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Positive results from two phase 3 studies evaluating risankizumab in adults with moderate to severe Crohn disease showed that the trials met both primary end points of clinical remission and endoscopic response.
The multicenter, randomized, double-blind, placebo-controlled induction phase 3 studies (ADVANCE [N=940] and MOTIVATE [N=618]) evaluated the efficacy and safety of risankizumab, an interleukin-23 (IL-23) inhibitor, in adults with moderate to severe Crohn disease. Patients were randomized to receive risankizumab 600mg, 1200mg, or placebo. The co-primary end points for both studies were the proportion of patients achieving clinical remission, measured by CDAI (Crohn Disease Activity Index) and PRO-2 (2-component patient-reported outcome), as well as endoscopic response, at week 12.
In the ADVANCE study, results showed that 45% and 42% of patients treated with risankizumab 600mg and 1200mg, respectively, achieved clinical remission per CDAI at week 12 vs 25% of those who received placebo (P <.001); per PRO-2, 43% and 41% of patients treated with risankizumab 600mg and 1200mg, respectively, achieved clinical remission vs 21% of the placebo arm (P <.001). Additionally, endoscopic response was achieved by 40% and 32% of patients treated with risankizumab 600mg and 1200mg, respectively, vs 12% of the placebo arm (P <.001).
In the MOTIVATE study, findings showed that 42% and 41% of patients treated with risankizumab 600mg and 1200mg, respectively, achieved clinical remission per CDAI at week 12 vs 19% of the placebo arm (P <.001); per PRO-2, 35% and 39% of patients treated with risankizumab 600mg and 1200mg, respectively, achieved clinical remission vs 19% of the placebo group (P =.001 for 600mg; P <.001 for 1200mg). Moreover, 29% and 34% of patients treated with risankizumab 600mg and 1200mg, respectively, achieved endoscopic response vs 11% in the placebo arm (P <.001).
Both studies also met key secondary end points including statistically significant clinical and endoscopic outcomes with symptom improvement observed as early as week 4. The most common adverse events reported with risankizumab were headache, nasopharyngitis, arthralgia, and fatigue; no new safety risks were observed in the studies.
“These positive results show how targeting IL-23 can rapidly induce improvements for people living with this condition,” said Michael Severino, MD, vice chairman and president, AbbVie. “We look forward to advancing research showing risankizumab’s potential to improve clinical and endoscopic outcomes and minimize the burden of Crohn disease for patients.”
Risankizumab is currently FDA-approved under the brand name Skyrizi for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
For more information visit abbvie.com.
Reference
Risankizumab (Skyrizi®) demonstrates significant improvements in clinical remission and endoscopic response in two phase 3 induction studies in patients with Crohn’s disease. [press release]. North Chicago, IL: AbbVie; January 7, 2021.
