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


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.

SUBMITTER: Schiff M 

PROVIDER: S-EPMC4838764 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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

Schiff Michael M   Weinblatt Michael E ME   Valente Robert R   Citera Gustavo G   Maldonado Michael M   Massarotti Elena E   Yazici Yusuf Y   Fleischmann Roy R  

RMD open 20160419 1


<h4>Objectives</h4>To evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial.<h4>Methods</h4>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, Bool  ...[more]

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