Health-related quality of life outcomes in patients with active ankylosing spondylitis treated with adalimumab: Results from a randomized controlled study

Authors

  • John C. Davis Jr.,

    Corresponding author
    1. University of California, San Francisco
    • University of California San Francisco, 533 Parnassus Avenue, Room U386, Box 0633, San Francisco, CA 94143
    Search for more papers by this author
    • Dr. Davis has received consultancies and/or honoraria (less than $10,000 each) from Amgen, Centocor, and Abbott. Dr. Revicki has received consultancies and/or honoraria (less than $10,000) from Abbott. Dr. van der Heijde has received consultancies and/or honoraria (less than $10,000 each) from Abbott, Amgen, Centocor, Wyeth, UCB, Merck, and Schering-Plough. Drs. Kupper, Luo, and Wong own stock in Abbott.

  • Dennis Revicki,

    1. Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland
    Search for more papers by this author
    • Dr. Davis has received consultancies and/or honoraria (less than $10,000 each) from Amgen, Centocor, and Abbott. Dr. Revicki has received consultancies and/or honoraria (less than $10,000) from Abbott. Dr. van der Heijde has received consultancies and/or honoraria (less than $10,000 each) from Abbott, Amgen, Centocor, Wyeth, UCB, Merck, and Schering-Plough. Drs. Kupper, Luo, and Wong own stock in Abbott.

  • Désirée M. F. van der Heijde,

    1. University Hospital Maastricht, Maastricht, The Netherlands
    Search for more papers by this author
    • Dr. Davis has received consultancies and/or honoraria (less than $10,000 each) from Amgen, Centocor, and Abbott. Dr. Revicki has received consultancies and/or honoraria (less than $10,000) from Abbott. Dr. van der Heijde has received consultancies and/or honoraria (less than $10,000 each) from Abbott, Amgen, Centocor, Wyeth, UCB, Merck, and Schering-Plough. Drs. Kupper, Luo, and Wong own stock in Abbott.

  • Anne M. Rentz,

    1. Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland
    Search for more papers by this author
  • Robert L. Wong,

    1. Abbott Laboratories, Parsippany, New Jersey
    Search for more papers by this author
    • Dr. Davis has received consultancies and/or honoraria (less than $10,000 each) from Amgen, Centocor, and Abbott. Dr. Revicki has received consultancies and/or honoraria (less than $10,000) from Abbott. Dr. van der Heijde has received consultancies and/or honoraria (less than $10,000 each) from Abbott, Amgen, Centocor, Wyeth, UCB, Merck, and Schering-Plough. Drs. Kupper, Luo, and Wong own stock in Abbott.

  • Hartmut Kupper,

    1. Abbott GmbH & Co. KG, Ludwigshafen, Germany
    Search for more papers by this author
    • Dr. Davis has received consultancies and/or honoraria (less than $10,000 each) from Amgen, Centocor, and Abbott. Dr. Revicki has received consultancies and/or honoraria (less than $10,000) from Abbott. Dr. van der Heijde has received consultancies and/or honoraria (less than $10,000 each) from Abbott, Amgen, Centocor, Wyeth, UCB, Merck, and Schering-Plough. Drs. Kupper, Luo, and Wong own stock in Abbott.

  • Michelle P. Luo

    1. Abbott Laboratories, Abbott Park, Illinois
    Search for more papers by this author
    • Dr. Davis has received consultancies and/or honoraria (less than $10,000 each) from Amgen, Centocor, and Abbott. Dr. Revicki has received consultancies and/or honoraria (less than $10,000) from Abbott. Dr. van der Heijde has received consultancies and/or honoraria (less than $10,000 each) from Abbott, Amgen, Centocor, Wyeth, UCB, Merck, and Schering-Plough. Drs. Kupper, Luo, and Wong own stock in Abbott.


Abstract

Objective

To evaluate the impact of adalimumab on health-related quality of life (HRQOL) in patients with active ankylosing spondylitis (AS).

Methods

Patients ≥18 years enrolled in the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in Ankylosing Spondylitis, a randomized controlled study, were randomly assigned to receive either adalimumab 40 mg subcutaneously or placebo every other week for 24 weeks. ASsessment of Ankylosing Spondylitis (ASAS) International Working Group criteria were used to evaluate clinical efficacy. HRQOL outcomes were assessed using the Short Form 36 (SF-36) Health Survey and Ankylosing Spondylitis Quality of Life (ASQoL) Questionnaire.

Results

A total of 315 patients enrolled (208 in the adalimumab group and 107 in the placebo group). Patients in the adalimumab group showed significant improvements in SF-36 Physical Component Summary (PCS) and ASQoL scores versus placebo at weeks 12 and 24 (P < 0.001). The observed differences between adalimumab and placebo patients exceeded the a priori minimum important difference (MID) at the group level, and significantly more adalimumab-treated patients achieved improvements greater than the MID on the patient level. These data suggest the HRQOL improvements were clinically meaningful. No differences were observed in SF-36 Mental Component Summary (MCS) scores. Significant differences favoring adalimumab were observed for SF-36 domains physical function, bodily pain, role-physical, general health, vitality, social function, and role–emotional. There was significant association between HRQOL improvements (measured by SF-36 PCS and MCS, and ASQoL scores) and ASAS clinical responses (P < 0.001).

Conclusion

Adalimumab significantly improved physical health status and overall HRQOL through 24 weeks in patients with active AS.

Ancillary