Intravenous Golimumab Is Effective In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Results Observed By 2 Weeks: Results Of The Phase 3, Multicenter, Double-Blind, Placebo-Controlled Trial

Objectives To evaluate the efficacy of IV GLM 2mg/kg+MTX in pts with active RA despite MTX. Methods Pts (n=592) with active RA (≥6/66 swollen joints, ≥6/68 tender joints, CRP≥1.0mg/dL, rheumatoid factor and/or anti-CCP antibodies positive at screening) despite ≥3mo of MTX (15-25mg/wk) participated in this multicenter, randomized, double-blind, placebo (PBO)-controlled phase 3 study. Pts were randomized to IV GLM 2mg/kg or PBO at wks0&4 and q8wks; all pts continued their stable MTX. Pts randomized to PBO with Results Baseline demographic and disease characteristics were comparable between grps (80.4% Caucasian, 81.6% female, median age 52yrs, median weight 69.6kg, median swollen joint/tender joint counts 12.0/23.0, median CRP 1.9mg/dL, median DAS28-CRP 5.9, median HAQ 1.625). Baseline mean CDAI scores were 38.5 and 38.4 and baseline mean SDAI scores were 41.3 and 40.6, for GLM+MTX and PBO+MTX grps, resp. 96% of pts (570/592) completed the 24wk study period; 4% (22/592) of pts discontinued, mostly due to AE (2.3%,GLM+MTX and 1.0, PBO+MTX). 34.5% of pts in the PBO+MTX grp entered early escape and initiated GLM at wk16 and were considered non-responders in subsequent analyses. At wk14, significantly (p Conclusions IV GLM+MTX significantly improved RA signs and symptoms in pts with active RA despite ongoing MTX,in some cases within 2 wks. Disclosure of Interest M. Weinblatt Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, C. Bingham III Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, A. Mendelsohn Employee of: Janssen Research & Development, LLC, L. Kim Employee of: Janssen Research & Development, LLC, M. Mack Employee of: Janssen Research & Development, LLC, J. Lu Employee of: Janssen Research & Development, LLC, D. Baker Employee of: Janssen Research & Development, LLC, R. Westhovens Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study