Population Pharmacokinetics and Exposure‐Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus

Autor: Chayan, Acharya, Mats O, Magnusson, Pavan, Vajjah, Ruth, Oliver, Miren, Zamacona
Rok vydání: 2023
Předmět:
Zdroj: The Journal of Clinical Pharmacology. 63:435-444
ISSN: 1552-4604
0091-2700
Popis: Systemic lupus erythematosus (SLE) is a systemic, autoimmune disease characterized by chronic inflammation and organ damage. Dapirolizumab pegol inhibits CD40 ligand (CD40L) and is currently undergoing phase 3 trials for the treatment of SLE. To describe the pharmacokinetic characteristics of dapirolizumab pegol and the relationship between exposure and probability of achieving a British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response, a population pharmacokinetic (popPK) model and an exposure-response model were developed, based on results of the phase 2b trial (RISE; NCT02804763) of dapirolizumab pegol in SLE. Dapirolizumab pegol pharmacokinetics were found to be dose-proportional and well described by a two-compartment model with first order elimination from the central compartment. In the popPK model, body weight was the only significant covariate. The average concentration of dapirolizumab pegol (C
Databáze: OpenAIRE
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