FDA Approves Guselkumab for Adult Patients With Crohn Disease

The FDA has approved guselkumab (Tremfya) as the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for adults with moderate to severe active Crohn disease. | Image Credit: Nirusmee - stock.adobe.com

The FDA approved guselkumab (Tremfya; Johnson & Johnson) for adult patients with moderate to severe active Crohn disease.¹ The approval marks the first and only IL-23 inhibitor that offers both subcutaneous and intravenous induction options.

“Tremfya provides people living with Crohn’s disease and their healthcare providers a new treatment option that is supported by data from multiple phase 3 studies, including pooled analyses showing statistical superiority versus Stelara across four endoscopic or combined clinical and endoscopic endpoints,” Chris Gasink, MD, vice president of medical affairs at Johnson & Johnson Innovative Medicine, said in a statement.

Guselkumab is the first approved fully human, dual-acting monoclonal antibody to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64. Studies on its dual action are limited to in vitro models that show guselkumab's CD64 binding.

The phase 3 GRAVITI study (NCT05197049) found the efficacy and safety of guselkumab in adult patients via an analysis of guselkumab subcutaneous induction and maintenance therapy vs placebo. The results demonstrated the superiority of guselkumab over ustekinumab (Stelara) in all pooled endoscopic endpoints, making it the only IL-23 inhibitor to achieve this in a double-blinded registrational program.

Patients in the GRAVITI study remained on the treatment to which they were initially randomized and endured a treat-through design including a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through 5 years total.

The FDA has now approved guselkumab across 4 indications in the US; it is also approved for moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis (UC). In September 2024, the FDA granted the latter approval, supported by the QUASAR study, which evaluated the efficacy and safety of guselkumab in patients who had an inadequate response or intolerance to conventional therapy, other biologics, or Janus kinase inhibitors.² At the 2024 Fall Clinical Dermatology Conference, Johnson & Johnson presented results from the phase 3b SPECTREM trial (NCT06039189), highlighting its beneficial effects on patients with moderate plaque psoriasis.³

For subcutaneous induction, guselkumab should be dosed at 400 mg at weeks 0, 4, and 8 as 2 consecutive 200-mg injections from a single induction pack.¹ Guselkumab also comes in a 200-mg prefilled syringe. For intravenous induction, the prescribing information recommends a 200-mg infusion at weeks 0, 4, and 8. For maintenance, a 100-mg subcutaneous injection is recommended at week 16 and every 8 weeks thereafter, or a 200-mg subcutaneous injection at week 12 and every 4 weeks thereafter.

The most common adverse effects of guselkumab include respiratory tract infections, headache, injection site reactions, joint pain, diarrhea, stomach flu, fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.

“With the approval of Tremfya, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,” said Gasink.

References

1. US FDA approves Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease. News release. Johnson & Johnson; March 20, 2025. Accessed March 21, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-the-first-and-only-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease

2. Tremfya (guselkumab) receives US FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. News release. Johnson & Johnson; September 11, 2024. Accessed March 21, 2025. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease

3. Steinzor P. Guselkumab clears skin in psoriasis resistant to topicals. AJMC^®. October 25, 2024. Accessed March 21, 2025. https://www.ajmc.com/view/guselkumab-clears-skin-in-patients-resistant-to-topicals