Skyrizi achieves outcomes of clinical, endoscopic remission in patients with Crohn’s
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Key takeaways:
- Risankizumab achieved primary endpoints of clinical remission at week 24 and endoscopic remission at week 48 vs. ustekinumab.
- Risankizumab also demonstrated superiority for all secondary endpoints.
Skyrizi demonstrated non-inferiority to Stelara in clinical remission at 24 weeks, as well as superiority in endoscopic remission at 48 weeks, in patients with moderate to severe Crohn’s disease, according to data presented at UEG Week.
“There are several approved treatment options available for the management of Crohn’s disease; however, many CD patients do not achieve disease control,” Laurent Peyrin-Biroulet, MD, PhD, director of the Infinity Institute, professor of gastroenterology and head of the inflammatory bowel disease group at the University Hospital of Nancy in France, told Healio. “We are encouraged by the results of the SEQUENCE study, which reaffirm Skyrizi as an efficacious interleukin-23 inhibitor that can support the achievement of stringent targets that contribute to improved care for patients.”
In the phase 3b open-label, multicenter SEQUENCE study, Peyrin-Biroulet and colleagues enrolled 520 patients with CD who failed one or more anti-tumor necrosis factor therapies.
Participants were randomly assigned 1:1 to IV Skyrizi (risankizumab, AbbVie) 600 mg at baseline and weeks 4 and 8, followed by subcutaneous 360 mg dosing every 8 weeks beginning at week 12 (n = 255), or a single IV dose of Stelara (ustekinumab, Janssen) at baseline, followed by subcutaneous 90 mg dosing every 8 weeks (n = 265), for 48 weeks. At week 2, patients began a mandatory tapering of steroids.
The study’s primary endpoints were clinical remission at week 24 (CD Activity Index < 150), which was tested after 50% of patients completed the week 24 visit or discontinued participation (risankizumab = 128; ustekinumab = 137), and endoscopic remission at week 48 (Simple Endoscopic Score for CD 4 and at least a 2-point reduction vs. baseline).
Secondary endpoints were clinical remission at week 48, endoscopic response (decrease in SES-CD > 50%) at weeks 48 and 24, and steroid-free endoscopic and clinical remission at week 48. Researchers also evaluated safety.
According to results, risankizumab met a non-inferiority margin of 10% vs. ustekinumab with a clinical remission rate of 58.6% vs. 39.5% at week 24, and also showed superiority at week 48 with an endoscopic remission rate of 31.8% vs. 16.2%.
“Additionally, for all ranked secondary endpoints, superiority compared to Stelara was demonstrated, including achievement of clinical remission at week 48, achievement of endoscopic response at weeks 48 and 24, achievement of steroid-free endoscopic remission at week 48 and achievement of steroid-free clinical remission at week 48,” Peyrin-Biroulet told Healio.
Researchers reported comparable exposure-adjusted adverse events between groups (risankizumab = 879 vs. ustekinumab = 763), although rates of serious adverse events and events leading to drug continuation were higher with ustekinumab. Serious infection and hepatic event rates also were similar between groups, with no serious hepatic events reported with risankizumab. There were two cases of malignancies between groups but no deaths.
“Overall, the study provides information to help inform health care providers in their decisions for caring for patients with Crohn’s disease,” Peyrin-Biroulet said. “Care for patients with inflammatory bowel disease continues to advance, with new therapies showing increased rates of clinical and endoscopic remission, and head-to-head studies such as the SEQUENCE trial add to the body of knowledge for health care providers pursuing these new treatment goals.”
Peyrin-Biroulet added: “Research in IBD continues to evolve and head-to-head studies like SEQUENCE are an example that can help further our understanding of the clinical and endoscopic landscape that are necessary to help inform appropriate care for patients.”
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Peyrin-Biroulet L, et al. Risankizumab vs. ustekinumab for patients with moderate to severe Crohn’s disease: results from the phase 3b SEQUENCE study. Presented at: UEG Week; Oct. 14-17, 2023; Copenhagen, Denmark (hybrid meeting).
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