The FDA has approved a TREMFYA label expansion to include inhibition of structural joint damage progression in active psoriatic arthritis, supported by Phase 3b APEX trial results showing reduced radiographic progression and sustained symptom improvement.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson has received U.S. Food and Drug Administration (FDA) approval for a supplemental Biologics License Application (sBLA) expanding the label for TREMFYA® (guselkumab) to include evidence of inhibition of structural joint damage progression in adults with active psoriatic arthritis (PsA).
With the update, TREMFYA becomes the first and only IL-23 inhibitor with label-supported evidence demonstrating protection against irreversible joint damage in PsA.
Evidence from Phase 3b APEX Trial
The approval is supported by results from the Phase 3b APEX trial (NCT04882098), which enrolled approximately 850 biologic-naïve patients with active PsA who had shown inadequate responses to standard therapies.
The study met its primary endpoint of improving joint symptoms, as measured by ACR20 response rates, and its major secondary endpoint of slowing radiographic progression, assessed by changes in the PsA-modified van der Heijde-Sharp (vdH-S) score.
Patients who switched from placebo to TREMFYA at Week 24 showed a 57% reduction in radiographic progression through Week 48, suggesting clinical benefit even after initial disease progression. Safety findings were consistent with the established guselkumab profile, and no new safety signals were identified.
Mechanism of Action
TREMFYA is a fully human monoclonal antibody that selectively targets interleukin-23 (IL-23), a key cytokine involved in the inflammatory pathways that drive PsA and other immune-mediated diseases. The therapy also binds CD64-expressing IL-23-producing cells, although the clinical significance of this activity remains unclear.
Clinical Significance
Psoriatic arthritis is a chronic immune-mediated disease that affects both joints and skin. Joint damage can develop early in the disease course and may lead to permanent disability, impaired physical function, and reduced quality of life. As a result, preventing irreversible disease progression remains a central treatment goal alongside symptom control.
Dr. Philip Mease, Director of Rheumatology Research at Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine, noted that joint damage can occur within months of disease onset, highlighting the need for therapies that provide both symptom relief and long-term joint protection.
Brandee Pappalardo, Ph.D., M.P.H., Vice President of Medical Affairs for Dermatology and Rheumatology at Johnson & Johnson Innovative Medicine, said the label expansion further differentiates TREMFYA by combining symptom improvement with evidence of protection against irreversible joint damage.
Market Positioning
TREMFYA was first approved for moderate-to-severe plaque psoriasis in 2017 and for active psoriatic arthritis in 2020. It is also approved in the U.S. for moderately to severely active ulcerative colitis and Crohn’s disease. The latest label expansion further strengthens its position among biologic therapies for patients with active PsA at risk of progressive joint damage.
The updated label reinforces TREMFYA’s role as a treatment that addresses both disease symptoms and long-term joint preservation, a key objective in the management of psoriatic arthritis.
Reference
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.