Improvements in physical function, health related quality of life and work productivity in patients with rheumatoid arthritis treated with golimumab: Sub-analysis of latin america n patients enrolled in mulitcentre phase III clinical trials

Objectives: To examine physical function, health-related quality of life(HRQOL) and work productivity in patients enrolled from Latin American countries (Argentina,Chile and Mexico) in Phase III clinical trials for golimumab(GLM) in rheumatoid arthritis(RA). Methods: Active RA patients not previously treated with methotrexate(MTX)(GO-BEFORE,N= 637) or with inadequate response to MTX(GOFORWARD, N= 444) were randomized to SC GLM(50 or 100mg)+MTX or PBO+MTX, q4wks.At wk24(GO-FORWARD) or wk52(GO-BEFORE), PBO+MTX group switched to GLM 50mg+MTX. Physical function was assessed using HAQ(0-3). HRQOL was assessed using SF-36 PCS(0-100) and SF-36 MCS(0-100). Impact of disease on work productivity was assessed using a productivity VAS (0-10). Clinically meaningful improvement was defined as improvement of ≥ 0.25 point in HAQ, or ≥ 5 points in SF-36 PCS and MCS. Results: At baseline, both MTX naive (N= 96) and MTX experienced (N= 56) RA patients enrolled in Latin American region experienced moderate to severe physical disability (mean HAQ score of 1.60 to 1.75) and impaired HRQOL (mean PCS of 30.0 to 30.3 and mean MCS of 9.4 to 42.6). The impact of RA on productivity was severe (mean VAS score of 6.3-6.7). Patients treated with GLM (50 or 100 mg)+MTX had significantly greater mean improvement than PBO+MTX group in HAQ (0.87 vs. 0.56, p= 0.01), PCS (12.44 vs. 6.93, p< 0.01) and work productivity (-3.69 vs. -2.25, p< 0.01) at wk 24, and greater proportions of patients in GLM+MTX group than PBO+MTX achieved clinically meaningful improvement in HAQ (84.04% vs. 65.45%, p= 0.01), PCS (74.47% vs. 49.09%, p< 0.01) and MCS (45.74% vs. 41.82%, p= 0.73). Similar results were observed in patients who were MTX naïve and experienced although the magnitudes of improvements were greater in MTX naïve patients than MTX-experienced patients. The improvements were sustained over wk52 and 104. Conclusions: MTX naïve and MTX experienced RA patients from Latin America treated with GLM demonstrated improved physical function, HRQOL, and work productivity.