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16 June 2013

ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in Year Two Data from Head-to-Head Study in Patients with Moderate to Severe Rheumatoid Arthritis

Bristol-Myers Squibb Company (NYSE: BMY) announces the results of year two data from AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïvrheumatoid arthritis (RA) Subjects With Background Methotrexate), a first-of-its-kind trial of 646 patients comparing the subcutaneous (SC) formulation of ORENCIA® (abatacept) vs. Humira®(adalimumab), each on a background of MTX, in biologic naïve patients with moderate to severe RA. The AMPLE year two data are being presented this week at the European League Against Rheumatism (EULAR) annual congress and highlighted during a congress press conference.
AMPLE met its primary endpoint as measured by non-inferiority of ACR20 (American College of Rheumatology 20 percent improvement) at year one. The ORENCIA regimen achieved comparable rates of efficacy vs. the Humira regimen (64.8% vs. 63.4%, respectively). Onset of response was also generally similar for the two groups.
Year two of the study remained investigator-blinded. At year two, the ORENCIA regimen achieved the same rate of efficacy (60%) as the Humira regimen based on ACR20. ACR50, 70, and 90, considered to be more stringent measures of efficacy, as well as DAS-28-CRP, were assessed over 24 months and were generally similar for the two arms.
Radiographic progression was also assessed at two years with 85% of patients on the ORENCIA regimen and 84% of patients on the Humira regimen achieving radiographic non-progression.
“Results from the second year of the AMPLE study confirm what we saw in year one data,” said Michael Schiff, M.D., M.A.C.R., University of Colorado, and principal AMPLE study investigator, “namely, that efficacy was comparable for the two agents in this study.”
At 24 months, overall safety data were similar for both groups, including frequency of adverse events (92.8% and 91.5%), serious adverse events (13.8% and 16.5%), and malignancies (2.2% and 2.1%) for the ORENCIA regimen and the Humira regimen, respectively. Discontinuations due to adverse events were 3.8% for the ORENCIA regimen and 9.5% for the Humira regimen, while discontinuations due to serious adverse events were 1.6% for the ORENCIA regimen and 4.9% for the Humira regimen. Additionally, zero of the 12 patients who experienced serious infections in the ORENCIA group discontinued, while nine of the 19 patients who experienced serious infections in the Humira group discontinued. Autoimmune events, of mild or moderate severity, were reported in 3.8% of patients in the ORENCIA group and 1.8% of patients in the Humira group. Injection site reactions were reported in 4.1% of patients taking the ORENCIA regimen and 10.4% of patients taking the Humira regimen.
“The two year follow-up data from AMPLE provide important information on the clinical profile of abatacept (ORENCIA) plus MTX as a first biologic treatment option for patients with severe to moderate RA,” said Dr. Schiff.

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