Risankizumab (SKYRIZI?) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease
- The overall safety results in these studies were generally consistent with the known safety profile of risankizumab, with no new safety risks observed[1-6] - 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[1,2,7,8]
- More than 3.5 million people globally live with inflammatory bowel diseases (IBD), including Crohn's disease, and the incidence continues to rise[9]
Efficacy Results at Week 12* |
||||||
ADVANCE1 |
MOTIVATE2 |
|||||
Risankizumab (n=336) |
Risankizumab (n=339) |
Placebo (n=175) |
Risankizumab (n=191) |
Risankizumab (n=191) |
Placebo (n=187) |
|
Clinical |
45% |
42% |
25% |
42% |
41% |
19% |
Clinical |
43% |
41% |
21% |
35% |
39% |
19% |
Endoscopic |
40% |
32% |
12% |
29% |
34% |
11% |
* In both studies, the primary endpoints were clinical remission (per CDAI for the U.S. protocol and per PRO-2 for the outside of the U.S. [OUS] protocol) and endoscopic response (for both protocols) at week 12. All endpoints shown for both studies achieved p-values of =0.001. |
a?Clinical remission (per CDAI) is defined as a CDAI score of <150. |
b?Clinical remission (per PRO-2) is based on average daily stool frequency and average daily abdominal pain score. |
c?Endoscopic response is defined as a decrease in simple endoscopic score for Crohn's disease (SES-CD) of?>50 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. |
- AbbVie. Data on File: ABVRRTI71474.
- AbbVie. Data on File: ABBVRRI71526.
- Gordon K., et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
- Reich, K., et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3.
- Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. Poster #478. 24th World Congress of Dermatology. 2019.
- Feagan, B., et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017 Apr 29;389(10080):1699-1709. doi: 10.1016/S0140-6736(17)30570-6. Epub 2017 Apr 12.
- A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov. 2020. Available at:?https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on?December 18, 2020.
- 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. 2020. Available at:?https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on?December 18, 2020.
- 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.
- 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?December 18, 2020.
- Crohn's disease. Symptoms and Causes. Mayo Clinic. 2020. Available at:?https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed on?December 18, 2020.
- 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?December 18, 2020.
- 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.
- 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.
- Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
- SKYRIZI (risan
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