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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
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  1. R. Fleischmann1,
  2. M. E. Weinblatt2,
  3. H. A. Ahmad3,
  4. M. A. Maldonado3,
  5. E. Alemao3,
  6. Y. Elbez4,
  7. M. Schiff5
  1. 1University of Texas Southwestern Medical Center, Dallas
  2. 2Brigham and Women's Hospital, Boston
  3. 3Bristol-Myers Squibb, Princeton, United States
  4. 4Excelya, Boulogne-Billancourt, France
  5. 5University of Colorado, Denver, United States

Abstract

Background 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.1 Results from a previous post hoc 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.2,3

Objectives To evaluate post hoc the impact of treatment with either SC ABA or ADA on sustained validated definitions of remission and DAS28 (CRP) <2.6 in patients with seropositive, early, rapidly progressing RA with inadequate response to MTX.

Methods This post hoc analysis of the AMPLE trial builds on previous work3 to compare clinical outcomes between treatment groups in two subsets: patients with disease duration ≤6 months, RF or anti-citrullinated protein antibody seropositivity and >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) <2.6, SDAI ≤3.3, CDAI <2.8 or Boolean remission. Endpoints were compared between ABA and ADA treatment groups using chi-square tests.

Results 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) <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.

Figure 1 Comparison of Treatments by Sustained Remission Outcomes and DAS28 (CRP) <2.6A) Cohort 1: Pts with early (<6 months disease duration) seropositive erosive RA. B) Cohort 2: Pts with the absence of any 1 factor in Cohort 1. All p>0.05 unless otherwise stated. *Boolean remission is defined as tender joint count ≤1, swollen joint count ≤1, CRP≤1 mg/dL and patient global assessment ≤1 (on a 0-10 scale).

Conclusions This post hoc analysis indicates a trend towards increased efficacy for abatacept compared with adalimumab on measures of sustained remission and DAS28 (CRP) <2.6 in patients with seropositive, erosive early RA. These results, along with results from other studies,4,5 support the pursuit of a clinically definable subset of patients who may respond differentially to targeted therapies.

References: [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.

Disclosure of Interest: 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 & Johnson, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb

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