Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration

Authors

• Michael Schiff, University of ColoradoFollow
• Michael E Weinblatt, Brigham and Women’s Hospital, Boston, Massachusetts
• Robert M. Valente, Arthritis Center of Nebraska
• Gustavo Citera, Instituto de Rehabilitacion Psicofisica
• Michael Maldonado, Bristol-Myers Squibb, Princeton
• Elena Massarotti, Brigham and Women’s Hospital, Boston, Massachusetts
• Yusuf Yazici, New York University Hospital for Joint Diseases
• Roy Fleischmann, University of Texas Southwestern Medical Center

Date of this Version

2016

Citation

Schiff M, et al. RMD Open 2016;2:e000210.

doi:10.1136/rmdopen-2015-000210

Comments

US government work

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 biweekly, 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.