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FRI0169 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
  1. M.E. Weinblatt1,
  2. C.O. Bingham III2,
  3. A.M. Mendelsohn3,
  4. L. Kim3,
  5. M. Mack3,
  6. J. Lu3,
  7. D. Baker3,
  8. R. Westhovens4
  9. on behalf of the GO-FURTHER Investigators
  1. 1Brigham & Women’s Hosp, Boston, MA
  2. 2Johns Hopkins, Baltimore, MD
  3. 3Janssen R&D, Spring House, PA, United States
  4. 4UZ Gasthuisberg, Leuven, Belgium

Abstract

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 <10% improvement in combined swollen & tender joint counts at wk16 could early escape to IV GLM 2mg/kg (wks16&20, q8wks). Primary study endpoint was ACR20 at wk14. Responses are reported using a non-responder imputation, with LOCF for continuous variables.

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<0.001) larger proportions of pts receiving GLM+MTX vs PBO+MTX achieved ACR20 (59% vs 25%, resp), DAS28-CRP good/moderate response (81% vs 40%, resp), ACR50 and a greater median improvement in HAQ score (0.500 vs 0.125, resp), all of which were also significantly improved vs PBO at wk2 (wk2 assessments not corrected for multiplicity). In post-hoc analysis, significant improvements were seen in CDAI and SDAI measurements at wk14 (p<0.001). At wk14, consistent treatment effects for ACR20 were observed across subgroup analyses. Similar proportions of pts receiving GLM+MTX and PBO+MTX reported AE through wk16 (47% and 44%) and wk24 (53% and 49%). Through wk24, serious AEs, most commonly serious infections, were reported by more GLM+MTX (4% and 1%, resp) than PBO+MTX (2% and 0%, resp) pts. No cases of TB or serious opportunistic infections were reported. 1 pt in PBO+MTX group died (presumed stroke). Through wk24,proportion of infusions with infusion reactions and pts with infusion reactions were 1.1% vs. 0.2% and 3.5% vs 0.5% in the GLM+MTX and PBO+MTX grps, resp. There were no serious infusion reactions.

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

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