INSPIRE topline results: Skyrizi achieves clinical remission in UC at 12 weeks
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Topline findings from the phase 3 INSPIRE induction trial showed that Skyrizi, met the primary endpoint of achieving clinical remission at 12 weeks in adults with moderately to severely active ulcerative colitis, AbbVie announced.
In addition, risankizumab (Skyrizi, AbbVie), an interleukin-23 inhibitor, achieved all secondary endpoints including clinical, endoscopic and histologic outcomes.
“Our commitment to people living with gastroenterological conditions continues to grow,” Roopal Thakkar, MD, senior vice president, development, regulatory affairs and chief medical officer at AbbVie, said in a company press release. “These encouraging results help support the potential risankizumab has to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis.”
In the INSPIRE study, a 12-week, double-blind, placebo-controlled trial, researchers enrolled patients with an intolerance or inadequate response to conventional therapies and/or advanced therapies, including biologics, JAK inhibitors and S1P receptor modulators.
According to results, 20.3% of patients who received intravenous risankizumab 1200 mg achieved the primary endpoint of clinical remission compared with 6.2% of those who received placebo (P < 0.00001).
Further, a significantly greater proportion of patients who received risankizumab achieved endoscopic improvement after 12 weeks compared with those who received placebo (36.5% vs. 12.1%; P < 0.00001) and 24.5% of patients who received risankizumab achieved endoscopic histologic mucosal improvement vs. 7.7% in those who received placebo (P < 0.00001).
In the study, the safety profile for risankizumab was consistent with safety observed in prior studies. Common adverse events reported for those treated with risankizumab included COVID-19, anemia and arthralgia. Researchers reported serious adverse events in 2.3% of patients treated with the risankizumab 1200 mg IV compared with 10.2% of patients who received placebo. One death due to COVID-19 pneumonia was reported in the risankizumab 1200 mg group.
“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,” Edouard Louis, MD, PhD, professor and head of the department of gastroenterology at the University Hospital CHU of Liège Belgium and INSPIRE study investigator, said. “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.”
The company noted that risankizumab is not yet approved to be used for UC and regulatory authorities have not yet assessed its safety and efficacy. In addition, the maintenance study of risankizumab for UC is ongoing.
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