PMID- 29386912
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220316
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 11
DP  - 2018
TI  - Safety and efficacy of subcutaneous tanezumab in patients with knee or hip 
      osteoarthritis.
PG  - 151-164
LID - 10.2147/JPR.S135257 [doi]
AB  - BACKGROUND/OBJECTIVE: The objective of this study was to investigate the safety 
      and efficacy of subcutaneous (SC) and intravenous (IV) tanezumab administration 
      in osteoarthritis (OA) patients. MATERIALS AND METHODS: Study 1027 (NCT01089725), 
      a placebo-controlled trial, evaluated the efficacy of SC tanezumab (ie, 2.5, 5, 
      and 10 mg) and the therapeutic equivalence of 10 mg tanezumab given 
      subcutaneously versus intravenously every 8 weeks in the symptomatic treatment of 
      OA. Coprimary endpoints were: change from baseline in Western Ontario and 
      McMaster Universities Osteoarthritis index (WOMAC) Pain and Physical Function 
      indices, and Patient's Global Assessment (PGA) of OA. Study 1043 (NCT00994890) 
      was a long-term, noncontrolled safety study of tanezumab (ie, 2.5, 5, and 10 mg) 
      subcutaneously administered every 8 weeks. Both studies were discontinued 
      prematurely due to a US Food and Drug Administration partial clinical hold. 
      RESULTS: Due to the clinical hold, Study 1027 was underpowered, and no 
      statistical analyses were performed. Mean (standard error [SE]) change from 
      baseline to week 8 in WOMAC Pain in tanezumab groups ranged from -3.59 (0.26) to 
      -3.89 (0.32), versus -2.74 (0.25) with placebo. Mean (SE) change from baseline to 
      week 8 in WOMAC Physical Function ranged from -3.13 (0.25) to -3.51 (0.28) with 
      tanezumab and was -2.26 (0.24) with placebo. PGA mean (SE) change from baseline 
      to week 8 ranged from -0.90 (0.11) to -1.08 (0.12) with tanezumab and was -0.78 
      (0.10) with placebo. Similar effectiveness was associated with tanezumab in Study 
      1043. Few patients in either study (1.4%-5.2%) discontinued due to adverse 
      events. Five patients required total joint replacements in Study 1027 (placebo, 
      n=2 [2.8%]; tanezumab 2.5 mg, n=3 [4.1%]) and 34 patients in Study 1043 
      (tanezumab 2.5 mg, n=11 [4.8%]; tanezumab 5 mg, n=8 [3.6%]; tanezumab 10 mg, n=15 
      [6.6%]). CONCLUSION: Preliminary results show similar efficacy and safety for 
      both SC and IV administration of tanezumab based on the direct comparisons 
      reported here and indirect comparisons with published results, confirming 
      pharmacokinetic/pharmacodynamic modeling predictions.
FAU - Birbara, Charles
AU  - Birbara C
AD  - Department of Medicine, University of Massachusetts School of Medicine, 
      Worcester, MA.
FAU - Dabezies, Eugene J Jr
AU  - Dabezies EJ Jr
AD  - Pensacola Research Consultants, Pensacola, FL.
FAU - Burr, Aimee M
AU  - Burr AM
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
FAU - Fountaine, Robert J
AU  - Fountaine RJ
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
FAU - Smith, Michael D
AU  - Smith MD
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
FAU - Brown, Mark T
AU  - Brown MT
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
FAU - West, Christine R
AU  - West CR
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
FAU - Arends, Rosalin H
AU  - Arends RH
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
FAU - Verburg, Kenneth M
AU  - Verburg KM
AD  - Clinical Development and Operations Business Unit, Pfizer Inc., Groton, CT, USA.
LA  - eng
PT  - Journal Article
DEP - 20180108
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC5764290
OTO - NOTNLM
OT  - efficacy
OT  - osteoarthritis
OT  - safety
OT  - subcutaneous
OT  - tanezumab
COIS- Disclosure Charles Birbara has received no financial support of any kind from any 
      pharmaceutical company except for work involved in conducting a clinical trial, 
      and is a member of a speakers' bureau for Forest Laboratories Inc., 
      GlaxoSmithKline, and Roche. Robert J Fountaine, Mark T Brown, Christine R West, 
      Rosalin H Arends, Aimee M Burr, and Kenneth M Verburg are employees of and hold 
      stock or stock options in Pfizer Inc. Michael D Smith was an employee of Pfizer 
      Inc. at the time of these studies and holds stock or stock options in Pfizer Inc. 
      His current affiliation is Astellas Inc. Eugene J Dabezies JR reports no 
      conflicts of interest in this work.
EDAT- 2018/02/02 06:00
MHDA- 2018/02/02 06:01
PMCR- 2018/01/08
CRDT- 2018/02/02 06:00
PHST- 2018/02/02 06:00 [entrez]
PHST- 2018/02/02 06:00 [pubmed]
PHST- 2018/02/02 06:01 [medline]
PHST- 2018/01/08 00:00 [pmc-release]
AID - jpr-11-151 [pii]
AID - 10.2147/JPR.S135257 [doi]
PST - epublish
SO  - J Pain Res. 2018 Jan 8;11:151-164. doi: 10.2147/JPR.S135257. eCollection 2018.