| Title: |
PK/PD modeling to characterize placebo and treatment effect of omalizumab for chronic spontaneous urticaria |
| Authors: |
Elise Oh, Russ Wada, Kha Le, Yanan Zheng, Jin Jin, Victor Poon, Kit Wong, Ryan Owen, Kenta Yoshida |
| Source: |
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 6, Pp 795-807 (2023) |
| Publisher Information: |
Wiley, 2023. |
| Publication Year: |
2023 |
| Collection: |
LCC:Therapeutics. Pharmacology |
| Subject Terms: |
Therapeutics. Pharmacology, RM1-950 |
| More Details: |
Abstract The pharmacokinetic (PK) characteristics of omalizumab and its pharmacodynamic (PD) effect in patients has yet to be fully characterized in chronic spontaneous urticaria, which could elucidate its pathogenesis and treatment response. This study has two objectives; (1) characterize the population PK of omalizumab and its PD effect on IgE, and (2) develop a drug effect model of omalizumab in urticaria (via change in weekly itch severity score). The target‐mediated population of PK/PD model incorporating omalizumab‐IgE binding and turnover adequately described PK and PD of omalizumab. The effect compartment model and linear drug effect and additive placebo response adequately described placebo and treatment effects of omalizumab. Several baseline covariates were identified for PK/PD and drug effect models. The developed model has the potential to aid in understanding variability in PK/PD as well as response to omalizumab treatment. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2163-8306 |
| Relation: |
https://doaj.org/toc/2163-8306 |
| DOI: |
10.1002/psp4.12953 |
| Access URL: |
https://doaj.org/article/a67e26c5a2c441d681efc08a0ea0d46f |
| Accession Number: |
edsdoj.67e26c5a2c441d681efc08a0ea0d46f |
| Database: |
Directory of Open Access Journals |
