Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain

Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.

Abstract

Objective: Evaluate efficacy and safety of tanezumab, a humanized monoclonal antibody against nerve growth factor, in neuropathic pain.

Design: Two randomized controlled trials.

Subjects: Patients with pain due to diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN).

Methods: In the DPN study, patients received subcutaneous tanezumab 20 mg or placebo on Day 1 and Week 8. Evaluations included change from baseline in average DPN pain (primary endpoint), Patient's Global Assessment of DPN, and safety (including neuropathy assessments). Due to a partial clinical hold limiting enrollment and treatment duration, the prespecified landmark analysis was modified post hoc from Week 16 to Week 8. In the PHN study, patients received intravenous tanezumab 50 μg/kg, tanezumab 200 μg/kg, or placebo on Day 1. Evaluations included change from baseline in average daily pain (primary endpoint), Brief Pain Inventory-short form, Patient's Global Assessment of pain from PHN, and safety.

Results: Mean DPN pain reduction from baseline to Week 8 was greater with tanezumab vs placebo (P = 0.009); differences in Patient's Global Assessment of DPN were not significant (P > 0.05). Neither tanezumab dose resulted in significant differences vs placebo in efficacy in PHN (P > 0.05), although tanezumab 200 μg/kg provided some benefit. Neuropathy assessments showed no meaningful changes.

Conclusions: Tanezumab provided effective pain reduction in DPN. In PHN, only the highest tanezumab dose reduced pain; treatment differences were not significant. No new safety concerns were observed despite preexisting neuropathy.

Trial registration: ClinicalTrials.gov NCT01087203 NCT00568321.

Keywords: Diabetic Peripheral Neuropathy; Nerve Growth Factor; Neuropathic Pain; Postherpetic Neuralgia; Tanezumab.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / pharmacology
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Dizziness / chemically induced
  • Double-Blind Method
  • Headache / chemically induced
  • Humans
  • Neuralgia / diagnosis*
  • Neuralgia / drug therapy*
  • Neuralgia / epidemiology
  • Pain Measurement / drug effects*
  • Pain Measurement / methods
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • tanezumab

Associated data

  • ClinicalTrials.gov/NCT01087203
  • ClinicalTrials.gov/NCT00568321