Guselkumab is being studied as a treatment for both Crohn's disease and ulcerative colitis.
If all goes according to plan in a phase 3 study, guselkumab (TREMFYA) could be a viable treatment options for patients with either Crohn’s disease or ulcerative colitis.
Currently the selective IL-23 p19 antagonist is approved by the US Food and Drug Administration for the treatment of psoriasis and psoriatic arthritis.
However, in data presented during the 2022 European Crohn’s and Colitis Organisation annual meeting from the GALAXI study, investigators touted the treatment in 200, 600, and 1200 mg intravenous doses.
Through week 48 of the phase 2, 248 patient trial, 57.4%-73% of patients treated with guselkumab achieved clinical remission regardless of dose and the majority of patients in clinical remission were also in corticosteroid-free remission at the same time, with rates ranging from 55.7%-71.4%.
The trial also featured similar key safety event rates between all of the dose groups, with no opportunistic infections, cases of tuberculosis, or deaths reported in any of the groups.
In an interview with HCPLive®, Silvio Danese, MD, PhD, Director, Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, explained the positive results and why investigators are confident the phase 3 trial will be equaling successful in treating patients with inflammatory bowel disease (IBD).