PMID- 22004765
OWN - NLM
STAT- MEDLINE
DCOM- 20120320
LR  - 20220408
IS  - 1522-9653 (Electronic)
IS  - 1063-4584 (Linking)
VI  - 19
IP  - 12
DP  - 2011 Dec
TI  - Preliminary assessment of the safety and efficacy of tanezumab in Japanese 
      patients with moderate to severe osteoarthritis of the knee: a randomized, 
      double-blind, dose-escalation, placebo-controlled study.
PG  - 1405-12
LID - 10.1016/j.joca.2011.09.006 [doi]
AB  - OBJECTIVE: To investigate the use of tanezumab, a humanized monoclonal antibody 
      that inhibits nerve growth factor, for the treatment of moderate to severe 
      osteoarthritis in Japanese patients. DESIGN: Patients received tanezumab 10, 25, 
      50, 100, 200 mug/kg, or placebo and were followed for 92 or 120 days. Endpoints 
      included the incidence of adverse events (AEs) and the change from baseline to 
      week 8 in pain intensity and the Western Ontario and McMaster Universities 
      Osteoarthritis (WOMAC) subscales. RESULTS: Patients (n = 83) were 69% female, age 
      44-73 years, with a Kellgren-Lawrence X-ray grade of 2-4. At week 8, compared 
      with placebo, tanezumab 25, 100, and 200 mug/kg improved index knee pain during 
      walking (-18.5, -14.3, and -27.6, respectively), index knee pain in the past 24 h 
      (-19.1, -14.6, and -24.2, respectively), current index knee pain (-16.5, -10.9, 
      and -22.8, respectively), and the WOMAC pain (-11.5, -9.6, and -18.8, 
      respectively), physical function (-8.7, -9.5, and -17.6, respectively), and 
      stiffness (-20.4, -11.2, and -10.2, respectively) subscales. Overall, seven 
      patients reported AEs of abnormal peripheral sensation: allodynia (two in the 
      tanezumab 200 mug/kg group); paresthesia (two in the tanezumab 200 mug/kg group), 
      dysesthesia (one in the tanezumab 200 mug/kg group); thermohypoesthesia (one in 
      the tanezumab 100 mug/kg group), and decreased vibratory sense (one in the placebo 
      group). All of these AEs were mild to moderate in severity and transient in 
      nature. CONCLUSIONS: Tanezumab was safe and generally well tolerated and may 
      improve pain symptoms in Japanese patients with moderate to severe osteoarthritis 
      of the knee. CLINICALTRIALS.GOV IDENTIFIER: NCT00669409.
CI  - Copyright (c) 2011 Osteoarthritis Research Society International. Published by 
      Elsevier Ltd. All rights reserved.
FAU - Nagashima, H
AU  - Nagashima H
AD  - Yanagibashi-Clinical Trial Center, Yanagibashi Hospital, Life Extension Research 
      Institute Foundation, Tokyo, Japan.
FAU - Suzuki, M
AU  - Suzuki M
FAU - Araki, S
AU  - Araki S
FAU - Yamabe, T
AU  - Yamabe T
FAU - Muto, C
AU  - Muto C
CN  - Tanezumab Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00669409
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20111005
PL  - England
TA  - Osteoarthritis Cartilage
JT  - Osteoarthritis and cartilage
JID - 9305697
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Placebos)
RN  - 0 (Receptor, Nerve Growth Factor)
RN  - EQL0E9GCX1 (tanezumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse 
      effects/blood/*therapeutic use
MH  - Antirheumatic Agents/administration & dosage/*adverse effects/blood/*therapeutic 
      use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Knee/blood/diagnostic imaging/*drug therapy
MH  - Pain Measurement/methods
MH  - Placebos
MH  - Radiography
MH  - Receptor, Nerve Growth Factor/antagonists & inhibitors
MH  - Treatment Outcome
FIR - Nagashima, Hirotaka
IR  - Nagashima H
FIR - Kaneda, Hideaki
IR  - Kaneda H
FIR - Yamakami, Shigeo
IR  - Yamakami S
FIR - Yokoyama, Takashi
IR  - Yokoyama T
FIR - Saitoh, Keiji
IR  - Saitoh K
FIR - Shimode, Masanori
IR  - Shimode M
FIR - Okazaki, Hiroshi
IR  - Okazaki H
FIR - Arai, Atsushi
IR  - Arai A
FIR - Hosono, Osamu
IR  - Hosono O
FIR - Nakamura, Eisuke
IR  - Nakamura E
FIR - Katsuragawa, Yozo
IR  - Katsuragawa Y
FIR - Hara, Michiya
IR  - Hara M
FIR - Hatsumi, Toshiaki
IR  - Hatsumi T
FIR - Masuzawa, Michinaga
IR  - Masuzawa M
EDAT- 2011/10/19 06:00
MHDA- 2012/03/21 06:00
CRDT- 2011/10/19 06:00
PHST- 2011/04/08 00:00 [received]
PHST- 2011/09/07 00:00 [revised]
PHST- 2011/09/21 00:00 [accepted]
PHST- 2011/10/19 06:00 [entrez]
PHST- 2011/10/19 06:00 [pubmed]
PHST- 2012/03/21 06:00 [medline]
AID - S1063-4584(11)00282-2 [pii]
AID - 10.1016/j.joca.2011.09.006 [doi]
PST - ppublish
SO  - Osteoarthritis Cartilage. 2011 Dec;19(12):1405-12. doi: 
      10.1016/j.joca.2011.09.006. Epub 2011 Oct 5.