Thresholds of patient-reported outcomes that define the patient acceptable symptom state in ankylosing spondylitis vary over time and by treatment and patient characteristics

Authors

  • Walter P. Maksymowych,

    Corresponding author
    1. University of Alberta, Edmonton, Alberta, Canada
    • 562 Heritage Medical Research Building, University of Alberta, Edmonton, Alberta, Canada T6G 2S2
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    • Dr. Maksymowych has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Abbott Laboratories.

  • Katherine Gooch,

    1. Abbott Laboratories, Abbott Park, Illinois
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    • Ms Gooch, Drs. Wong and Kupper, and Mr. Chen own stock and/or hold stock options in Abbott Laboratories.

  • Maxime Dougados,

    1. Hôpital Cochin, University of Paris, Paris, France
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    • Dr. Dougados has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott Laboratories and Merck Sharpe & Dohme-Chibret Laboratories.

  • Robert L. Wong,

    1. Abbott Laboratories, Parsippany, New Jersey
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    • Ms Gooch, Drs. Wong and Kupper, and Mr. Chen own stock and/or hold stock options in Abbott Laboratories.

  • Naijun Chen,

    1. Abbott Laboratories, Abbott Park, Illinois
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    • Ms Gooch, Drs. Wong and Kupper, and Mr. Chen own stock and/or hold stock options in Abbott Laboratories.

  • Hartmut Kupper,

    1. Abbott GmbH & Co. KG, Ludwigshafen, Germany
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    • Ms Gooch, Drs. Wong and Kupper, and Mr. Chen own stock and/or hold stock options in Abbott Laboratories.

  • Désirée van der Heijde

    1. Leiden University Medical Center, Leiden, The Netherlands
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    • Dr. van der Heijde has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott Laboratories, Centocor, BMS, Schering-Plough, Roche, UCB, and Wyeth.


Abstract

Objective

The patient acceptable symptom state (PASS) is a single-question outcome tool to assess the level of symptoms at which patients with rheumatic diseases consider themselves well. We evaluated whether ankylosing spondylitis (AS) patient characteristics were associated with attaining the PASS and whether these characteristics influenced PASS thresholds for patient-reported outcome (PRO) tools.

Methods

The Adalimumab Trial Evaluating Long-term Efficacy and Safety for Ankylosing Spondylitis was a randomized, placebo-controlled study that evaluated the efficacy and safety of adalimumab in treating AS. The PASS and PROs were assessed over 24 weeks. PASS thresholds for PROs were set as either the 25th or 75th percentiles of the PRO response score. Logistic regression analyses were conducted to determine the associations of particular patient characteristics with the PASS and other response outcomes at 12 weeks (ASessment in Ankylosing Spondylitis International Working Group criteria for 20% improvement [ASAS20], ASAS40, ASAS5/6, ASAS partial remission, and Bath Ankylosing Spondylitis Disease Activity Index 50% improvement).

Results

Age >40 years, disease duration >10 years, female sex, placebo treatment, and English-speaking site were consistently associated with greater PASS thresholds for PROs. Age, male sex, disease duration, and treatment were each independently associated with attainment of the PASS at 12 weeks. Only age and treatment were independently associated with other response outcomes. PASS thresholds also decreased over 24 weeks.

Conclusion

PASS thresholds for PROs changed over time. These thresholds, as well as the attainment of the PASS, were affected by covariates unrelated to treatment. If confirmed in other studies, these results cast doubt on using the PASS to assess absolute health status in clinical research.

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