Background/Purpose: To evaluate the impact of intravenously (IV) administered golimumab (GLM) on health related quality of life (HRQoL) and work productivity in patients (pts) with rheumatoid arthritis (RA).

Methods: GO-FURTHER was a multicenter, randomized, placebo-controlled study. Adult pts with active RA despite MTX therapy (≥6 tender and swollen joints, CRP ≥1.0mg/dL, and RF and/or anti-CCP positive) were randomized to placebo + MTX (PBO group) or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 week thereafter (GLM group). Pts in PBO group with <10% improvement in tender and swollen joint count from baseline at week 16 entered early escape (EE) and received a 2mg/kg GLM infusion at Weeks 16 and 20 and every 8 weeks subsequent. HRQoL was assessed using Short-Form of 36 items questionnaire (SF-36) and EQ5D. The EQ5D instrument consists of a 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 and 1=full health) using the US D1 model. Impact of disease on daily work productivity was assessed using a visual analogue scale (VAS) of 0-10 (0=no affect at all, 10=affected very much). Clinically meaningful improvements were defined as a change of ≥5 points in SF-36 physical and medical component summary score (PCS and MCS) or a change in magnitude of half of standard deviation in EQ VAS and EQ5D index. Correlation of remission measured by disease activity score (DAS28 using CRP <2.6) with change in PCS and MCS, and productivity scores were analyzed. Comparisons between groups were 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) and MCS (37.6±11.28) were notably below the US norm of 50.  The impact of disease on daily work productivity was 6.4 (2.32).  Compared to the PBO group, significantly greater changes were observed in the GLM-treatment group in SF-36 PCS (5.92 vs. 3.19), SF-36 MCS (4.91 vs. 1.46), EQ VAS scores (11.43 vs. 2.53) and EQ5D index (0.13 vs. 0.09) at week 12, which were sustained through week 16 and 24 (all p-values<0.01). Compared to the PBO group, a greater proportion of pts in the GLM group achieved clinically meaningful improvement in SF-36 PCS, SF36 MCS, EQ VAS and EQ5D index. Similarly, significantly greater improvements in all 8 SF-36 sub-scores for the GLM group, compared to the PBO group, were observed (all p-values<0.001). At week 24, mean change (improvement) from baseline in impact of disease of daily work productivity was significantly better in the GLM group than in the PBO group (-2.78 vs. -1.03, p<0.001). Change in SF-36 and work productivity score were correlated with change in DAS28 score, and those who achieved DAS28 remission had greater improvement in SF-36 PCS, MCS and productivity VAS scores than those who did not achieve remission.

Conclusion: Treatment with IV administered GLM significantly improved HRQoL and work productivity in pts with RA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/intravenously-administered-golimumab-significantly-improves-health-related-quality-of-life-and-work-productivity-in-patients-with-rheumatoid-arthritis-results-of-a-phase-iii-placebo-controlled-trial/