Objectives To assess golimumab (GLM) treatment effect in patients with rheumatoid arthritis (RA) naïve to methotrexate (MTX) therapy with severe, active and progressive disease.
Methods The GO-BEFORE trial studied GLM 50mg and 100mg + MTX in MTX-naïve patients. In the overall GO-BEFORE study population, patients exhibited lower disease activity (baseline ACR components and DAS28) than was observed in previous studies of biologic agents in MTX-naive patients1. This is a retrospective analysis of GO-BEFORE wk 52 data which compares efficacy outcomes in subsets of RA patients with severe, active disease to the overall study population. 637 MTX-naïve pts were randomized to PBO+MTX (Grp 1), GLM 100mg+PBO (Grp 2), GLM 50mg+MTX (Grp 3), or GLM 100mg+MTX (Grp 4). GLM/PBO received injections q4wks. Pts with 5.1, and CRP ≥3 mg/dL. Treatment effect for each subset and the overall population was defined as the differences between GLM 50mg or 100mg +MTX and MTX-alone in ACR50, DAS28 (CRP) remission, change in HAQ ≥0.25 and total vdHS score ≤0. Differences in the treatment effect between each subset of severe, active and progressive RA and the overall population was examined.
Results Greater proportions of patients achieved the efficacy endpoints in the GLM+MTX groups versus MTX-alone and the difference between the treatment groups (tx effect) was generally larger in the severe, active and progressive subsets compared with the overall population (Table).
Conclusions Overall, treatment effect in the efficacy parameters between GLM 50mg +MTX and GLM 100mg +MTX versus MTX-alone was greater for the severe, active and progressive subsets versus the overall population.
Emery et al. Arthritis & Rheumatism 2009;60(8):2272-2283.
Disclosure of Interest P. Emery Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, R. Fleischmann Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, E. Hsia Employee of: Janssen Research & Development, LLC, S. Xu Employee of: Janssen Research & Development, LLC, W. Xu Employee of: Janssen Research & Development, LLC, D. Baker Employee of: Janssen Research & Development, LLC