I am a
Home I AM A Search Login

Papers of the Week

Papers: 29 Jan 2022 - 4 Feb 2022

Pharmacology/Drug Development

2022 Feb 02

Br J Clin Pharmacol

Population Pharmacokinetics of Tanezumab Following Intravenous or Subcutaneous Administration to Patients with Osteoarthritis or Chronic Low Back Pain.


Describe population pharmacokinetics of intravenous (IV) and subcutaneous (SC) tanezumab across Phase 2b/3 studies of osteoarthritis (OA) and chronic low back pain (CLBP). Methods Data from 10 studies of IV or SC tanezumab (2.5-20 mg every 8 weeks for up to 56 weeks) were included in a multi-step analysis. In Step 1, a two-compartment model with linear and non-linear elimination (based on prior analysis of pre-2015 IV osteoarthritis studies) was expanded to include other pre-2015 studies. In Step 2, post-2015 SC studies were combined into the model. Steps 3 and 4 evaluated impact of baseline nerve growth factor (NGF) and treatment-emergent anti-drug antibodies (TE ADA).