title: 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.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of 6 weeks' treatment with celecoxib in patients with AS in China.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Celecoxib 200 mg once daily is noninferior to diclofenac sustained release 75 mg once daily for pain treatment in Chinese patients with AS. ClinicalTrials.gov identifier: NCT00762463.
authors.affiliation: Department of Rheumatology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Huang
authors.affiliation: Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
authors.forename: Jieruo
authors.initials: J
authors.lastname: Gu
authors.affiliation: Department of Rheumatology and Immunology, West China Hospital of Sichuan University, Sichuan, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Rheumatology and Immunology, Xijing Hospital, Shanxi, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Zhu
authors.affiliation: Department of Rheumatology and Immunology, Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Clinical Program Lead, Global Innovation Pharma, Clinical Science, Pfizer Investment Co, Ltd, Beijing, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Fu
authors.affiliation: Emerging Markets Business Unit, Pfizer Inc, New York, NY.
authors.forename: Sharon
authors.initials: S
authors.lastname: Pan
authors.affiliation: Former employee of Department of Clinical Development and Operation (China), Pfizer Investment Co, Ltd, Beijing, China.
authors.forename: Shi
authors.initials: S
authors.lastname: Le
keywords: COX-2 inhibitors; ankylosing spondylitis; musculoskeletal system; nonsteroidal anti-inflammatory drugs