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Skyrizi Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients

NORTH CHICAGO, Ill., June 15, 2023. AbbVie 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<0.01).1

"Through important programs such as the Phase 3 COMMAND study, we continue to drive research and development to help manage the impact of serious gastroenterological conditions," said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "Risankizumab is already approved in moderately to severely active Crohn's disease, and these results demonstrate that this treatment can be a potentially effective option for ulcerative colitis as well."

In COMMAND, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved endoscopic improvement at week 52 vs 32% of patients in the induction-only control group (p<0.001).1 Additionally, significantly more patients treated with risankizumab 180 mg and 360 mg achieved histologic endoscopic mucosal improvement at week 52 compared to those treated with induction only: 43% and 42%, respectively, vs 23% (p<0.001).1 A significantly higher proportion of patients who received risankizumab 180 mg or 360 mg achieved steroid-free clinical remission compared to the induction-only control group at week 52 (40% and 37%, respectively, vs 25%; p<0.01).1

"These positive results suggest that risankizumab is a promising therapy to help ulcerative colitis patients with challenging symptoms that disrupt their daily lives," said Stefan Schreiber, M.D., director of department of internal medicine, University Hospital Schleswig-Holstein, Germany, COMMAND study investigator. "Risankizumab's achievement of a broad range of difficult-to-reach endpoints encompassing endoscopic-histologic outcomes and many others represents important progress toward addressing the need for additional treatment options for patients with ulcerative colitis."

The safety profile of risankizumab in the 52-week, double-blind, placebo-controlled COMMAND study was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed.1 The most common adverse events observed in the risankizumab groups were colitis ulcerative, COVID-19, nasopharyngitis and arthralgia.1 Serious adverse events occurred in 5.2% and 5.1% of patients in the risankizumab 180 mg and 360 mg groups compared to 8.2% of patients in the control group.1 There was one death in the 360 mg group due to adenocarcinoma assessed as unrelated to study drug. There were no adjudicated major adverse cardiac events (MACE) and no adjudicated anaphylactic reaction events.

Full results from the COMMAND study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

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

About Ulcerative Colitis

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.2,3 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death.4,5 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.6

About COMMAND

The COMMAND study is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active ulcerative colitis. This study had a re-randomized withdrawal design in which all patients received risankizumab IV induction and those who responded to risankizumab were re-randomized to receive risankizumab 180 mg or 360 mg SC or withdrawal from risankizumab treatment (induction-only control group). For those randomized to the withdrawal from risankizumab treatment (induction-only control group), the rest of the study duration was a risankizumab washout. The objective of the Phase 3 study is to evaluate the efficacy and safety of risankizumab 180 mg or 360 mg as maintenance therapy versus withdrawal from risankizumab treatment (control) in patients with moderately to severely active ulcerative colitis who responded to risankizumab IV induction in the INSPIRE study.

The primary endpoint is clinical remission (per Adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without evidence of friability) at week 52. Secondary endpoints include endoscopic improvement (endoscopic subscore ≤1 without evidence of friability), HEMI (endoscopic subscore of ≤1 without evidence of friability and Geboes score ≤3.1), and steroid-free clinical remission (defined as clinical remission per Adapted Mayo Score at week 52 and corticosteroid free for ≥90 days prior to week 52) at week 52.

About Risankizumab (SKYRIZI)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.7 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.8 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.8,9,10

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.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

  1. AbbVie. Data on File: ABVRRTI76012
  2. Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
  3. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation of America. Accessed March 8, 2023.https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
  4. Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
  5. Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014;27(2):95-104.
  6. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
  7. Duvallet E, Sererano L, Assier E, Falgarone G, Boissier MC. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011;43(7):503-11. doi:10.3109/07853890.2011.577093
  8. Pipeline. AbbVie. Accessed March 3, 2023. https://www.abbvie.com/our-science/pipeline.html
  9. 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. Updated February 28, 2023. Accessed March 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148
  10. 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. Updated March 10, 2023. Accessed March 12, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148

SOURCE AbbVie

Posted: June 2023

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