On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust” results in subcutaneous induction and maintenance therapy, demonstrating “significant” clinical remission and endoscopic response at 48 weeks. Based on these results, J&J considers that guselkumab could become the first IL-23 treatment to offer both SC and IV induction options for Crohn’s disease.
In a separate Phase 3b study (SPECTREM), sponsored by J&J, Tremfya® was shown to result in clear or almost clear skin in the majority of patients with low body surface area moderate plaque psoriasis with special site involvement who had failed topical treatment. These results were presented on 25 October at the 2024 Fall Clinical Dermatology Conference.
Tremfya® is approved in Europe, the USA and other countries for moderate to severe plaque psoriasis and active psoriatic arthritis. Tremfya® received FDA approval in September 2024 for moderately to severely active ulcerative colitis. J&J submitted applications for approval of Tremfya® for Crohn’s disease to the FDA in June 2024 and in Europe in May 2024.