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Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases
book

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

by Honghui Zhou, Diane R. Mould
March 2019
Intermediate to advanced content levelIntermediate to advanced
496 pages
15h
English
Wiley
Content preview from Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

17Case Examples of Using Quantitative Pharmacology in Developing Therapeutic Proteins in Systemic Lupus Erythematosus – Belimumab

Herbert Struemper

Clinical Pharmacology Modeling & Simulation (CPMS), GSK, 5 Moore Drive, Research Triangle Park, NC, 27709, USA

17.1 Introduction

B‐lymphocyte stimulator (BLyS), also known as B‐cell activating factor, is a cytokine that promotes B‐cell selection, survival, maturation, and differentiation [1]. Elevated levels of BLyS have been observed in patients with systemic lupus erythematosus (SLE) [2] a systemic autoimmune disease that is characterized by autoantibody production, and in other autoimmune diseases. Belimumab is a recombinant, human IgG1λ monoclonal antibody (mAb) that targets and neutralizes soluble BLyS, and thereby inhibits B‐cell survival and differentiation without directly causing B‐cell death [ 1 ,3].

Pharmacometrics played a key role in the clinical development and subsequent approvals of the Benlysta intravenous (IV) and subcutaneous (SC) formulations in SLE. At the core of these modeling and simulation efforts were two population pharmacokinetic (popPK) analyses that combined serially sampled early phase studies with pivotal Phase 3 studies for the IV [4,5] and SC [6] formulations. These popPK analyses, an exposure–response analysis for the SC formulation [6] , and subsequent simulations supported protocol development, bridging from weight‐based IV dosing to fixed dose SC administration, pediatric development, a customized ...

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Publisher Resources

ISBN: 9781119289197Purchase book