Objectives To assess the efficacy and safety of golimumab (GLM) as monotherapy in Japanese patients (pts) with active rheumatoid arthritis (RA) despite DMARD therapy.
Methods GO-MONO is a multicenter, randomized, double-blind, placebo (PBO)-controlled study in pts with active RA despite treatment with DMARDs. Pts were randomized to SC PBO, GLM50 mg, or GLM100 mg q4wks as monotherapy. At wk16, pts in the PBO group (grp) crossed over (CO) GLM50 mg q4wks. Primary endpoint was the proportion of pts achieving ACR20 at wk14. Secondary endpoints included ACR50, ACR70, and ACR-N, changes from baseline (BL) to wks14/24/52 in DAS28 and HAQ, and changes from BL to wks24/52 in total modified vdH-Sharp (vdH-S) score. Comparisons of vdH-S score at wks24 and 52 were between GLM and PBO grps, based on the original randomized grps even for PBO pts who CO to 50 mg after wk16.
Results 308 pts received treatment (105 PBO, 101 GLM50 mg, and 102 GLM100 mg). At wk14, GLM50 mg and 100 mg grps had significantly greater improvements in signs and symptoms of RA and physical function vs PBO. Efficacy response was maintained through wk 52. At wk24, GLM100 mg grp had significantly less radiographic progression (RP) vs PBO. At wk52, both GLM50 mg and 100 mg grps had significantly less RP vs PBO. Significantly more GLM100 mg-treated pts had no progression, defined as change in TSS ≤0, vs PBO-treated pts at wk52. Subgroup analysis (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 both GLM 50 mg and 100 mg grps of the pts with BL CRP <1.5 mg/dL. However, for the pts with BL CRP ≥1.5 mg/dL, pts in GLM 100 mg grp had a median change in TSS of 0.5, as compared with a median change of 1.0 in GLM 50 mg. Eleven out of 295 (3.7%) pts treated with GLM were positive for anti-GLM antibody through 52 wks and their serum GLM concentrations were lower than those in pts with negative for anti-GLM antibody. The incidence of AEs up to Wk 52 was 82.0% (242/295 pts, 973 events) among all GLM-treated pts. Among the AEs, the system organ class that showed the highest incidence was “Infections and Infestations”. The incidences of serious AEs in PBO, PBO→GLM50 mg, GLM50 mg and 100 mg grps were 2.9%, 7.6%, 5.9%, and 5.9%, respectively. There were no deaths and no tuberculosis.
Conclusions Both doses of GLM significantly improved signs and symptoms of RA and physical function compared with PBO. The GLM50 mg and GLM100 mg grps had significantly less RP vs PBO at wks 24 (GLM100 mg only) and 52 (both dose grps). GLM monotherapy was well-tolerated with safety profile similar to other anti-TNF agents.
Disclosure of Interest None Declared