Orencia available as prefilled syringes for subcutaneous administration

1 February 2013

BMS has launched a prefilled syringe presentation of the immunomodulator Orencia (abatacept) for subcutaneous administration in adults with rheumatoid arthritis (RA).

Abatacept is recommended by NICE but only in patients with severe RA who have responded inadequately to (or who have not tolerated) other DMARDS, including methotrexate and a TNF inhibitor, and in whom rituximab is contraindicated or not tolerated.

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.

Licensed dose

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 study 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