A blinded, randomized clinical trial comparing the efficacy and safety of oclacitinib and ciclosporin for the control of atopic dermatitis in client‐owned dogs. Issue 1 (12th December 2014)

• Record Type: Journal Article
• Authors: Little, Peter R.; King, Vickie L.; Davis, Kylie R.; Cosgrove, Sallie B.; Stegemann, Michael R.
• Is Part Of: Veterinary dermatology. Volume 26:Issue 1(2015:Feb.)
• Page Start: 23
• Page End: e8
• Publication Date: 2014-12-12
• Subjects: Veterinary dermatology -- Periodicals; Pet medicine -- Periodicals; 636.08965
• DOI: 10.1111/vde.12186
• Languages: English
• ISSNs: 0959-4493

Abstract

<abstract abstract-type="main" xml:lang="en" id="vde12186-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="vde12186-sec-0001" sec-type="section"> <title>Background</title> <p>Ciclosporin is approved for the treatment of atopic dermatitis (AD) in dogs and has been shown to be safe and effective. Placebo‐controlled studies suggest that oclacitinib is a safe and effective alternative therapy.</p> </sec> <sec id="vde12186-sec-0002" sec-type="section"> <title>Hypothesis/Objectives</title> <p>To evaluate the efficacy and safety of oclacitinib, in comparison to ciclosporin, for the control of AD in a blinded, randomized clinical trial, incorporating a noninferiority test at day 28.</p> </sec> <sec id="vde12186-sec-0003" sec-type="section"> <title>Animals</title> <p>A total of 226 client‐owned dogs with a history of AD from eight sites were enrolled.</p> </sec> <sec id="vde12186-sec-0004" sec-type="section"> <title>Methods</title> <p>Enrolled animals were randomized to receive oral oclacitinib (0.4–0.6 mg/kg twice daily for 14 days, then once daily) or oral ciclosporin (3.2–6.6 mg/kg once daily) for 12 weeks. Owners assessed pruritus using an enhanced visual analog scale (VAS), and veterinarians assessed dermatitis using the Canine Atopic Dermatitis Extent and Severity Index (CADESI)‐02.</p> </sec> <sec id="vde12186-sec-0005" sec-type="section"> <title>Results</title> <p>On days 1, 2, 7, 14, 28, 56 and 84, the percentage reduction from baseline for owner‐assessed pruritus changed from 25.6 to 61.0% in the oclacitinib group compared with 6.5 to 61.5% in the ciclosporin group; differences were significant at all time points up to day 28. On day 56, ciclosporin‐treated dogs showed a similar decrease in pruritus to oclacitinib‐treated dogs. On day 14, the percentage reduction from baseline CADESI‐02 was significantly greater in the oclacitinib group (58.7%) than in the ciclosporin group (43.0%). Three times as many adverse events attributed to gastrointestinal signs were reported in the ciclosporin group compared with the oclacitinib group.</p> </sec> <sec id="vde12186-sec-0006" sec-type="section"> <title>Conclusions and clinical importance</title> <p>In this study of treatment for canine AD, oclacitinib had a faster onset of action and a lower frequency of gastrointestinal side effects compared with ciclosporin.</p> </sec> </abstract>