SAT0108 Efficacy of abatacept versus adalimumab on the proportion of patients with seropositive, erosive early ra achieving das28 (CRP) <2.6 or validated measures of remission: a post hoc analysis of the 2-year ample trial
Authors: R. Fleischmann, M. E. Weinblatt, H. A. Ahmad, M. A. Maldonado, E. Alemao, Y. Elbez, M. Schiff
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Binary cut-offs for disease activity are frequently used in clinical decision-making for patients with RA because they are accurate reflections of disease activity, discriminate well between disease acvitiy states and are feasible to perform in routine clinical practice.<sup>1</sup> Results from a previous <i>post hoc</i> analysis of the randomized, controlled, head-to-head AMPLE trial (NCT00929864) indicated a trend for increased efficacy, as assessed using DAS28 (CRP), for abatacept (ABA) compared with the TNF inhibitor adalimumab (ADA) in patients with seropositive, erosive early RA.<sup>2,3</sup> <h3>Objectives</h3> To evaluate <i>post hoc</i> the impact of treatment with either SC ABA or ADA on sustained validated definitions of remission and DAS28 (CRP) &lt;2.6 in patients with seropositive, early, rapidly progressing RA with inadequate response to MTX. <h3>Methods</h3> This <i>post hoc</i> analysis of the AMPLE trial builds on previous work<sup>3</sup> to compare clinical outcomes between treatment groups in two subsets: patients with disease duration ≤6 months, RF or anti-citrullinated protein antibody seropositivity and &gt;1 radiographic erosion (Cohort 1), and patients in whom ≥1 of these inclusion criteria were absent (Cohort 2). Disease activity and patient-reported outcomes were evaluated at Weeks 26, 52 and 104. Endpoints were defined as percentages of patients with DAS28 (CRP) &lt;2.6, SDAI ≤3.3, CDAI &lt;2.8 or Boolean remission. Endpoints were compared between ABA and ADA treatment groups using chi-square tests. <h3>Results</h3> Of 646 randomized patients, 83 were included in Cohort 1 (ABA, n=38; ADA, n=45) and 563 in Cohort 2 (ABA, n=280; ADA, n=283). At Week 52, significantly more ABA- than ADA-treated patients achieved DAS28 (CRP) &lt;2.6 in Cohort 1 (p=0.03), a trend that was not seen at Week 104 or in Cohort 2 at either time point. At Weeks 52 and 104, more ABA- than ADA-treated patients achieved CDAI, SDAI and Boolean remission in Cohort 1, a trend not seen in Cohort 2. <h3>Conclusions</h3> This <i>post hoc</i> analysis indicates a trend towards increased efficacy for abatacept compared with adalimumab on measures of sustained remission and DAS28 (CRP) &lt;2.6 in patients with seropositive, erosive early RA. These results, along with results from other studies,<sup>4,5</sup> support the pursuit of a clinically definable subset of patients who may respond differentially to targeted therapies. <h3>References:</h3> [1] Anderson J, et al. Arthritis Care Res (Hoboken) 2012;64:640-7. [2] Schiff M, et al. Ann Rheum Dis 2014;73:86-94. [3] Fleischmann R, et al. EULAR 2017; poster SAT0041. [4] Harrold LR, et al. J Rheumatol 2018;45:32-9. [5] Emery P, et al. Ann Rheum Dis 2015;74:19-26. <h3>Disclosure of Interest:</h3> R. FleischmannGrant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, EMD-Serono, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Consultant for: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, GSK, Eli Lilly, Novartis, Pfizer, Sanofi-Genzyme, UCB, M. Weinblatt Grant/research support from: Bristol-Myers Squibb, Amgen, Crescendo Bioscience, Sanofi, Consultant for: Bristol-Myers Squibb, Amgen, Crescendo Bioscience, AbbVie, Eli Lilly, Pfizer, Roche, Merck, Samsung, Novartis, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Y. Elbez Consultant for: Bristol-Myers Squibb, M. Schiff Consultant for: Abbvie, Bristol-Myers Squibb, Eli Lilly, Johnson &amp; Johnson, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb