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)
Shreekant Parasuraman, PhD, Senior Director1, Jacqueline Buchanan, PhD, Associate Director1, 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, C Han, PhD, Assistant Director11Johnson & 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. 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 q4ks. At wks0 and 24, patients rated their productivity on a VAS scale (0-10 cm) at work, school or at home after 4wks. 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 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
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PMS48
Topic
Economic Evaluation, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, Work & Home Productivity - Indirect Costs
Disease
Musculoskeletal Disorders
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