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AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints

Published: 2023-10-15 15:15:00 ET

SEQUENCE, a Phase 3 head-to-head study, compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs1
Risankizumab met both primary endpoints of non-inferiority for clinical remissiona (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remissionb at week 48 versus ustekinumab1
Risankizumab showed superiority versus ustekinumab for all ranked secondary endpoints, including achievement of clinical remissiona at week 48, achievement of endoscopic responsec at week 48 and 24, achievement of steroid-free endoscopic remissiond at week 48 and achievement of steroid-free clinical remissione at week 481
Safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified

NORTH CHICAGO, Ill., Oct. 15, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today presented positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of risankizumab (SKYRIZI®, 600 mg intravenous [IV] at week 0, 4 and 8 and 360 mg subcutaneous [SC] starting at week 12 and every 8 weeks thereafter) compared to ustekinumab (STELARA®, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.1 The data were presented at the United European Gastroenterology (UEG) Week 2023, October 14-17.

"At AbbVie, we are committed to developing medicines and generating evidence that advance care for people living with immune-mediated conditions, including inflammatory bowel diseases," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. "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."

The SEQUENCE study included two sequentially tested primary endpoints:

The results of the first primary endpoint, clinical remission (CDAI

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.