AbbVie has confirmed that its Crohn’s disease drug Skyrizi has hit both of its two primary end points. Credit: Shutterstock / Emily frost

AbbVie has announced positive results from its Phase III head-to-head study evaluating the efficacy and safety of Crohn’s disease drug Skyrizi (risankizumab) hitting two of its primary endpoints.

The data analysis found that the drug showed superiority against the comparator Stelara for all ranked secondary endpoints, including achievement of clinical remission at week 48.

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The Phase III head-to-head study compared Skyrizi to Janssen’s Stelara (ustekinumab) in adult patients with moderately to severe Crohn’s disease. The SEQUENCE trial also saw the achievement of an endoscopic response at weeks 48 and 24.

The Chicago-based firm set two primary endpoints as part of the Phase III trial, the first focused on clinical remission, with the study finding that patients administered Skyrizi saw remission rates of 59%, whilst patients administered Stelara experienced a slightly lower remission rate of 40%.

The second primary endpoint sought to examine endoscopic remission of Crohn’s disease at week 48, with Skyrizi demonstrating a 32% rate of remission, whilst Stelara showed a remission rate of 16%.

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Additionally, Skyrizi demonstrated superiority over Stelara for all ranked secondary endpoints, which included clinical remission at week 48, achievement of endoscopic response at week 48 and 24, as well as steroid-free endoscopic remission at week 48.

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Laurent Peyrin-Biroulet, head of the inflammatory bowel disease group at the University Hospital of Nancy, said: “The results from the SEQUENCE study provide physicians with important data to help inform therapy options that can help patients reach treatment goals.

“These findings reaffirm Skyrizi as an efficacious interleukin-23 inhibitor that can support the achievement of stringent targets that contribute to improved care for patients.”

According to GlobalData’s, the US market size for Crohn’s disease-related treatments averaged around $7.4m in 2022, with the market size expected to grow to $12.2m by 2033. GlobalData is the parent company to Clinical Trials Arena.