Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing.

ABSTRACT: There are no  dose-finding trials available for rituximab that could guide dosing in non-malignant diseases. We hypothesized that currently used doses (≥375 mg/m²) exceed several hundred-fold the half-maximal effective dose, which is most sensitive for detecting putative differences between biosimilars and important for dose finding. In an open label, exploratory trial healthy volunteers received single infusions of rituximab at doses of 0.1, 0.3 or 1.0 mg/m². Subsequently, in a double-blind, randomized trial healthy volunteers received single infusions of two rituximab products at doses of 0.1 and 0.3 mg/m². In the exploratory trial rituximab transiently depleted CD20+ cells by a mean 68% (range: 57-95%), 74% (55-82%) and 97% (94-100%) immediately after th

SUBMITTER: Schoergenhofer C 

PROVIDER: S-EPMC5760686 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature