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

• Published in: Annals of the rheumatic diseases Vol. 67; no. 3; pp. 323 - 329
• Main Authors: Sieper, J, Klopsch, T, Richter, M, Kapelle, A, Rudwaleit, M, Schwank, S, Regourd, E, May, M
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and European League Against Rheumatism 01.03.2008; BMJ; BMJ Publishing Group LTD
• Subjects: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Celecoxib; Cyclooxygenase Inhibitors - administration & dosage; Cyclooxygenase Inhibitors - adverse effects; Cyclooxygenase Inhibitors - therapeutic use; Diclofenac - adverse effects; Diclofenac - therapeutic use; Diseases of the osteoarticular system; Diseases of the spine; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug dosages; Female; Gastrointestinal Diseases - chemically induced; Humans; Inflammatory joint diseases; Male; Medical sciences; Middle Aged; Pain Measurement; Pharmacology. Drug treatments; Pyrazoles - administration & dosage; Pyrazoles - adverse effects; Pyrazoles - therapeutic use; Severity of Illness Index; Side effects; Spondylitis, Ankylosing - drug therapy; Studies; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Treatment Outcome; Tumor necrosis factor-TNF; Prostaglandin-endoperoxide synthase; Enzyme; Diseases of the osteoarticular system; Enzyme inhibitor; Cyclooxygenase 2 inhibitor; Inflammatory joint disease; Spine disease; Celecoxib; Diclofenac; Spondylarthropathy; Non steroidal antiinflammatory agent; Chronic; Arylacetic acid derivatives; Analgesic; Treatment; Antipyretic; Double blind study; Oxidoreductases; Comparative study; Ankylosing spondylitis
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/ard.2007.075309

Objectives: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.