EC clears new Remicade dosing for use in RA

Centocor, a subsidiary of global health care major Johnson & Johnson, and fellow US firm Schering-Plough say that the European Commission has approved a label extension for the co-developed tumor necrosis factor-alpha inhibitor Remicade (infliximab). The commission has cleared a new dosing regimen for the treatment of rheumatoid arthritis, which the firms say will allow physicians a greater degree of flexibility.

The companies explained that the new labeling, which is designed to treat patients who do not achieve a complete response to 3mg/kg of Remicade plus methotrexate, allows physicians to carry out a stepwise dosage increase to a maximum of 7.5mg/kg every eight weeks. The firms added that the EC decision allows for the administration of a 3mg/kg dose of the drug on a more frequent four-weekly basis.

The approval is based on the results of the START study which was a randomized double-blind, three-arm, parallel-group program, that enrolled 1,082 patients with active RA. The trial showed that, while the majority (67%) of patients did not require a dosage adjustment to benefit from treatment, of those who did, 80% demonstrated a clinical response, with 64% needing only one 1.5mg/kg dosage increase.