Tremfya Demonstrates Sustained Response Up to 92 Weeks
Guselkumab is the first and only IL-23 inhibitor to demonstrate robust data as a fully subcutaneous regimen.
Johnson & Johnson presented new data for guselkumab (Tremfya) as a treatment for moderately to severely active ulcerative colitis (UC), which is the first and only IL-23 inhibitor that demonstrated robust data as a fully subcutaneous regimen. Findings from the phase 3 ASTRO study and phase 3 QUASAR (NCT04033445) showed that guselkumab demonstrated sustained clinical and endoscopic efficacy at 24 weeks and 92 weeks, respectively.1,2
Guselkumab is the first and only IL-23 inhibitor to demonstrate robust data as a fully subcutaneous regimen. | Image Credit: eddows - stock.adobe.com
“People living with ulcerative colitis seek treatments that both address the challenging symptoms of the disease and provide durable results,” Gary R. Lichtenstein, vice chief of the division of gastroenterology and hepatology in the development and philanthropy at the University of Pennsylvania, said in a news release.2 “These new data show Tremfya delivers long-term, sustained clinical and endoscopic remission, marking important progress in UC care.”
In the ASTRO study, investigators found that patients treated with guselkumab 400 mg subcutaneous induction followed by 100 mg every 8 weeks or 200 mg every 4 weeks as maintenance therapy demonstrated clinical remission at 35.3% and 36.4%, respectively, compared with the placebo at 9.4%. Clinical response was seen at 63.3% and 61.4%, respectively, compared with 30.9% for the placebo. Further, symptomatic remission was 54.7% and 50%, respectively, and endoscopic improvement was 40.3% and 45%, respectively, compared with the placebo at 25.2% and 12.2%, respectively.1
Patients included in the study had an inadequate response or intolerance to corticosteroids, immunosuppressives, biologics, Janus kinase inhibitors, and/or sphingosine 1-phosphate inhibitors. There were 418 patients that received randomized treatment of guselkumab 400 mg followed by 100 mg every 8 weeks, followed by 200 mg every 4 weeks, or the placebo.3
“Data from the ASTRO study demonstrate that subcutaneous induction treatment with Tremfya provides clinically meaningful remission in patients with ulcerative colitis, similar to the effects seen with intravenous induction,” Millie Long, MD, MPH, professor of gastroenterology and hepatology at the University of North Carolina at Chapel Hill, said in a news release.1 “The availability of both subcutaneous and intravenous induction options would offer physicians and patients greater flexibility in their treatment approach.”
In the long-term extension study, QUASAR, investigators found that 72% of patients were in clinical remission, with 99% of patients remaining corticosteroid-free for 8 or more weeks, and 43% were in endoscopic remission at 92 weeks. They also found that the safety data was consistent with the well-established safety profile of guselkumab, and no new safety concerns were seen.2
Adverse events were reported by 49% of patients in both groups during the induction study, with 3% reporting serious AEs for treatment with guselkumab and 7% for the placebo. Discontinuation occurred for 2% and 4% of patients, respectively. There were similar rates of AEs in the maintenance study, with the most frequently reported being UC, COVID-19, and arthralgia, according to the study authors.4
A total of 701 patients were included in the long-term extension study and had an inadequate response or intolerance to conventional or advanced therapy for UC. Patients received randomized treatment 3:2 for guselkumab 200 mg intravenously or the placebo at weeks 0, 4, and 9 as the phase 3 induction study. Patients in clinical response at week 12 continued therapy at 200 mg every 4 weeks subcutaneously, 100 mg every 8 weeks, or the placebo for 44 weeks as maintenance therapy.4
READ MORE: Digestive Health Resource Center
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