J&J Files sBLA for Guselkumab Structural Damage Data

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Today, Johnson & Johnson announced it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to update the label for guselkumab (Tremfya) to include new data on its ability to inhibit the progression of structural joint damage in adults with active psoriatic arthritis (PsA).¹ The submission is supported by findings from the phase 3b APEX study, which met both primary and major secondary endpoints.²

"PsA is a complex disease that can lead to severe and irreversible joint damage, which is why we are dedicated to developing innovative therapies that comprehensively address the long-term impact as well as the everyday challenges of this condition," said Brandee Pappalardo, PhD, MPH, vice president, medical affairs, dermatology & rheumatology, Johnson & Johnson Innovative Medicine, in a news release. "With this new evidence, [guselkumab] would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA."

Study Data

The APEX study (NCT04882098), a multicenter, randomized, double-blind, placebo-controlled trial, evaluated guselkumab in biologic-naïve patients with active PsA who had an inadequate response to standard therapies, including conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), apremilast, and/or nonsteroidal anti-inflammatory drugs (NSAIDs). The 24-week double-blind period was followed by an additional 24-week active treatment phase, with an optional long-term extension of 2 years.

According to Johnson & Johnson, patients treated with guselkumab demonstrated “statistically significant improvements” in American College of Rheumatology 20% improvement (ACR20) response criteria—a composite measure of tender and swollen joint counts and additional patient and physician-reported outcomes—when compared to placebo. Notably, the study also met a major secondary endpoint: inhibition of radiographic progression, measured by change from baseline in the modified van der Heijde-Sharp (vdH-S) score at 24 weeks.

The drug's safety profile in the APEX study was consistent with previously reported data, with no new safety signals identified. Additional data from the study are expected to be shared at upcoming medical conferences.

Background

Guselkumab is a fully-human, dual-acting monoclonal antibody that blocks interleukin-23 (IL-23), a key cytokine involved in the pathogenesis of multiple immune-mediated diseases, including PsA. The drug also binds to CD64, a receptor found on IL-23-producing cells. While this dual mechanism has been demonstrated in vitro, the clinical significance of CD64 binding remains to be fully understood.

Initially approved for the treatment of moderate to severe plaque psoriasis, guselkumab has since received regulatory clearance for use in adults with active PsA, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease. Its proposed label update for PsA would emphasize the inhibition of structural joint damage—a feature that, if approved, would differentiate it from other IL-23 inhibitors in the market.

Psoriatic arthritis affects an estimated 30% of patients with plaque psoriasis and can be associated with fatigue, depression, and other comorbidities. Its onset typically occurs between the ages of 30 and 50, though it can present at any age. Inflammatory joint damage is a key driver of long-term disability, making disease-modifying therapies that halt radiographic progression critical to patient outcomes.

Conclusion

With this sBLA, Johnson & Johnson aims to reinforce the role of guselkumab as a comprehensive treatment for PsA—addressing both symptoms and structural outcomes. The FDA’s decision on the label expansion will determine whether this treatment can be positioned as the only IL-23 inhibitor with evidence supporting the inhibition of joint damage progression in PsA.

References

1. Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA® (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis. News release. Johnson and Johnson. Published July 29, 2025. Accessed July 29, 2025. https://www.investor.jnj.com/news/news-details/2025/Johnson--Johnson-files-with-U-S--FDA-to-include-new-evidence-in-TREMFYA-guselkumab-label-as-the-only-IL-23-inhibitor-to-demonstrate-significant-inhibition-of-joint-structural-damage-in-active-psoriatic-arthritis/default.aspx
2. Ritchlin CT, Coates LC, Mease PJ, et al. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023;24(1):22. Published 2023 Jan 10. doi:10.1186/s13063-022-06945-y