August 27, 2009
Updated labeling approved for OrenciaThe FDA has approved updated labeling for Orencia (abatacept, from Bristol-Myers Squibb) to include clinical data from the AGREE trial (Abatacept study to Gauge Remission and joint damage progression in methotrexate-naive patients with Early Erosive rheumatoid arthritis), an active-controlled clinical trial in methotrexate-naive patients with moderate to severe rheumatoid arthritis of <2 years disease duration, that showed that earlier treatment could benefit some patients. In the AGREE trial, a greater proportion of patients treated with Orencia plus methotrexate achieved a disease activity score (DAS28-CRP) of <2.6, which indicates a low level of disease activity, at 12 months compared to those taking methotrexate plus placebo, 41% versus 23% of patients, respectively (p< 0.001). Joint damage progression was also assessed, as measured by the Total Sharp Score, with a score of zero meaning no damage. The study data demonstrated a statistically significant difference between the Total Sharp Scores at 12 months, 0.6 and 1.1, respectively, for the Orencia and placebo groups. ACR70, 50, and 20 scores, which evaluated percent improvement in signs and symptoms (ie, ACR70 indicates 70% improvement), showed a larger proportion of patients treated with Orencia plus methotrexate to have achieved greater improvement than those who received placebo plus methotrexate: ACR70: 43% versus 27% of patients, ACR50: 57% versus 42% of patients, and ACR20: 76% versus 62% of patients, respectively.
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