Johnson & Johnson (JNJ) revealed data on Thursday highlighting the efficacy of TREMFYA (guselkumab) in treating Crohn's disease (CD) and ulcerative colitis (UC). These findings show significant rates of endoscopic remission, indicating normal appearances of the intestinal mucosa, in patients who are both new to biologic treatments and those who have not responded to previous biologics.
The results stem from subgroup analyses of pooled data from the Phase 3 GALAXI 2 & 3 studies, which focused on adults with moderately to severely active CD, and the Phase 3 QUASAR maintenance study, which targeted adults with moderately to severely active UC.
Remarkably, endoscopic remission rates with TREMFYA were achieved by 90% more biologic-naïve patients and three times as many biologic-refractory patients with ulcerative colitis. Currently, TREMFYA has received FDA approval for treating ulcerative colitis and is under review for Crohn's disease. Notably, it is the sole IL-23 inhibitor proven to surpass ustekinumab in effectiveness for the overall population of Crohn's disease patients, including both biologic-naïve and biologic-refractory individuals.
