title: Assessment of clinical efficacy and safety in a randomized double-blind study of etanercept and sulfasalazine in patients with ankylosing spondylitis from Eastern/Central Europe, Latin America, and Asia.
abstract: Despite the demonstrated efficacy of etanercept for the treatment of ankylosing spondylitis (AS), sulfasalazine is often prescribed, especially in countries with limited access to biologic agents. The objective of this subset analysis of the ASCEND trial was to compare the efficacy of etanercept and sulfasalazine in treating patients with AS from Asia, Eastern/Central Europe, and Latin America. A total of 287 patients, 190 receiving etanercept 50 mg once weekly and 97 receiving sulfasalazine 3 g daily, from eight countries were included in this subset analysis. Differences in disease activity and patient-reported outcomes assessing health-related quality-of-life (HRQoL) parameters in response to treatment were analyzed using the Cochran-Mantel-Haenszel test for categorical efficacy endpoints and analysis of covariance model for continuous variables. At week 16, a significantly greater proportion of patients receiving etanercept achieved ASAS20 (79.0 %) compared with patients receiving sulfasalazine (61.9 %; p = 0.002). At week 16, treatment with etanercept also resulted in significantly better responses than sulfasalazine for ASAS40 (64.7 vs. 35.1 %; p < 0.001), ASAS5/6 (48.1 vs. 26.3 %; p < 0.001), proportion of patients achieving 50 % response in Bath AS Disease Activity Index (65.8 vs. 42.3 %; p < 0.001), partial remission (35.3 vs. 17.5 %; p = 0.002), and all HRQoL parameters. Both treatments were well tolerated. Etanercept was significantly more effective than sulfasalazine in the treatment of patients with AS from Asia, Central/Eastern Europe, and Latin America.
authors.affiliation: Institute of Rheumatology, University of Belgrade School of Medicine, Belgrade, Resavska 69, Belgrade, 11000, Serbia. nemanjadamjanov@yahoo.com.
authors.forename: Nemanja
authors.initials: N
authors.lastname: Damjanov
authors.affiliation: Al Biraa Arthritis Centre, Dubai, United Arab Emirates.
authors.forename: Waleed Al
authors.initials: WA
authors.lastname: Shehhi
authors.affiliation: Chinese People's Liberation Army General Hospital, Beijing, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Huang
authors.affiliation: Pfizer, New York, NY, USA.
authors.forename: Sameer
authors.initials: S
authors.lastname: Kotak
authors.affiliation: Hospital General de México y Universidad Nacional Autónoma de México, Mexico, DF, Mexico.
authors.forename: Ruben
authors.initials: R
authors.lastname: Burgos-Vargas
authors.affiliation: Pfizer, Dubai Media City, Dubai, United Arab Emirates.
authors.forename: Khalid
authors.initials: K
authors.lastname: Shirazy
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Eustratios
authors.initials: E
authors.lastname: Bananis
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Annette
authors.initials: A
authors.lastname: Szumski
authors.affiliation: Pfizer, Makati City, Philippines.
authors.forename: Lyndon J Q
authors.initials: LJ
authors.lastname: Llamado
authors.affiliation: Pfizer, Collegeville, PA, USA.
authors.forename: Ehab
authors.initials: E
authors.lastname: Mahgoub
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001208:Asia; D004311:Double-Blind Method; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D012460:Sulfasalazine; D000068800:Etanercept
keywords: Ankylosing spondylitis; Efficacy; Etanercept; HRQoL; Subset analysis