Johnson & Johnson (JNJ) Submits TREMFYA® for Psoriatic Arthritis Treatment Advancement

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Johnson & Johnson Advances Psoriatic Arthritis Treatment with TREMFYA® Submission

Johnson & Johnson (JNJ) takes a significant step forward in the treatment of psoriatic arthritis (PsA) by submitting a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for its drug, TREMFYA® (guselkumab). This submission aims to include new evidence in the drug’s label that highlights its potential to inhibit the progression of structural damage in adults suffering from active PsA. The application is supported by promising results from the Phase 3b APEX study, which shows that TREMFYA® not only reduces joint symptoms, as indicated by the primary endpoint of ACR20, but also effectively inhibits the progression of structural damage measured by the modified van der Heijde-Sharp (vdH-S) score over 24 weeks compared to a placebo in biologic-naïve patients.

The APEX study is a pivotal multicenter, randomized, double-blind, placebo-controlled trial that includes participants who have not adequately responded to standard therapies. Data presented at the recent European Alliance of Associations for Rheumatology (EULAR) 2025 Congress highlights the drug’s ability to address the long-term impacts of PsA. Brandee Pappalardo, Vice President of Medical Affairs at Johnson & Johnson, underscores the significance of developing therapies that not only alleviate symptoms but also mitigate the long-term joint damage often associated with this chronic inflammatory condition. If approved, TREMFYA® will stand out as the first IL-23 inhibitor with evidence supporting its efficacy in controlling symptoms and significantly reducing joint damage progression in active PsA patients.

What sets TREMFYA® apart is its unique mechanism of action as the first fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor involved in immune-mediated diseases like active PsA. The safety profile of the drug remains consistent with previous findings, further reassuring clinicians and patients of its potential as a reliable treatment option. Johnson & Johnson intends to share additional findings from the APEX study at future medical meetings, indicating a commitment to transparency and ongoing research in the field of rheumatology.

In addition to its focus on psoriatic arthritis, Johnson & Johnson continues to prioritize the development of innovative therapies across various immunological conditions. The company recognizes the importance of addressing unmet medical needs in chronic diseases and remains dedicated to enhancing patient care through its extensive pipeline of biologic treatments. As the healthcare landscape evolves, Johnson & Johnson stands poised to lead in providing solutions that significantly improve the quality of life for patients.