SPRING HOUSE, PA — Johnson & Johnson’s TREMFYA met the primary and major secondary endpoints in a Phase 4 trial of adults with psoriatic arthritis and axial involvement, showing improvements in symptoms and MRI-confirmed inflammation as the company builds clinical evidence for the drug across additional manifestations of the disease.
The STAR study evaluated biologic-naïve adults with active psoriatic arthritis and axial involvement confirmed through magnetic resonance imaging. Johnson & Johnson described it as the first prospective, randomized, double-blind, placebo-controlled study specifically evaluating an IL-23 inhibitor in patients with MRI-confirmed axial involvement.
At Week 24, TREMFYA, or guselkumab, met the primary endpoint by producing an improvement compared with placebo on the Bath Ankylosing Spondylitis Disease Activity Index, a composite measure covering spinal pain, stiffness, fatigue, joint symptoms and areas of tenderness.
The drug also met major secondary endpoints measuring axial symptoms and inflammation. Johnson & Johnson reported a significant improvement on an ASDAS-CRP assessment and a significant reduction in MRI-detected inflammation of the sacroiliac joints.
The company reported no new safety signals, with the study’s overall safety profile consistent with the established profile of TREMFYA in psoriatic arthritis. Detailed efficacy, safety and MRI findings are expected to be presented at a scientific congress.
Axial involvement in psoriatic arthritis affects the spine and sacroiliac joints and can produce back pain, morning stiffness, fatigue and impaired mobility. Estimates cited by Johnson & Johnson indicate it may affect about 5% to 28% of patients with early psoriatic arthritis and 25% to 70% of those with longer-standing disease.
The condition presents a clinical challenge because there are no universally accepted classification criteria specific to axial psoriatic arthritis and few prospective trials have focused specifically on that patient population.
“What makes the STAR study particularly noteworthy is that, for the first time in a prospective, randomized, double-blinded, placebo-controlled PsA study, it evaluates MRI assessments for inclusion and provides a rigorous and objective measure of improvements in inflammation alongside clinical outcomes in axial PsA,” Dr. Philip J. Mease, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said.
The results follow a recent U.S. Food and Drug Administration label expansion for TREMFYA covering inhibition of the progression of structural joint damage in adults with active psoriatic arthritis.
TREMFYA is a fully human monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. The cytokine is associated with immune-mediated diseases including active psoriatic arthritis.
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