Population Pharmacokinetics and Exposure-Response Relationship of Intravenous and Subcutaneous Abatacept in Patients With Rheumatoid Arthritis.

ABSTRACT: Abatacept population pharmacokinetics (PK) and exposure-response (E-R) models for selective efficacy end points were developed using phase 2 and 3 study data in patients with rheumatoid arthritis treated with abatacept (intravenous [IV] or subcutaneous [SC]), followed by simulations. Two efficacy end points were assessed in the E-R analyses: Disease Activity Score in 28 joints (DAS28) and American College of Rheumatology response criteria for 20/50/70% improvement (ACR20/50/70). The analyses were performed with data from 11 clinical studies for the population PK analysis and from 3 clinical studies for the E-R analyses (DAS28 and ACR20/50/70). The PK of abatacept were time invariant and can be described by a linear 2-compartment model with first-order elimination and with zero-order IV inf

SUBMITTER: Li X 

PROVIDER: S-EPMC6585965 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature