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Original article
Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration
  1. Michael Schiff1,
  2. Michael E Weinblatt2,
  3. Robert Valente3,
  4. Gustavo Citera4,
  5. Michael Maldonado5,
  6. Elena Massarotti2,
  7. Yusuf Yazici6 and
  8. Roy Fleischmann7
  1. 1University of Colorado, Denver, Colorado, USA
  2. 2Brigham and Women's Hospital, Boston, Massachusetts, USA
  3. 3Arthritis Center of Nebraska, Lincoln, Nebraska, USA
  4. 4Instituto de Rehabilitacion Psicofisica, Buenos Aires, Argentina
  5. 5Bristol-Myers Squibb, Princeton, New Jersey, USA
  6. 6New York University Hospital for Joint Diseases, New York, New York, USA
  7. 7University of Texas Southwestern Medical Center, Dallas, Texas, USA
  1. Correspondence to Dr Michael Schiff; michael.schiff{at}me.com

Abstract

Objectives To evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial.

Methods Patients were randomised to subcutaneous abatacept 125 mg weekly or adalimumab 40 mg bi-weekly, with background methotrexate. As part of a post hoc analysis, the achievement of validated definitions of remission (Clinical Disease Activity Index (CDAI) ≤2.8, Simplified Disease Activity Index (SDAI) ≤3.3, Routine Assessment of Patient Index Data 3 (RAPID3) ≤3.0, Boolean score ≤1), low disease activity (CDAI <10, SDAI <11, RAPID3 ≤6.0), Health Assessment Questionnaire-Disability Index response and American College of Rheumatology responses were evaluated by baseline disease duration (≤6 vs >6 months). Disease Activity Score 28 (C-reactive protein) <2.6 or ≤3.2 and radiographic non-progression in patients achieving remission were also evaluated.

Results A total of 646 patients were randomised and treated (abatacept, n=318; adalimumab, n=328). In both treatment groups, comparable responses were achieved in patients with early rheumatoid arthritis (≤6 months) and in those with later disease (>6 months) across multiple clinical measures.

Conclusions Abatacept or adalimumab with background methotrexate were associated with similar onset and sustainability of response over 2 years. Patients treated early or later in the disease course achieved comparable clinical responses.

Trial registration number NCT00929864, Post-results.

  • DAS28
  • Disease Activity
  • Rheumatoid Arthritis
  • DMARDs (biologic)

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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