Low-dose methotrexate adverse reaction risk in renal impairment: pharmacovigilance and physiological pharmacokinetic model assessment.

ABSTRACT:

Objective

Low-dose methotrexate (LD-MTX), a treatment regimen involving weekly doses ≤20 mg, is widely used in rheumatoid arthritis. Methotrexate (MTX) is primarily excreted via the kidneys. However, the assessment protocol for the adverse reaction risk threshold of the LD-MTX dosing regimen in renal impairment remains inadequate. This study aims to use pharmacovigilance analysis and physiologically-based pharmacokinetic (PBPK) model to combine the analysis of the risk of adverse reactions of LD-MTX in patients with renal impairment.

Methods

Collected and analyzed disproportionate signals from adverse reaction reports on MTX in patients with renal impairment from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024. The restricted cubic spline (RCS) model e

SUBMITTER: Zhang L 

PROVIDER: S-EPMC12631143 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature