Evaluation of the patient acceptable symptom state as an outcome measure in patients with ankylosing spondylitis: Data from a randomized controlled trial

Authors

  • Maxime Dougados,

    Corresponding author
    1. Hôpital Cochin and University of Paris, Paris, France
    • Service de Rhumatologie B, Hôpital Cochin, University of Paris, 27 Rue du Faubourg Saint Jacques, 75014 Paris, France
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    • Dr. Dougados received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Abbott Laboratories and Merck Sharpe & Dohme-Chibret Laboratories.

  • Michelle P. Luo,

    1. Abbott Laboratories, Abbott Park, Illinois
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    • Dr. Luo owns stock and/or holds stock options in Abbott Laboratories.

  • Walter P. Maksymowych,

    1. University of Alberta, Edmonton, Alberta, Canada
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    • Dr. Maksymowych received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Abbott Laboratories.

  • Joseph J. Chmiel,

    1. Abbott Laboratories, Abbott Park, Illinois
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    • Dr. Chmiel owns stock and holds stock options in Abbott.

  • Naijun Chen,

    1. Abbott Laboratories, Abbott Park, Illinois
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    • Mr. Chen owns stock in Abbott.

  • Robert L. Wong,

    1. Abbott Laboratories, Parsippany, New Jersey
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    • Dr. Wong owns stock and/or holds stock options in Abbott Laboratories.

  • John C. Davis Jr.,

    1. University of California at San Francisco
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    • Dr. Davis received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Abbott Laboratories.

  • DÉsirÉe van der Heijde,

    1. Leiden University Medical Center, Leiden, The Netherlands
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  • ATLAS STUDY GROUP


  • ClinicalTrials.gov identifier: NCT00085644.

Abstract

Objective

To evaluate the feasibility/acceptability, reliability, external validity, and discriminant capacity of the Patient Acceptable Symptom State (PASS) concept in patients with active ankylosing spondylitis (AS).

Methods

PASS was assessed by asking patients to respond yes or no to a single question: “Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?” during the 24-week, randomized (2:1 ratio), double-blind, placebo-controlled portion of an adalimumab study of 315 patients.

Results

PASS reliability was high (κ = 0.86) in patients with stable disease. Significantly more patients who answered yes to PASS than patients who answered no to PASS were responders based on the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria for 20% improvement (75% who answered yes versus 29% who answered no), the ASAS criteria for 40% improvement (61% versus 16%), the ASAS partial remission criteria (37% versus 3%), and ≥50% improvement on the Bath Ankylosing Spondylitis Disease Activity Index (65% versus 19%; P < 0.001 for all comparisons), demonstrating external validity of the PASS concept. More adalimumab-treated than placebo-treated patients achieved PASS at week 12 (42.3% versus 22.4%; P < 0.001), and more adalimumab-treated than placebo-treated patients achieved sustained PASS through week 20 (34.6% versus 12.3%; P < 0.001), indicating excellent discriminant capacity.

Conclusion

PASS is a feasible, acceptable, reliable, and valid assessment of satisfactory health state in patients with AS.

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