Abstract
Objective: The combined efficacy of selective and non-selective cyclo-oxygenase-2 (COX-2) inhibition on the axial manifestations of ankylosing spondylitis (AS) in the presence or absence of chronic peripheral arthritis was evaluated.
Methods: In a post hoc subgroup analysis of a 6 week, randomised, double blind, placebo controlled trial, 387 patients with active axial AS were randomised to receive etoricoxib 90 mg or 120 mg once a day, naproxen 500 mg twice daily, or placebo. Randomisation was stratified by the presence or absence of chronic peripheral arthritis. The primary outcome measure was the time weighted average change from baseline of spine pain intensity. Efficacy data from the three groups receiving active treatment (the NSAID/COX-2 inhibitor group) were combined to improve precision. An analysis of covariance 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 had a significant treatment response compared with the placebo group for all efficacy measures, both in patients with and without peripheral arthritis. A significantly greater difference in mean patient assessment of spine pain was found between active and placebo treatments in patients without compared with those with peripheral arthritis (p = 0.005; –32.5 mm v –17.0 mm, respectively). Similar differences, although not statistically significant, were seen for other end points.
Conclusion: NSAIDs and COX-2 inhibitors have a clinically relevant symptomatic effect on axial AS irrespective of the presence of peripheral arthritis. In this exploratory analysis spinal improvement appeared to be greater in patients without peripheral disease.
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Figure 1.
AS patients with and without peripheral arthritis who demonstrated symptomatic improvement based on ASAS 20 criteria. Note that the treatment by strata interaction did not reach significance for the ASAS 20 end point (p = 0.52).
Selected References
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- Amor B., Dougados M., Listrat V., Menkes C. J., Roux H., Benhamou C., Blotman F., Pattin S., Paolaggi J. B., Duquesnoy B. Are classification criteria for spondylarthropathy useful as diagnostic criteria? Rev Rhum Engl Ed. 1995 Jan;62(1):10–15. [PubMed] [Google Scholar]
- Anderson J. J., Baron G., van der Heijde D., Felson D. T., Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 2001 Aug;44(8):1876–1886. doi: 10.1002/1529-0131(200108)44:8<1876::AID-ART326>3.0.CO;2-F. [DOI] [PubMed] [Google Scholar]
- Calin A., Garrett S., Whitelock H., Kennedy L. G., O'Hea J., Mallorie P., Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281–2285. [PubMed] [Google Scholar]
- Claudepierre P., Rymer J. C., Authier F. J., Allanore Y., Larget-Piet B., Gherardi R., Chevalier X. A relationship between TGF-beta 1 or IL-6 plasma levels and clinical features of spondyloarthropathies. Br J Rheumatol. 1997 Mar;36(3):400–401. doi: 10.1093/rheumatology/36.3.400. [DOI] [PubMed] [Google Scholar]
- Dougados Maxime, van der Heijde Désirée. Ankylosing spondylitis: how should the disease be assessed? Best Pract Res Clin Rheumatol. 2002 Sep;16(4):605–618. doi: 10.1053/berh.2002.0252. [DOI] [PubMed] [Google Scholar]
- Garrett S., Jenkinson T., Kennedy L. G., Whitelock H., Gaisford P., Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286–2291. [PubMed] [Google Scholar]
- Matsumoto Alan K., Cavanaugh Paul F., Jr Etoricoxib. Drugs Today (Barc) 2004 May;40(5):395–414. [PubMed] [Google Scholar]
- Siegle I., Klein T., Backman J. T., Saal J. G., Nüsing R. M., Fritz P. Expression of cyclooxygenase 1 and cyclooxygenase 2 in human synovial tissue: differential elevation of cyclooxygenase 2 in inflammatory joint diseases. Arthritis Rheum. 1998 Jan;41(1):122–129. doi: 10.1002/1529-0131(199801)41:1<122::AID-ART15>3.0.CO;2-8. [DOI] [PubMed] [Google Scholar]
- Spoorenberg A., van der Heijde D., de Klerk E., Dougados M., de Vlam K., Mielants H., van der Tempel H., van der Linden S. Relative value of erythrocyte sedimentation rate and C-reactive protein in assessment of disease activity in ankylosing spondylitis. J Rheumatol. 1999 Apr;26(4):980–984. [PubMed] [Google Scholar]
- van der Heijde Désirée, Baraf Herbert S. B., Ramos-Remus Cesar, Calin Andrei, Weaver Arthur L., Schiff Michael, James Margaret, Markind Jan E., Reicin Alise S., Melian Agustin. Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty-two-week, randomized, controlled study. Arthritis Rheum. 2005 Apr;52(4):1205–1215. doi: 10.1002/art.20985. [DOI] [PubMed] [Google Scholar]
- van der Linden S., Valkenburg H. A., Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361–368. doi: 10.1002/art.1780270401. [DOI] [PubMed] [Google Scholar]