Exploring the Role of Tanezumab as a Novel Treatment for the Relief of Neuropathic Pain. Issue 6 (16th January 2015)

• Record Type: Journal Article
• Authors: Bramson, Candace; Herrmann, David N.; Carey, William; Keller, David; Brown, Mark T.; West, Christine R.; Verburg, Kenneth M.; Dyck, Peter J.
• Is Part Of: Pain medicine. Volume 16:Issue 6(2015)
• Page Start: 1163
• Page End: 1176
• Publication Date: 2015-01-16
• Subjects: Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesics -- Periodicals; Pain -- Periodicals; Pain Management -- Periodicals; Douleur -- Périodiques; Douleur -- Traitement -- Périodiques; Analgésiques -- Périodiques; Analgésique; Soulagement de la douleur; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.047205
• DOI: 10.1111/pme.12677
• Languages: English
• ISSNs: 1526-2375

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="pme12677-sec-0001" sec-type="section"> <title>Objective</title> <p>Evaluate efficacy and safety of tanezumab, a humanized monoclonal antibody against nerve growth factor, in neuropathic pain.</p> </sec> <sec id="pme12677-sec-0002" sec-type="section"> <title>Design</title> <p>Two randomized controlled trials.</p> </sec> <sec id="pme12677-sec-0003" sec-type="section"> <title>Subjects</title> <p>Patients with pain due to diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN).</p> </sec> <sec id="pme12677-sec-0004" sec-type="section"> <title>Methods</title> <p>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 <italic>post hoc</italic> 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.</p> </sec> <sec id="pme12677-sec-0005" sec-type="section"> <title>Results</title> <p>Mean DPN pain reduction from baseline to Week 8 was greater with tanezumab vs placebo (<italic>P</italic> = 0.009); differences in Patient's Global Assessment of DPN were not significant (<italic>P</italic> > 0.05). Neither tanezumab dose resulted in significant differences vs placebo in efficacy in PHN (<italic>P</italic> > 0.05), although tanezumab 200 μg/kg provided some benefit. Neuropathy assessments showed no meaningful changes.</p> </sec> <sec id="pme12677-sec-0006" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>