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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.

Author information

1
Department of Rheumatology, Chinese PLA General Hospital, Beijing, China.
2
Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
3
Department of Rheumatology and Immunology, West China Hospital of Sichuan University, Sichuan, China.
4
Department of Rheumatology and Immunology, Xijing Hospital, Shanxi, China.
5
Department of Rheumatology and Immunology, Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing, China.
6
Clinical Program Lead, Global Innovation Pharma, Clinical Science, Pfizer Investment Co, Ltd, Beijing, China.
7
Emerging Markets Business Unit, Pfizer Inc, New York, NY.
8
Former employee of Department of Clinical Development and Operation (China), Pfizer Investment Co, Ltd, Beijing, China.

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.

KEYWORDS:

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

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