• Clifton O Bingham, Michael Weinblatt, Chenglong Han, Timothy A Gathany, Lilianne Kim, Kim Hung Lo, Dan Baker, Alan Mendelsohn, and Rene Westhovens.
• From the Division of Rheumatology and Allergy and Clinical Immunology, Johns Hopkins University, Baltimore, Maryland; Department of Clinical Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts; Patient Reported Outcomes, Janssen Global Services LLC, Malvern, Pennsylvania; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA; Department of Rheumatology, UZ Gasthuisberg, KU Leuven, Belgium.C.O. Bingham III, MD, Division of Rheumatology and Allergy and Clinical Immunology, Johns Hopkins University; M. Weinblatt, MD, Department of Clinical Rheumatology, Brigham and Women's Hospital; C. Han, PhD; T.A. Gathany, PhD, Patient Reported Outcomes, Janssen Global Services; L. Kim, PhD; K.H. Lo, PhD, Biostatistics, Janssen Research & Development LLC; D. Baker, MD; A. Mendelsohn, MD, Immunology, Janssen Research & Development LLC; R. Westhovens, MD, Department of Rheumatology, University Hospitals Leuven; Department of Development and Regeneration, KU Leuven. cbingha2@jhmi.edu.
• J Rheumatol. 2014 Jun 1; 41 (6): 1067-76.

ObjectiveTo evaluate the effects of intravenous (IV) golimumab 2 mg/kg + methotrexate (MTX) on patient-reported measures of health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA) despite prior MTX therapy.MethodsIn this randomized, multicenter, double-blind, placebo-controlled, phase III trial, adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0, Week 4, and every 8 weeks thereafter. All patients continued stable oral MTX (15-25 mg/wk). HRQOL assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI; physical function), Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary (SF-36 PCS/MCS) scores, EQ-5D assessment of current health state, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire, and disease effect on productivity [10-cm visual analog scale (VAS)].ResultsMean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12, Week 16, and Week 24, and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001). Improvements in physical function, HRQOL, fatigue, and productivity significantly correlated with disease activity improvement.ConclusionIn active RA, IV golimumab + MTX significantly improved physical function, HRQOL, fatigue, and productivity using multiple measurement tools; all correlated with improvements in disease activity (NCT00973479, EudraCT 2008-006064-11).

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