FRI0033 Association of Radiographic Outcomes with Low Disease Activity and Remission and Sustainability of Response with Subcutaneous Abatacept or Adalimumab: 2-Year Results from the AMPLE Trial
Authors: R. Fleischmann, M. Schiff, M. Weinblatt, M. Maldonado, E. Massarotti, J. Fay, Y. Yazici
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Remission and low disease activity (LDA) are now more achievable goals in RA. Year 1 and 2 data from the head-to-head AMPLE (Abatacept vs Adalimumab Comparison in Biologic-Naive RA Patients with Background MTX) trial showed comparable rates of remission and LDA for patients (pts) treated with subcutaneous (SC) abatacept (ABA) or adalimumab ADA).<sup>1,2</sup> <h3>Objectives</h3> To evaluate the relationship of radiographic outcomes with achieving LDA and remission and assess the sustainability of LDA/remission using 2-year data from the AMPLE trial. <h3>Methods</h3> AMPLE is a 2-year, Phase IIIb, randomized, investigator-blinded study. Biologic-naïve pts with RA and an inadequate response to MTX were randomized to 125 mg SC ABA weekly or 40 mg SC ADA bi-weekly, with background MTX.<sup>1</sup> The proportions of pts achieving remission (defined as Clinical Disease Activity Index [CDAI] ≤2.8, Simplified Disease Activity Index [SDAI] ≤3.3, Routine Assessment of Pt Index Data [RAPID]3 &lt;3, Boolean score ≤1), LDA (defined as CDAI ≤10, SDAI ≤11, RAPID3 ≤6), or with Disease Activity Scores [DAS]28 [C-reactive protein; CRP] of &lt;2.6 or ≤3.2 were analysed. Radiographic non-progression (defined as change in modified total Sharp score [mTSS] of ≤2.2 [smallest detectable change]) was analysed in pts achieving remission at 2 years. <h3>Results</h3> 646 pts were randomized and treated with SC ABA (n=318) or ADA (n=328) on background MTX. Across all criteria for remission and LDA, most pts who achieved remission, LDA or DAS28 (CRP) scores of &lt;2.6 or ≤3.2 at Year 1 maintained these states through to Year 2 (≥65% and ≥79%, respectively). Similar rates of sustained disease activity were observed in both treatment groups, regardless of the criteria used. Overall, &gt;85% of pts had radiographic non-progression at Year 2 (Table). Pts who achieved remission according to more stringent criteria (SDAI, CDAI, and Boolean) were more likely to be non-progressors than those who achieved LDA or DAS28 (CRP) ≤3.2. The correlation between clinical response and radiographic progression was less evident when non-progression was defined as mTSS ≤0.5 or 0. <h3>Conclusions</h3> The data demonstrate that achieving remission, LDA or DAS28 (CRP) scores of &lt;2.6 or ≤3.2 is highly correlated with prevention of radiographic progression (mTSS ≤2.2). Irrespective of the criteria used to assess disease activity, ≥65% of pts in both the SC abatacept and adalimumab treatment arms achieved a sustained clinical response. However, pts who achieved remission according to more stringent criteria were more likely to be radiographic non-progressors than those who achieved LDA or DAS28 (CRP) ≤3.2. <h3>References</h3> Schiff M, et al. Ann Rheum Dis 2013;73:86-94; 2. Fleischmann R, et al. Arthitis Rheum 2013;65(Suppl 10):S209. <h3>Disclosure of Interest</h3> R. Fleischmann Grant/research support: Abbvie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Dynavax, Genzyme, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Xoma, Consultant for: Abbvie, Amgen, AstraZeneca, BMS, Celgene, Janssen, Eli Lilly, Pfizer, Roche, Sanofi-Aventis, UCB, M. Schiff Consultant for: Bristol-Myers Squibb, Abbvie, Speakers bureau: Bristol-Myers Squibb, Abbvie, M. Weinblatt Grant/research support: BMS, Crescendo Bioscience, UCB, Consultant for: BMS, Crescendo Bioscience, UCB, Abbvie, Roche, Janssen, M. Maldonado Shareholder of: BMS, Employee of: BMS, E. Massarotti Shareholder of: Merck (Under 10,000 US dollars), Grant/research support: Investigator: BMS, Sanofi, Human Genome Sciences, J. Fay Shareholder of: BMS, Employee of: BMS, Y. Yazici Shareholder of: Samumed, Grant/research support: BMS, Genentech, Consultant for: Abbvie, BMS, Genentech, Pfizer, Samumed, UCB <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.2959