PMID- 21696889
OWN - NLM
STAT- MEDLINE
DCOM- 20120625
LR  - 20220409
IS  - 1872-6623 (Electronic)
IS  - 0304-3959 (Linking)
VI  - 152
IP  - 10
DP  - 2011 Oct
TI  - Efficacy and safety of tanezumab in the treatment of chronic low back pain.
PG  - 2248-2258
LID - 10.1016/j.pain.2011.05.003 [doi]
AB  - 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 mug/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.
CI  - Copyright (c) 2011. Published by Elsevier B.V.
FAU - Katz, Nathaniel
AU  - Katz N
AD  - 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.
FAU - Borenstein, David G
AU  - Borenstein DG
FAU - Birbara, Charles
AU  - Birbara C
FAU - Bramson, Candace
AU  - Bramson C
FAU - Nemeth, Mary Anne
AU  - Nemeth MA
FAU - Smith, Mike D
AU  - Smith MD
FAU - Brown, Mark T
AU  - Brown MT
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110621
PL  - United States
TA  - Pain
JT  - Pain
JID - 7508686
RN  - 0 (Analgesics, Non-Narcotic)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 9061-61-4 (Nerve Growth Factor)
RN  - EQL0E9GCX1 (tanezumab)
SB  - IM
CIN - Pain. 2011 Oct;152(10):2200-1. PMID: 21719197
CIN - Pain. 2012 May;153(5):1128-9; author reply 1129-31. PMID: 22445793
MH  - Adult
MH  - Aged
MH  - Analgesics, Non-Narcotic/*administration & dosage/*adverse effects
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/*adverse effects
MH  - Chronic Pain/*drug therapy/physiopathology
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Injections, Intravenous
MH  - Low Back Pain/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Nerve Growth Factor/antagonists & inhibitors
EDAT- 2011/06/24 06:00
MHDA- 2012/06/26 06:00
CRDT- 2011/06/24 06:00
PHST- 2010/11/12 00:00 [received]
PHST- 2011/04/27 00:00 [revised]
PHST- 2011/05/04 00:00 [accepted]
PHST- 2011/06/24 06:00 [entrez]
PHST- 2011/06/24 06:00 [pubmed]
PHST- 2012/06/26 06:00 [medline]
AID - 00006396-201110000-00014 [pii]
AID - 10.1016/j.pain.2011.05.003 [doi]
PST - ppublish
SO  - Pain. 2011 Oct;152(10):2248-2258. doi: 10.1016/j.pain.2011.05.003. Epub 2011 Jun 
      21.