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FRI0019 Clinical Responses by Baseline RA Disease Duration in the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve RA Patients with Background Methotrexate) Trial: 2-Year Results
  1. M. Schiff1,
  2. M.E. Weinblatt2,
  3. R. Valente3,
  4. D. van der Heijde4,
  5. G. Citera5,
  6. M.A. Maldonado6,
  7. J. Fay6,
  8. R. Fleischmann7
  1. 1University of Colorado, Denver
  2. 2Brigham & Women's Hospital, Boston
  3. 3Arthritis Center of Nebraska, Lincoln, United States
  4. 4Leiden University Medical Center, Leiden, Netherlands
  5. 5Instituto de Rehabilitacion Psicofisica, Buenos Aires, Argentina
  6. 6Bristol-Myers Squibb, Princeton
  7. 7University of Texas Southwestern Medical Center, Dallas, United States


Background Duration of disease has a considerable impact on the response to treatment with DMARDs in patients (pts) with RA. Those with longer disease duration do not respond as well to MTX compared with pts with early RA.1 Data that informs decision making, especially early in the disease course, is of significant clinical utility when treating pts with biologic DMARDs.

Objectives To assess clinical outcomes in pts with early RA (≤6 months' disease duration) treated with subcutaneous (SC) abatacept (ABA) or adalimumab (ADA) compared with pts with >6 months' disease duration, using 2-year data from AMPLE.

Methods 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.1 Disease duration at baseline (≤6 months and >6 months for each treatment) was analysed in the intention-to-treat population, and the proportions of pts achieving ACR20, 50 and 70 response, remission (rem; defined as Clinical Disease Activity Index [CDAI] ≤2.8, Simplified Disease Activity Index [SDAI] ≤3.3, Boolean score ≤1), low disease activity (LDA; CDAI ≤10, SDAI ≤11) or improvement in physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI] >0.3) were assessed by disease duration and treatment subgroups.

Results 646 pts were randomized and treated with SC ABA (n=318) or ADA (n=328) on background MTX (71 and 70 pts with ≤6 months' disease duration; 247 and 258 pts with >6 months' disease duration). Baseline characteristics were balanced between the disease duration subgroups, with the exception of a higher percentage of males among pts with ≤6 months' disease duration treated with ADA compared with the other subgroups. Among pts with ≤6 months' disease duration, 23.9% (SC ABA) and 30.0% (ADA) of pts discontinued study treatment; 19.8% (SC ABA) and 24.0% (ADA) of pts with >6 months' disease duration discontinued. Clinical responses by disease duration at Years 1 (AMPLE primary endpoint) and 2 are summarized in the table.

Conclusions In contrast to what has been shown with DMARDs, data from this post hoc analysis of the AMPLE trial show that pts treated with effective biologic DMARDs (SC abatacept or adalimumab), whether treated early in the course of disease (≤6 months) or later, achieved comparable responses across a range of clinical measures.


  1. Anderson JJ, et al. Arthritis Rheum 2000;43:22–9

Disclosure of Interest M. Schiff Consultant for: Bristol-Myers Squibb, Abbvie, M. Weinblatt Grant/research support: BMS, Crescendo Bioscience, UCB, Consultant for: BMS, Crescendo Bioscience, UCB, Abbvie, Roche, Janssen, R. Valente Grant/research support: Lilly, Novartis, UCB, BMS, Takeda, Vertex, Pfizer, Abbvie, Speakers bureau: Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharma, Eisai Pharma, Mitsubishi-Tanabe Pharma, Pfizer, Takeda Pharmaceutical, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex, Director of Imiaging Rheumatology bv, G. Citera Consultant for: Bristol-Myers Squibb, Pfizer, Abbvie, Roche, M. Maldonado Shareholder of: BMS, Employee of: BMS, J. Fay Shareholder of: BMS, Employee of: BMS, R. Fleischmann Grant/research support: Abbvie, Amgen, Astellas, Astra Zeneca, BMS, Celgene, Dynavax, Genzyme, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Xoma, Consultant for: Abbvie, Amgen, Astra Zeneca, BMS, Celgene, Janssen, Eli Lilly, Pfizer, Roche, Sanofi-Aventis, UCB

DOI 10.1136/annrheumdis-2014-eular.2942

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