AbbVie’s Skyrizi (risankizumab) against Stelara (ustekinumab) has met all the primary and secondary endpoints in head-to-head phase 3 SEQUENCE study of in patients with moderately to severely active Crohn’s disease.
Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23 is said to be a cytokine involved in inflammatory processes and is associated with several chronic immune-mediated diseases.
The multi-centre, randomised SEQUENCE trial included two sequentially tested primary endpoints in which the first primary endpoint was clinical remission at week 24.
The results met the non-inferiority of Skyrizi versus Stelara with a remission rate of 59% in risankizumab group and 40% in the ustekinumab group.
As per the results of the second primary endpoint, endoscopic remission at week 48 showed superiority with Skyrizi against Stelara with remission rates of 32% in risankizumab group and 16% in the ustekinumab group.
In addition, the IL-23 inhibitor showed superiority compared to ustekinumab for all ranked secondary endpoints, including achievement of clinical remission at week 48, achievement of endoscopic response at weeks 48 and 24, and others.
Furthermore, the safety profile of Skyrizi was consistent with its known safety profile with no new safety risks observed.
AbbVie chief medical officer and development and regulatory affairs SVP Roopal Thakkar said: “At AbbVie, we are committed to developing medicines and generating evidence that advances care for people living with immune-mediated conditions, including inflammatory bowel diseases.
“Results such as these not only help differentiate Skyrizi as an option for managing Crohn’s disease, but also may help to evolve the field by further informing on therapeutic strategies for patients.”
Risankizumab is cleared for Crohn’s disease, psoriatic arthritis, and psoriasis and is being assessed as a potential treatment for moderate to severe ulcerative colitis.
It was developed as part of a collaboration between Boehringer Ingelheim and AbbVie, with the latter leading the development and marketing around the world.
