Background Nonsteroidal anti-inflammatory drugs (NSAIDs) are first-line pharmacotherapy in axial spondyloarthritis (axSpA) but are recommended for use at the lowest effective dose for the shortest possible time due to safety concerns. Although NSAID discontinuation is common in clinical practice after response to biologic therapy in axSpA patients, its impact has not been evaluated in prospective controlled trials.
Objectives The SPARSE trial was conducted to assess the effects of etanercept (ETN) on NSAID intake as measured by the ASAS-NSAID score1 and conventional clinical outcomes in axSpA.
Methods In the initial 8-week, double-blind (DB), placebo (PBO)-controlled period, patients with active (mini BASDAI ≥4) axSpA (ASAS criteria) despite optimal NSAID intake were randomised to ETN 50 mg or PBO once weekly for 8 weeks. All patients were advised to taper/stop their NSAID intake (self-reported diary) during the study treatment period. Completers were eligible for ETN 50 mg in the subsequent 8-week open-label (OL) period. ASAS-NSAID scores were calculated according to ASAS recommendations.1 The primary endpoint, the change from baseline (BL) to week 8 in the ASAS-NSAID score, was analysed using an analysis of covariance (ANCOVA).
Results In 90 randomised patients at BL, mean age (±SD) was 38.9±11.8 years; disease duration, 5.7±8.1 years; 62% were male; 66% were HLA-B27 positive; and 50% were MRI sacroiliitis positive. Mean ASAS-NSAID scores at BL (ETN vs PBO: 98.2±39.0 vs 93.0±23.4), BASDAI (6.0±1.7 vs 5.9±1.5), and BASFI (5.2±2.1 vs 5.1±2.2) were similar between groups. A between-group difference in changes in ASAS-NSAID scores of -27.3 (P=0.002) favouring ETN was observed at week 8 (table). Significantly more patients in the ETN vs PBO group achieved BASDAI50 and ASAS40 at week 8. Significant reductions in ASAS-NSAID scores were seen in the ETN/ETN group from BL to week 16 and in the PBO/ETN group from week 8 to 16 (table); response rates increased in the ETN/ETN and PBO/ETN groups for most clinical endpoints in the OL period.
Conclusions In this population of patients with axSpA, etanercept was associated with clinically relevant NSAID-sparing effects in addition to significant improvements in conventional clinical outcomes.
Dougados M, et al. Ann Rheum Dis 2011;70(2):249-51.
Acknowledgements This study was sponsored by Pfizer Inc. Medical writing support was provided by Donna McGuire of Engage Scientific and was funded by Pfizer Inc.
Disclosure of Interest M. Dougados Grant/research support: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi-Aventis., Consultant for: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi-Aventis., E. Wood Consultant for: Full-time employee of Quanticate International, contracted by Pfizer Inc. to provide statistical input to the study and manuscript., B. Combe Grant/research support: Pfizer., Speakers bureau: Merck, Pfizer, UCB., C. Miceli-Richard Grant/research support: AbbVie, Bristol-Myers Squibb, Janssen, and Pfizer., Consultant for: AbbVie, Bristol-Myers Squibb, Janssen, and Pfizer., F. Berenbaum Grant/research support: Boehringer, Merck, Pfizer, Roche, BMS, UCB., Consultant for: AbbVie, UCB, Roche., N. Koppiker Shareholder of: Pfizer., Employee of: Pfizer., A. Dubanchet Shareholder of: Pfizer., Employee of: Pfizer., I. Logeart Shareholder of: Pfizer., Employee of: Pfizer.