September 22, 2025
1 min read
The FDA has approved a subcutaneous induction regimen of guselkumab for the treatment of adults with moderately to severely active ulcerative colitis.
The approval makes guselkumab (Tremfya, Johnson & Johnson) the first and only interleukin-23 inhibitor to have both subcutaneous and IV induction options for UC and Crohn’s disease, according to a manufacturer press release.
The FDA has approved a subcutaneous induction regimen of guselkumab for the treatment of adults with moderately to severely active ulcerative colitis.
“Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians,” David T. Rubin, MD, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine, said in the release. “With today’s approval, UC patients and providers now have the choice of starting Tremfya with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice.”
The approval was based on data from the phase 3 ASTRO trial, which evaluated efficacy and safety of induction with subcutaneous guselkumab for adults with moderately to severely active UC who had inadequate response or intolerance to conventional and advanced therapies.
According to the release, guselkumab outperformed placebo in symptomatic response as early as 2 weeks, with sustained results through week 24.
Study results also showed significantly greater proportions of patients treated with the recommended subcutaneous induction dose of 400 mg guselkumab every 4 weeks achieved both clinical remission (26% vs. 7%; P < .001) and endoscopic improvement (36% vs. 12%; P < .001) at week 12 compared with those who received placebo.
These results are comparable to FDA-approved 200 mg IV induction with guselkumab, including among patients with severe or refractory disease. Both induction routes demonstrate similar time to efficacy onset, as well.
“With today’s approval, Tremfya is the first and only IL-23 inhibitor to offer inflammatory bowel disease patients robust clinical and endoscopic results with a fully subcutaneous regimen, now across both ulcerative colitis and Crohn’s disease,” Chris Gasink, MD, vice president of medical affairs in gastroenterology and autoantibody at Johnson & Johnson Innovative Medicine, said in the release. “The initiation of a head-to-head study in Crohn’s disease is a further testament to our commitment to advancing the clinical evidence of Tremfya in IBD.”
