TREMFYA is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis study – J&J

Johnson & Johnson 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). 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]) at Week 24 versus placebo. TREMFYA also met major secondary endpoints demonstrating a significant reduction in both axial symptoms, as measured by ASDAS-CRP, 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.

“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.”

Advancing the evidence in psoriatic arthritis with axial involvement A

Axial involvement is a clinical domain of PsA in which inflammation affects the spine and sacroiliac joints. It can cause back pain, morning stiffness, fatigue, impaired mobility and reduced physical function, and is associated with poorer quality of life than PsA without axial involvement. Axial involvement may affect approximately 5 to 28 percent of patients with early PsA and 25 to 70 percent of those with longer-standing disease. Despite advances in treating PsA, axial involvement remains an area of significant unmet need. There are currently no universally accepted classification criteria specific to axial PsA, and very few prospective clinical trials have been dedicated specifically to this patient population.

Building on the growing body of evidence supporting TREMFYA in psoriatic arthritis

“Clinical data continue to expand the evidence base for TREMFYA effectiveness across multiple domains of psoriatic arthritis,” said Philip J. Mease, M.D., MACR, FRCP, Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine in Seattle, WA. “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. Together, these findings contribute to a more comprehensive understanding of disease activity and treatment effects.”

Johnson & Johnson recently received FDA approval of a label expansion for the inhibition of progression of structural joint damage in adults with active PsA, cementing TREMFYA as the only IL-23 inhibitor proven to help stop further joint damage.

TREMFYA is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.

About the STAR study (NCT04929210)
STAR is a Phase 4, multicenter, randomized, double-blind, placebo-controlled study evaluating TREMFYA in biologic-naïve adults with active psoriatic arthritis (PsA) and axial involvement. Eligible participants had active PsA with objective evidence of axial inflammation confirmed by centrally read MRI and elevated C-reactive protein despite previous treatment with non-biologic disease-modifying antirheumatic drugs (DMARDs), apremilast and/or nonsteroidal anti-inflammatory drugs (NSAIDs). The study enrolled 411 participants worldwide and includes a 24-week placebo-controlled treatment period followed by a 24-week active treatment period. The primary endpoint evaluated change from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24. Secondary endpoints include additional assessments of axial symptoms, MRI inflammation, physical function, peripheral musculoskeletal manifestations, skin disease and safety.