Johnson & Johnson (J&J) has announced that its drug Tremfya (guselkumab) has met primary and secondary endpoints in the Phase 3b APEX study for adults with active psoriatic arthritis (PsA).
The trial demonstrated that the medication significantly reduces both the signs and symptoms, as well as the progression of structural damage, compared to a placebo at 24 weeks.
Tremfya is a fully-human, dual-acting monoclonal antibody approved to treat PsA by inhibiting IL-23 and binding to CD64, a receptor on cells producing IL-23. This cytokine is associated with immune-mediated conditions such as active psoriatic arthritis.
In the APEX study, patients treated with Tremfya showed less progression of structural damage than those on a placebo, based on the PsA modified van der Heijde-Sharp (vdH-S) score, which evaluates joint space narrowing and erosion. The safety profile remained consistent with previous data, with no new safety concerns identified.
Johnson & Johnson innovative medicine vice president, rheumatology disease area leader Terence Rooney said: “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.
“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.”
APEX is a multicentre, randomised, double-blind, placebo-controlled trial involving patients who have not responded adequately to standard treatments like csDMARDs, apremilast, or NSAIDs.
The trial includes a 24-week double-blind period followed by an active treatment phase and a safety follow-up period. Long-term extension data will assess the continued efficacy of Tremfya over three years.
Tremfya is approved in multiple regions worldwide for treating moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and Crohn’s disease. Johnson & Johnson holds exclusive global marketing rights for Tremfya.
