Topline results were announced from a head-to-head study comparing risankizumab (Skyrizi®) to ustekinumab (Stelara®) in patients with moderately to severely active Crohn disease who have failed at least 1 anti-tumor necrosis factor (TNF) therapy.

The SEQUENCE study ( Identifier: NCT04524611) included 527 adults with a confirmed diagnosis of Crohn disease for at least 3 months. Eligible study participants also had a Crohn Disease Activity Index (CDAI) score of 220 to 450 at baseline, a confirmed diagnosis of moderate to severe Crohn disease assessed by stool frequency, abdominal pain score, and Simple Endoscopy Score for Crohn Disease (SES-CD), and had demonstrated intolerance or inadequate response to 1 or more anti-TNF therapies. 

Patients were randomly assigned to receive either risankizumab (600mg intravenous [IV] induction at week 0, 4, and 8, then 360mg subcutaneous [SC] injection at week 12 and every 8 weeks thereafter) or ustekinumab (IV dose at week 0 then 90mg SC every 8 weeks thereafter) for 48 weeks. The coprimary endpoints were clinical remission (defined as CDAI score <150) and endoscopic remission (defined as SES-CD ≤4 and at least a 2-point reduction from baseline and no sub score >1 in any individual variable).

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Results showed risankizumab was noninferior to ustekinumab on the primary endpoint of clinical remission (noninferiority margin of 10%); remission rates were reported to be 59% in the risankizumab arm and 40% in the ustekinumab arm. With regard to endoscopic remission, risankizumab was found to be superior to ustekinumab, with remission rates of 32% and 16%, respectively (P <.0001). No new safety signals were identified in the trial. 

Additional data from the SEQUENCE study will be presented at a future medical meeting, according to AbbVie.


AbbVie’s Skyrizi® (risankizumab) met all primary and secondary endpoints versus Stelara® (ustekinumab) in head-to-head study in Crohn’s disease. News release. AbbVie. September 12, 2023.

This article originally appeared on MPR