SIMPONI (golimumab) - (GALAXI)
- Indication
- Pediatric Ulcerative Colitis Crohn's Disease (GALAXI)
- Stage
- phase3
- Event
- Conference Presentation
- Details
Oct. 12, 2026: Johnson & Johnson (NYSE: JNJ) reported new three-year Phase 3 GALAXI 2 and 3 long-term extension data for TREMFYA (guselkumab) in adults with moderately to severely active Crohn’s disease, presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting.
At Week 144, after IV induction and SC maintenance, clinical remission (CDAI <150) was achieved by 94% of patients on 100 mg every 8 weeks and 91% on 200 mg every 4 weeks. Ninety-day corticosteroid-free clinical remission was reached by 88% in both dosing groups. Endoscopic remission was reported in 52% of the every-8-weeks group and 61% of the every-4-weeks group. Overall, 74% of TREMFYA-treated patients remained on treatment through three years.
The company said safety through Week 144 was consistent with TREMFYA’s established Crohn’s disease safety profile. The GALAXI program includes a five-year long-term extension to continue assessing clinical, endoscopic, and safety outcomes. A referenced ACG presentation is dated October 13, 2026.
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