The Efficacy of Cyclooxygenase-2 Inhibition by Etoricoxib and Naproxen on the Axial Manifestations of Ankylosing Spondylitis in the Presence of Peripheral Arthritis

Laure Gossec ^1*, Désirée van der Heijde ², Agustin Melian ³, David A. Krupa ³, Margaret K James ³, Paul F. Cavanaugh, Jr. ³, Alise S. Reicin ³ and Maxime Dougados ¹

¹ René Descartes University, Cochin Hospital, Rheumatology B Department, Paris, France
² University Hospital Maastricht, Maastricht, Netherlands
³ Merck Research Laboratories, Rahway, NJ, United States

^* To whom correspondence should be addressed. E-mail: laure.gossec{at}cch.aphp.fr.

Accepted 17 February 2005

Abstract

Objective: We evaluated the combined efficacy of selective and non-selective cyclooxygenase-2 (COX-2) inhibition on the axial manifestations of ankylosing spondylitis in the presence or absence of chronic peripheral arthritis.

Methods: This was a post-hoc subgroup analysis of a 6-week, randomized, double-blind, placebo-controlled trial. A total of 387 patients with active axial AS were randomized to receive etoricoxib 90mg or 120mg q.d., naproxen 500mg b.i.d., or placebo. Randomization was stratified by the presence or absence of chronic peripheral arthritis. The primary outcome measure for this analysis consisted of time-weighted average change from baseline of spine pain intensity. Efficacy data from the 3 active treatment groups (the NSAID/COX-2 inhibitor group) were combined to improve precision. An ANCOVA model was used to evaluate the effect of peripheral disease on treatment response.

Results: 93 patients were allocated to receive placebo and 294 to active treatment (naproxen or etoricoxib). The combined NSAID/COX-2 inhibitor group demonstrated a significant treatment response versus placebo for all efficacy measures both in patients with and without peripheral arthritis. However there was a significantly greater difference in mean patient assessment of spine pain between active and placebo treatments in patients without versus those with peripheral arthritis (p=0.005; -32.5 mm vs. -17.0 mm, respectively). Although not statistically significant, similar differences were seen for other endpoints.

Conclusion: NSAIDs and COX-2 inhibitors have a clinically relevant symptomatic effect on axial AS irrespective of the presence of peripheral arthritis. However, in this exploratory analysis spinal improvement appears greater in patients without peripheral disease.

Keywords: NSAIDs, ankylosing spondylitis, efficacy, etoricoxib, peripheral arthritis

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