FDA Approves Subcutaneous Induction of Tremfya for Ulcerative Colitis Patients

The FDA has approved a subcutaneous injection induction regimen of Tremfya (guselkumab) for adults with moderately to severely active ulcerative colitis, according to a recent news release.

Tremfya is now the first and only IL-23 inhibitor to offer both subcutaneous and intravenous (IV) induction options for the treatment of ulcerative colitis and Crohn’s disease. The FDA approved both subcutaneous and intravenous forms of Tremfya for the treatment of Crohn’s disease in March 2025. The IV formulation of Tremfya was approved by the FDA in Sept. 2024.

Inflammatory bowel disease affects approximately 3 million Americans. Ulcerative colitis and Crohn’s disease are two of the most common inflammatory bowel diseases in the United States. Both are considered autoimmune diseases. Ulcerative colitis affects approximately 600,000 to 900,000 Americans. It is characterized by inflammation of the lining of the colon, which leads to the formation of ulcers that produce pus and mucus. Symptoms include rectal bleeding, persistent diarrhea or fatigue. Crohn’s disease affects approximately half a million Americans and can lead to inflammation anywhere in the digestive tract, not just the colon.

Tremfya is a monoclonal antibody that blocks IL-23, a type of immune cell involved in autoimmune diseases, while binding to CD64, a receptor on cells that produce IL-23, the news release says.

“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, M.D., director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine and confirmatory study investigator, said in the news release. “With today’s approval, ulcerative colitis 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.”

This approval was made using positive results from the phase 3 ASTRO trial, in which subcutaneous Tremfya demonstrated clinically meaningful results compared with placebo.

Specifically, 26% of patients treated with 400 mg of subcutaneous Tremfya every four weeks achieved remission, compared with 7% of patients treated with placebo. Endoscopic improvement was also seen in 36% of Tremfya patients, compared with 12% of placebo patients.

The recommended subcutaneous induction dose of Tremfya is 400 mg given at weeks 0, 4 and 8. The IV formulation induction is administered as 200 mg in weeks 0, 4 and 8.

The recommended maintenance dosage varies by patient need, as decided by a healthcare provider. Patients will be prescribed either 100 mg at Week 16 and then every eight weeks after, or 200 mg at Week 12 and then every 4 weeks after.

The safety of subcutaneous Tremfya was tested in 230 patients total at two dose strengths—400 mg/100 mg and 400 mg/200 mg—and as a placebo. Respiratory tract infections were the most common adverse reaction, occurring in 38%, 30% and 26% of patients, respectively. Other adverse reactions include headache and injection site reactions.

Patient support is available through Tremfya withMe, where commercially insured patients may be eligible to receive their first induction treatment within 24 hours. Eligible patients may also pay as little as $0 per dose.