title: Efficacy and safety of tanezumab in the treatment of chronic low back pain.
abstract: Increased nerve growth factor levels are associated with chronic pain conditions, including chronic low back pain (LBP). This study examined safety and analgesic efficacy of tanezumab, a humanized anti-nerve growth factor antibody, in adults with chronic LBP. Patients received intravenous tanezumab 200 μg/kg plus oral placebo (n=88), intravenous placebo plus oral naproxen 500 mg twice a day (n=88), or intravenous placebo plus oral placebo (n=41). Primary outcome was average LBP intensity (aLBPI) at Week 6. Secondary outcomes were proportion of patients with ≥30% or ≥50% reduction in aLBPI, Roland-Morris Disability Questionnaire and Brief Pain Inventory-short form scores, Patients' Global Assessment of LBP, Patients' Global Evaluation of study medication, and rescue medication use. Mean aLBPI change from baseline to Week 6 was greater with tanezumab vs naproxen (P=0.004) and placebo (P<0.001). Greater proportions of patients reported ≥30% and ≥50% reduction in aLBPI with tanezumab vs naproxen (P≤0.013) and placebo (P<0.001), and greater improvements in Roland-Morris Disability Questionnaire (P<0.001) and other secondary outcomes except rescue medication use. Tanezumab was associated with adverse events (AEs) of abnormal peripheral sensation that were generally mild and resolved before study completion; however, there were no serious AEs. Nine patients (4 of whom were tanezumab-treated) discontinued due to AEs. In conclusion, tanezumab resulted in analgesic efficacy that was clinically and statistically superior to placebo and naproxen in patients with chronic LBP. Tanezumab clinical development is on regulatory hold due to AEs in osteoarthritis patients.
authors.affiliation: Analgesic Solutions, Needham, MA, USA Department of Anesthesiology, Tufts University School of Medicine, Boston, MA, USA Department of Medicine, The George Washington University Medical Center, Washington, DC, USA University of Massachusetts School of Medicine, Worcester, MA, USA Pfizer Inc, New London, CT, USA.
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Katz
authors.forename: David G
authors.initials: DG
authors.lastname: Borenstein
authors.forename: Charles
authors.initials: C
authors.lastname: Birbara
authors.forename: Candace
authors.initials: C
authors.lastname: Bramson
authors.forename: Mary Anne
authors.initials: MA
authors.lastname: Nemeth
authors.forename: Mike D
authors.initials: MD
authors.lastname: Smith
authors.forename: Mark T
authors.initials: MT
authors.lastname: Brown
mesh_terms: D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects*; D059350:Chronic Pain / Q000188:drug therapy* / Q000503:physiopathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D017116:Low Back Pain / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020932:Nerve Growth Factor / Q000037:antagonists & inhibitors
chemical_list: D018712:Analgesics, Non-Narcotic; D061067:Antibodies, Monoclonal, Humanized; D020932:Nerve Growth Factor; C549319:tanezumab