VIDEO: Risankizumab a ‘great option for patients,’ induces clinical remission in UC
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Key takeaways:
- More patients in the treatment arm achieved clinical remission at week 12 (20.3% vs. 6.2%).
- Risankizumab also outperformed placebo in clinical response and endoscopic improvement and remission.
VANCOUVER, British Columbia — In a Healio video exclusive, Edward V. Loftus Jr., MD, FACG, discusses results from the INSPIRE trial, in which more patients with ulcerative colitis achieved clinical remission on IV risankizumab vs. placebo.
“Risankizumab, as you know, is a monoclonal antibody to interleukin-23,” Loftus, professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic, said at the ACG Annual Scientific Meeting. “This is important in the inflammatory cascade and inflammatory bowel diseases.”
In the phase 3 INSPIRE trial, Loftus and colleagues evaluated the safety and efficacy of risankizumab compared with placebo among 975 adult patients with moderate to severe UC who were intolerant or had an inadequate response to conventional or biologic therapies. Participants received IV risankizumab 1,200 mg (n = 650) or placebo (n = 325) at weeks 0, 4 and 8.
The primary endpoint was clinical remission — based on stool frequency, rectal bleeding and endoscopic score — at week 12. Secondary endpoints included clinical response, endoscopic improvement and remission, and histologic-endoscopic mucosal improvement (HEMI) and remission (HEMR).
Results showed significantly more patients in the treatment arm achieved clinical remission compared with placebo at week 12 (20.3% vs. 6.2%).
“The primary endpoint was met,” Loftus said, “and the difference between the study group and placebo was about 14%.”
Risankizumab also outperformed placebo in clinical response at weeks 4 and 12 (52.2% vs. 30.5% and 64.3% vs. 35.7%, respectively), endoscopic improvement (36.5% vs. 12.1%) and remission (10.6% vs. 3.4%), and HEMI (24.5% vs. 7.7%) and HEMR (6.3% vs. 0.6%).
In addition, patients on risankizumab reported significant improvements at week 12 in bowel urgency, nocturnal bowel movements and abdominal pain compared with those on placebo.
“Hospitalizations were actually higher in placebo,” Loftus added. “At the end of 12 weeks, 5.5% of placebo-treated patients vs. less than 1% of the risankizumab-treated patients had been hospitalized.”
Further, serious (2.3% vs. 10.2%) and severe adverse events (2.5% vs. 10.2%), events leading to discontinuation (0.6% vs. 3.7%) and serious infections were “numerically lower” among patients in the risankizumab group vs. placebo.
“In conclusion, this looks like a great option for patients: It worked in both the advanced therapy-naive and exposed patients,” Loftus said. “It’s great to have another treatment in our armamentarium.”
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Loftus E, et al. Risankizumab therapy in patients with moderately to severely active ulcerative colitis: Efficacy and safety in the randomized phase 3 INSPIRE study. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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