J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data

July 29, 2025

News

Article

The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.

Credit: and.one | stock.adobe.com

Key takeaways

J&J has submitted an sBLA to the FDA seeking to update Tremfya’s label to include data on inhibiting structural joint damage in adults with active PsA.
Phase IIIb APEX trial results showed significant improvements in both symptom control (ACR responses) and structural damage progression (vdH-S scores).
Tremfya could become the first IL-23 inhibitor with proven efficacy in preventing joint damage, offering a potential new standard for bio-naïve PsA patient care.

Johnson & Johnson (J&J) has submitted a supplemental Biologics License Application (sBLA) to the FDA for approval to include new evidence in Tremfya’s (guselkumab) label for the inhibition of progression of structural damage in adult patients with active psoriatic arthritis (PsA).¹

APEX trial supports efficacy in joint damage prevention

This sBLA submission by J&J is based on recent data from the Phase IIIb APEX clinical trial (NCT04882098) evaluating Tremfya in patients with active PsA. The study achieved its primary outcome measure of reducing joint symptoms (ACR20), as well as its major secondary measure of inhibited progression of structural damage as measured by change in the modified van der Heijde-Sharp (vdH-S) score at Week 24, compared to placebo in bio-naïve patients.

In a press release, Brandee Pappalardo, PhD, MPH, vice president, medical affairs, dermatology & rheumatology, Johnson & Johnson Innovative Medicine, said: “Psoriatic arthritis 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. With this new evidence, Tremfya 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.”

Radiographic and clinical response data highlight Tremfya’s impact

J&J shared detailed data from this most recent readout of the APEX study in June. According to the findings, Tremfya demonstrated significant slowing of joint structural damage progression, such as joint erosions and space narrowing, as assessed by the PsA modified vdH-S score.²

By Week 24, patients receiving Tremfya showed significantly less radiographic progression, with mean changes in modified vdH-S scores of 0.55 (Q4W) and 0.54 (Q8W), compared to 1.35 in the placebo group (p=0.002 and p<0.001, respectively).
No radiographic progression was observed in 67% of patients on Q4W dosing and 63% on Q8W dosing, compared to 53% in the placebo arm.
ACR20 responses were achieved by 67% of patients in the Q4W group and 68% in the Q8W group, versus 47% in the placebo group (p<0.001).
ACR50 response rates were 41% for Q4W and 42% for Q8W dosing, compared to 20% for placebo.
Nearly three-quarters of patients receiving Tremfya every four weeks (73%) and 68% on the eight-week regimen had clear or nearly clear skin (IGA 0/1) at Week 24, while only 31% of placebo patients achieved this outcome.

In a press release from the time of when this data was shared at the 2025 European Alliance of Associations for Rheumatology Congress, study investigator Philip J. Mease, MD, director of rheumatology research at the Swedish Medical Center, said: “In psoriatic arthritis, joint damage can begin early and progress quickly if left untreated, significantly impacting a patient’s ability to move, work and maintain independence. The results of the APEX study are promising as the data show guselkumab to be the only IL-23 inhibitor in its class that has inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for safe, effective options that address the full burden of disease.”

Study design targets biologic-naïve PsA population

The APEX trial is evaluating patients with active PsA who have not responded adequately to conventional treatments such as csDMARDs, apremilast, or NSAIDs and have not previously received biologics.
Participants are randomly assigned in a double-blind, placebo-controlled design for the first 24 weeks, followed by 24 weeks of active treatment.
Those who opt into the extension phase may continue active treatment for an additional two years, with a final safety follow-up afterward.

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 & Johnson. July 29, 2025. Accessed July 29, 2025. https://www.jnj.com/media-center/press-releases/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

2. Phase IIIb APEX Trial Finds Tremfya Significantly Slows Joint Damage Progression in Psoriatic Arthritis. Applied Clinical Trials. June 11, 2025. Accessed July 29, 2025. https://www.appliedclinicaltrialsonline.com/view/apex-trial-tremfya-joint-damage-psoriatic-arthritis

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Subscribe Now!