-        Third approved indication for SKYRIZI® (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's disease in the European Union (EU) -        A significantly higher proportion of patients on SKYRIZI achieved clinical remission, endoscopic response, mucosal healing and endoscopic remission at week 12 in induction studies compared to placebo1,2,3-        A significantly higher proportion of patients achieved clinical remission and endoscopic response at week 52 with SKYRIZI maintenance1,2,3-        Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care4,5,6

NORTH CHICAGO, Ill., Nov. 23, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the European Commission (EC) approved SKYRIZI® (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.1,2,3 

"There are still many patients suffering from debilitating symptoms associated with Crohn's disease, such as abdominal pain and stool frequency, which is why we've embraced the challenge of serving these patients in need," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "The approval of SKYRIZI in the European Union is a significant milestone in our pursuit to expand our IBD portfolio."

The EC approval for SKYRIZI in Crohn's disease is supported by results from the global Phase 3 program, which included three studies: ADVANCE induction, MOTIVATE induction and FORTIFY maintenance.1 The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies and include assessments of efficacy, safety and tolerability of SKYRIZI.1,2,3 

Clinical Remission & Endoscopic Response*,†

•  In the ADVANCE and MOTIVATE induction trials, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response.1,2,3
• In ADVANCE and MOTIVATE, 43% and 35% of patients treated with SKYRIZI 600 mg IV achieved clinical remission at week 12, respectively, compared to 22% and 19% of patients receiving placebo.1
• Additionally, 40% and 29% of SKYRIZI treated patients achieved endoscopic response at week 12 compared to 12% and 11% of patients receiving placebo.1
• In the FORTIFY maintenance trial, a significantly greater proportion of patients treated with SKYRIZI 360 mg SC achieved the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response.1,2,3
• In FORTIFY, 52% of patients treated with SKYRIZI 360 mg SC achieved clinical remission at week 52 compared to 40% of patients receiving placebo.1
• Additionally, 47% of patients treated with SKYRIZI achieved endoscopic response at week 52 compared to 22% of patients receiving placebo.1

Mucosal Healing & Endoscopic Remission‡,§ 

• During the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients treated with SKYRIZI 600 mg IV achieved mucosal healing and endoscopic remission.1,2,3
• In ADVANCE and MOTIVATE, 21% and 14% of patients treated with SKYRIZI 600 mg IV achieved mucosal healing at week 12, respectively, compared to 8% and 4% of patients receiving placebo.1
• Additionally, during the induction studies, 24% and 19% of patients treated with SKYRIZI 600 mg IV achieved endoscopic remission at week 12, respectively, compared to 9% and 4% of patients receiving placebo.1
• Mucosal healing and endoscopic remission were observed during the FORTIFY maintenance trial in patients treated with SKYRIZI 360 mg SC.1,2,3
• In FORTIFY, mucosal healing was observed at week 52 in 31% of patients treated with SKYRIZI 360 mg SC compared to 10% of patients receiving placebo (nominal p-value50 percent from baseline (or ≥50 percent from baseline for subjects with isolated ileal disease and a baseline SES-CD of 4), as scored by central reviewer.‡ Mucosal healing: SES-CD ulcerated surface subscore of 0 in subjects with a subscore of ≥1 at Baseline.§ Endoscopic remission is defined as SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual component, as scored by a central reviewer.
  1. 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 November 17, 2022.
  2. D'Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. The Lancet. 2022;399(10340):2015-2030. doi:10.1016/S0140-6736(22)00467-6.
  3. Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. The Lancet. 2022;399(10340):2031-2046. doi:10.1016/S0140-6736(22)00466-4.
  4. Crohn's disease. Symptoms and Causes. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
  5. 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.
  6. Alatab S, Sepanlou SG, Ikuta K, et al. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17-30. doi:10.1016/S2468-1253(19)30333-4.
  7. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
  8. Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 22, 2022.
  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. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on August 22, 2022.
  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. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on August 22, 2022.

  

  

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