Nerve safety of tanezumab, a nerve growth factor inhibitor for pain treatment

Mark T. Brown, David N. Herrmann, Mark Goldstein, Aimee M. Burr, Michael D. Smith, Christine R. West, Kenneth M. Verburg, Peter J. Dyck

Research output: Contribution to journalArticle

20 Scopus citations

Abstract

Objective: To evaluate peripheral nerve safety and clinical efficacy of tanezumab in patients with painful osteoarthritis. Methods: Patients received intravenous tanezumab 5 mg, tanezumab 10 mg, 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; Ó5NC + 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 Ó5NC + HRdb were not significant. Tanezumab 5 mg vs placebo exceeded the prespecified clinically important difference using last observation carried forward imputation, but notwith observed data orwhen patientswith evidence of neuropathy at baselinewere 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 amodulating effect on pain, does not appear to increase neurological safety signals, and offers a potentially promising, novel approach in treatment of pain.

Original languageEnglish (US)
Pages (from-to)139-147
Number of pages9
JournalJournal of the neurological sciences
Volume345
Issue number1
DOIs
StatePublished - Oct 15 2014

Keywords

  • Intraepidermal nerve fiber density
  • Nerve growth factor
  • Neurological safety
  • Osteoarthritis
  • Pain
  • [limit 6] Tanezumab

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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  • Cite this

    Brown, M. T., Herrmann, D. N., Goldstein, M., Burr, A. M., Smith, M. D., West, C. R., Verburg, K. M., & Dyck, P. J. (2014). Nerve safety of tanezumab, a nerve growth factor inhibitor for pain treatment. Journal of the neurological sciences, 345(1), 139-147. https://doi.org/10.1016/j.jns.2014.07.028