Topline, Phase 3 Data Supports the Use of Risankizumab for Ulcerative Colitis

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The results from the INSPIRE trial show risankizumab met all primary and secondary endpoints in treating adult patients with moderately to severely active ulcerative colitis.

New topline data show risankizuman (SKYRIZI) results in clinical remission at week 12 in adult patients with moderately to severely active ulcerative colitis.

In the phase 3 induction study, the treatment, developed by AbbVie, at a 1200 mg intravenous dose at weeks 0, 4, and 8, met the primary endpoint defined by the Adapted Mayo Score at week 12, as well as all secondary endpoints.

In the INSPIRE trial, 20.3% of patients that demonstrated intolerance or inadequate response to conventional and/or advanced therapies, in the risankizumab group achieved clinical remission, significantly higher than the 6.2% of patients in the placebo group (P <0.00001).

There were also a significantly greater proportion of patients treated with the study drug who achieved endoscopic improvement at week 12 compared to placebo (36.5% vs 12.1%; P <0.00001), as well as histologic-endoscopic mucosal improvement (24.5% vs 7.7%; P <0.0001).

In the safety analysis, the safety profile was consistent with what has been found in other studies, with no new safety risk identified. The most common adverse events were COVID-19, anemia and arthralgia. In addition, only 2.3% of patients suffered a serious adverse event in the risankizumab group, compared to 10.2% of the placebo group, while the rate of serious adverse infections were 0.6% in the treatment group and 1.2% in those treated with the placebo.

However, there was 1 death in the Risankizumab group due to COVID-19 pneumonia and no adjudicated major adverse cardiac events, anaphylactic reaction events, or malignancy events.

"It is impressive to see the meaningful responses that were achieved in the INSPIRE study, which demonstrates the potential of risankizumab to serve as an option across inflammatory bowel diseases," said Edouard Louis, M.D., Ph.D., professor and head of the department of gastroenterology, University Hospital CHU of Liège Belgium, INSPIRE study investigator, in a statement. "These results suggest that Risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and fecal incontinence."

In June, the US Food and Drug Administration (FDA) has approved risankizumab-rzaa for the treatment of adults with moderately to severely active Crohn’s disease. The approval represents the first and only specific interleukin-23 (IL-23) inhibitor for this patient population.