Evaluation of the non-steroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE studyReport as inadecuate




Evaluation of the non-steroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study - Download this document for free, or read online. Document in PDF available to download.

* Corresponding author 1 Service de rhumatologie 2 Statistical Consultancy 3 Département de RhumatologieMontpellier 4 Service de rhumatologie 5 Service de rhumatologie 6 CR Saint-Antoine - Centre de Recherche Saint-Antoine 7 Pfizer PGRD 8 Pfizer SAS 9 Pfizer PIO

Abstract : IntroductionIn clinical practice, nonsteroidal anti-inflammatory drugs NSAIDs are commonly discontinued after response to biologic therapy is achieved in patients with axial spondyloarthritis axSpA, but the impact of NSAID discontinuation has not been assessed in prospective controlled trials. The aim of the SPARSE study was to evaluate the effects of the anti-tumor necrosis factor agent etanercept on NSAID intake and conventional clinical outcomes in axSpA patients.MethodsIn the double-blind, placebo-controlled period, patients with active mini Bath Ankylosing Spondylitis Disease Activity Index BASDAI ≥4 axSpA despite optimal NSAID intake were randomized to receive etanercept 50 mg or placebo once weekly for 8 weeks. All patients were advised to taper-discontinue their NSAID intake during the treatment period. NSAID intake was self-reported by diary and Assessment of SpondyloArthritis International Society ASAS-NSAID scores calculated based on ASAS recommendations. The primary endpoint was change from baseline to week 8 in ASAS-NSAID score analysis of covariance.ResultsIn 90 randomized patients at baseline, mean age standard deviation was 38.9 11.8 years; disease duration, 5.7 8.1 years; 59-90 66% were human leukocyte antigen-B27 positive; 51-90 57% had radiographic sacroiliitis; and 45-90 50% were magnetic resonance imaging sacroiliitis-positive. Mean ASAS-NSAID scores were similar between etanercept and placebo groups at baseline 98.2 39.0 versus 93.0 23.4, as were BASDAI 6.0 1.7 versus 5.9 1.5, and Bath Ankylosing Spondylitis Functional Index 5.2 2.1 versus 5.1 2.2. Mean changes SE in ASAS-NSAID score from baseline to week 8 were –63.9 6.1 and –36.6 5.9 in the etanercept and placebo groups between-group difference, –27.3; P = 0.002. Significantly higher proportions of patients receiving etanercept versus placebo had an ASAS-NSAID score



Author: Maxime Dougados - Emily Wood - Bernard Combe - Thierry Schaeverbeke - Corinne Miceli Richard - Francis Berenbaum - Nandan Koppike

Source: https://hal.archives-ouvertes.fr/



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