Johnson & Johnson: FDA approves TREMFYA label update for PsA joint‑damage inhibition
- APEX Phase 3b in biologic‑naïve PsA patients: 24‑week double‑blind period met primary ACR20 and showed inhibition of structural damage by PsA‑modified vdH‑S score versus placebo.
- Patients switching from placebo to guselkumab at Week 24 had 57% less radiographic progression from Week 24–48, with no new safety signals observed.
- TREMFYA (guselkumab) is an IL‑23–targeting monoclonal antibody that also binds CD64; study design: 24‑week placebo‑controlled, 24‑week active treatment, 12‑week safety follow‑up and optional 2‑year extension.
FDA label update
The FDA approved a supplemental BLA adding evidence that TREMFYA (guselkumab) inhibits progression of structural joint damage in adults with active psoriatic arthritis; the label now includes this outcome and is reported as the only IL‑23 inhibitor with structural inhibition in its label.
APEX study results
In biologic‑naïve patients, the Phase 3b APEX trial met its 24‑week primary endpoint (ACR20) and its major secondary endpoint, showing significant inhibition of structural damage versus placebo by the PsA‑modified van der Heijde‑Sharp score; patients switching from placebo to guselkumab at Week 24 had a 57% reduction in radiographic progression from Week 24–48.
Safety and mechanism
Safety results were consistent with the established profile and identified no new safety signals; guselkumab targets IL‑23 and also binds CD64 on IL‑23–producing cells, with the CD64 binding demonstrated in vitro and clinical significance not established.
Study design and clinical context
APEX was a randomized, double‑blind, placebo‑controlled multicenter trial in biologic‑naïve patients with inadequate response to csDMARDs, apremilast or NSAIDs, consisting of a 24‑week placebo‑controlled period, 24‑week active treatment, 12‑week safety follow‑up and an optional two‑year extension; up to half of patients with active PsA may develop early irreversible joint damage.
Source: J&J