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
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 i...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2014-12-01
|
| Series: | Current Therapeutic Research |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0011393X14000198 |
| _version_ | 1818589067951996928 |
|---|---|
| author | Feng Huang, MD Jieruo Gu, MD Yi Liu, MD Ping Zhu, MD Yi Zheng, MD Jin Fu, MD Sharon Pan, PhD Shi Le, MD |
| author_facet | Feng Huang, MD Jieruo Gu, MD Yi Liu, MD Ping Zhu, MD Yi Zheng, MD Jin Fu, MD Sharon Pan, PhD Shi Le, MD |
| author_sort | Feng Huang, MD |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-16T09:34:46Z |
| format | Article |
| id | doaj.art-bdf74bd02ff84a3e8848a113fe826612 |
| institution | Directory Open Access Journal |
| issn | 0011-393X 1879-0313 |
| language | English |
| last_indexed | 2024-12-16T09:34:46Z |
| publishDate | 2014-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Current Therapeutic Research |
| spelling | doaj.art-bdf74bd02ff84a3e8848a113fe8266122022-12-21T22:36:25ZengElsevierCurrent Therapeutic Research0011-393X1879-03132014-12-0176C12613310.1016/j.curtheres.2014.08.002Efficacy and Safety of Celecoxib in Chinese Patients with Ankylosing Spondylitis: A 6-Week Randomized, Double-Blinded Study with 6-Week Open-Label Extension TreatmentFeng Huang, MD0Jieruo Gu, MD1Yi Liu, MD2Ping Zhu, MD3Yi Zheng, MD4Jin Fu, MD5Sharon Pan, PhD6Shi Le, MD7Department of Rheumatology, Chinese PLA General Hospital, Beijing, ChinaDepartment of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, ChinaDepartment of Rheumatology and Immunology, West China Hospital of Sichuan University, Sichuan, ChinaDepartment of Rheumatology and Immunology, Xijing Hospital, Shanxi, ChinaDepartment of Rheumatology and Immunology, Beijing Chaoyang Hospital, Capital University of Medical Science, Beijing, ChinaClinical Program Lead, Global Innovation Pharma, Clinical Science, Pfizer Investment Co, Ltd, Beijing, ChinaEmerging Markets Business Unit, Pfizer Inc, New York, NYFormer employee of Department of Clinical Development and Operation (China), Pfizer Investment Co, Ltd, Beijing, ChinaBackground: 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.http://www.sciencedirect.com/science/article/pii/S0011393X14000198ankylosing spondylitisCOX-2 inhibitorsmusculoskeletal systemnonsteroidal anti-inflammatory drugs |
| spellingShingle | Feng Huang, MD Jieruo Gu, MD Yi Liu, MD Ping Zhu, MD Yi Zheng, MD Jin Fu, MD Sharon Pan, PhD Shi Le, MD 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 Current Therapeutic Research ankylosing spondylitis COX-2 inhibitors musculoskeletal system nonsteroidal anti-inflammatory drugs |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | ankylosing spondylitis COX-2 inhibitors musculoskeletal system nonsteroidal anti-inflammatory drugs |
| url | http://www.sciencedirect.com/science/article/pii/S0011393X14000198 |
| work_keys_str_mv | AT fenghuangmd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT jieruogumd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT yiliumd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT pingzhumd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT yizhengmd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT jinfumd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT sharonpanphd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment AT shilemd efficacyandsafetyofcelecoxibinchinesepatientswithankylosingspondylitisa6weekrandomizeddoubleblindedstudywith6weekopenlabelextensiontreatment |