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AB0486 New, provisional american college of rheumatology and european league against rheumatism remission criteria: Results from 2 randomized, controlled golimumab trials in patients with rheumatoid arthritis
  1. P. Emery1,
  2. E. Keystone2,
  3. R. Fleischmann3,
  4. M. Genovese4,
  5. L. Klareskog5,
  6. S. Xu6,
  7. C. Han6,
  8. E.C. Hsia6,7
  9. on behalf of the GO-BEFORE and GO-FORWARD Study Investigators
  1. 1University of Leeds, Leeds, United Kingdom
  2. 2University of Toronto, Toronto, ON, Canada
  3. 3University of Texas Southwest Medical Center at Dallas, Dallas, TX
  4. 4Stanford University, Palo Alto, CA, United States
  5. 5Karolinska Institute, Stockholm, Sweden
  6. 6Janssen Research & Development, LLC, Spring House, PA
  7. 7University of Pennsylvania, Philadelphia, PA, United States

Abstract

Objectives To assess wk24 remission rates from GO-BEFORE and GO-FORWARD using new, “provisional” criteria proposed by the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) (Felson et al).1

Methods This is a retrospective analysis from GO-BEFORE (methotrexate (MTX)-naïve RA pts) and GO-FORWARD (RA pts with inadequate response to MTX) through wk24. In GO-BEFORE (N=637) MTX-naïve pts and in GO-FORWARD (N=444) pts with active RA despite MTX were randomized to PBO+MTX, GLM100mg+PBO, GLM50mg+MTX, or GLM100mg+MTX, grps 1-4, respectively. In GO-FORWARD, pts with <20% improvement in SJC/TJC at wk16 entered early escape: PBO+MTX$→ $GLM50mg+MTX, GLM 100mg+PBO$→ $GLM100mg+MTX, GLM 50mg+MTX$→ $GLM100mg+MTX. GLM/PBO was injected q4wks. New ACR/EULAR remission was defined as follows: Definition A [Def A]-(TJC/SJC [28 joints], CRP mg/dL, and pt global assessment, each score ≤1) and Definition B [Def B]-SDAI score is the sum of (TJC/SJC [28 joints], pt global assessment, physician global assessment, and CRP mg/dL), scoring ≤3.3. Data handling rules were applied to wk24 analysis of data (Table).

Results Using new ACR/EULAR remission criteria (Def A and B), a significantly greater proportion of pts achieved remission in the combined GLM+MTX treatment grps vs grp 1 in GO-BEFORE and GO-FORWARD. A comparison between new criteria and previously published DAS28 remission criteria for the combined GLM+MTX treatment grps show: GO-BEFORE (13.2% (Def A)/15.4% (Def B) vs 26.7% (prev pub’d) and GO-FORWARD (11.2% (Def A)/12.9% (Def B) vs 28.7% (prev pub’d). As expected, the new, more stringent criteria resulted in lower remission rates vs DAS28 remission criteria. Def A and B had generally similar remission rates in both studies, with slightly lower numbers for Def A vs B. A comparison between individual treatment grps using the new criteria show: GO-BEFORE remission rates significantly greater in grp 3 for Def A and grp 4 for Def B, with grp 3 approaching statistical significance (p=0.052) (Def B) vs grp 1. In GO-FORWARD, significantly greater remission rates using Def A were achieved in grps 3 and 4, with grp 2 approaching statistical significance (p=0.053) vs grp 1, while significantly greater proportions of pts achieved remission in all GLM treatment grps vs grp 1 using Def B.

Conclusions Significantly greater remission rates were achieved in the combined GLM grp vs grp 1 in GO-BEFORE and GO-FORWARD through wk24 based on new, more stringent ACR/EULAR criteria. Remission rates were generally slightly lower using Def A vs Def B.

  1. Felson D, Smolen J, Wells G, et al. Arthritis & Rheumatism 2011:63 (3)573-586.

Disclosure of Interest P. Emery Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, E. Keystone 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, M. Genovese Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, L. Klareskog Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, S. Xu Employee of: Janssen Research & Development, LLC, C. Han Employee of: Janssen Research & Development, LLC, E. Hsia Employee of: Janssen Research & Development, LLC

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