The FDA approved a subcutaneous induction of guselkumab (Tremfya, Johnson & Johnson) for patients with moderate to severe ulcerative colitis, following data that show efficacy comparable to IV induction.
The approval makes guselkumab the first interleukin (IL)-23 inhibitor with IV and subcutaneous induction options for UC and Crohn’s disease.
“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,” noted David T. Rubin, MD, a study investigator and the director of the Inflammatory Bowel Disease Center at University of Chicago Medicine, in a news release announcing the approval.
The approval is based on results from the phase 3 ASTRO trial, in which a subcutaneous induction dosage of 400 mg every four weeks improved 12-week clinical remission and endoscopic improvement better than placebo at 12 weeks (clinical remission, 26% vs. 7%; endoscopic improvement, 35% vs. 12%; P<0.001 for both). These results are similar to those seen previously in a study comparing a 200-mg IV induction regimen of guselkumab with placebo (clinical remission, 23% vs. 8%; endoscopic improvement, 27% vs. 11%; P<0.001 for both groups); both induction methods were comparable across subgroups with respect to efficacy and time to onset of efficacy.
In the news release, Johnson & Johnson announced it was initiating a head-to-head trial of guselkumab and risankizumab (Skyrizi, AbbVie) for moderate to severe CD, the first such trial to compare IL-23 inhibitors.
—GEN Staff