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Clinical Efficacy of Oclacitinib and Lokivetmab in Dogs with Canine Atopic Dermatitis

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Clinical Efficacy of Oclacitinib and Lokivetmab in Dogs with Canine Atopic Dermatitis Original Article pISSN 1598-298X • eISSN 2384-0749 J Vet Clin 2021;38:127-134 https://doi.org/10.17555/jvc.2021.38.3.127 JVCJournal of Veterinary Clinics Clinical Efficacy of Oclacitinib and Lokivetmab in Dogs with Canine Atopic Dermatitis Sora Lee Abstract Canine atopic dermatitis (CAD) is a genetically predisposed inflamma- Taesik Yun tory and pruritic skin disease presenting characteristic clinical features in dogs. Yoonhoi Koo Despite oclacitinib and lokivetmab being commonly used, no study has compared Yeon Chae their efficacies in CAD. This study aimed to compare the efficacy, safety, and con- Dohee Lee trol of CAD-associated pruritus and skin lesions between oclacitinib and lokivet- Dongjoon Choi mab. It also investigated whether switching to lokivetmab from oclacitinib or pred- Yujin Choi nisolone had any benefits. Twenty-five client-owned dogs, newly diagnosed with Hakhyun Kim CAD, were allocated to the oclacitinib (n = 20) and lokivetmab (n = 5) groups and Mhan-Pyo Yang administered oclacitinib (0.4-0.6 mg/kg orally, twice daily for 14 days, then once Byeong-Teck Kang* daily) and lokivetmab (2 mg/kg subcutaneously, every month) for 8 weeks, respec- tively. The switching group included five dogs previously administered with oclac- Laboratory of Veterinary Internal Med- itinib (n = 4) or prednisolone (n = 1) who were switched to lokivetmab directly at icine, College of Veterinary Medicine, the start of the study. The pruritus visual analog scale (PVAS) and Canine Atopic Chungbuk National University, Cheongju 28644, Korea Dermatitis Extent and Severity Index (CADESI-04) values were surveyed at weeks 0, 4, and 8. Oclacitinib and lokivetmab significantly reduced the PVAS and CADE- SI-04 scores. Switching from oclacitinib or prednisolone to lokivetmab maintained the severity of pruritus (4 weeks: p = 0.068; 8 weeks: p = 0.068) and dermatitis (4 weeks: p = 0.144; 8 weeks: p = 0.068) at the levels measured at baseline. Thus, both oclacitinib and lokivetmab reduced CAD-associated pruritus by a similar de- *Correspondence: [email protected] gree. Switching to lokivetmab maintained the severity of pruritus and dermatitis at the same level as the previous treatment. ORCID Sora Lee: https://orcid.org/0000-0001-5930-1498 Key words canine, atopic dermatitis, oclacitinib, lokivetmab. Taesik Yun: https://orcid.org/0000-0003-1372-4430 Yoonhoi Koo: https://orcid.org/0000-0002-3810-4193 Yeon Chae: https://orcid.org/0000-0002-9816-6900 Dohee Lee: https://orcid.org/0000-0001-7162-9592 Dongjoon Choi: https://orcid.org/0000-0002-6507-2019 Yujin Choi: https://orcid.org/0000-0002-8440-842X Hakhyun Kim: https://orcid.org/0000-0002-8882-2329 Mhan-Pyo Yang: https://orcid.org/0000-0002-8043-0152 Byeong-Teck Kang: https://orcid.org/0000-0002-4471-4342 Copyright © The Korean Society of Veterinary Clinics Received March 2, 2021 / Accepted May 28, 2021 This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/ by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. www.ksvc.or.kr 127 Sora Lee, et al. Introduction Diseases of Animals guidelines, and fulfillment of more than five postulates of the Favrot’s criteria (11,17). The possibility Canine atopic dermatitis (CAD) is a genetically predisposed of other diseases such as bacterial or fungal dermatitis, flea inflammatory and pruritic skin disease presenting characteris- allergy dermatitis, cutaneous adverse food reactions that can tic clinical features in dogs (10). There are several treatments cause pruritus and skin lesions was ruled out through proper available for CAD, including glucocorticoids, cyclosporine, tests and treatments. oclacitinib, and lokivetmab, which reduce pruritus and in- Study group flammation (8,18). Oclacitinib is a Janus kinase (JAK) inhibitor that selectively The dogs diagnosed with CAD were divided into two inhibits JAK 1-dependent cytokines involved in itching and groups: oclacitinib group, treated with oclacitinib (Apoquel®, inflammation associated with allergies, with minimal effects Zoetis; Florham Park, NJ, USA); and lokivetmab group, treat- against JAK 2-dependent cytokines involved in hematopoiesis ed with lokivetmab (Cytopoint®, Zoetis; Parsippany, NJ, USA). (1,6,22). It has been approved for the control and treatment The PVAS and CADESI-04 scores of the two groups were of pruritus associated with allergic dermatitis. evaluated and compared. None of these dogs received any Lokivetmab, a caninized, anti-canine interleukin (IL)-31 other medication for CAD. monoclonal antibody, binds specifically to circulating IL-31, Five dogs receiving oclacitinib (n = 5) or prednisolone thereby inhibiting the binding of IL-31 to the IL-31 receptor (n = 1) were included in the switching group to evaluate the (4). IL-31 is considered an essential cytokine involved in pruri- benefit of switching the treatment to lokivetmab. These dogs tus associated with CAD in many species, including humans received oclacitinib or prednisolone for at least 2 months be- and dogs (7). Neutralization of IL-31 following subcutaneous fore the change in treatment. administration of lokivetmab results in a dose-dependent Drug administration reduction in IL-31-induced pruritus in dogs for up to 8 weeks following a single dose (23). The oclacitinib group was administered 0.4 mg/kg of oclac- There are few studies illustrating the efficacy of oclacitinib itinib, twice daily for 2 weeks, followed by 0.4-0.6 mg/kg, compared with other known treatments, including cyclospo- once daily until the end of the study. During the treatment rine and prednisolone (5,13). However, no prospective studies period, allergen-specific immunotherapy and systemic ther- have compared the efficacy of oclacitinib and lokivetmab in apy were not allowed, but other anti-infective treatments, dogs diagnosed with CAD. Therefore, this study aimed to such as antimicrobial, antifungal, and antiparasitic therapies, evaluate the efficacy and safety of oclacitinib and lokivetmab were permitted. and to compare their control of pruritus and skin lesions The lokivetmab and switching groups were administered 2 associated with CAD. Furthermore, this study investigated mg/kg of lokivetmab every month from 0 week (baseline) to whether dogs receiving oclacitinib or prednisolone benefited 8 weeks. from switching to lokivetmab. The treatment of the dogs included in the switching group was switched from prednisolone or oclacitinib to lokivetmab Materials and Methods directly at the start of the study. Animals Efficacy estimates This study recruited dogs diagnosed with CAD between PVAS scoring 2017 and 2020. All dogs were client-owned, 12 months of The severity of pruritus was graded using the PVAS on a age or older, and in overall good health, based on the initial scale of 0-10 (0, no pruritus; 10, most severe pruritus) (21). physical examination (0 week/baseline). The eligibility criteria The PVAS values were determined based on history and eval- for this study was a minimum score of 3 on the pruritus vi- uation by the owners. Treatment success for PVAS was de- sual analog scale (PVAS) as assessed by the dog owners or a fined as a 50% or greater score reduction on the assessment minimum score of 30 out of a possible 180 points on the Ca- day as compared to the baseline score (3,18). nine Atopic Dermatitis Extent and Severity Index (CADESI)-04 as assessed by clinicians (19,21). CADESI-04 scoring All dogs were diagnosed with CAD. The diagnosis was The extent and severity of skin lesions were evaluated us- established based on the medical history, typical clinical ing the CADESI-04, which is designed to assess 20 different signs according to the International Committee on Allergic body parts (19). Clinicians assessed three skin lesions, includ- 128 https://doi.org/10.17555/jvc.2021.38.3.127 Oclacitinib vs. Lokivetmab ing erythema, lichenification, and excoriation/alopecia, based mab after obtaining consent from the owners. The PVAS and on a 4-point severity scale (0, none; 1, mild; 2, moderate; CADESI-04 scores were evaluated three times at weeks 0, 4, 3, severe). The clinicians assessed total 20 body sites, three and 8 after the first injection of lokivetmab. types of lesions, and four grades of severity, thus generating Data analysis a maximal score of 20 × 3 × 3 = 180. The CADESI-04 cut- off scores for mild, moderate, and severe AD were 10, 35, Data were analyzed using GraphPad Prism 6 software and 60, respectively (19). Treatment success for CADESI-04 (GraphPad Software Inc., San Diego, CA, USA) and Statisti- was defined as a 50% or greater score reduction on the as- cal Package for the Social Sciences (SPSS 22.0 for Windows, sessment day as compared to the baseline score (20). IBM, New York, NY, USA). Signalments (sex, age, and body weight) were compared between the two groups using Fish- Side effects er’s exact test to identify factors related to the therapeutic re- Clinicians recorded any abnormal health events reported sponse of oclacitinib and lokivetmab. The Wilcoxon test was by owners or those identified during physical examination used to compare the PVAS and CADESI-04 scores at differ- throughout the study period. The adverse drug effects of ent time points in each of the three groups. The differences oclacitinib include urinary tract infection, cystitis, vomiting, in values between the two groups were analyzed using the otitis, dermatitis, and diarrhea, while that of lokivetmab in- non-parametric Mann-Whitney U test. Signalment data were clude vomiting, diarrhea, lethargy, dermatitis, and pruritus expressed as mean and range, and PVAS and CADESI-04 (2,16). data were expressed as mean ± standard deviation (SD). The abnormal health events were categorized as gastroin- Differences were considered statistically significant at p-value testinal, dermatological, urogenital, immunological, neuro- <0.05. logical, behavioral, and musculoskeletal problems.
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