- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Abatacept (Orencia) and Adalimumab (Humira) Show Comparable Efficacy in RA Patients
Two-year data reported at EULAR congress (June 11)
Two-year data from the AMPLE (Abatacept Versus AdaliMumab ComParison in BioLogic-NaïvE Rheumatoid Arthritis Subjects With Background Methotrexate) trial will be presented this week at the European League Against Rheumatism (EULAR) annual congress in Madrid, Spain.
The study compared the subcutaneous (SC) formulation of abatacept (Orencia; Bristol-Myers Squibb) with adalimumab (Humira; AbbVie) in 646 biologic-naïve patients with moderate-to-severe rheumatoid arthritis (RA). The patients were randomly assigned to receive either abatacept SC 125 mg weekly or adalimumab 40 mg every other week, both on a background of methotrexate.
The trial met its primary endpoint: non-inferiority of American College of Rheumatology 20% improvement (ACR20) at year 1. The abatacept regimen achieved comparable rates of efficacy versus the adalimumab regimen (64.8% vs. 63.4%, respectively). The onset of response was also generally similar for the two groups.
At year 2, the abatacept regimen achieved the same rate of efficacy (60%) as the adalimumab regimen, based on ACR20.
Radiographic progression was also assessed at 2 years, with 85% of patients on the abatacept regimen and 84% of patients on the adalimumab regimen achieving radiographic non-progression.
At year 2, the cumulative rates of adverse events (AEs) were 92.8% and 91.5%, and serious AEs were 13.8% and 16.5%, in the abatacept and adalimumab groups, respectively.
Source: Bristol-Myers Squibb; June 11, 2013.