Topline results show TREMFYA met the primary and major secondary endpoints of axial involvement in PsA - including spinal pain and stiffness - and demonstrated significant improvement in MRI-confirmed inflammation
First-ever study to use objective MRI assessments to confirm presence of axial involvement and demonstrate axial inflammation reduction in PsA
SPRING HOUSE, Pa., Sept. 25, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that TREMFYA® (guselkumab) met the primary and major secondary endpoints demonstrating both improvement in axial symptoms and reduction in inflammation by MRI assessment in the Phase 4 STAR study evaluating biologic-naïve adults with active psoriatic arthritis and axial involvement (axial PsA). STAR is the first and only dedicated randomized, double-blind, placebo-controlled study of its kind designed to prospectively evaluate an IL-23 inhibitor specifically in patients with axial involvement confirmed by magnetic resonance imaging (MRI).1 These topline findings represent an important milestone in advancing disease-specific evidence for patients living with axial PsA. Detailed efficacy and safety results, including MRI findings, will be presented at an upcoming scientific congress.
In the STAR study, TREMFYA met the primary endpoint evaluating improvement in a composite patient-reported disease activity score that includes spinal pain, stiffness, fatigue, joint symptoms and areas of tenderness (the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])a at Week 24 versus placebo. TREMFYA also met major secondary endpoints demonstrating a significant reduction in both axial symptoms, as measured by ASDAS-CRPb, and objective (MRI) inflammation of the sacroiliac joints. The overall safety profile observed in the STAR study was consistent with the established safety profile of TREMFYA in PsA, and no new safety signals were identified.1
"Axial PsA involves inflammation of the spine and sacroiliac joints, often leading to debilitating pain, stiffness, and fatigue. Patients face reduced mobility and a diminished quality of life, underscoring the urgent need for a treatment that helps stop further joint damage and targets the underlying disease," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "As the first Phase 4 study of an IL-23 inhibitor in this patient population, STAR further strengthens the growing body of evidence supporting TREMFYA as a first-line treatment option proven to help stop further joint damage."