Guselkumab (TREMFYA®) is the first IL-23 inhibitor to demonstrate superiority over ustekinumab in all pooled endoscopic endpoints for Crohn’s disease in a double-blind registrational trial.
The FDA has approved guselkumab (TREMFYA®), an interleukin-23 (IL-23) inhibitor, for the treatment of adults with moderately to severely active Crohn's disease. The approval is supported by results from the phase III GRAVITI study—led by Dr. Remo Panaccione of the University of Calgary—and the GALAXI clinical program, both of which evaluated the efficacy and safety of guselkumab in this population.
GRAVITI
GRAVITI was a randomized, double-blind, placebo-controlled trial involving patients with inadequate response or intolerance to conventional therapies or biologics. Participants received subcutaneous guselkumab 400 mg at Weeks 0, 4, and 8, followed by maintenance doses of either 100 mg every 8 weeks or 200 mg every 4 weeks. At Week 12, clinical remission occurred in 56% of the guselkumab group vs 22% in the placebo group (P < .001).
By Week 48 in the 100 mg maintenance dose group, 59% of guselkumab-treated patients achieved clinical remission compared with 17% on placebo. Endoscopic response and remission at Week 48 were 39% and 31% for guselkumab, compared with 5% and 6%, respectively, for placebo.
By Week 48 in the 200 mg maintenance group, clinical remission reached 65% in the guselkumab arm vs 17% with placebo. Endoscopic response and remission rates were 48% and 40%, respectively, in the guselkumab group, vs 5% and 6% with placebo.
GALAXI
The GALAXI 2 and 3 studies further assessed efficacy using an intravenous induction regimen. At Week 12 of GALAXI 2, 47% of patients receiving guselkumab achieved clinical remission compared with 20% in the placebo group (P < .001). Endoscopic response was 36% in the guselkumab group compared with 9% in the placebo group (P < .001).
In GALAXI 3 at Week 12, 47% of patients receiving guselkumab achieved clinical remission compared with 15% in the placebo group (P < .001). Endoscopic response was 34% in the guselkumab group compared with 13% in the placebo group (P < .001).
Pooled data from GALAXI 2 and 3 showed guselkumab’s superiority over ustekinumab across all endoscopic endpoints in a double-blind, registrational setting.
These results demonstrate the efficacy of guselkumab in inducing and maintaining clinical and endoscopic remission in patients with moderately to severely active Crohn’s disease. The availability of both intravenous and subcutaneous induction options offers added flexibility in treatment approaches.
Reference:
Johnson & Johnson. U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease [press release]. Horsham, PA: Johnson & Johnson.
