J&J(US:JNJ) Prnewswire·2025-07-29 12:00Core 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]