PARIS, June 11, 2013 /PRNewswire/ --
AMPLE Study results highlighted during a press conference at the European League Against Rheumatism (EULAR) Annual congress
- Year 2 data shows similar efficacy between ORENCIA plus methotrexate ( MTX) and Humira plus MTX, consistent with the year 1 result which demonstrated comparable efficacy based on a non-inferiority endpoint for ACR 20 response
- Radiographic non-progression at 2 years was achieved by 85 percent of patients on ORENCIA plus MTX and 84 percent of patients on Humira plus MTX
- T he frequency of adverse events was overall similar in both groups; there were numerically fewer discontinuations due to adverse events, serious adverse events, serious infections, and fewer local injection site reactions in patients treated with ORENCIA plus MTX
Bristol-Myers Squibb Company (NYSE: BMY) today announced the results of year two data from AMPLE ( A batacept Versus Adali m umab Com p arison in Bio l ogic-Naïv e rheumatoid 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 were presented today 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.