The pharmacokinetics and its covariates of rituximab in different clinical populations: a systematic review and narrative synthesis.

Authors

Bo Zhenyan, Liang Huang, Jiayi Lu, Zhe Chen, Zhimei Jiang, Linan Zeng, Yuhong Tao, Lingli Zhang

Published in

European journal of clinical pharmacology. Volume 82. Issue 8. Jul 10, 2026. Epub Jul 10, 2026.

Abstract

The regimen of rituximab we not determined based on evidence from pharmacokinetics. However, rituximab exhibited significant pharmacokinetic variability among different clinical populations, which might be a key factor influencing individual exposure and response to this monoclonal antibody. This systematic review aimed to analyze the traditional and population pharmacokinetics of rituximab and to investigate covariates influencing its pharmacokinetics.
A systematic search was conducted in three English databases (Medline, Embase, Cochrane Central Register of Controlled Trials) and two Chinese database (China National Knowledge Infrastructure and Wanfang Data). Traditional and population pharmacokinetics of rituximab conducted in humans were included. Study designs, population characteristics, pharmacokinetic parameters, and covariates were extracted. The ClinPK's checklist was used to assess the reporting quality of the included studies. The PROSPERO registered ID was CRD420251085784.
The systematic research yield 25 traditional pharmacokinetics studies and 26 population pharmacokinetics studies. The included studies mainly investigated the pharmacokinetics of rituximab in patients with non-Hodgkin's lymphoma, rheumatoid arthritis, kidney disease and anti-neutrophil cytoplasmic antibody-associated vasculitis. Significant variability in pharmacokinetic parameters existed among different clinical populations as well as among different subjects encountering similar clinical conditions. Most (23, 88.5%) population pharmacokinetics studies used a two-compartment model to describe rituximab pharmacokinetics. However, the elimination kinetics were inconsistent including the first-order elimination, time-varying elimination and target-mediated drug disposition. Body size descriptors such as body surface area, body mass index and body weight were the most frequently observed significant covariates, which appeared in 17 studies. Other significant covariates included gender, basal CD19⁺/20⁺ count, tumor stage, baseline total metabolic tumor volume, anti-drug antibodies, disease progression, urinary protein to creatinine ratios and the number of rituximab treatment courses. In addition, the pharmacokinetic parameters of rituximab biosimilars were proved to be non-inferior to that of the originators. Compared with intravenous administration, subcutaneous administration with a specific dose of 1600 mg or 1400 mg could achieve non-inferior C_trough in chronic lymphocytic leukemia and diffuse large B-cell lymphoma respectively.
This systematic review presented a comprehensive overview of rituximab's pharmacokinetics across various clinical populations. It highlighted the complexity and variability of rituximab's pharmacokinetics. Future research should place emphasis on the model informed precision dosing of rituximab based on pharmacokinetics and various influencing factors in clinical practice.

PMID:
42426484
Bibliographic data and abstract were imported from PubMed on 10 Jul 2026.

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