Risankizumab Meets All Endpoints Vs Ustekinumab for Crohn's Disease Advances

In the phase 3 head-to-head SEQUENCE study, risankizumab met all primary and secondary endpoints including noninferiority to ustekinumab for inducing clinical remission among patients with moderate to severe Crohn’s disease at week 24, and superiority to ustekinumab in achieving endoscopic remission at week 48.

Patients treated with risankizumab during the trial achieved clinical remission rates of 59% versus 40% among patients treated with ustekinumab; 32% in risankizumab group and 16% in ustekinumab group achieved endoscopic remission, according to AbbVie, which announced the results on September 12.

SEQUENCE compared the efficacy and safety of risankizumab versus ustekinumab among adult patients with moderately to severely active Crohn's disease who had failed one or more tumor necrosis factor inhibitors (TNFis). Patients received 600 mg intravenous (IV) risankizumab at weeks 0, 4, and 8, followed by 360 mg subcutaneous injection (SC) starting at week 12 and every 8 weeks thereafter. The ustekinumab cohort received an IV dose at week 0 and 90 mg SC every 8 weeks after.

Clinical remission was measured by the Crohn's Disease Activity Index (CDAI) at week 24. For the second primary endpoint, endoscopic remission was defined as a Simple Endoscopic Score-Crohn’s Disease (SES-CD) of ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual component.

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

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. 

Risankizumab (Skyrizi) is an interleukin-23 (IL-23) inhibitor that binds to its p19 subunit. Risankizumab is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of Crohn's disease, plaque psoriasis, and psoriatic arthritis. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.

References:

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. Accessed October 10, 2023. https://news.abbvie.com/news/press-releases/abbvies-skyrizi-risankizumab-met-all-primary-and-secondary-endpoints-versus-stelara-ustekinumab-in-head-to-head-study-in-crohns-disease.htm

AbbVie. Data on File: ABVRRTI76627

Crohn's disease. symptoms and causes. Mayo Clinic. Accessed September 1, 2023. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.

The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation of America. Published November 2014. Accessed September 1, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.

SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed on September 11, 2023.

Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 22, 2022.

A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov identifier: NCT03671148. Updated February 28, 2023. Accessed March 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148

A multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis. ClinicalTrials.gov identifier: NCT03398148. Updated March 10, 2023. Accessed March 12, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148 

SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.