GOLIMUMAB SIGNIFICANTLY REDUCES TIME LOST FROM WORK FOR PATIENTS WITH RHEUMATOID ARTHRITIS- POOLED RESULTS FROM THREE PHASE 3 STUDIES

Author(s)

Shreekant Parasuraman, PhD, Senior Director1, Jacqueline Buchanan, PhD, Associate Director1, Paul Emery, MD, Professor of Rheumatology2, Edward C. Keystone, MD, Director, Arthritis & Immune Disorder Research Centre3, Josef Smolen, MD, Professor of Medicine4, Mittie K. Doyle, MD, Associate Director, Clinical Research5, Elizabeth C. Hsia, MD, Director, Clinical Research5, Mahboob U. Rahman, MD, PhD, Senior Director, Clinical Research5, Timothy Gathany, PhD, Analyst1, Chenglong Han, PhD, Associate Director11Johnson & Johnson Pharmaceutical Services LLC, Malvern, PA, USA; 2 University of Leeds, Leeds, United Kingdom; 3 University of Toronto/ Mount Sinai Hospital, Toronto, ON, Canada; 4 Medical University of Vienna, Vienna, Austria; 5 Centocor Research and Development, Inc./ U Penn Medical School, Malvern/ Philadelphia, PA, USA

OBJECTIVES To evaluate the effect of golimumab (GLM) on time lost from work in patients with rheumatoid arthritis (RA). METHODS The effect of GLM on time lost from work (days) was prospectively evaluated in 3 multicenter, randomized, double-blind, placebo-controlled studies in patients with RA. Pooled data from patients receiving any injection of study agent (GLM or placebo) with or without methotrexate (MTX) in 3 RA studies (GO-BEFORE, GO-FORWARD, and GO-AFTER) were included. GLM SC injections of 50 or 100 mg were administered q4 weeks. Time lost from work for patients was collected through a questionnaire at baseline and q8 weeks through week 24 and was summarized cumulatively through week 24 with comparisons between groups using ANOVA on van der Waerden normal scores. The proportion of patients reporting no time lost from work in the GLM +/- MTX group was compared with the PBO +/-MTX group using the chi square test. RESULTS Through week 24, significant differences in time lost from work were observed between the GLM +/- MTX group and the PBO +/- MTX group. At week 24, the PBO +/- MTX group lost 6.9 ± 19.7 days compared with 5.0 ± 19.4 days for the combined GLM +/- MTX group. At week 24, the 75th percentile for the combined GLM +/- MTX group was 1.000 day (range 0-180) compared with 3.000 days (range 0-120) for the PBO +/- MTX group. A significantly higher proportion of patients in the combined GLM +/- MTX group reported no time lost from work compared with the PBO +/-MTX group (73.1% vs. 60.7%; p=0.002). CONCLUSIONS GLM +/- MTX significantly reduced time lost from work for patients with RA compared with PBO +/- MTX.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PMS29

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies, Work & Home Productivity - Indirect Costs

Disease

Musculoskeletal Disorders

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