Long-term Study Solidifies TREMFYA® as Leading Treatment for Psoriatic Arthritis

The latest data from the Phase 3b APEX study showcases the remarkable efficacy of TREMFYA® (guselkumab), establishing it as the only IL-23 inhibitor that significantly inhibits structural joint damage in patients with active psoriatic arthritis (PsA). Conducted by Johnson & Johnson, these findings bolster TREMFYA®'s position as a vital therapy for individuals battling this chronic condition.

Key Findings from the APEX Study

On November 17, 2025, Johnson & Johnson revealed compelling results indicating that TREMFYA® consistently reduced the signs and symptoms of PsA over an impressive 48-week period. This data was presented at the Inflammatory Skin Disease Summit (ISDS) 2025, emphasizing the long-term benefits of the medication.

Inhibition of Joint Damage

The APEX study documented that TREMFYA® exhibited an astonishing 2.5 times greater efficacy in preventing structural joint damage at Week 24 compared to a placebo. This effectiveness was maintained through Week 48. Both dosage regimens—administering the drug every four weeks (Q4W) or every eight weeks (Q8W)—yielded significant results as assessed by the PsA-modified van der Heijde-Sharp (vdH-S) score. Notably, patients who transitioned from the placebo group to TREMFYA® showed a 57% reduction in radiographic progression over this period.

Dr. Christopher Ritchlin, a prominent investigator at the University of Rochester Medical Center and involved in the APEX study, highlighted that early treatment is crucial in managing PsA, given that joint damage can escalate quickly if left untreated. He noted, "The APEX study results show that guselkumab can inhibit this process, even once it has begun, making it a valuable treatment option for patients who already show signs of joint damage."

Improving Patient Outcomes

Moreover, the study illustrated significant improvement in patient-reported outcomes, with nearly half of those initially in the placebo group achieving ACR50—a substantial improvement rate defined as at least a 50% enhancement from baseline in both tender and swollen joint counts. This underscores TREMFYA®'s potential to dramatically enhance the quality of life for those afflicted with PsA.

Linda Dragone, MD, PhD, from Johnson & Johnson, stated, "These long-term data show that TREMFYA has set a new benchmark as the only IL-23 inhibitor proven to inhibit structural damage in active psoriatic arthritis." This supports its use as a preferred first-line treatment for patients exhibiting psoriatic manifestations.

Mechanism of Action

What sets TREMFYA® apart is its innovative mechanism as the first and only fully-human, dual-acting monoclonal antibody targeting IL-23 while also binding to CD64—a receptor on IL-23 producing cells. This dual-action mechanism provides a comprehensive approach to managing inflammation at its source, highlighting its potential for fostering long-term remission in PsA patients.

Safety Profile and Regulatory Updates

The APEX study affirmed TREMFYA®'s well-established safety profile, indicating no new safety signals. The findings support Johnson & Johnson's recent supplemental Biologics License Application (sBLA) to the U.S. FDA, aimed at revising the TREMFYA® label to reflect its efficacy in inhibiting structural damage progression in adults with active PsA.

Conclusion

In summary, TREMFYA® (guselkumab) continues to demonstrate its efficacy as a groundbreaking treatment option in the realm of psoriatic arthritis. With its unique mechanism and compelling long-term data, it stands as a beacon of hope for individuals fighting this challenging condition. As our understanding of PsA evolves and treatments advance, reflections on the data from studies like APEX pave the way for improved patient outcomes and management strategies in the future.

For more information on TREMFYA®, visit TREMFYA.