US-based pharmaceutical company Johnson & Johnson (J&J) has reported positive results from a Phase IIIb trial of its monoclonal antibody Tremfya (guselkumab) for active psoriatic arthritis (PsA).
The APEX trial met both its primary and major secondary endpoints at 24 weeks in adults with active PsA.
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The double-blind, multi-centre trial showed that the fully human, dual-acting antibody was effective in decreasing the signs and symptoms of PsA against a placebo.
Tremfya has shown results in slowing structural damage in subjects as measured by the PsA-modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores.
The drug inhibits interleukin-23 (IL-23) and attaches to cluster of differentiation 64 (CD64).
The APEX trial has enrolled subjects who are biologic-naïve and had not responded adequately to standard therapies.
The study’s treatment phase includes a 24-week double-blind period, followed by 24 weeks of active treatment and an additional 12-week safety follow-up.
Subjects who are set to enter the long-term extension will be scheduled for an additional period of two years of active treatment before the follow-up of final safety.
Data from the trial were found to be consistent with the antibody’s established safety profile, with no safety signals observed.
PsA is a condition that leads to stiffness, pain and swelling in and around the joints.
J&J innovative medicine vice-president and rheumatology disease area leader Terence Rooney said: “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.”
In May 2024, J&J reported that Tremfya outperformed Stelara on all endoscopic endpoints in a Phase II/III trial for Crohn’s disease.
