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Phase 3 QUASAR Clinical Study Results of Tremfya® (guselkumab) for Ulcerative Colitis

May 20, 2024

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC).  The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients receiving Tremfya® (guselkumab) achieved clinical remission at 44 weeks compared to placebo-treated patients.   

Tremfya® is currently approved in the US and Europe for treatment of severe plaque psoriasis and psoriatic arthritis.  In March 2024, Johnson & Johnson submitted an sBLA to the FDA for Tremfya® for moderately to severely active ulcerative colitis.  This is part of a strategy to expand into inflammatory bowel disease indications.