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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

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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.

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Acknowledgments

Medical writing support was provided by Mukund Nori, PhD, MBA, CMPP, of Engage Scientific Solutions and was funded by Pfizer, New York, NY, USA.

Funding

This research was funded by Pfizer, New York, NY, USA.

Author contributions

ND, WAS, FH, KS, LJQL, EB, RB-V, SK, and EM have made substantial contributions to the conception and design of this subset analysis. AS provided all the statistical analyses for this manuscript. All authors contributed substantially to the interpretation of data presented, drafting the manuscript, and revising it critically for important intellectual content and have given final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that issues related to either accuracy or integrity of any part of the manuscript are appropriately addressed and resolved.

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Authors and Affiliations

  1. Institute of Rheumatology, University of Belgrade School of Medicine, Belgrade, Resavska 69, Belgrade, 11000, Serbia

    Nemanja Damjanov

  2. Al Biraa Arthritis Centre, Dubai, United Arab Emirates

    Waleed Al Shehhi

  3. Chinese People’s Liberation Army General Hospital, Beijing, China

    Feng Huang

  4. Pfizer, New York, NY, USA

    Sameer Kotak

  5. Hospital General de México y Universidad Nacional Autónoma de México, Mexico, DF, Mexico

    Ruben Burgos-Vargas

  6. Pfizer, Dubai Media City, Dubai, United Arab Emirates

    Khalid Shirazy

  7. Pfizer, Collegeville, PA, USA

    Eustratios Bananis, Annette Szumski & Ehab Mahgoub

  8. Pfizer, Makati City, Philippines

    Lyndon J. Q. Llamado

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  1. Nemanja Damjanov
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  2. Waleed Al Shehhi
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  3. Feng Huang
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Correspondence to Nemanja Damjanov.

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Conflict of interest

Author ND declares that there is no conflict of interest. Author WAS declares that there is no conflict of interest. Author FH declares that there is no conflict of interest. Author SK is an employee of Pfizer. Author RB-V has been on the speakers’ bureau and advisory boards of Abbvie, Janssen, Pfizer, and UCB. Author KS is an employee of Pfizer. Author EB is an employee of Pfizer. Author AS is an employee of Inventive Health, who was a paid contractor to Pfizer in the development of this manuscript. Author LJQL is an employee of Pfizer. Author EB is an employee of Pfizer. All authors declare that they have no other competing interests (neither financial competing interests nor political, personal, religious, ideological, academic, intellectual, commercial, or any other) in relation to this manuscript.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Damjanov, N., Shehhi, W.A., Huang, F. et al. 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. Rheumatol Int 36, 643–651 (2016). https://doi.org/10.1007/s00296-016-3452-0

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  • DOI: https://doi.org/10.1007/s00296-016-3452-0

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