Comparison of two different dosages of celecoxib with diclofenac for the treatment of active ankylosing spondylitis: results of a 12-week randomised, double-blind, controlled study.
OBJECTIVE
To demonstrate the non-inferiority of celecoxib compared with diclofenac in subjects with ankylosing spondylitis (AS).


METHODS
The 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.


RESULTS
A 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%).


CONCLUSIONS
The 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.
Sieper
J
J
Benjamin Franklin University Berlin, Berlin, Germany. joachim.sieper@charite.de
Klopsch
T
T
Richter
M
M
Kapelle
A
A
Rudwaleit
M
M
Schwank
S
S
Regourd
E
E
May
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D004008:Diclofenac; D000068579:Celecoxib