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These data are from a four-month open-label trial involving 100 patients. The study showed that weekly administration of a 125mg subcutaneous dose of Orencia resulted in minimal, transient immunogenicity prior to month four after repeat dosing. The immunogenicity was similar whether Orencia was administered in combination with methotrexate, a common treatment for rheumatoid arthritis, or as a monotherapy. At month four, patients had no antibody response to subcutaneous Orencia, said Bristol-Myers.
Of the 100 patients enrolled in the open-label study, 51 received subcutaneous Orencia plus methotrexate and 49 received subcutaneous Orencia monotherapy. Orencia was self-administered once weekly at a fixed dose of 125mg in a ready-to-use pre-filled syringe.
The primary objective of the short-term open-label treatment period was to evaluate the immunogenicity of Orencia when used with or without methotrexate in the absence of an intravenous loading dose of Orencia.
Bristol Myers-Squibb has a comprehensive development program underway to evaluate the potential subcutaneous administration of Orencia through an injection into the skin in adults with moderate to severe rheumatoid arthritis.
Orencia is already available for the treatment of adults with moderate to severe rheumatoid arthritis. The subcutaneous program utilizes a new formulation of Orencia, which has been specifically designed for subcutaneous administration.
Peter Nash, associate professor for department of medicine at University of Queensland, Brisbane, Australia, said: "These new data assessing subcutaneous Orencia confirm no new safety signal, demonstrate efficacy both in combination with methotrexate and as monotherapy and show no immunogenicity with the subcutaneous formulation at four months."
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