FDA Approves Guselkumab as First IL-23 Inhibitor with Both SC and IV Induction Options for UC and CD

The FDA has approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya) for adults with moderately to severely active ulcerative colitis (UC). This makes guselkumab the first and only IL-23 inhibitor to provide both SC and intravenous (IV) induction options for treating UC and Crohn’s disease, offering patients flexibility including self-administration from the start of treatment.

TREMFYA® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.

“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,” said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine and study investigator. “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 UC SC induction approval is based on results from the Phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of TREMFYA® SC induction therapy in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy and advanced therapies. All multiplicity-controlled primary and secondary endpoints demonstrated statistically significant and clinically meaningful improvements with TREMFYA® compared to placebo across all clinical and endoscopic measures:

• Early symptomatic response was observed, with TREMFYA® separating from placebo as early as two weeks and sustained through Week 24.

• Significantly greater proportions of patients treated with TREMFYA® 400 mg SC every four weeks (q4w) achieved clinical remission (26% vs. 7%; p<0.001) and endoscopic improvement (36% vs. 12%; p<0.001) at Week 12 vs. those treated with placebo.

• Results were consistent with the FDA-approved 200mg IV induction regimen, which previously achieved clinical remission (23% vs. 8%; p<0.001) and endoscopic improvement (27% vs. 11%; p<0.001) vs. those treated with placebo. The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease and both routes demonstrated a similar time to onset of efficacy.

• Week 24 SC induction followed by SC maintenance data also demonstrated statistically significant and clinically meaningful improvements in clinical remission (100 mg: 34%, 200 mg: 34% vs. 10%; p<0.001) and endoscopic improvement (100 mg: 39%, 200 mg: 44% vs. 12%; p<0.001) vs. those treated with placebo.

“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,” said Chris Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “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.”

TREMFYA® dosing in the treatment of moderately to severely active UC:

• The recommended SC induction dosage is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one Induction Pack) at Weeks 0, 4 and 8. TREMFYA® is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at Weeks 0, 4 and 8.

• Recommended maintenance dosage is either 100 mg administered by SC injection at Week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at Week 12, and every 4 weeks thereafter. Healthcare providers are instructed to use the lowest effective recommended dosage to maintain therapeutic response.

Johnson & Johnson is committed to supporting access to all its treatments, including offering a patient support program called TREMFYA withMe. Commercially insured adult patients who are prescribed TREMFYA® for UC may be eligible to receive their first induction treatment in as little as 24 hours through TREMFYA withMe.

In September 2024, Johnson & Johnson received FDA approval of TREMFYA® (with IV induction) for the treatment of adults with moderately to severely active UC, based on the Phase 3 QUASAR study. In March 2025, TREMFYA® received FDA approval, including both SC and IV induction options, for the treatment of adults with moderately to severely active CD.4 Based on the positive outcomes of clinical programs, Johnson & Johnson is initiating the first IL-23 inhibitor head-to-head study seeking to demonstrate the superiority of TREMFYA® vs. Skyrizi® (risankizumab), representing an important next step in Crohn’s disease research.

This approval is another important milestone for patients and is emblematic of Johnson & Johnson’s continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases, including inflammatory bowel disease.