ORIGINAL RESEARCH ARTICLE Population Pharmacokinetics of Sifalimumab, an Investigational Anti-Interferon-a Monoclonal Antibody, in Systemic Lupus

The Author(s) 2013. This article is published with open access at Springerlink.com Background and Objectives Sifalimumab is a fully human immunoglobulin G1j monoclonal antibody that binds to and neutralizes a majority of the subtypes of human interferon-a. Sifalimumab is being evaluated as a treatment for systemic lupus erythematosus (SLE). The primary objectives of this analysis were (a) to develop a population pharmacokinetic model for sifalimumab in SLE; (b) to identify and quantitate the impact of patient/disease characteristics on pharmaco-kinetic variability; and (c) to evaluate fixed versus body weight (WT)-based dosing regimens. Methods Sifalimumab serum concentration-time data were collected from a phase Ib study (MI-CP152) designed to evaluate the safety and tolerability of sifalimumab i