Clinical Trials Arena

J&J’s Tremfya meets endpoints in Phase III ulcerative colitis trial

The company’s monoclonal antibody met primary and secondary endpoints as a maintenance therapy for ulcerative colitis in a Phase III trial.

Johnson and Johnson (J&J) has announced positive data from the Phase III QUASAR maintenance trial for Tremfya (guselkumab) as a maintenance therapy in patients with moderate to severe active ulcerative colitis.

Tremfya is an interleukin (IL)-23 and CD64-inhibiting monoclonal antibody. It was first approved as a treatment for moderate to severe plaque psoriasis by the US Food and Drug Administration (FDA), in 2017. Tremfya has since been approved to treat psoriatic arthritis.

The therapy achieved the primary and nine major secondary endpoints in the placebo-controlled Phase III QUASAR maintenance study (NCT04033445). The participants in the trial were randomised to receive either placebo or one of the two doses of subcutaneous Tremfya – 200mg every four weeks (q4w) or 100mg every eight weeks (q8w).

The trial met its primary endpoint by inducing remission in 50% and 45.2% of the participants in the q4w and q8w treatment groups respectively at 44 weeks, compared to the placebo. Of the participants who were in clinical remission, 67% and 71% of the participants in the q4w and q8w treatment groups respectively also achieved endoscopic remission at 44 weeks.

Clinical response was seen in 74.7% and 77.7% of the participants in the q4w and q8w treatment groups respectively at 44 weeks, compared to 43.2% of participants in the placebo group. Endoscopic improvement was seen in 51.6% and 49.5% of the participants in the q4w and q8w treatment groups respectively at 44 weeks, compared to 18.9% of participants in the placebo group.

The data from the trial was presented at the Digestive Disease Week 2024 taking place in Washington DC from 19 to 21 May.

J&J’s Tremfya is expected to be the successor to the company’s IL-12/IL-23 inhibitor Stelara (ustekinumab). Stelara is an approved treatment for severe plaque psoriasis, active psoriatic arthritis, and ulcerative colitis. As per J&J’s annual report, the therapy generated $10.8bn in global sales last year, but its future sales are expected to decline with multiple biosimilars entering the market.

J&J is also evaluating Tremfya as a treatment for Crohn’s disease in a Phase II GALAXI trial (NCT03466411). The therapy maintained efficacy for three years, with 54.1% of the participants demonstrating clinical remission.