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Population Pharmacokinetics of Fasinumab in Healthy Volunteers and Patients With Pain Due to Osteoarthritis of the Knee or Hip

Kuan-Ju Lin,Kenneth C. Turner,Hazem E Hassan,Lutz O. Harnisch,John D. Davis,A. T. Dicioccio

Published 2024 in Clinical pharmacology in drug development

ABSTRACT

Osteoarthritis (OA) pain management options are currently limited. Fasinumab, an anti‐nerve growth factor monoclonal antibody, has been investigated in healthy volunteers and patients with OA‐related pain, among other conditions. Data from 12 Phase I‐III clinical trials of 92 healthy volunteers and 7430 patients with OA were used to develop a population pharmacokinetic model to characterize fasinumab concentration‐time profiles and assess the covariates’ effect on fasinumab pharmacokinetic parameters. Participants received single or repeated fasinumab doses intravenously (IV)/subcutaneously (SC), based on body weight (0.03‐1 mg/kg IV or 0.1‐0.3 mg/kg SC)/fixed dose (9‐12 mg IV or 1‐12 mg SC). Fasinumab concentration‐time data following IV and SC administration in healthy volunteers and patients with OA‐related pain were adequately described by a 2‐compartment model. Bioavailability increased with higher doses; estimated at 55.1% with 1 mg SC dose, increasing in a greater‐than‐proportional manner above this. Body weight had the largest predicted impact on fasinumab steady‐state exposures, participants at the 5th and 95th percentiles had a 43%‐45% higher/22%‐23% lower exposure versus reference, respectively. Other covariates had small but clinically irrelevant impacts.

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