Bristol-Myers Squibb Reports Clinical Data To Labeling For Orencia

Bristol-Myers Squibb has reported that clinical data added to the labeling for Orencia (abatacept) support use of Orencia for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

The FDA has approved on August 25, 2009, the addition of data from the AGREE trial, an active-controlled clinical trial in methotrexate-naive patients with moderate to severe rheumatoid arthritis of less than two years disease duration.

Reportedly, the labeling update marks the first time that the Orencia labeling includes disease activity score (DAS28-CRP) data in patients with moderate to severe rheumatoid arthritis of less than or equal to 2 years duration.

The data from the AGREE study shows that a greater proportion of patients with Orencia plus methotrexate achieved a DAS28-CRP of less than 2.6 at 12 months when compared to those taking methotrexate plus placebo.

The study also reveals that of patients treated with Orencia plus methotrexate who achieved a DAS28-CRP of less than 2.6, there were 54% with no active joints, 17% had one active joint, 7% had two active joints and 22% had 3 or more active joints, where an active joint was tender and/or swollen.

For patients taking Orencia plus methotrexate, 43% achieved ACR70, which means they had a 70% improvement in signs and symptoms, while 57% achieved a 50% improvement (ACR50) and 76% of patients achieved at least a 20% improvement (ACR20).

Moreover, the patients who received only methotrexate, among them 27% achieved ACR70, 42% achieved ACR50 and 62% achieved ACR20. These results indicate that treatment of moderate to severe rheumatoid arthritis of less than or equal to 2 years duration with Orencia plus methotrexate could benefit some patients.