The Steady-State Pharmacokinetic Profile Across a Range of Patient Body Weight Categories Supports Weight-Based Dosing for Intravenous Reslizumab

Authors: Jaworowicz DJ, Fiedler-Kelly J, Rabinovich-Guilatt L, Bond M
Conference: American Thoracic Society (ATS) International Congress
Keywords: intravenous, IV, population pharmacokinetic, PPK, pulmonary, reslizumab
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Background

Reslizumab is an IgG4 kappa humanized monoclonal antibody that targets interleukin-5, leading to marked reductions in airway eosinophil levels, and is indicated as an ‘add-on’ maintenance treatment for adult patients (≥18 years of age) with severe asthma and eosinophilic phenotype.1–3

  • The efficacy and safety of intravenous (IV) reslizumab (3.0mg/kg) in patients with severe asthma and elevated eosinophil levels has been shown in four large, placebo-controlled, phase 3 clinical trials (BREATH clinical program).4–6
  • The dosage of intravenously administered reslizumab in these studies was based on patient body weight (weight-based dosing).3
  • Our aim was to develop a population pharmacokinetic (PPK) model to characterize the disposition of reslizumab and to evaluate the influence of key covariates, including body weight, on steady-state reslizumab exposures in support of the recently US Food and Drug Administration-approved IV dosing regimen of reslizumab.

American Thoracic Society (ATS) International Congress. May 13-18, 2016, San Francisco, CA

By David Jaworowicz, Jill Fiedler-Kelly, L. Rabinovich-Guilatt and M. Bond