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

Vet Dermatol. 2016 Dec;27(6):505-e136. doi: 10.1111/vde.12364. Epub 2016 Sep 19.

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.

Hypothesis/objectives: 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.

Animals: 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 and clinical importance: 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Animals
  • Antibodies, Monoclonal / immunology*
  • Dermatitis, Atopic / drug therapy
  • Dermatitis, Atopic / veterinary*
  • Dog Diseases / drug therapy*
  • Dogs
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Interleukins / immunology*
  • Male

Substances

  • Antibodies, Monoclonal
  • Interleukins