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
Authors: P. Emery, E. Keystone, R. Fleischmann, M. Genovese, L. Klareskog, S. Xu, C. Han, E.C. Hsia
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Objectives</h3> 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).<sup>1</sup> <h3>Methods</h3> 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 &lt;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). <h3>Results</h3> 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. <h3>Conclusions</h3> 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. <h3>References</h3> Felson D, Smolen J, Wells G, et al. Arthritis &amp; Rheumatism 2011:63 (3)573-586. <h3>Disclosure of Interest</h3> P. Emery Grant/Research support from: Investigators for Janssen Research &amp; Development, LLC sponsored clinical study, E. Keystone Grant/Research support from: Investigators for Janssen Research &amp; Development, LLC sponsored clinical study, R. Fleischmann Grant/Research support from: Investigators for Janssen Research &amp; Development, LLC sponsored clinical study, M. Genovese Grant/Research support from: Investigators for Janssen Research &amp; Development, LLC sponsored clinical study, L. Klareskog Grant/Research support from: Investigators for Janssen Research &amp; Development, LLC sponsored clinical study, S. Xu Employee of: Janssen Research &amp; Development, LLC, C. Han Employee of: Janssen Research &amp; Development, LLC, E. Hsia Employee of: Janssen Research &amp; Development, LLC