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ARTICLE | Clinical News

Orencia abatacept: Phase IIIb data

July 28, 2014 7:00 AM UTC

The double-blind, international Phase IIIb AVERT trial in 351 patients with early RA showed that first-line treatment with once-weekly 125 mg subcutaneous Orencia plus methotrexate for 12 months met the co-primary endpoints of a greater proportion of patients with a DAS28-CRP score of <2.6 points at 12 months (60.9% vs. 45.2%) and at both 12 and 18 months - 6 months after all RA treatment was withdrawn - vs. methotrexate alone. In the once-weekly 125 mg subcutaneous Orencia alone for 12 months arm, 42.5% of patients achieved a DAS28-CRP score of <2.6 points at 12 months. The trial enrolled patients with symptoms of RA for <2 years, a DAS28-CRP score of >3.2 points and who had not previously received methotrexate or biologic therapies.

Patients who had a DAS28-CRP score <3.2 points at 12 months were eligible to continue the trial in a withdrawal period of up to 12 months in which all RA treatment, including Orencia, methotrexate and steroids, were withdrawn. Following withdrawal of all RA therapy, 79.4% of patients went back on therapy because of worsening RA symptoms. At 6 months after withdrawal, drug-free remission rates were 14.8% for the Orencia plus methotrexate arm, 12.4% for the Orencia monotherapy arm and 7.8% for the methotrexate alone arm. Data were presented at the European League Against Rheumatism meeting in Paris. ...