Impact of golimumab on physical function, health-related quality of life, productivity and employment in rheumatoid arthritis patients: Week 52 results from GO-FORWARD

Purpose: To evaluate impact of SC golimumab (GLM) on physical function, HRQoL and fatigue. Methods: 444 pts with active RA (2 4 TJC and 24 SJC) despite MTX were randomized to PBO+MTX, GLM 100 mg+PBO, GLM 50 mg+MTX, or GLM 100 mg+MTX q4 wks through wk48. At wk16, any pt with <20% improvement from baseline in SJC & TJC entered early escape (EE) in a double-blinded fashion such that PBO+MTX received GLM 50mg+MTX, MTX was added for GLM 100 mg+PBO, and GLM 50 mg+MTX received GLM 100 mg+MTX; dosing for GLM 100 mg+MTX was unchanged. PBO+MTX crossed over to GLM 50 mg+MTX at wk24. Physical function was assessed using HAQ disability index and SF-36 PCS score. HRQoL was assessed using the PCS and MCS scores of the SF-36. Productivity was assessed on a 10-cm VAS. An ANOVA on van der Waerden normal scores was performed for between-group comparisons at wk24. At wk52, observed efficacy was summarized; no treatment grp comparisons were performed. Results: Mean baseline HAQ scores indicated moderate functional impairment; PCS scores were lower than US population norm (50±10). GLM+MTX was significantly better than PBO+MTX in improving physical function, HRQoL, productivity, and time lost from work by pt (50 mg only) at wk24 (p<0.05). Through wk24, there were no statistically significant improvements in employability, time lost from work by caregiver or healthcare resource consumption. Improvements in HAQ, PCS, MCS, and productivity observed at wk24 were sustained/enhanced through wk52. By wk52, approx 75% of pts receiving GLM 50 or 100 mg+MTX achieved improvement in baseline HAQ >= 0.25 and mean changes in productivity ranged from -2.4 to -2.7 across GLM grps. Time lost from work by pts and caregivers decreased from wks24-52. (Table presented) Conclusion: In pts with active RA despite MTX, GLM 50 mg or 100 mg q4wks + MTX improved physical function, HRQoL, and productivity.