Bristol-Myers Orencia equals Humira in head-to-head AMPLE RA study

US drug major Bristol-Myers Squibb (NYSE: BMY) has announced the results of year two data from AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive rheumatoid arthritis (RA) Subjects With Background Methotrexate), a first-of-its-kind trial of 646 patients comparing the subcutaneous (SC) formulation of Orencia (abatacept) versus AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab), each on a background of MTX, in biologic naive 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% 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. Orencia is already approved and marketed by B-MS, and generated first-quarter 2013 sales of $320 million.

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.