title: Efficacy of cyclo-oxygenase-2 inhibition by etoricoxib and naproxen on the axial manifestations of ankylosing spondylitis in the presence of peripheral arthritis.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Hôpital Cochin, Rhumatologie B, Paris, France. laure.gossec@cch.aphp.fr
authors.forename: L
authors.initials: L
authors.lastname: Gossec
authors.forename: D
authors.initials: D
authors.lastname: van der Heijde
authors.forename: A
authors.initials: A
authors.lastname: Melian
authors.forename: D A
authors.initials: DA
authors.lastname: Krupa
authors.forename: M K
authors.initials: MK
authors.lastname: James
authors.forename: P F
authors.initials: PF
authors.lastname: Cavanaugh
authors.forename: A S
authors.initials: AS
authors.lastname: Reicin
authors.forename: M
authors.initials: M
authors.lastname: Dougados
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001168:Arthritis / Q000150:complications; D002908:Chronic Disease; D051546:Cyclooxygenase 2 / Q000378:metabolism*; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000627:therapeutic use*; D010147:Pain Measurement; D011725:Pyridines / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000150:complications / Q000188:drug therapy*; D013450:Sulfones / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D011725:Pyridines; D013450:Sulfones; D009288:Naproxen; D051546:Cyclooxygenase 2; D000077613:Etoricoxib
references.citation: Drugs Today (Barc). 2004 May;40(5):395-414
references.pmid: 15319795
references.citation: Arthritis Rheum. 1984 Apr;27(4):361-8
references.pmid: 6231933
references.citation: J Rheumatol. 1994 Dec;21(12):2281-5
references.pmid: 7699629
references.citation: J Rheumatol. 1994 Dec;21(12):2286-91
references.pmid: 7699630
references.citation: Rev Rhum Engl Ed. 1995 Jan;62(1):10-5
references.pmid: 7788318
references.citation: Best Pract Res Clin Rheumatol. 2002 Sep;16(4):605-18
references.pmid: 12406429
references.citation: Arthritis Rheum. 1998 Jan;41(1):122-9
references.pmid: 9433877
references.citation: J Rheumatol. 1999 Apr;26(4):980-4
references.pmid: 10229432
references.citation: Arthritis Rheum. 2005 Apr;52(4):1205-15
references.pmid: 15818702
references.citation: Arthritis Rheum. 2001 Aug;44(8):1876-86
references.pmid: 11508441
references.citation: Br J Rheumatol. 1997 Mar;36(3):400-1
references.pmid: 9156766