Celecoxib is efficacious and well tolerated in treating signs and symptoms of ankylosing spondylitis.
OBJECTIVE
To evaluate the efficacy and safety of celecoxib in patients with ankylosing spondylitis (AS).


METHODS
This was a 12-week randomized, double-blind, placebo-controlled study with 4 treatment arms: celecoxib 200 mg qd, celecoxib 400 mg qd, naproxen 500 mg bid, and placebo. Patients (age 18-75 yrs) requiring daily treatment with nonselective nonsteroidal antiinflammatory drugs, and with a pain intensity on visual analog scale (VAS) > or = 50 mm worsening by 30% compared with a preinclusion visit (14 days prior) were studied. Primary endpoints were least-squares mean changes from baseline in pain intensity, disease activity (patient global assessment VAS), and functional impairment [Bath Ankylosing Spondylitis Functional Index (BASFI)]. Adverse events were monitored throughout the study.


RESULTS
Of 611 randomized patients, 137 were allocated to celecoxib 200 mg, 161 to celecoxib 400 mg, 157 to naproxen, and 156 to placebo. Improvements in least-squares mean pain intensity, disease activity, and BASFI scores were significantly greater in the celecoxib 200 mg, celecoxib 400 mg, and naproxen groups than in the placebo group (p < or = 0.001) at Week 12 and the interim timepoints, Weeks 1, 3, and 6. Celecoxib 400 mg was as effective as naproxen; however, naproxen was more effective than celecoxib 200 mg. Celecoxib was well tolerated, with an adverse event profile similar to placebo. However, 3 naproxen-treated patients experienced serious treatment-related gastrointestinal (GI) adverse events (one severe gastric ulcer, one moderate GI hemorrhage, one severe GI hemorrhage).


CONCLUSIONS
In this 12-week study, celecoxib 200 mg qd and 400 mg qd were efficacious and well tolerated in treating signs and symptoms of AS.
Barkhuizen
André
A
Department of Medicine, Oregon Health and Science University and Portland Veterans Affairs Medical Center, Portland, Oregon 97239, USA. barkhuiz@ohsu.edu
Steinfeld
Serge
S
Robbins
Jeffery
J
West
Christine
C
Coombs
John
J
Zwillich
Samuel
S
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D000068579:Celecoxib; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D015990:Placebo Effect; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013167:Spondylitis, Ankylosing / Q000175:diagnosis* / Q000188:drug therapy*; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib