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- Title
A blinded, randomized, placebo-controlled, dose determination trial of lokivetmab ( ZTS-00103289), a caninized, anti-canine IL-31 monoclonal antibody in client owned dogs with atopic dermatitis.
- Authors
Michels, Gina M.; Ramsey, Deborah S.; Walsh, Kelly F.; Martinon, Olivier M.; Mahabir, Sean P.; Hoevers, Jacquelien D.; Walters, Rodney R.; Dunham, Steven A.
- Abstract
Background Pruritus is the hallmark clinical sign of atopic dermatitis ( AD) in dogs. Lokivetmab, a caninized anti-canine IL-31 monoclonal antibody, reduced pruritus and associated inflammatory skin lesions in a proof-of-concept study in dogs with AD. Hypothesis/Objectives The objective was to describe lokivetmab dose response in a randomized, double blind, placebo-controlled trial. Animals Clinicians at 15 referral clinics enrolled 211 client owned dogs with a history of chronic AD. Methods Dogs were randomized to treatment with lokivetmab (0.125, 0.5 or 2.0 mg/kg) or placebo administered subcutaneously once on Day 0. Dog owners assessed visual analog scale ( VAS) scores of pruritus on days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42, 49 and 56. Clinicians assessed Canine AD Extent and Severity Index ( CADESI-03) scores on days 0, 7, 14, 28, 42 and 56. Results Treatment with lokivetmab (2 mg/kg) resulted in a greater percentage reduction from baseline in owner assessed pruritus (days 1-49) and clinician assessed CADESI-03 scores (days 7-56) compared to placebo ( P < 0.05); differences were achieved in lower dose groups but at later time points and for shorter duration for both owner assessed pruritus (0.5 mg/kg, days 2-35; 0.125 mg/kg, days 7-21) and clinician assessed CADESI-03 scores (0.5 mg/kg and 0.125 mg/kg, Day 14). Conclusions and clinical importance Lokivetmab (0.5, 2.0 mg/kg) reduced pruritus compared to placebo for at least 1 month. Level and duration of response increased with increasing dose. Further studies are needed to better understand variability in individual responses across a broader population of dogs with AD.
- Subjects
ATOPIC dermatitis treatment; THERAPEUTIC use of monoclonal antibodies; DOG diseases; VETERINARY therapeutics; ITCHING; RANDOMIZED controlled trials; THERAPEUTICS
- Publication
Veterinary Dermatology, 2016, Vol 27, Issue 6, p478
- ISSN
0959-4493
- Publication type
Article
- DOI
10.1111/vde.12376