REPORT FROM THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING, NEW ORLEANS LA, APRIL 21-28, 2012 – The initial dose-ranging study of natalizumab indicated that 1-3 mg/kg was clinically effective (Sheremata et al. Neurology 1999;52:1072-1074) and this was the dose selected by the Natalizumab MS Trial Group (O’Connor et al. Neurology 2004;62:2038-2043).
Higher doses of 3-6 mg/kg were used in phase II testing (Miller et al. N Engl J Med 2003;348:15-23; free full text at www.nejm.org/doi/pdf/10.1056/NEJMoa020696). Dosing by body weight was replaced by the one-size-fits-all 300 mg when natalizumab was initially approved in 2004 based on the dose used in the AFFIRM and SENTINEL phase III pivotal trials.