PMID- 35217440
OWN - NLM
STAT- MEDLINE
DCOM- 20220413
LR  - 20220413
IS  - 1878-5883 (Electronic)
IS  - 0022-510X (Linking)
VI  - 434
DP  - 2022 Mar 15
TI  - Neurological safety of subcutaneous tanezumab versus NSAID in patients with 
      osteoarthritis.
PG  - 120184
LID - S0022-510X(22)00046-6 [pii]
LID - 10.1016/j.jns.2022.120184 [doi]
AB  - OBJECTIVE: To assess the long-term neurological safety of tanezumab, a monoclonal 
      antibody against nerve growth factor. METHODS: Patients with osteoarthritis of 
      the hip or knee received stable doses of oral nonsteroidal anti-inflammatory 
      drugs (NSAIDs) before study entry and during a </= 37-day screening period. 
      Patients were randomized 1:1:1 to double-dummy tanezumab (2.5 mg or 5 mg, 
      subcutaneous every 8 weeks) or oral NSAIDs (twice-daily) for 56 weeks, with a 
      24-week follow-up. Neurological safety evaluation focused on peripheral and 
      sympathetic adverse events (AEs), neurologic examinations, and consultations with 
      blinded, external diagnostic reviews. RESULTS: During the treatment period, 6.2%, 
      9.0%, and 4.6% of patients experienced AEs of abnormal peripheral sensation (APS) 
      in the tanezumab 2.5 mg, 5 mg, and NSAID groups, respectively. Hypoesthesia, 
      paresthesia, and carpal tunnel syndrome were the most common AEs of APS. 
      Clinically significant worsening on examination occurred in <1% in any treatment 
      group at the last study assessment. Diagnoses following external neurological 
      consultation included mononeuropathy (1.3%, 2.1%, and 1.0%), radiculopathy (0.9%, 
      0.4%, and 0.5%), and polyneuropathy (0.3%, 0.5%, and 0%) in tanezumab 2.5 mg, 
      5 mg, and NSAID groups, respectively. AEs potentially associated with sympathetic 
      neuropathy were reported for 1.8%, 2.3%, and 2.9% of patients in the tanezumab 
      2.5 mg, 5 mg, and NSAID groups, respectively. No patient was diagnosed with 
      sympathetic neuropathy. CONCLUSION: Tanezumab had an increased incidence of AEs 
      of APS versus NSAID; these were typically mild/moderate in severity, resolved 
      during the study, and rarely resulted in discontinuation. Tanezumab was not 
      associated with peripheral neuropathy and did not adversely affect the 
      sympathetic nervous system. TRIAL REGISTRATION: ClinicalTrials.gov Identifier 
      NCT02528188 (https://clinicaltrials.gov/ct2/show/NCT02528188).
CI  - Copyright (c) 2022 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Brown, Mark T
AU  - Brown MT
AD  - Pfizer Inc., Groton, CT, United States. Electronic address: 
      marktbrown3@gmail.com.
FAU - Sandroni, Paola
AU  - Sandroni P
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Low, Phillip A
AU  - Low PA
AD  - Mayo Clinic, Rochester, MN, United States.
FAU - Gorson, Kenneth C
AU  - Gorson KC
AD  - St. Elizabeth's Medical Center, Boston, MA, United States.
FAU - Hunter, David J
AU  - Hunter DJ
AD  - The University of Sydney, Sydney, Australia.
FAU - Pixton, Glenn C
AU  - Pixton GC
AD  - Pfizer Inc., Morrisville, NC, United States.
FAU - Fountaine, Robert J
AU  - Fountaine RJ
AD  - Pfizer Inc., Groton, CT, United States.
FAU - Viktrup, Lars
AU  - Viktrup L
AD  - Eli Lilly and Company, Indianapolis, IN, United States.
FAU - West, Christine R
AU  - West CR
AD  - Pfizer Inc., Groton, CT, United States.
FAU - Verburg, Kenneth M
AU  - Verburg KM
AD  - Pfizer Inc., Groton, CT, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT02528188
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220214
PL  - Netherlands
TA  - J Neurol Sci
JT  - Journal of the neurological sciences
JID - 0375403
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - EQL0E9GCX1 (tanezumab)
SB  - IM
MH  - Anti-Inflammatory Agents, Non-Steroidal/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Double-Blind Method
MH  - Humans
MH  - *Osteoarthritis, Hip/complications/drug therapy
MH  - *Osteoarthritis, Knee/complications/drug therapy
MH  - Pain Measurement/methods
MH  - Paresthesia/complications
MH  - Treatment Outcome
OTO - NOTNLM
OT  - NSAID
OT  - Nerve growth factor
OT  - Neurological safety
OT  - Osteoarthritis
OT  - Tanezumab
EDAT- 2022/02/27 06:00
MHDA- 2022/04/14 06:00
CRDT- 2022/02/26 05:40
PHST- 2021/05/04 00:00 [received]
PHST- 2021/10/27 00:00 [revised]
PHST- 2022/02/10 00:00 [accepted]
PHST- 2022/02/27 06:00 [pubmed]
PHST- 2022/04/14 06:00 [medline]
PHST- 2022/02/26 05:40 [entrez]
AID - S0022-510X(22)00046-6 [pii]
AID - 10.1016/j.jns.2022.120184 [doi]
PST - ppublish
SO  - J Neurol Sci. 2022 Mar 15;434:120184. doi: 10.1016/j.jns.2022.120184. Epub 2022 
      Feb 14.