J&J(US:JNJ) Prnewswire·2025-11-17 13:05Core Insights - TREMFYA has shown significant inhibition of radiographic progression in patients with active psoriatic arthritis (PsA) at Week 24, with results sustained through Week 48, indicating its effectiveness in preserving joint health [1][4][5] - More than half of the patients treated with TREMFYA achieved a 50% improvement in signs and symptoms of PsA by Week 48 in the Phase 3b APEX study [1][4] - The study results support Johnson & Johnson's submission of a supplemental Biologics License Application (sBLA) to the FDA for including new evidence in the TREMFYA label regarding the inhibition of structural damage progression in adults with active PsA [6] Efficacy and Safety - At Week 24, TREMFYA demonstrated a 2.5 times greater ability to inhibit joint structural damage compared to placebo, with sustained results through Week 48 [2][3] - Patients in the placebo group who switched to TREMFYA at Week 24 experienced a 57% reduction in the rate of radiographic progression from baseline to Week 48 [3] - The ACR50 response rates, indicating a clinically meaningful improvement, increased from Week 24 to Week 48 in both dosing groups, with nearly half of the patients transitioning from placebo achieving ACR50 by Week 48 [4] Treatment Implications - TREMFYA is positioned as a valuable treatment option for both early intervention and for patients already showing signs of joint damage, as it can inhibit the progression of joint damage [4][5] - It is the first and only fully-human, dual-acting monoclonal antibody approved for treating PsA, targeting IL-23 and binding to CD64, which is significant for immune-mediated diseases [5][11] - The established safety profile of TREMFYA remains consistent, with no new safety signals identified during the study [4][5]