Subcutaneous Formulation of Orencia Approved for Rheumatoid Arthritis

The FDA has approved a subcutaneous formulation of Orencia (abatacept; Bristol-Myers Squibb) for the reduction of signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA). This approval was based on data from the ACQUIRE study, a Phase 3, randomized, double-blind, double-dummy, multinational study designed to determine non-inferiority of Orencia SC plus methotrexate (MTX) to Orencia IV plus MTX by difference in ACR 20 response at 6 months. The study included 1,457 patients with moderately-to-severely active RA, most of whom had an inadequate response to MTX. Comparable ACR 20 response rates of 76% were seen in both groups of patients receiving SC injections plus MTX or IV infusions plus MTX at month 6. ACR 50 and ACR 70 responses were comparable between Orencia SC and IV as were improvements in all patient-reported outcomes studied – pain, physical function and global assessment of disease activity for Orencia SC and IV at 6 months. High retention rates were seen at month 6: 94% of patients receiving Orencia SC injections plus MTX and 94% of patients receiving Orencia IV plus MTX remained in the study.

The self-injectable subcutaneous formulation of Orencia is a fixed 125mg dose injection that will be available in September 2011.

Orencia is already available in an IV formulation that is indicated for adult rheumatoid arthritis and moderately-to-severely active polyarticular juvenile idiopathic arthritis.

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