TREMFYA® (guselkumab) dramatically slows the progression of structural joint damage in patients with active psoriatic arthritis (PsA) over a 48-week period, according to new long-term data from Johnson & Johnson’s Phase 3b APEX study, which was released today. The results were showcased at the 2025 Inflammatory Skin Disease Summit (ISDS).
The study confirms that TREMFYA® is the only IL-23 inhibitor that has been shown to significantly reduce structural damage in this patient population to date.
According to the data, first-line treatment with TREMFYA® showed a significant ability to inhibit radiographic progression, or joint damage, at Week 24, a result that was sustained through Week 48. At the 24-week mark, TREMFYA® demonstrated an ability to inhibit joint damage that was two and a half times greater than that of a placebo, as measured by the PsA-modified van der Heijde-Sharp (vdH-S) score.
The study also highlighted significant improvement for patients who initially received a placebo. Patients in the placebo group were switched to TREMFYA® at Week 24. From that point through Week 48, this group experienced a 57% reduction in their rate of radiographic progression.
These long-term data show that TREMFYA has set a new benchmark,
It’s durable efficacy and established safety make TREMFYA an attractive first-line treatment option for patients with psoriatic disease.
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In addition to inhibiting structural damage, TREMFYA® showed durable efficacy in improving the signs and symptoms of PsA. More than half of the patients treated with TREMFYA® achieved at least a 50% improvement in signs and symptoms (ACR50) by Week 48. The safety profile of the drug remained consistent with previous studies, with no new safety signals identified.
Building on these results, Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to add this new evidence for inhibiting structural damage to the TREMFYA® label.
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