FDA OKs Subcutaneous Guselkumab Regimen for Ulcerative Colitis: Daily Dose

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On September 22, 2025, we reported on the FDA approval of a subcutaneous (SC) induction regimen of guselkumab (Tremfya; Johnson & Johnson) for adults with moderately to severely active ulcerative colitis (UC).

The approval

With this decision, guselkumab becomes the first IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn disease (CD).

Approval was supported by results from the phase 3 ASTRO trial, which evaluated SC guselkumab in adults with UC who had inadequate response or intolerance to conventional and advanced therapies. Patients received 400 mg every 4 weeks for induction.

At week 12, 26% of patients in the guselkumab group achieved clinical remission compared with 7% in the placebo group (P<.001). Endoscopic improvement was observed in 36% of patients on guselkumab vs 12% on placebo (P<.001). Early separation from placebo occurred as early as week 2 and was sustained through week 24.

Week 24 data showed continued benefit with SC induction followed by maintenance therapy. Clinical remission rates were 34% for both 100 mg and 200 mg regimens compared with 10% for placebo (P<.001). Endoscopic improvement was reported in 39% and 44% of patients, respectively, vs 12% for placebo (P<.001). Efficacy was consistent with prior results from the QUASAR study that supported approval of intravenous (IV) induction in UC in 2024.

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