Treatment of moderate-to-severe canine atopic dermatitis with modified-release mycophenolate (OKV-1001): A pilot open-label, single-arm multicentric clinical trial.

IF 1.9 3区 农林科学 Q3 DERMATOLOGY Veterinary dermatology Pub Date : 2024-12-01 Epub Date: 2024-08-12 DOI:10.1111/vde.13283
Michael Klotsman, Wayne H Anderson, Danielle Wyatt, Tom Lewis, Natalie Theus, Domenico Santoro
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Abstract

Background: Mycophenolate is an immunomodulating agent successfully used for the treatment of moderate-to-severe atopic dermatitis (AD) in people. Mycophenolate is an effective steroid-sparing treatment option for use in dogs with inflammatory skin diseases.

Objective: To evaluate whether once-daily modified-release mycophenolate (OKV-1001) is safe and effective for treating moderate-to-severe canine AD.

Animals: Client-owned atopic dogs (n = 9) were enrolled.

Materials and methods: In an open-label multicentre pilot study, OKV-1001 (30 mg/kg every 24 h) was given orally for ≤84 days. Concomitant tapering doses of glucocorticoids were administered up to Day (D)28. Clinicians assessed Canine Atopic Dermatitis Extent and Severity Index, 4th iteration (CADESI-04) on D0, D14, D28, D56 and D84. Body weight and clinical pathological parameters were measured at baseline and at the end of the study.

Results: Treatment with OKV-1001 combined with glucocorticoids significantly reduced the severity of AD within two weeks in seven of nine (77.8%) dogs. The mean percentage change from baseline in the CADESI-04 score was 29% (p = 0.009) at D14 (n = 9), 39% (p = 0.008) at D28 (n = 9) and 49% (p = 0.03) at D56 (n = 7) at which point glucocorticoids had been withdrawn. In two dogs the improvement in CADESI-04 was 62% and 23% (respectively) on D84. No significant adverse events including clinical pathological findings were reported.

Conclusions and clinical relevance: Modified-release mycophenolate (OKV-1001) may represent a promising alternative treatment option for dogs with moderate-to-severe AD. The safety and efficacy profile of OKV-1001 will need to be established in larger, placebo-controlled clinical trials.

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用改良释放型霉酚酸盐(OKV-1001)治疗中重度犬特应性皮炎:一项开放标签、单臂多中心临床试验。
背景:霉酚酸酯是一种免疫调节药物,成功用于治疗人的中重度特应性皮炎(AD)。对于患有炎症性皮肤病的狗来说,霉酚酸酯也是一种有效的节省类固醇的治疗选择:目的:评估每日一次的改良释放型霉酚酸盐(OKV-1001)治疗中重度犬特应性皮炎是否安全有效:材料与方法:在一项开放标签的多中心试验研究中,口服 OKV-1001(30 毫克/千克,每 24 小时一次)≤84 天。同时给予糖皮质激素逐渐减量,直至第(D)28天。临床医生在第0天、第14天、第28天、第56天和第84天评估犬特应性皮炎范围和严重程度指数(第4次迭代,CADESI-04)。在基线和研究结束时测量体重和临床病理参数:结果:使用OKV-1001和糖皮质激素治疗的九只狗中有七只(77.8%)在两周内明显减轻了AD的严重程度。与基线相比,CADESI-04评分的平均百分比变化分别为:D14时29%(p = 0.009)(9只)、D28时39%(p = 0.008)(9只)和D56时49%(p = 0.03)(7只),此时糖皮质激素已被停用。两只狗的 CADESI-04 在第 84 天分别改善了 62% 和 23%。未报告包括临床病理结果在内的重大不良事件:改良释放型霉酚酸盐(OKV-1001)可能是治疗中重度AD犬的一种很有前景的替代疗法。OKV-1001的安全性和疗效还需要在更大规模的安慰剂对照临床试验中加以确定。
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来源期刊
Veterinary dermatology
Veterinary dermatology 农林科学-兽医学
CiteScore
3.20
自引率
21.40%
发文量
92
审稿时长
12-24 weeks
期刊介绍: Veterinary Dermatology is a bi-monthly, peer-reviewed, international journal which publishes papers on all aspects of the skin of mammals, birds, reptiles, amphibians and fish. Scientific research papers, clinical case reports and reviews covering the following aspects of dermatology will be considered for publication: -Skin structure (anatomy, histology, ultrastructure) -Skin function (physiology, biochemistry, pharmacology, immunology, genetics) -Skin microbiology and parasitology -Dermatopathology -Pathogenesis, diagnosis and treatment of skin diseases -New disease entities
期刊最新文献
Long-lasting otic solution containing mometasone furoate can influence intradermal testing in dogs with healthy ears and otitis externa. Clinical features, surgical management and outcome of squamous and basal cell carcinoma in squamates and chelonians. Skin barrier, phenotypic and genotypic characterisation of autosomal recessive ichthyosis in TGM1-deficient Jack Russell Terriers and response to topical ceramide. Treatment of moderate-to-severe canine atopic dermatitis with modified-release mycophenolate (OKV-1001): A pilot open-label, single-arm multicentric clinical trial. Analysis of the immunomodulatory properties of mycobacterium cell wall fraction on the cytokine production of peripheral blood mononuclear cells of healthy dogs.
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