Johnson & Johnson’s tremfya shows two-year durable remission in Crohn’s disease

Johnson & Johnson announced new 96-week data from the long-term extensions of the Phase 3 GRAVITI, GALAXI 2 and GALAXI 3 studies, which show the durability of tremfya – guselkumab – in adults with moderately to severely active Crohn’s disease at two years. At Week 96, patients treated with tremfya 400 mg subcutaneous induction or 200 mg intravenous induction followed by SC maintenance dose regimens of either 100 mg every eight weeks or 200 mg every four weeks show high rates of long-term clinical remission, endoscopic response, endoscopic remission, and deep remission. Safety data through 96 weeks in the LTE periods of the GALAXI and GRAVITI studies were consistent with the well-established safety profile of tremfya. Previously presented pooled data from the GALAXI clinical program showed tremfya was superior to stelara for all endoscopic endpoints at Week 48, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. Tremfya has received FDA approval for both SC and IV induction options for the treatment of adults with moderately to severe active Crohn’s disease and for the treatment of adults with moderately to severely active ulcerative colitis.