A new study is one of the first to directly compare the efficacy of anti–interleukin-17 therapy with a second anti–tumor necrosis factor treatment in patients with axial spondyloarthritis who have failed initial anti–tumor necrosis factor therapy.
Axial spondyloarthritis (axSpA), a chronic inflammatory disorder characterized by inflammatory low back pain, often necessitates the use of biological disease-modifying antirheumatic drugs (bDMARDs) when nonsteroidal anti-inflammatory drugs fail to control symptoms.
The Rotation Or Change of biotherapy after first anti–tumor necrosis factor (TNF) treatment failure in axSpA patients study is a randomized, multicenter, open-label, phase IV trial designed to evaluate optimal treatment strategies in patients with axSpA following inadequate response to initial anti-TNF therapy.
The trial compared two therapeutic approaches: transitioning to an anti–interleukin (IL)-17 inhibitor (secukinumab or ixekizumab) vs initiating a second anti-TNF therapy. A total of 31 centers in France and Monaco participated. Eligible patients included those with active axSpA who had not achieved adequate control after 3 months of anti-TNF therapy. The participants were randomized in a 1:1 ratio to either treatment arm and were followed for 52 weeks, with primary and secondary endpoints assessed at weeks 12, 24, and 52. The study included 300 participants, who were evenly divided into two groups of 150 patients each.
The primary outcome was the proportion of patients achieving an Assessment of SpondyloArthritis International Society 40 (ASAS40) response at 24 weeks. Secondary outcomes included ASAS40 response at earlier and later time points as well as additional clinical measures of disease activity, safety profiles, and cost-effectiveness analyses. Pharmacokinetic parameters of the bDMARDs were also evaluated.
The ASAS40 response rate for a second anti-TNF therapy at 24 weeks was anticipated to be about 20%, whereas the response rate for secukinumab following the failure of a first anti-TNF was projected to be around 40%.
Full disclosures can be found in the published study.