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Adalimumab plus Methotrexate Improved SF-36 Scores and Reduced the Effect of Rheumatoid Arthritis (RA) on Work Activity for Patients with Early RA

MIRIAM KIMEL, MARY CIFALDI, NAIJUN CHEN, and DENNIS REVICKI

ABSTRACT.

Objective.
To compare the effect of adalimumab plus methotrexate (MTX) versus MTX monotherapy on health-related quality of life (HRQOL) and work activities in patients with early rheumatoid arthritis (RA).

Methods. Patients in this PREMIER study subanalysis (n = 525) were randomized to adalimumab 40 mg every other week plus MTX or MTX monotherapy. Medical Outcome Study Short-Form 36 Health Survey (SF-36) scores of RA patients were compared with US population norms at Weeks 12, 52, and 104.

Results. Physical Component Summary (PCS) scores at Week 12 for both groups improved from baseline and were significantly lower than US population scores (43.5 combination, 39.4 MTX, 49.4 US norm; p < 0.001). At Week 52, PCS score for adalimumab plus MTX was similar to that of the US population (47.5 vs 48.3; p = 0.25), while the PCS score for MTX was not similar to that of the US population (44.2 vs 48.3; p < 0.001). Criterion- and content-based interpretations for between-treatment differences in PCS scores suggest that those receiving combination therapy had fewer employment difficulties than those receiving MTX.

Conclusion. After 2 years, HRQOL for patients with early RA treated with adalimumab plus MTX improved to US norms. Combination therapy had reduced the influence of RA on work activity. (First Release Dec 15 2007; J Rheumatol 2008;35:206-15)

Key Indexing Terms:

RHEUMATOID ARTHRITIS
ADALIMUMAB
TUMOR NECROSIS FACTOR ANTAGONISTS
SHORT-FORM 36 HEALTH SURVEY
HEALTH-RELATED QUALITY OF LIFE
RANDOMIZED CONTROLLED TRIAL


From the Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland; and Global Health Economics and Outcomes Research, Abbott Laboratories, Abbott Park, Illinois, USA.

Supported by Abbott Laboratories.

M. Kimel, PhD; D. Revicki, PhD, United BioSource Corporation; M. Cifaldi, PhD; N. Chen, MS, Abbott Laboratories.

Address reprint requests to M. Kimel, Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814. E-mail: miriam.kimel@unitedbiosource.com

Accepted for publication October 9, 2007.




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