Author(s)
Shreekant Parasuraman, PhD, Senior Director1, Jurgen Braun, MD, Prof. Dr. med2, Robert D Inman, MD, Professor of Medicine/ Immunology3, Desiree van der Heijde, MD, Dr4, Michael Mack, PhD, Associate Director, Biostatistics5, Jacqueline Buchanan, PhD, Associate Director, Worldwide Health Economics and Pricing1, Benjamin Hsu, MD, Director, Clinical Research5, Anna Beutler, MD, Senior Director, Clinical Research5, C Han, PhD, Assistant Director1, Atul Deodhar, MD, Associate Professor of Medicine61Johnson & Johnson Pharmaceutical Services LLC, Malvern, PA, USA; 2 Rheumazentrum Ruhrgebiet, Herne, Germany; 3 University of Toronto, Toronto, ON, Canada; 4 Leiden University Medical Center, Leiden, Netherlands; 5 Centocor Research and Development, Inc, Malvern, PA, USA; 6 Oregon Health & Science University, Portland, OR, USA
OBJECTIVES To evaluate the impact of golimumab (GLM) on productivity in ankylosing spondylitis (AS) patients. METHODS GLM was studied in a multicenter, randomized, placebo (PBO)-controlled study (GO-RAISE) in which 356 patients were randomized (1.8:1.8:1 ratio) to receive subcutaneous GLM 50 mg, 100 mg, or PBO q4wks. Patients with Ankylosing Spondylitis (AS) (BASDAI and back pain score each ³ 4) were eligible. Productivity was measured on a VAS scale (0-10 cm). Change in productivity from baseline to wk16 and wk24 was compared between groups. At wk16, patients who received PBO or GLM 50 mg and had <20% improvement in total back pain and morning stiffness entered early escape in a double-blind fashion. All other patients remained on their previous medication until wk24. The last observation for patients who entered early escape prior to change in treatment was carried forward in the wk24 analyses. Observed values at wk24 were used for GLM 100 mg patients. An ANOVA on van der Waerden normal scores was performed for between-group differences. RESULTS Patients in the GLM 50 mg, 100 mg, and PBO groups had similar mean ±SD baseline scores of 6.6 ±2.5, 6.8 ±2.3, and 6.3 ±2.5, respectively. Mean improvement in self-reported productivity was significantly greater with the GLM 50 mg group than the PBO group at wk16 (-2.8 ±3.0 vs. -0.4 ±2.7; p<0.001) and wk24 (-2.7 ±3.1 vs. -0.5 ±3.0; p<0.001). Significantly greater improvement was observed with the GLM 100 mg group than the PBO group at wk16 (-2.9 ± 2.9 vs -0.4 ± 2.7; p<0.001) and wk24 (-2.9 ±3.0 vs. -0.5 ±3.0; p<0.001). Change from baseline in productivity was similar in both GLM dose groups at wk16 and wk24. CONCLUSIONS AS patients treated with GLM 50 mg and 100 mg had significant improvement in self-reported productivity, with improvement at wk16 maintained through wk24.
Conference/Value in Health Info
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PMS47
Topic
Economic Evaluation, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, Work & Home Productivity - Indirect Costs
Disease
Multiple Diseases, Musculoskeletal Disorders
