Subcutaneous Orencia abatacept: Phase IIIb data

The double-blind, international Phase IIIb AMPLE trial in 646 patients with active moderate to severe RA who had an inadequate response to methotrexate showed that once-weekly subcutaneous 125 mg Orencia plus methotrexate met the primary endpoint of non-inferiority to 40 mg Humira adalimumab every other week plus methotrexate in the proportion of patients achieving an ACR20 response at 1 year (64.8% vs. 63.4%). At week 4, ACR20 response rates were 42.5% for subcutaneous Orencia vs. 47.6% for Humira. At 1 year, Orencia led to ACR50 and ACR70 response rates of 46.2% and 29.2%, respectively, vs. 46% and 26.2% for Humira.

Furthermore, Bristol-Myers said that subcutaneous Orencia showed generally comparable inhibition of radiographic damage compared to Humira at 1 year. Specifically, mean changes in radiographic non-progression rates were similar between Orencia and Humira as measured by mTSS, erosion and joint narrowing scores. Subcutaneous Orencia was also associated with significantly fewer injections-site reactions compared to Humira (3.8% vs. 9.1%, p=0.006). Data were presented at the European League Against Rheumatism meeting in Berlin. ...