BioCentury
ARTICLE | Clinical News

Clazakizumab meets in Phase IIb RA trial

October 29, 2013 12:46 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) and partner Alder Biopharmaceuticals Inc. (Bothell, Wash.) said once-monthly subcutaneous clazakizumab ( BMS-945429) with or without methotrexate met the primary endpoint of improving ACR20 response rates at week 12 vs. methotrexate alone in a Phase IIb trial to treat rheumatoid arthritis. The ACR20 response rates at week 12 were 78% for 25 mg clazakizumab plus methotrexate (p<0.001), 71.7% for 100 mg clazakizumab plus methotrexate (p<0.001), 60% for 200 mg clazakizumab plus methotrexate (p=0.015), 55% for 100 mg clazakizumab alone (p=0.042) and 61% for 200 mg clazakizumab alone (p=0.015) vs. 39.3% for methotrexate alone. The double-blind, international trial enrolled 418 adults with moderate to severe RA who had an inadequate response to methotrexate. Data were presented at the American College of Rheumatology meeting in San Diego.

Humira adalimumab from AbbVie Inc. (NYSE:ABBV) plus methotrexate was included as a reference arm and led to an ACR20 response rate at week 12 of 76.3%. Bristol-Myers said the study was not designed to show significant differences between the clazakizumab arms and Humira arm. ...