Abstract
Comparing two biologics Based on 1-year results from the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate) trial, Roy Fleischmann, MD, and colleagues reported that use of subcutaneous abatacept (Orencia—Bristol-Myers Squibb) or adalimumab (Humira—Abbott) resulted in comparable rates of remission in biologic-naive patients who had an inadequate response to methotrexate (abstract 1340). AMPLE is the fi rst head-to-head trial to compare the effi cacy of two different biologics for the management of RA. In this ongoing, randomized, investigator-blinded, 24-month Phase IIIb study, researchers randomized biologic-naive patients with RA who had an inadequate response to methotrexate to abatacept 125 mg weekly (n = 318) or adalimumab 40 mg biweekly (n = 328). All patients remained on a stable dose of methotrexate throughout the trial. Researchers assessed various remission criteria, including DAS28CRP (Disease Activity Score 28 Based on C-Reactive Protein), RAPID3 (Routine Assessment of Patient Index Data 3), CDAI (Clinical Disease Activity Index), and SDAI (Simple Disease Activity Index). After 12 months, clinical, functional, and radiographic effi cacy, and safety were similar between the two groups. The proportion of patients meeting the various remission criteria for abatacept and adalimumab were 43.3% versus 41.9% for DAS28-CRP ≤ 2.6, 27.2% versus 25.1% for RAPID3 < 1.0, 23.5% versus 24.0% for CDAI ≤ 2.8, and 23.3% versus 24.8% for SDAI ≤ 3.3. Across all assessed remission criteria, 76% to 85% of patients in both treatment arms achieved Health Assessment Questionnaire response at year 1. In addition, 63% to 100% of patients had no radiographic progression, depending on the remission criteria employed.
Published Version
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