title: A blinded, randomized, placebo-controlled trial of the safety of lokivetmab (ZTS-00103289), a caninized anti-canine IL-31 monoclonal antibody in client-owned dogs with atopic dermatitis.
abstract: BACKGROUND
  Lokivetmab (ZTS-00103289) is a caninized anti-canine IL-31 monoclonal antibody that has demonstrated efficacy in reducing pruritus associated with atopic dermatitis (AD) in dogs in field trials.
  
  
  OBJECTIVE
  This study evaluated the safety of lokivetmab in a randomized, double blind, placebo-controlled trial in client owned dogs with AD with minimal restrictions on concomitant medications and co-morbidities.
  
  
  METHODS
  Clinicians at 14 veterinary clinics enrolled client owned dogs (n = 245) with chronic AD.
  
  
  METHODS
  Dogs were randomized at a 2:1 ratio to receive either lokivetmab (1.0-3.3 mg/kg) or placebo administered subcutaneously on days 0 and 28. Clinicians examined dogs, and collected blood and urine for assessment of clinical pathology and immunogenicity (days 0, 28 and 42).
  
  
  RESULTS
  There were no immediate hypersensitivity reactions (e.g. wheals, vomiting). Discomfort at administration occurred in 5.1% of dogs and was similar in frequency and severity between lokivetmab- and placebo-treated groups. Pruritus was reported as an adverse event during the study less frequently in the lokivetmab-treated group (4.9% and 19.3%, respectively); otherwise, adverse events occurred at a similar frequency between treatment groups. There were no clinically important differences between groups in clinical pathology results. Treatment-induced immunogenicity was found in 2.5% of lokivetmab treated dogs. A wide variety of concomitant medications were used with no clinically apparent adverse interactions.
  
  
  CONCLUSIONS
  Among a diverse population of 162 client owned dogs with a clinical diagnosis of AD, treatment with two monthly doses of lokivetmab was safe, based on observed adverse events and clinical pathology results over a 42 day period.
authors.affiliation: Global Development and Operations, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Gina M
authors.initials: GM
authors.lastname: Michels
authors.affiliation: Global Development and Operations, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Kelly F
authors.initials: KF
authors.lastname: Walsh
authors.affiliation: Global Development and Operations, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Kristina A
authors.initials: KA
authors.lastname: Kryda
authors.affiliation: Global Development and Operations, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Sean P
authors.initials: SP
authors.lastname: Mahabir
authors.affiliation: Global Therapeutics Research, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Rodney R
authors.initials: RR
authors.lastname: Walters
authors.affiliation: Global Development and Operations, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Jacquelien D
authors.initials: JD
authors.lastname: Hoevers
authors.affiliation: Global Therapeutics Research, Zoetis Inc., 333 Portage Street, Kalamazoo, MI, 49007, USA.
authors.forename: Olivier M
authors.initials: OM
authors.lastname: Martinon
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology*; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000662:veterinary*; D004283:Dog Diseases / Q000188:drug therapy*; D004285:Dogs; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D007378:Interleukins / Q000276:immunology*; D008297:Male
chemical_list: D000911:Antibodies, Monoclonal; D007378:Interleukins