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Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.

Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment.

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Department of Rheumatology, Chinese PLA General Hospital, Beijing, China.
Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Department of Rheumatology and Immunology, West China Hospital of Sichuan University, Sichuan, China.
Department of Rheumatology and Immunology, Xijing Hospital, Shanxi, China.
Department of Rheumatology and Immunology, Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing, China.
Clinical Program Lead, Global Innovation Pharma, Clinical Science, Pfizer Investment Co, Ltd, Beijing, China.
Emerging Markets Business Unit, Pfizer Inc, New York, NY.
Former employee of Department of Clinical Development and Operation (China), Pfizer Investment Co, Ltd, Beijing, China.



Nonsteroidal anti-inflammatory drugs are the first-line option for treating ankylosing spondylitis (AS) in China. However, no large-scale controlled trials have been conducted in this ethnic population.


To evaluate the efficacy and safety of 6 weeks' treatment with celecoxib in patients with AS in China.


This Phase 3, double-blind, parallel-group study randomized patients with AS aged ≥18 to 65 years 1:1 to receive celecoxib 200 mg once daily or diclofenac sustained release 75 mg once daily. After 6 weeks, patients could use celecoxib 400 mg once daily or maintain blinded therapy. The primary efficacy end point was mean change from baseline at Week 6 for Patient's Global Assessment of Pain Intensity score (100-mm visual analog scale). Noninferiority was established if the upper bound of the CI was <10 mm. Secondary objectives included patients' and physicians' assessments of disease activity, change from baseline in C-reactive protein level, and safety.


In the per-protocol analysis set the least squares mean change from baseline in the Patient's Global Assessment of Pain Intensity score at Week 6 was -23.8 mm and -27.1 mm in patients receiving celecoxib (n = 111) and diclofenac (n = 108), respectively. The 2-sided 95% CI for the treatment difference (celecoxib - diclofenac) was -2.2 to 8.8. Overall, 4.2% and 6.7% of patients in the celecoxib and diclofenac groups, respectively, reported treatment-related adverse events. All were mild to moderate in severity.


Celecoxib 200 mg once daily is noninferior to diclofenac sustained release 75 mg once daily for pain treatment in Chinese patients with AS. identifier: NCT00762463.


COX-2 inhibitors; ankylosing spondylitis; musculoskeletal system; nonsteroidal anti-inflammatory drugs

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