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.
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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.
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By GlobalDataJ&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.
