Objectives To assess the efficacy and safety of golimumab (GLM) in Japanese patients (pts) with active RA despite MTX therapy.
Methods GO-FORTH is a multicenter, randomized, double-blind, placebo (PBO)-controlled study in pts with active RA despite MTX. Pts were randomized to SC PBO, GLM50 mg, or GLM100 mg q4 wks. All pts received MTX 6-8 mg orally/wk. Pts with <20% improvement in SJC/TJC entered early escape (EE) at wk16 in a blinded manner so that PBO→GLM50 mg and GLM50 mg→100 mg. Pts receiving GLM100 mg continued the same dose. Pts who did not enter EE continued initial therapy until wk 24. After wk24, pts who entered EE maintained the wk24 regimen. Pts randomized to PBO who did not enter EE crossed over (CO) to GLM50 mg at wk24. Primary endpoint was the proportion of pts achieving ACR20 at wk14. Secondary variables included ACR20, ACR50, ACR70, DAS28 and HAQ, and changes from BL to wks 24/52 in total vdH-modified Sharp (vdH-S) score. For vdH-S score, treatment grp comparisons at wks 24/52 were based on randomized grps regardless of EE/CO status.
Results 261 pts received treatment (88 PBO, 86 GLM50mg, 87 GLM100mg). Both GLM doses were significantly better than PBO in improving signs and symptoms/physical function through wk14 (PBO-controlled period). After wk24, all pts received either GLM50mg or 100mg, and wk 14 efficacy was sustained thorough wk52. At wk52, both of GLM50mg and 100mg yielded significantly less radiographic damage than PBO and pts who received 100mg continued to exhibit less progression through wk52. Significantly more pts treated with GLM 100mg vs PBO had no progression (change in TSS≤0) at wk52. Subgroup analysis (baseline;BL CRP levels ≥1.5 mg/dL vs <1.5 mg/dL) of TSS change from BL was performed in accordance with the report by Emery et al, 2011. Median change in TSS from BL to wk24 was 0.0 in any grp for the pts with BL CRP <1.5 mg/dL. However, for pts with BL CRP ≥1.5 mg/dL, pts in GLM 100mg grp showed less radiographic progression at wk24 than those in pts with PBO and GLM 50mg. The incidence of adverse events (AEs) through wk52 was 89.1% in all GLM-treated pts. Among all AEs, the system organ class with the highest incidence by treatment grp (except for pts who CO GLM50 mg→100 mg) was “Infections and Infestations.” Through wk52, serious AEs occurred in 1.1%, 9.3% and 6.9% of PBO, GLM50mg only and GLM100mg only treated pts, respectively. There were no deaths and no tuberculosis.
Conclusions Treatment with GLM50 mg and 100 mg+MTX significantly improved signs/symptoms and inhibited progression of structural damage vs. PBO+MTX. The GLM+MTX safety profile was similar to other anti-TNF agents.
Disclosure of Interest None Declared