Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life

Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life
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DOI:
10.1111/vde.12194
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发表时间:
2015-06-01
影响因子:
1.4
通讯作者:
Stegemann, Michael R.
Stegemann, Michael R.
中科院分区:
农林科学3区
文献类型:
--
作者:
Cosgrove, Sallie B.;Cleaver, Dawn M.;Stegemann, Michael R.

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背景Oclacitinib是一种安全有效的治疗犬过敏性和特应性皮炎相关瘙痒的药物,基于长达4个月的随机临床试验。在同情使用项目中登记接受奥拉替尼治疗犬的疗效和生活质量。拥有的狗过敏性皮肤病,以前受益于oclacitinib therapy.MethodsDogs在26个兽医诊所参加了一项开放标签的研究。犬接受0.4- 0.6 mg/kg奥拉替尼,每天两次,持续14天,然后每天一次,持续630天。以类似于90天的间隔进行评估。犬主人完成生活质量调查,并在每次诊所访视时使用视觉模拟量表(VAS)评估瘙痒。兽医使用相似的VAS评估皮炎。异常健康事件,伴随用药和临床病理结果进行了总结。ResultsVisual Analog Scale评分显示,从基线改善在所有时间点。第90天瘙痒和皮炎较基线降低50%的犬百分比分别为63.9%和66.4%。主人看到了对91%以上的狗的生活质量的积极影响。尿路感染/膀胱炎、呕吐、耳炎、脓毒症和腹泻是最常报告的(>5%的犬)异常临床体征。血液学和血清化学平均值保持在正常参考范围内。结论和临床重要性结果表明,奥拉替尼是安全和有效的长期使用,并改善生活质量的狗在这项研究中。
BackgroundOclacitinib is safe and effective for treating dogs with pruritus associated with allergic and atopic dermatitis, based on randomized clinical trials of up to 4months duration.Hypothesis/ObjectivesThis study assessed long-term safety, efficacy and quality of life of oclacitinib-treated dogs enrolled in a compassionate use programme.AnimalsTwo hundred and forty-seven client-owned dogs with allergic skin disease that had previously benefited from oclacitinib therapy.MethodsDogs were enrolled in an open-label study at 26 veterinary clinics. Dogs received 0.4-0.6mg/kg oclacitinib twice a day for 14days, then once a day for up to 630days. Assessments were performed at similar to 90day intervals. Owners completed a quality-of-life survey and assessed pruritus using a Visual Analog Scale (VAS) at each clinic visit. Veterinarians assessed dermatitis using a similar VAS. Abnormal health events, concomitant medication and clinical pathology results were summarized.ResultsVisual Analog Scale scores showed improvement from baseline at all time points. The percentage of dogs showing 50% reduction from baseline on day90 was 63.9% for pruritus and 66.4% for dermatitis. Owners saw a positive impact on quality of life in >91% of all dogs. Urinary tract infection/cystitis, vomiting, otitis, pyoderma and diarrhoea were the most frequently reported (>5% of dogs) abnormal clinical signs. Haematology and serum chemistry means remained within the normal reference ranges. Concomitant medications were well tolerated.Conclusions and clinical importanceResults indicated that oclacitinib was safe and efficacious for long-term use and improved the quality of life for dogs in this study.