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June 10, 2014
18:43 EDTBMYBristol-Myers: AVERT trial shows high rates of DAS-defined remission
Bristol-Myers Squibb announced its first release of new data from a Phase IIIb RA trial showing that the T-cell co-stimulation modulator, Orencia, in combination with methotrexate achieved significantly higher rates of DAS-defined (DAS28 CRP <2.6) remission at 12 months than treatment with standard of care agent MTX - 60.9% vs. 45.2%, respectively, in biologic and MTX-naïve patients with early active RA. The data are being presented this week at the 2014 annual meeting of the European League Against Rheumatism. In this trial, known as AVERT, a co-primary endpoint assessed maintenance of remission following the withdrawal of all RA drug therapy including Orencia, MTX and steroids. A small but statistically significantly higher number of patients treated with Orencia plus MTX, versus MTX alone, for 12 months maintained remission 6 months after all RA treatment was withdrawn. Orencia was well tolerated in the study patients. In particular, serious adverse events, serious infection events and discontinuation due to serious adverse events were comparable to patients treated with MTX. “These data demonstrating higher remission rates and a similar safety profile for Orencia plus methotrexate versus methotrexate alone, in conjunction with insights from the withdrawal phase of the study, support the use of Orencia as a first line biologic therapy for patients with RA,” said Michael Giordano, senior vice president, head of development, Oncology and Immunology, Bristol-Myers Squibb.
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