Orencia (abatacept) is indicated for use in adults with moderate to severe active rheumatoid arthritis who have responded inadequately to one or more DMARDS, including methotrexate and a TNF inhibitor.
Treatment should be initiated with a loading dose of abatacept by intravenous infusion. Patients should receive their first 125mg subcutaneous injection within a day of the infusion, which is then followed by 125mg injections once weekly.
Subcutaneous formulation non-inferior to intravenous administration
In a double-blind randomised phase IIIb in 1,457 patients, the subcutaneous formulation demonstrated non-inferiority to intravenous infusion when given monthly, following an initial loading dose by intravenous infusion.
Patients achieved similar clinical responses, measured using ACR criteria, and investigators found proportions of adverse events were comparable in the two treatment arms, with low rates of (mostly mild) injection site reactions for both routes.
Not suitable for paediatric patients
Orencia is also licensed for the treatment of severe active polyarticular juvenile idiopathic arthritis in children but the subcutaneous route should not be used in this setting as safety and efficacy have not been established.
View Orencia drug record
Further information: Bristol-Myers Squibb Pharmaceuticals Ltd