Accessibility StatementSkip Navigation First-line treatment with TREMFYA shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new d ...

Core Insights - Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the FDA for TREMFYA® (guselkumab) to include new evidence for inhibiting structural damage progression in adults with active psoriatic arthritis (PsA) [1][2] - The submission is backed by results from the Phase 3b APEX study, which met its primary endpoint of reducing joint symptoms and a major secondary endpoint of inhibiting structural damage progression at 24 weeks compared to placebo [2][3] - TREMFYA® is the first and only dual-acting IL-23 inhibitor that has demonstrated both symptom control and significant inhibition of joint damage progression in active PsA patients [3][4] Study Details - The APEX study is a multicenter, randomized, double-blind, placebo-controlled trial involving biologic-naïve patients with active PsA who had inadequate responses to standard therapies [6] - The study included a 24-week double-blind placebo-controlled period followed by a 24-week active treatment phase, with an option for a long-term extension of an additional 2 years [6] Psoriatic Arthritis Overview - Psoriatic arthritis is a chronic, immune-mediated inflammatory disease that can lead to severe joint damage and is characterized by joint inflammation, enthesitis, and dactylitis [7] - The disease commonly appears between the ages of 30 and 50, with nearly half of patients experiencing moderate fatigue and about one-third suffering from severe fatigue [7] Product Information - TREMFYA® is a fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on IL-23 producing cells, addressing inflammation at the cellular source [4][8] - The product is approved in the U.S. and several other countries for treating adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis [9]

Core Insights - TREMFYA® (guselkumab) demonstrated significant efficacy in inhibiting joint structural damage and improving symptoms in patients with active psoriatic arthritis (PsA) in the Phase 3b APEX study [1][2][3] Efficacy Results - TREMFYA® showed a 2.5 times greater ability to inhibit joint structural damage compared to placebo [1] - At Week 24, 67% of patients receiving TREMFYA® every four weeks (Q4W) and 63% every eight weeks (Q8W) experienced no radiographic progression, compared to 53% in the placebo group [2] - More than 40% of TREMFYA®-treated patients achieved ACR50 response at Week 24, significantly higher than the 20% in the placebo group [1][5] Safety Profile - The safety profile of TREMFYA® remained consistent with previous studies, with no new safety signals identified [3] - TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved for treating PsA, targeting IL-23 and binding to CD64 [3][9] Study Design - The APEX study was a multicenter, randomized, double-blind, placebo-controlled trial involving biologic-naïve patients with active PsA who had inadequate responses to standard therapies [7] Market Position - Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®, which is approved in multiple regions for treating moderate-to-severe plaque psoriasis and active PsA [10][24]