Cure8 news brief
These Phase 3 results suggest guselkumab (TREMFYA) may provide durable clinical and endoscopic benefit through three years for adults with moderate to severe Crohn’s disease and may help with perianal fistula remission—an important concern for many patients.
Adults with Crohn’s disease, especially those with perianal fistulas; patients considering or on biologic therapy; gastroenterologists and IBD researchers.
This is a company press release summarising Phase 3 study findings. The GALAXI long-term extension reports as-observed rates of clinical remission and endoscopic remission at Week 144 for two maintenance dosing regimens (100 mg q8w and 200 mg q4w).
The analyses were as-observed and exclude patients who discontinued or lacked Week 144 data, so they do not represent the full randomized population.
The FUZION results presented are Week 48 analyses for patients with perianal fistula; combined (clinical plus radiologic) fistula remission was reported to be maintained or improved, with an increase from 28% to 35% in one dosing group. The press release also reiterates the known safety profile and common adverse reactions.
The source is a company press release summarising conference data. The three-year GALAXI findings are as-observed long-term extension results (exclude discontinuations). Peer-reviewed publications or conference abstracts should be reviewed for full methods and intent-to-treat analyses.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Perianal fistulas are a common and debilitating complication of Crohn’s disease that often need medical and surgical care. A Phase 3 trial reporting improved fistula remission with an IL-23–targeting therapy could offer...
Long-term (3-year) data on a biologic for Crohn's disease may indicate how durable treatment benefits and steroid-free remission can be for people considering or already on biologic therapy.
Long-term control of symptoms and intestinal inflammation is a major need in Crohn's disease. Three-year data showing sustained clinical and endoscopic remission and high rates of steroid-free remission could be...
