OBJECTIVES: To evaluate IV golimumab(GLM) on HRQol and work productivity in RA. METHODS: Patients with active RA despite MTX(>6TJC&SJC,CRP>1.0mg/dL,and RF and/or anti-CCP+) were randomized to placebo+MTX(placebo group) or GLM2mg/kg+MTX(GLM group) at wk0,2,and q8wk,thereafter.Patients in placebo group with<10% improvement in TJC&SJC from baseline at wk16 entered early escape and received IV GLM2mg/kg infusion at wks16 and 20 and q8wks,thereafter.HRQol was assessed using SF-36 and EQ5D(five-item descriptive system of health states and a visual analog scale[EQ VAS,0-100]).Scores for the five health states were converted into a utility score(EQ5D index,0-1,0=dead,1=full health)using the US D1 model.Impact of disease on daily work productivity was assessed using VAS 0-10(0=no affect,10=affected very much).Clinically meaningful improvements were defined as change of≥5 points in SF-36 PCS and MCS or a change in magnitude of half of standard deviation in EQVAS and EQ5D index.Correlation of remission measured by DAS28(using CRP<2.6) with change in PCS and MCS,and productivity scores were analyzed.Comparisons performed using ANOVA on van der Waerden normal scores for continuous outcomes or Chi-square test for binary outcomes. RESULTS: At baseline,mean(SD)SF-36 PCS(30.8±6.95)andMCS(37.6±11.28)were below the US norm(50).Impact of disease on daily work productivity was 6.4(2.32).Compared to placebo,significantly greater changes were observed in the GLM-treatment group inSF-36 PCS(5.92vs3.19),SF-36MCS(4.91vs1.46),EQVAS scores(11.43vs2.53) and EQ5D index(0.13 vs0.09) at wk12,which were sustained through wk16 and 24(p-values<0.01).Compared to placebo,a greater proportion of patients in the GLM group achieved clinically meaningful improvement in SF-36PCS,SF36MCS,EQVAS and EQ5Dindex.Significantly greater improvements in 8 SF-36 sub-scores for the GLM group vs placebo,were observed(p<0.001).At wk24,mean change(improvement) from baseline in impact of disease on daily work productivity was significantly better in GLM group vs placebo(-2.78vs-1.03,p<0.001).Change in SF-36 and work productivity were correlated with change in DAS28,and those who achieved DAS28 remission had greater improvement in SF-36 PCS,MCS and productivity VAS scores than those who didn’t achieve remission. CONCLUSIONS: IV GLM significantly improved HRQol and work productivity in RA.