OBJECTIVE: To evaluate peripheral nerve safety and clinical efficacy of 
tanezumab in patients with painful osteoarthritis.
METHODS: Patients received intravenous tanezumab 5mg, tanezumab 10mg, or placebo 
every 8 weeks for 24 weeks. Neurological safety was evaluated via a composite 
score (nerve conduction attributes and heart rate variability with deep 
breathing; Σ5NC + HRdb), intraepidermal nerve fiber (IENF) density, and clinical 
assessments. Efficacy and general safety were also evaluated.
RESULTS: The study was stopped prematurely by an FDA partial clinical hold 
(joint safety issues in other studies). Differences in change from baseline to 
Week 24 in Σ5NC + HRdb were not significant. Tanezumab 5mg vs placebo exceeded 
the prespecified clinically important difference using last observation carried 
forward imputation, but not with observed data or when patients with evidence of 
neuropathy at baseline were excluded. No significant differences were found in 
individual nerve conduction measures. No treatment exceeded the prespecified 
clinically important decrease in IENF. Tanezumab resulted in significant 
improvement in pain, physical function, and Patient's Global Assessment. Safety 
was similar to previous tanezumab clinical trials.
CONCLUSIONS: Tanezumab has a modulating effect on pain, does not appear to 
increase neurological safety signals, and offers a potentially promising, novel 
approach in treatment of pain.