Papers of the Week

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).