Inter-regional pharmacokinetics and exposure-response analyses of belimumab in patients with system lupus erythematosus.

ABSTRACT:

Aims

The pharmacokinetics (PK) of belimumab, a human immunoglobulin G1λ (IgG1λ) monoclonal antibody treatment for systemic lupus erythematosus (SLE), have been well reported. Clinical PK data in healthy participants and patients with SLE from Mainland China suggest lower-than-expected belimumab exposure. This study assessed inter-regional differences in belimumab exposure and efficacy via the exposure-response relationship to inform any dose-adjustment requirements.

Methods

Data from nine interventional belimumab studies in healthy participants and patients with SLE were used to update two-compartment PK models with first-order subcutaneous (SC) absorption, and a logistic regression model characterizing the 52-week SLE Responder Index (SRI) response in adult and paediatric p

SUBMITTER: Wu J 

PROVIDER: S-EPMC11773103 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature