On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-action inhibitor targeting interleukin 23 (IL-23) approved for the treatment of active ulcerative colitis, further solidifying Johnson & Johnson's leadership in the field of inflammatory bowel disease.

Guselkumab is the first approved interleukin 23 (IL-23) inhibitor in the world, selectively binding to the p19 subunit of IL-23 to inhibit its interaction with the IL-23 receptor. It has shown strong efficacy for various autoimmune diseases; it can block IL-23 while also binding to the CD64 receptors on cells that produce IL-23. It is currently approved for the treatment of plaque psoriasis, active psoriatic arthritis, and UC. Furthermore, in June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA for the treatment of adult patients with moderate to severe active Crohn’s disease (CD).

The approval for the UC indication is primarily based on data from the phase 2b/3 QUASAR study, which evaluated the efficacy and safety of Tremfya in adult patients with moderate to severe active UC who were inadequate responders or intolerant to conventional therapies, other biologic agents, and/or JAK inhibitors. Results showed that 50% of patients receiving Tremfya 200 mg subcutaneously (SC) every four weeks (q4w) and 45% of patients receiving Tremfya 100 mg SC every eight weeks (q8w) achieved clinical remission at week 44, compared to 19% of patients receiving a placebo (p<0.001). After one year of SC maintenance treatment with Tremfya, 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission, while the percentage for placebo recipients was 15% (p<0.001).

In the induction treatment phase, the most common adverse reactions (>2%) among patients treated with Tremfya or placebo were respiratory infections. During the maintenance treatment phase, the most common adverse reactions (>3%) among patients receiving TREMFYA treatment or placebo were injection site reactions, joint pain, and upper respiratory infections.

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