Abstract

Objectives: To demonstrate the non-inferiority of celecoxib compared with diclofenac in subjects with ankylosing spondylitis (AS).

Methods: This was a 12-week randomised, double-blind, controlled study in active AS subjects with 3 treatment arms: Celecoxib 200mg qd, celecoxib 200mg bid, and diclofenac SR 75mg bid. Primary efficacy endpoint was the change from baseline in global pain intensity VAS at Week 12. Secondary endpoints covered changes in disease activity, functional and mobility capacities, and adverse events.

Results: 458 subjects were randomly assigned to either celecoxib 200mg qd (n=153), celecoxib 200mg bid (n=150), or diclofenac (n=155). Least square (LS) mean changes from baseline at Week 12 in pain VAS were clinically relevant in all treatment groups (celecoxib 200mg qd: 29.1 mm; celecoxib 200mg bid: 31.7 mm; diclofenac: 32.7 mm) and non-inferior when compared to diclofenac. ASAS 20 response and mean improvement in BASDAI scores at Week 12 were numerically better on celecoxib 200mg bid (59.7% and 1.32 points) and on diclofenac (60.2% and 1.48 points) than on celecoxib 200mg qd (46.0% and 0.99 points). The incidence of gastrointestinal adverse events was significantly higher on diclofenac (28.4%) than on celecoxib 200mg qd (15.0%) or 200mg bid (16.7%).

Conclusions: The efficacy of celecoxib 200mg qd and 200mg bid was comparable to that of diclofenac 75mg bid concerning pain reduction. Celecoxib 200mg bid and diclofenac reduced some parameters associated with inflammation more effectively than celecoxib 200mg qd. Treatment was well tolerated, with celecoxib (either dose) exhibiting less frequent gastrointestinal adverse events than diclofenac.