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Phase 3 Maintenance Results Show Patients with Crohn's Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

Published: 2021-06-02 12:00:00 ET

- In Crohn's disease patients with clinical response to risankizumab IV induction treatment, a significantly greater proportion of patients treated with risankizumab 360 mg SC achieved endoscopic response and clinical remission at one year (52 weeks) versus those who were withdrawn from risankizumab (control group)[1]

- The overall safety results in this study were generally consistent with the known safety profile of risankizumab, with no new safety risks observed[1-7]

- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with moderate to severe Crohn's disease and several other immune-mediated conditions[1,8-10]

NORTH CHICAGO, Ill., June 2, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from the Phase 3 maintenance study, FORTIFY, showing risankizumab 360 mg (subcutaneous [SC]; administered every eight weeks) achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn's disease.1

In this study, patients who responded to 12 weeks of risankizumab intravenous (IV) induction treatment (in a prior study) were re-randomized to receive risankizumab 180 mg, risankizumab 360 mg or withdrawal from risankizumab treatment (risankizumab IV induction-only control group).1 This study included different sets of primary and secondary endpoints for the U.S. analysis plan and the outside of the U.S. (OUS) analysis plan due to regulatory requirements in the different regions.1 The co-primary endpoints were endoscopic response and clinical remission at week 52.1 Clinical remission was defined by Crohn's Disease Activity Index (CDAI) in the U.S. analysis plan and by stool frequency and abdominal pain (SF/AP) in the OUS analysis plan.1

After one year, 47 percent of patients receiving risankizumab 360 mg achieved endoscopic response compared with 22 percent of patients 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.