Johnson & Johnson TREMFYA shows sustained remission through three years in Crohn’s disease
- 94% (100 mg q8w) and 91% (200 mg q4w) of patients achieved clinical remission at Week 144 (as‑observed).
- 88% of patients on each maintenance regimen achieved 90‑day corticosteroid‑free clinical remission at Week 144 (as‑observed).
- Endoscopic remission at Week 144 was 52% for 100 mg q8w and 61% for 200 mg q4w (SES‑CD ≤4, ≥2‑point reduction, no subscore >1).
- 74% of TREMFYA‑treated patients remained on treatment through three years; safety through Week 144 was consistent with the established profile.
Study and dosing
The results come from the Phase 3 GALAXI 2 and 3 programs with a Week 144 long‑term extension (LTE). Participants received an intravenous induction followed by maintenance dosing of either 100 mg subcutaneously every eight weeks (q8w) or 200 mg subcutaneously every four weeks (q4w).
Three‑year efficacy outcomes
As‑observed LTE data at Week 144 showed clinical remission in 94% of patients on 100 mg q8w and 91% on 200 mg q4w. Ninety‑day corticosteroid‑free clinical remission was 88% for both regimens. Endoscopic remission (defined as SES‑CD ≤4 with a ≥2‑point reduction and no subscore >1) was 52% for 100 mg q8w and 61% for 200 mg q4w.
Safety and treatment retention
Safety findings through Week 144 were reported as consistent with the known safety profile of the medicine. Overall, 74% of TREMFYA‑treated patients remained on treatment through three years.
Analysis notes
The reported Week 144 results reflect the as‑observed analysis set: participants who entered the LTE, received ≥1 partial or complete LTE dose, remained on treatment, and had data available at Week 144; participants with dose adjustments were excluded from this analysis.
Source: J&J