AbbVie has submitted a regulatory application to the Food and Drug Administration for risankizumab-rzaa for the treatment of patients 16 years of age and older with moderate to severe Crohn disease.
The application is supported by data from two phase 3 induction studies, ADVANCE (ClinicalTrials.gov Identifier: NCT03105128) and MOTIVATE (ClinicalTrials.gov Identifier: NCT03104413), and one phase 3 maintenance study, FORTIFY (ClinicalTrials.gov Identifier: NCT03105102). The studies evaluated the efficacy and safety of risankizumab, an interleukin-23 inhibitor, in patients 16 years of age and older with moderate to severe Crohn disease.
In the ADVANCE and MOTIVATE studies, patients were randomly assigned to receive risankizumab 600mg, 1200mg, or placebo as intravenous (IV) induction therapy. In the FORTIFY study, patients who responded to IV induction therapy were then randomly assigned to receive risankizumab 180mg, 360mg, or withdrawal from risankizumab treatment (control group).
Results from ADVANCE and MOTIVATE showed that a significantly greater proportion of patients treated with risankizumab met the co-primary endpoints of clinical remission (as measured by the Crohn Disease Activity Index [CDAI]) and endoscopic response at week 12 compared with placebo. Both studies also met key secondary end points including statistically significant clinical and endoscopic outcomes with symptom improvement observed as early as week 4.
In the FORTIFY study, results showed that 47% and 52% of patients treated with risankizumab 360mg achieved endoscopic response and clinical remission (as measured by CDAI), respectively, at week 52 compared with 22% and 41% of those in the control group (P <.001 and P <.01, respectively). Additionally, 52% of patients treated with risankizumab 360mg achieved endoscopic remission compared with 13% of those in the control group (nominal P <.001). A greater proportion of patients treated with risankizumab 360mg also achieved deep remission, defined as clinical remission and endoscopic remission, vs the control group (29% vs 10%, respectively; nominal P <.001).
The safety profile of risankizumab was consistent with that seen in previous studies across indications. There were no new safety risks identified.
Risankizumab is currently marketed under the trade name Skyrizi and is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- AbbVie submits regulatory application to FDA for risankizumab-rzaa (Skyrizi®) for the treatment of patients 16 years and older with moderate to severe Crohn’s disease. News release. AbbVie. Accessed September 20, 2020. https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-fda-for-risankizumab-rzaa-skyrizi-for-the-treatment-of-patients-16-years-and-older-with-moderate-to-severe-crohns-disease-301380440.html.
- Phase 3 maintenance results show patients with Crohn’s disease receiving risankizumab (Skyrizi®) achieved endoscopic response and clinical remission at one year. News release. AbbVie. June 2, 2021. Accessed September 20, 2021. https://news.abbvie.com/news/press-releases/phase-3-maintenance-results-show-patients-with-crohns-disease-receiving-risankizumab-skyrizi-achieved-endoscopic-response-and-clinical-remission-at-one-year.htm.