Core 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]

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]