Johnson & Johnson (JNJ) announced Thursday TREMFYA (guselkumab) data in both Crohn's disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients, indicating a normal appearance of intestinal mucosa.
These subgroup analyses are from pooled data from the Phase 3 GALAXI 2 & 3 studies of TREMFYA in adults with moderately to severely active CD and the Phase 3 QUASAR maintenance study of TREMFYA in adults with moderately to severely active UC.
Ninety percent more biologic-naïve patients and three times more biologic-refractory patients with ulcerative colitis achieved endoscopic remission with TREMFYA.
TREMFYA is now U.S. FDA-approved for ulcerative colitis and under review for Crohn's disease
TREMFYA is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of patients with Crohn's disease, inclusive of those who are biologic-naïve and biologic-refractory.
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