25073573
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 .
METHODS	Neurological safety was evaluated via a composite score ( nerve conduction attributes and heart rate variability with deep breathing ; 5NC + HRdb ) , intraepidermal nerve fiber ( IENF ) density , and clinical assessments .
METHODS	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 ) .
RESULTS	Differences in change from baseline to Week 24 in 5NC + HRdb were not significant .
RESULTS	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 .
RESULTS	No significant differences were found in individual nerve conduction measures .
RESULTS	No treatment exceeded the prespecified clinically important decrease in IENF .
RESULTS	Tanezumab resulted in significant improvement in pain , physical function , and Patient 's Global Assessment .
RESULTS	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 .

