Safety and Efficacy of Anakinra in Severe Hidradenitis Suppurativa A Randomized Clinical Trial
Safety and Efficacy of Anakinra in Severe Hidradenitis Suppurativa A Randomized Clinical Trial
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DOI：
10.1001/jamadermatol.2015.3903
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发表时间：
2016-01-01
期刊：
影响因子：
10.9
通讯作者：
Giamarellos-Bourboulis, Evangelos J.
中科院分区：
文献类型：
--
作者：
Tzanetakou, Vassiliki;Kanni, Theodora;Giamarellos-Bourboulis, Evangelos J.
重要性化脓性汗腺炎（HS）是一种常见的皮肤病，其中过度炎症被认为具有重要作用。有没有具体的治疗HS。目的调查的安全性和有效性的抗炎生物治疗阿那白滞素在HS。设计，设置，和参与者双盲，随机，安慰剂对照的临床试验，治疗期为12周，随访期为12周。该设置是Attikon大学总医院，在雅典，希腊的三级保健机构。参与者为20例Hurley II或III期HS患者。研究和分析在2012年3月1日至2014年2月28日之间进行。干预患者随机接受含有安慰剂或阿那白滞素的相同注射器皮下注射，每天一次，持续12周。在治疗开始前、第12周（治疗结束）和第24周分离外周血单个核细胞并刺激细胞因子的产生。主要结果和指标主要终点是阿那白滞素对HS疾病严重程度的影响。次要终点是一个新的恶化和生产cytokines.Results在20名试验参与者，10人被随机分组接受阿那白滞素或安慰剂组的时间。阿那白滞素组和安慰剂组的平均（SD）年龄分别为42.8（13.8）岁和36（11.3）岁。治疗结束时，安慰剂组20%（2/10）的患者疾病活动评分下降，而阿那白滞素组67%（6/9）的患者疾病活动评分下降（P = 0.04）。在12周时，30%（3/10）的安慰剂组和78%（7/9）的阿那白滞素组达到化脓性汗腺炎临床应答（P =.04）。阿那白滞素组外周血单个核细胞产生的干扰素-γ减少，白细胞介素22增加。对数秩检验显示，阿那白滞素组至新HS加重的时间延长（对数秩，6.137; P = .01）。没有严重的不良事件reported.CONCLUSIONS和相关性阿那白滞素有可能是一个有效的和耐受性良好的治疗HS。抑制白细胞介素1是一种有前途的治疗策略。
IMPORTANCE Hidradenitis suppurativa (HS) is a common skin disorder in which excessive inflammation is believed to have an important role. There is no specific therapy for HS.OBJECTIVE To investigate the safety and efficacy of the anti-inflammatory biological therapy anakinra in HS.DESIGN, SETTING, AND PARTICIPANTS Double-blind, randomized, placebo-controlled clinical trial with a 12-week treatment phase and a 12-week follow-up phase. The setting was Attikon University General Hospital, a tertiary care institution in Athens, Greece. Participants were 20 patients with Hurley stage II or III HS. The study and the analysis were conducted between March 1, 2012, and February 28, 2014.INTERVENTIONS Patients were randomized to receive injections from identical syringes containing placebo or anakinra subcutaneously once daily for 12 weeks. Peripheral blood mononuclear cells were isolated and stimulated for cytokine production before the beginning of treatment and at week 12 (the end of treatment) and week 24.MAIN OUTCOMES AND MEASURES The primary end point was the effect of anakinra on HS disease severity. Secondary end points were the time to a new exacerbation and the production of cytokines.RESULTS Among the 20 trial participants, 10 each were randomized to the group to receive anakinra or the placebo group. The mean (SD) ages were 42.8 (13.8) and 36 (11.3) years in the anakinra and placebo groups, respectively. The disease activity score was decreased at the end of treatment in 20%(2 of 10) of the placebo arm compared with 67%(6 of 9) of the anakinra arm (P = .04). Hidradenitis suppurativa clinical response at 12 weeks was achieved in 30% (3 of 10) of the placebo arm and in 78%(7 of 9) of the anakinra arm (P =.04). The production of interferon-gamma by peripheral blood mononuclear cells in the anakinra arm was decreased, and the production of interleukin 22 was increased. The time to a new HS exacerbation was prolonged in the anakinra arm by log-rank test (log rank, 6.137; P = .01). No serious adverse events were reported.CONCLUSIONS AND RELEVANCE Anakinra has the potential to be an effective and well-tolerated treatment for HS. Inhibition of interleukin 1 is a promising treatment strategy.