Fatigue Is an Independent Variable Predicting Physical Function and Disease Activity Score-28 Remission for Patients with Rheumatoid Arthritis Treated with Intravenously Administered Golimumab: Results From Phase 3, Placebo Controlled Clinical Trial

ARTHRITIS AND RHEUMATISM(2012)

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摘要
Objectives To evaluate the association of fatigue with physical function and disease activity in patients with rheumatoid arthritis (RA), and the impact of treatment with intravenously administered golimumab (GLM) on fatigue using data from the Phase III clinical trial GO-FURTHER. Methods GO-FURTHER was a multicenter, randomized, placebo-controlled study. Adult patients with active RA despite MTX therapy were randomized to placebo + MTX (placebo group) or GLM 2mg/kg plus MTX (GLM group) at week 0, 2, and every 8 week thereafter. Patients in placebo group with Results At baseline, mean (SD) FACIT-Fatigue score was 25.5 (10.54), indicating significant fatigue. Significant correlations of FACIT-Fatigue with HAQ (r=-0.62, p Conclusions RA patients inadequately responsive to MTX experienced severe fatigue. Fatigue was a significant independent predictor of physical function and disease activity in patients with RA. Treatment with intravenously administered GLM significantly improved clinical symptoms of fatigue in patients with RA inadequately responsive to MTX. Disclosure of Interest R. Westhovens Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, M. Weinblatt Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, C. Han Employee of: Johnson & Johnson Pharmaceutical Services, LLC, T. Gathany Employee of: Johnson & Johnson Pharmaceutical Services, LLC, L. Kim Employee of: Janssen Research & Development, LLC, M. Mack Employee of: Janssen Research & Development, LLC, J. Lu Employee of: Janssen Research & Development, LLC, D. Baker Employee of: Janssen Research & Development, LLC, A. Mendelsohn Employee of: Janssen Research & Development, LLC, C. Bingham III Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study
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关键词
rheumatoid arthritis,golimumab,fatigue,placebo
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