Topline Results from Phase IIIb APEX Trial Shows Efficacy of Tremfya for Active Psoriatic Arthritis

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Findings from the Phase IIIb APEX trial (NCT04882098) found that Tremfya (guselkumab) produced a significant reduction in the symptoms of active psoriatic arthritis (PsA) while inhibiting the progression of structural joint damage compared to placebo.^1,2

The long-term extension (LTE) data through three years of treatment will continue to evaluate the sustained efficacy of Tremfya in limiting structural damage in patients with active PsA, with full results to be presented at upcoming medical meetings.

“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,” Terence Rooney, vice president, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine, said in a press release. “These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, Tremfya equips healthcare providers with critical data so their patients do not have to compromise their future joint health.”¹

Tremfya was the first FDA-approved, fully-human, dual-acting monoclonal antibody to block interleukin (IL)-23—a significant driver of the pathogenesis of inflammatory diseases—by attaching to the p19 subunit of IL-23 and to CD64, a receptor on cells that produce IL-23.

Tremfya has previously been approved by the FDA to treat adult patients with active PsA; for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; for adult patients with moderately to severely active ulcerative colitis; and for adult patients with moderately to severely active Crohn disease. A post-hoc analysis of the Phase III VOYAGE 2 (NCT02207244) clinical trial found that Tremfya was associated with greater treatment persistence compared with Taltz (ixekizumab) or Cosentyx (secukinumab) in bio-experienced and bio-naïve patients with moderate-to-severe plaque psoriasis, showing durable clinical efficacy, itch relief, and quality-of-life improvements.³

Trial Design

The multicenter, randomized, double-blind, placebo-controlled APEX trial enrolled patients with active PsA who had not received prior treatment with biologic drugs or who demonstrated an inadequate response to standard therapies such as conventional synthetic disease-modifying antirheumatic drugs, apremilast, and/or nonsteroidal anti-inflammatory drugs. The trial regimen was comprised of a 24-week, double-blind, placebo-controlled period, a 24-week active treatment period, and then a 12-week safety follow-up period. For the trial’s LTE period, patients will receive an additional two years of active treatment before the final safety follow-up.

Enrollment criteria also included having a diagnosis of PsA for at least six months prior to first administration of Tremfya; presence of active PsA defined as at least three swollen joints and three tender joints at screening and baseline, and C-reactive protein greater than or equal to 0.3 milligrams per deciliter (mg/dL) at screening; greater than or equal to two joints with erosions on baseline radiographs of the hands and feet as determined by central read; at least one of either distal interphalangeal joint involvement, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis; presence of active plaque psoriasis with at least one psoriatic plaque of greater than or equal to two centimeters in diameter or nail changes consistent with psoriasis.²

The trial’s primary endpoint is percentage of participants achieving an American College of Rheumatology (ACR) 20 response at week 24, with secondary endpoints that included change from baseline in PsA modified Van Der Heijde-Sharp (vdH-S) total score at week 24, as well as various safety and tolerability measures.

Tremfya achieved the trial’s primary endpoint of ACR20 by lowering the signs and symptoms of active PsA. For the key secondary endpoint, patients administered Tremfya showed significantly less structural damage progression compared to patients administered placebo at week 24 as per the PsA modified vdH-S score. In terms of safety, adverse events were consistent with the known profile of Tremfya with no new safety signals reported.

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. Johnson & Johnson. April 4, 2025. Accessed April 7, 2025. https://www.jnj.com/media-center/press-releases/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

2. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). ClinicalTrials.gov. Updated April 3, 2025. Accessed April 7, 2025. https://clinicaltrials.gov/study/NCT04882098

3. Tremfya (guselkumab) real-world data analyses show greater treatment persistence than IL-17s in both bio-naïve and bio-experienced patients living with moderate to severe plaque psoriasis. News release. Johnson & Johnson. March 17, 2023. Accessed April 7, 2025. https://www.jnj.com/tremfya-guselkumab-real-world-data-analyses-show-greater-treatment-persistence-than-il-17s-in-both-bio-naive-and-bio-experienced-patients-living-with-moderate-to-severe-plaque-psoriasis