Guselkumab Demonstrates Impact on Both Disease Progression and Symptoms in Psoriatic Arthritis

Johnson & Johnson (J&J) announced today that its drug, guselkumab (Tremfya), has become the first IL-23 inhibitor to demonstrate measurable impacts on both disease progression and symptoms in adult patients with active psoriatic arthritis (PsA), with guselkumab use leading to improvements in progression of disease-related structural damage.¹

The data associated with this distinction stems from the phase 3b APEX study (NCT04882098), from which J&J shared positive results and topline efficacy at week 24.²

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Background and Methods

The randomized, double-blind, placebo-controlled trial, conducted across 273 global sites, enrolled 1,054 adults who had not previously received biologic therapy but continued to experience active PsA despite treatment. Participants were randomized into 3 groups receiving either guselkumab, placebo, or a placebo followed by a switch to guselkumab.

Eligible participants had to meet CASPAR criteria, present with at least 3 tender and swollen joints, and demonstrate radiographic evidence of joint erosions. The trial also required evidence of active plaque psoriasis and at least 1 PsA subset phenotype, such as asymmetric arthritis or spondylitis.

Findings

The study demonstrated that guselkumab delivered statistically significant improvements in signs and symptoms of active PsA, achieving its primary endpoint of ACR20 response and its major secondary endpoint of reduced structural damage at week 24 compared to placebo.

Patients receiving treatment with guselkumab experienced significantly less radiographic progression, as measured by the PsA-modified van der Heijde-Sharp score, which includes joint space narrowing and erosion.

Furthermore, the safety profile observed in the study was consistent with prior guselkumab data, with no new safety concerns reported.

Expert Insights

"Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities," said Terence Rooney, MD, vice president, rheumatology disease area leader at J&J Innovative Medicine, in a news release.¹

"These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible," Rooney said. "As the only IL-23 treatment to show significant inhibition of structural damage, Tremfya equips health care providers with critical data so their patients do not have to compromise their future joint health."

The APEX trial is ongoing, with long-term extension data expected to provide further insight into sustained efficacy and joint protection through 3 years.

References

1. TREMFYA (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis. News release. April 4, 2025. Accessed April 4, 2025. https://www.investor.jnj.com/news/news-details/2025/TREMFYA-guselkumab-is-the-first-and-only-IL-23-inhibitor-to-significantly-reduce-both-the-signs-and-symptoms-and-the-progression-of-structural-damage-in-adults-living-with-active-psoriatic-arthritis/default.aspx
2. Janssen Research & Development, LLC. A study of guselkumab in participants with active psoriatic arthritis (APEX). ClinicalTrials.gov. Updated April 3, 2025. Accessed April 4, 2025. https://clinicaltrials.gov/study/NCT04882098