TREMFYA improves spinal symptoms and MRI confirmed inflammation in Phase IV axial psoriatic arthritis study

Johnson & Johnson has reported positive topline results from the Phase IV STAR study evaluating TREMFYA, also known as guselkumab, in biologic naive adults with active psoriatic arthritis and axial involvement.

The study met its primary endpoint and major secondary endpoints, demonstrating improvements in axial symptoms as well as a reduction in inflammation identified through magnetic resonance imaging.

STAR is a randomised, double blind and placebo controlled study designed specifically to prospectively evaluate an interleukin 23 inhibitor in patients whose axial involvement was confirmed using MRI.

Johnson & Johnson said the study is the first of its kind to use objective MRI assessments both to confirm axial involvement at enrolment and to assess reductions in axial inflammation during treatment.

Detailed efficacy and safety findings, including the complete MRI results, are expected to be presented at an upcoming scientific congress.

At week 24, TREMFYA met the primary endpoint by significantly improving the Bath Ankylosing Spondylitis Disease Activity Index compared with placebo.

The composite patient reported measure assesses several aspects of disease activity, including spinal pain, stiffness, fatigue, joint symptoms and areas of tenderness.

TREMFYA also achieved major secondary endpoints assessing axial disease.

Treatment resulted in a significant reduction in axial symptoms measured using the Ankylosing Spondylitis Disease Activity Score with C reactive protein.

Patients receiving TREMFYA also experienced a significant reduction in MRI detected inflammation of the sacroiliac joints.

No new safety signals were identified in STAR, and the overall safety profile remained consistent with the established profile of TREMFYA in psoriatic arthritis.

David M. Lee, MD, PhD, Global Immunology Therapeutic Area Head at Johnson & Johnson, said axial psoriatic arthritis involves inflammation affecting the spine and sacroiliac joints and can lead to significant pain, stiffness and fatigue.

He said these symptoms can reduce mobility, physical function and quality of life, highlighting the need for therapies capable of addressing the underlying inflammatory process.

Lee said the STAR results add to the evidence supporting TREMFYA across different manifestations of psoriatic arthritis and highlighted its potential role earlier in the treatment pathway.

Axial involvement is a recognised clinical domain of psoriatic arthritis in which inflammation affects the spine and sacroiliac joints.

Symptoms can include back pain, morning stiffness and fatigue, alongside impaired mobility and reduced physical function.

Johnson & Johnson said axial disease is also associated with poorer quality of life compared with psoriatic arthritis without axial involvement.

Estimates suggest axial involvement may affect around 5% to 28% of people with early psoriatic arthritis and between 25% and 70% of those with longer standing disease.

Despite advances in psoriatic arthritis treatment, axial involvement remains an area of unmet need.

There are currently no universally accepted classification criteria specifically for axial psoriatic arthritis, and relatively few prospective clinical studies have focused exclusively on this patient population.

Philip J. Mease, MD, Director of Rheumatology Research at Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine, said the growing clinical evidence for TREMFYA continues to expand understanding of its effects across different aspects of psoriatic arthritis.

He highlighted STAR’s use of MRI to confirm axial involvement before enrolment and to objectively assess inflammatory changes alongside clinical outcomes.

Johnson & Johnson recently received U.S. Food and Drug Administration approval to expand the TREMFYA label to include inhibition of structural joint damage progression in adults with active psoriatic arthritis.

The company said this makes TREMFYA the only interleukin 23 inhibitor with an approved indication covering inhibition of further structural joint damage in the disease.

TREMFYA is a fully human monoclonal antibody that blocks interleukin 23 and also binds to CD64, a receptor found on cells involved in producing interleukin 23.

Interleukin 23 is a cytokine released by activated immune cells and is known to contribute to immune mediated conditions including active psoriatic arthritis.

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Related Topics and Keywords

clinical trials, guselkumab, Immunology, Johnson & Johnson, Johnson and Johnson, joint health, mri, pharma news, psa, psoriatic arthritis, rheumatology, STARstudy, TREMFYA®