The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI) in Crohn’s Disease – BioSpace

NORTH CHICAGO, Ill., May 27, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study) evaluating risankizumab (SKYRIZI) in patients with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Data from the three studies formed the basis of the company's application for approval by the global health authorities. The publication of ADVANCE and MOTIVATE reports the efficacy and safety results of the two induction studies evaluating clinical remission and endoscopic response with intravenous (IV) risankizumab versus placebo over 12 weeks.1 The publication of FORTIFY shares the results of the maintenance study evaluating the safety and efficacy of subcutaneous (SC) risankizumab versus placebo (the withdrawal from IV risankizumab) over 52 weeks in patients who achieved clinical response during the ADVANCE and MOTIVATE studies.2

The use of risankizumab for Crohn's disease is not approved and its safety and efficacy remain under regulatory review.

About Crohn's DiseaseCrohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain.3,4,5 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients.2,3 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the diseasenot only physically, but also emotionally and economically.6

About the ADVANCE and MOTIVATE Studies7,8,9,10The ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, in adults with moderate to severe Crohn's disease, compared to placebo. Both studies included different sets of primary and secondary endpoints for outside U.S. (OUS) protocol and U.S. protocol. The primary endpoints were achievement of clinical remission (per PRO-2 for the OUS protocol, which was measured by daily stool frequency and abdominal pain score, and per CDAI for the U.S. protocol, which was measured by a CDAI score less than 150) and endoscopic response (for both protocols) at week 12. Endoscopic response is defined as a decrease in SES-CD of greater than 50 percent from baseline (or at least a greater than or equal to 50 percent decrease from baseline in patients with isolated ileal disease and a baseline SES-CD of 4), as scored by a central reviewer.

The ADVANCE study included a mixed population of patients who had responded inadequately or were intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy. Topline results of the studies were shared in January 2021. More information can be found on http://www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).

About the FORTIFY Study11,12The FORTIFY study is a Phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab 180 mg and 360 mg as maintenance therapy versus withdrawal in patients who responded to risankizumab induction treatment in the ADVANCE and MOTIVATE studies. This study included different sets of primary and secondary endpoints for the OUS analysis plan and U.S. analysis plan due to regulatory requirements in the different regions. The co-primary endpoints were achievement of endoscopic response and clinical remission at week 52. Endoscopic response is defined as a decrease in SES-CD of greater than 50 percent from baseline (or at least a greater than or equal to 50 percent decrease from baseline in patients with isolated ileal disease and a baseline SES-CD of 4), as scored by a central reviewer. Clinical remission is defined by SF/AP, which was measured by daily stool frequency and abdominal pain score, in the OUS analysis plan and defined by CDAI, which was measured by a CDAI score less than 150, in the U.S. analysis plan.

Topline results were announced in June 2021. An open label extension of FORTIFY will continue to assess the long-term safety of risankizumab in subjects who completed participation in FORTIFY. More information can be found on http://www.clinicaltrials.gov (NCT03105102).

About SKYRIZI (Risankizumab) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.13,14 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.7 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg pre-filled syringe injections or one 150 mg prefilled pen or pre-filled injection) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter. The use of risankizumab in Crohn's disease is not approved and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.7,9,15,16,17

EU Indications and Important Safety Information about SKYRIZI (Risankizumab)7SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information.

See SKYRIZI full summary of product characteristics (SmPC) at http://www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVieAbbVie'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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking StatementsSome 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, among others, 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 indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2021 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 to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 D'Haens G., et al. Risankizumab as Induction Therapy for Crohn's Disease. Lancet.

2 Ferrante M., et al. Risankizumab as Maintenance Therapy for Crohn's Disease. Lancet.

3 Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec; 12(12):720-7. Doi: 10.1038/nrgastro.2015.150.

4 The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed on January 11, 2022.

5 Crohn's disease. Symptoms and Causes. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed on January 11, 2022.

6 The Economic Costs of Crohn's Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf. Accessed on January 11, 2022.

7 AbbVie. Data on File: ABVRRTI71474.

8 AbbVie. Data on File: ABBVRRI71526.

9 A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03105128. Accessed on December 18, 2020.

10 A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03104413. Accessed on December 18, 2020.

11 AbbVie. Data on File: ABVRRTI72293.

12 A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed May 21, 2021.

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

14 Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.

15 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. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on January 13, 2022.

16 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. 2022. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on January 13, 2022.

17 Pipeline Our Science | AbbVie. AbbVie. 2022. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on January 13, 2022.

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI) in Crohn's Disease - BioSpace