J&J Seeks New Guselkumab Label Reflecting Inhibition of PsA Joint Damage

Johnson & Johnson (J&J) has submitted a supplemental biologics license application (sBLA) to include new evidence in guselkumab’s label supporting its ability to inhibit progression of structural damage in adults with active psoriatic arthritis (PsA).1

The therapy, approved under the name Tremfya, was originally approved for adults with active PsA in July 2020.2 More recently, J&J submitted 2 sBLAs for guselkumab for treating of children aged 6 and older with moderate-to-severe psoriasis and those aged 5 and older with active juvenile PsA.3

“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,” Brandee Pappalardo, PhD, MPH, Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine, said in a statement.1 “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.”

The new submission is supported by data from the Phase 3b APEX study which were presented at June’s European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.The findings demonstrated that guselkumab met its primary endpoint of reducing joint symptoms on ACR20 and also its major secondary endpoint of significantly inhibiting progression of joint structural damage, including joint erosions and space narrowing, in patients with active PsA at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score. The mean change from baseline to Week 24 in the modified vdH-S score was 0.55 and 0.54 for patients receiving guselkumab every 4 weeks (Q4W) and every 8 weeks (Q8W) respectively, compared with 1.35 in the placebo group (P = .002 for Q4W and P <.001 for Q8W dosing versus placebo, respectively). In the 2 guselkumab Q4W and Q8W dose groups, 67% and 63%, respectively, experienced no radiographic progression, compared with 53% in the placebo group.4

“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,” Philip Mease, MD, Clinical Professor, University of Washington School of Medicine and Director, Rheumatology Research, Swedish Medical Center, who has served as a primary investigator on multiple guselkumab trials, said in a statement.4

Safety findings were consistent with that seen in previous studies. Furthermore, on APEX’s primary endpoint, investigators found that 67% of guselkumab Q4W and 68% Q8W achieved ACR20 at Week 24 compared with 47% receiving placebo (P <.001); these trends were similar on ACR50 responses (41% for Q4W and 42% for Q8W versus 20% placebo at week 24). Concerning skin clearance, 73% in guselkumab Q4W and 68% Q8W achieved an Investigator’s Global Assessment (IGA) score of 0/1d (clear or almost clear skin) at Week 24 versus 31% receiving placebo.4 The new structural findings may set guselkumab apart from the increasing number of entering the market for PsA.

“We are now getting more and more choices, so as we strive to get patients into minimal disease activity state and maintain them there, even when we lose effect with one drug or one mechanism, we've now got others to be able to cycle to, and that's very helpful for us,” Mease recently told HCPLive.

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. 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. TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis. News release. Johnson & Johnson. July 14, 2020. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-approved-by-u-s-food-and-drug-administration-as-the-first-selective-interleukin-il-23-inhibitor-for-active-psoriatic-arthritis

3. Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab). Johnson & Johnson. December 2, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-u-s-fda-approval-for-first-pediatric-indications-for-tremfya-guselkumab

4. New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis. News release. Johnson & Johnson. June 11, 2025. https://www.jnj.com/media-center/press-releases/new-data-show-tremfya-guselkumab-is-the-only-il-23-inhibitor-proven-to-significantly-inhibit-progression-of-joint-structural-damage-in-active-psoriatic-arthritis