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Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients

Published: 2023-06-15 12:45:00 ET

In ulcerative colitis patients with a clinical response to risankizumab induction treatment, a significantly higher proportion of patients treated with risankizumab (180 mg or 360 mg) achieved the primary endpoint of clinical remissiona (per Adapted Mayo Score) at week 52 compared to withdrawal from risankizumab treatment1
Key secondary endpoints were met, including endoscopic improvementb, histologic endoscopic mucosal improvementc and steroid-free remissiond at one year
Safety results in this study were consistent with the known safety profile of risankizumab, with no new safety risks observed1
Building on AbbVie's growing gastroenterology portfolio, risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderate to severe ulcerative colitis and approved for Crohn's disease, psoriatic arthritis and psoriasis1

NORTH CHICAGO, Ill., June 15, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from COMMAND, its Phase 3 maintenance study, showing risankizumab (SKYRIZI®, 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the COMMAND maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment (risankizumab intravenous [IV] induction-only control group).1 Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for ulcerative colitis.1

A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the induction-only control group (p

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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.