GOLIMUMAB, A HUMAN ANTI-TNF-ALPHA MONOCLONAL ANTIBODY, SIGNIFICANTLY IMPROVES SELF-REPORTED PRODUCTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS- RESULTS FROM THREE PHASE 3 STUDIES
Author(s)
Jacqueline Buchanan, PhD, Associate Director, Worldwide Health Economics and Pricing1, Roy Fleischmann, MD, Clinical Professor of Medicine2, Mark C. Genovese, MD, Immunology and Rheumatology3, Jonathan Kay, MD, Associate Clinical Professor of Medicine4, Elizabeth C. Hsia, MD, Director, Clinical Research5, Mittie K. Doyle, MD, Associate Director, Clinical Research5, Mahboob U. Rahman, MD, PhD, Senior Director, Clinical Research5, Chenglong Han, PhD, Associate Director1, Shreekant Parasuraman, PhD, Senior Director11Johnson and Johnson Pharmaceutical Services, LLC, Malvern, PA, USA; 2 Univeristy of Texas Southwestern Medical Center, Dallas, TX, USA; 3 Stanford University, Palo Alto, CA, USA; 4 Massachussetts General Hospital/ Harvard Medical School, Boston, MA, USA; 5 Centocor Research and Development, Inc./ U Penn Medical School, Malvern/ Philadelphia, PA, USA
OBJECTIVES: To evaluate the effect of golimumab (GLM) on self-reported productivity in rheumatoid arthritis (RA) patients. METHODS: The effect of GLM on self-reported productivity was evaluated in three multicenter, randomized, double-blind, placebo (PBO)-controlled studies in RA patients. Data from patients receiving GLM or PBO with or without methotrexate (MTX) are presented. The trials evaluated different patient populations and included patients naïve to MTX (GO-BEFORE), patients with active RA despite MTX (GO-FORWARD), and patients previously treated with anti-TNF-alpha agent(s) (GO-AFTER). GLM subcutaneous injections of 50 mg or 100 mg were administered q4wks. At wks0 and 24, patients were asked to indicate how much their disease affected their productivity at work, school or at home in the past 4wks using a 0 (did not affect productivity at all) to 10 (affected productivity very much) VAS scale. A negative mean change from baseline is an improvement in self-reported productivity. An ANOVA on van der Waerden normal scores was performed for between-group comparisons. RESULTS: In each of the trials mean baseline scores for self-reported productivity were comparable between groups (ranges were 6.3-6.4[GO-BEFORE] 5.4-5.7[GO-FORWARD], 6.2-6.7[GO-AFTER]). In GO-FORWARD, the mean(±SD) improvements in self-reported productivity were significantly greater in the GLM 50 and 100 mg + MTX groups compared with PBO + MTX at wk24 (-1.97 ± 3.12,-2.00 ± 2.53, and -0.45 ± 2.98, respectively,p<0.001). In GO-AFTER, the mean(±SD) improvements in self-reported productivity were significantly greater in the GLM 50 and 100mg groups compared with PBO at wk24 (-1.77 ± 2.90, -2.10 ± 2.92, and -0.52 ± 2.79, respectively, p<0.001). In GO-BEFORE, numerical improvements in self-reported productivity were observed in the GLM 50 and 100 mg + MTX groups (-2.48 ± 2.94 and -2.90 ± 2.80, respectively); these improvements were not significantly different from PBO + MTX (-2.27 ± 3.02). CONCLUSIONS: In two studies, GLM resulted in significant improvements in self-reported productivity. In the third trial, GLM resulted in trends towards improvement in self-reported productivity compared with PBO+MTX.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PMS65
Topic
Economic Evaluation
Topic Subcategory
Work & Home Productivity - Indirect Costs
Disease
Musculoskeletal Disorders
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