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The first study to test naproxen in combination with infliximab in axial spondyloarthritis finds that it significantly increases efficacy. Even alone, given in a sufficiently large dose, it may prove a useful treatment.
Seiper J, lenaerts J, Wollenhaupt J, et al., Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1. Ann Rheum Dis. 2013 May 21. [Epub ahead of print]
Patients with early, active axial spondyloarthritis (SpA) who are nave to NSAIDs (or treated suboptimally in the past) achieve clinical remission twice as often when they take 1000 mg daily of the NSAID naproxen sodium (NPX) along with 5 mg/kg of the tumor necrosis factor (TNF)-Î± antagonist infliximab (IFX). This is the conclusion from the first clinical trial of this combination.
The 28-week INFAST Trial (Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial) is a Phase IIIb, randomized, placebo-controlled study involving 158 patients in nine countries who have moderate-to-severe, active axial SpA previously responsive to a lower daily dose of NSAIDs.
Among the patients, mostly white males (mean age 31, average disease duration < 3 years), almost 62% in the IFX+NPX group achieved partial remission versus 35.3% in the NPX-alone group by Assessment of SpondyloArthritis international Society (ASAS) standards, a statistically significant difference. This difference inresponse emerged early as the second week and increased steadily by week 28.
The trial also shows decreasing disease activity by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score over 28 weeks.
The researchers conclude that this result supports early treatment of SpA with a full dose of NSAIDs, escalating to combination NSAIDs plus TNF-Î± therapy in patients who respond unsatisfactorily to the NSAID alone.