VIDEO: More than 75% of UC patients achieve clinical response at 24 weeks with Tremfya
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Key takeaways:
- Tremfya bested placebo for achieved clinical response as early as week 1 (28.3% vs. 18.9%).
- The majority of Tremfya-treated patients demonstrated clinical response at weeks 12 and 24.
VANCOUVER, British Columbia — In a Healio video exclusive, Jan Wehkamp, MD, PhD, discusses results from the QUASAR study, in which Tremfya outperformed placebo in clinical response at weeks 12 and 24 among patients with ulcerative colitis.
“There is still a tremendous unmet need for patients with ulcerative colitis and Crohn’s disease: Only 10% are in remission and, as of today, there are 3 million patients in the U.S. and many more around the world, and there’s no cure available,” Wehkamp, vice president and gastroenterology disease area leader at Johnson & Johnson Innovative Medicines, said. “Our goal is to get these patients into steroid-free, long-term remission.”
According to Wehkamp, studies for Tremfya (guselkumab, J&J Innovative Medicines) in patients with inflammatory bowel disease are underway, including the phase 3 QUASAR induction study, the results of which were presented at the ACG Annual Scientific Meeting.
The double-blind, multicenter study included 701 patients with moderately to severely active UC, who were randomized to receive 200 mg IV guselkumab or placebo at baseline and weeks 4 and 8.
“The majority of patients, about 62%, showed clinical response after 12 weeks,” Wehkamp said. “What we also show, which is very encouraging, is that if you follow patients for 24 weeks, almost 80% had clinical response.”
In addition, the percentage of patients achieving clinical response as early as week 1 was greater with guselkumab compared with placebo (28.3% vs. 18.9%). Among patients treated with guselkumab who did not achieve clinical response to IV induction therapy at week 12 and who received subcutaneous treatment for an additional 12 weeks, 55% achieved clinical response at week 24.
“In terms of safety, what we see is consistent with other trials,” Wehkamp said. “No additional safety signals.”
References:
- Lichtenstein G, et al. Early symptomatic improvement with guselkumab induction treatment in moderately to severely active ulcerative colitis: Results from the phase 3 QUASAR induction study. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
- New phase 3 Tremfya (guselkumab) results in ulcerative colitis show a 77% overall clinical response rate and early symptom improvement. https://www.jnj.com/new-phase-3-tremfya-guselkumab-results-in-ulcerative-colitis-show-a-77-percent-overall-clinical-response-rate-and-early-symptom-improvement. Published Oct. 23, 2023. Accessed Oct. 23, 2023.