AbbVie's SKYRIZI® (risankizumab) Met All Primary and Secondary Endpoints Versus Stelara® (ustekinumab) in Head-to-Head Study in Crohn's Disease
- Category: Antibodies
- Published on Tuesday, 12 September 2023 14:45
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- SEQUENCE, a Phase 3 head-to-head study (study drug open-label and efficacy assessment blinded) 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 remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at week 48 versus ustekinumab
- All secondary endpoints achieved statistical significance for superiority versus ustekinumab
- Safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified
NORTH CHICAGO, IL, USA I Septemer 12, 2023 I AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3 SEQUENCE clinical trial evaluating risankizumab (SKYRIZI®, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection [SC] starting at week 12 and every 8 weeks thereafter) versus ustekinumab (STELARA®, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) through week 48 in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.
The results of the first primary endpoint, clinical remission (per Crohn's Disease Activity Index [CDAI], defined as CDAI <150) at week 24, met non-inferiority of risankizumab versus ustekinumab (non-inferiority margin of 10%); remission rates were 59% in risankizumab group and 40% in ustekinumab group.1
The results of the second primary endpoint, endoscopic remission (SES-CD ≤4 and at least a 2-point reduction versus baseline and no sub-score greater than 1 in any individual component) at week 48 met superiority of risankizumab versus ustekinumab; remission rates were 32% in risankizumab group and 16% in ustekinumab group (p <0.0001).1
"We are encouraged by these results, which demonstrate the impact SKYRIZI can have in helping patients achieve both clinical and endoscopic remission," said Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, AbbVie. "These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn's disease."
The safety profile of risankizumab in the SEQUENCE study was consistent with the known safety profile of risankizumab, with no new safety risks observed.1 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.1
"Head-to-head studies like the SEQUENCE study are important in helping physicians understand differences in therapies and define treatment algorithms in clinical practice," said Laurent Peyrin-Biroulet, M.D., Ph.D., director of the Infinity Institute, professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy, France. "These results add to our growing body of evidence for SKYRIZI in Crohn's Disease. This study highlights the efficacy of SKYRIZI compared to ustekinumab in helping eligible patients achieve clinical and endoscopic treatment goals and also reinforces the safety profile observed in previous studies."
Full results from the SEQUENCE study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.2,3 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.2,3 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.2
About the SEQUENCE Study1
The SEQUENCE study is a Phase 3, multicenter, randomized, head-to-head study (study drug open-label and efficacy assessment blinded) to evaluate risankizumab with ustekinumab for the treatment of adults with moderate to severe Crohn's disease with a history of one or more failed anti-tumor necrosis factor (TNF) therapies. All participants had confirmed diagnosis of Crohn's disease for at least 3 months, Crohn's Disease Activity Index (CDAI) score of 220 to 450 at baseline, confirmed diagnosis of moderate to severe Crohn's disease assessed by stool frequency, abdominal pain score, Simple Endoscopy Score for Crohn's Disease (SES-CD), and demonstrated intolerance or inadequate response to one or more anti-TNF therapies.
More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT04524611).
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.4 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.5 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.5-7
U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)8
SKYRIZI is a prescription medicine used to treat adults with:
- moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn's disease.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
- 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.