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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

Michels, Gina M., Walsh, Kelly F., Kryda, Kristina A., Mahabir, Sean P., Walters, Rodney R., Hoevers, Jacquelien D., Martinon, Olivier M.
Veterinary dermatology 2016 v.27 no.6 pp. 505
atopic dermatitis, blood, dogs, field experimentation, immune response, monoclonal antibodies, placebos, pruritus, urine, veterinary clinics, vomiting
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.