A blinded, randomized, placebo-controlled trial of the efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis
A blinded, randomized, placebo-controlled trial of the efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis
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DOI：
10.1111/vde.12088
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发表时间：
2013-12-01
影响因子：
1.4
通讯作者：
Stegemann, Michael R.
中科院分区：
文献类型：
--
作者：
Cosgrove, Sallie B.;Wren, Jody A.;Stegemann, Michael R.
瘙痒是犬特应性皮炎(AD)的临床特征。初步研究结果表明，Oclacitinib是一种选择性Janus激酶抑制剂，可以减少AD犬的瘙痒和相关的炎症性皮肤病变。目的：通过随机、双盲、安慰剂对照试验，评估Oclacitinib(Apoquel((R)控制AD的有效性和安全性。动物18家专科诊所的临床医生招募了299只有慢性AD病史的客户所有的狗(n=299)。方法狗被随机分为两组，一组接受oclacitinib(0.4-0.6 mg/kg，连续14天，然后每天一次，持续112天)，另一组接受赋形剂匹配的安慰剂。所有者在第0、1、2、7、14、28、56、84和112天评估瘙痒视觉类比量表(VAS)评分。临床医生在第0、14、28、56、84和112天对犬类AD程度和严重程度指数(CADESI-02)进行评分。结果在第1、2、7、14和28天，奥克拉西尼治疗组的主人评估的瘙痒评分分别比基线降低29.5、42.3、61.5、66.7和47.4%，而安慰剂组分别减少6.5、9.1、6.5、3.9和10.4%。在第14天和第28天，皮肤科医生记录到，服用奥克拉西尼的狗的CADESI-02评分降低了48.4%，而服用安慰剂的狗降低了1.7%，增加了3.6%。第28天后，所有接受安慰剂治疗的狗中有86%转移到了一项开放标签的研究中，这使得组间比较存在偏见。在评估的所有时间点，差异均有统计学意义(P
BackgroundPruritus is the hallmark clinical sign of atopic dermatitis (AD) in dogs. Preliminary study results suggest that oclacitinib, a selective Janus kinase inhibitor, could reduce pruritus and associated inflammatory skin lesions in dogs with AD.Hypothesis/ObjectivesThe objective was to evaluate efficacy and safety of oclacitinib (Apoquel((R))) for the control of AD in a randomized, double-blind, placebo-controlled trial.AnimalsClinicians at 18 specialty clinics enrolled client-owned dogs (n=299) with a history of chronic AD.MethodsDogs were randomized to receive either oclacitinib (0.4-0.6mg/kg twice daily for 14days and then once daily for up to 112days) or an excipient-matched placebo. Owners assessed visual analog scale (VAS) scores of pruritus on days 0, 1, 2, 7, 14, 28, 56, 84 and 112. Clinicians assessed Canine AD Extent and Severity Index (CADESI-02) scores on days 0, 14, 28, 56, 84 and 112.ResultsOn days 1, 2, 7, 14 and 28, oclacitinib-treated dogs had a 29.5, 42.3, 61.5, 66.7 and 47.4% reduction from baseline in owner-assessed pruritus scores, respectively, compared with a 6.5, 9.1, 6.5, 3.9 and 10.4% reduction in placebo-treated dogs. On days 14 and 28, dermatologists recorded a 48.4% reduction in CADESI-02 scores in oclacitinib-treated dogs compared with a 1.7% reduction and a 3.6% increase in placebo-treated dogs. After day28, >86% of all placebo-treated dogs had moved to an open-label study, making between-group comparisons biased. Differences were significant at all time points assessed (P