of at least 2 points from baseline and no subscore greater than 1). Risankizumab was superior to ustekinumab; the remission rate in the risankizumab group was 32%, compared to 16% in the ustekinumab group (p<0.0001).

In the SEQUENCE study, the safety profile of risankizumab was consistent with the known safety profile of risankizumab, and no new safety risks were observed. The most common adverse events in the risankizumab treatment group included COVID-19, headache, and Crohn's disease; in the ustekinumab treatment group, the most common adverse events included COVID-19, Crohn's disease, and arthralgia.

The full results of the SEQUENCE study will be presented at upcoming medical conferences and submitted to peer-reviewed journals for publication.

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the global development and commercialization of this product.

Editor: Cotton Tree

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