• J Sieper, T Klopsch, M Richter, A Kapelle, M Rudwaleit, S Schwank, E Regourd, and M May.
• Benjamin Franklin University Berlin, Berlin, Germany. joachim.sieper@charite.de
• Ann. Rheum. Dis. 2008 Mar 1;67(3):323-9.

ObjectivesTo demonstrate the non-inferiority of celecoxib compared with diclofenac in subjects with ankylosing spondylitis (AS).MethodsThe basis of the present work was a 12-week randomised, double-blind, controlled study in active AS subjects with three treatment arms: celecoxib 200 mg once a day, celecoxib 200 mg twice a day, and diclofenac SR 75 mg twice a day. The primary efficacy endpoint was the change from baseline in global pain intensity on a visual analogue scale (VAS) at week 12. Secondary endpoints covered changes in disease activity, functional and mobility capacities, and adverse events.ResultsA total of 458 subjects were randomly assigned to either celecoxib 200 mg once a day (n = 153), celecoxib 200 mg twice a day (n = 150), or diclofenac (n = 155). Least square (LS) mean changes from baseline at week 12 on a pain VAS were clinically relevant in all treatment groups (celecoxib 200 mg once a day: -29.1 mm; celecoxib 200 mg twice a day:-31.7 mm; diclofenac:-32.7 mm) and non-inferior when compared to diclofenac. Ankylosing Spondylitis Assessment Study group 20% (ASAS 20) response and mean improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores at week 12 were numerically better on celecoxib 200 mg twice a day (59.7% and-1.32 points) and on diclofenac (60.2% and-1.48 points) than on celecoxib 200 mg once a day (46.0% and-0.99 points). The incidence of gastrointestinal adverse events was significantly higher on diclofenac (28.4%) than on celecoxib 200 mg once a day (15.0%) or 200 mg twice a day (16.7%).ConclusionsThe efficacy of celecoxib 200 mg once a day and 200 mg twice a day was comparable to that of diclofenac 75 mg twice a day with respect to pain reduction. Celecoxib 200 mg twice a day and diclofenac reduced some parameters associated with inflammation more effectively than celecoxib 200 mg once a day. Treatment was well tolerated, with celecoxib (either dose) exhibiting less frequent gastrointestinal adverse events than diclofenac.

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