BACKGROUND Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). OBJECTIVE To assess the long-term safety and efficacy of dupilumab in patients with AD. METHODS This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. LIMITATIONS Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. CONCLUSION The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.

中文翻译：

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在一项3期开放标签扩展研究中，Dupilumab对中度至重度特应性皮炎患者显示出长期安全性和有效性。

背景技术存在对中度至重度特应性皮炎（AD）的长期治疗的未满足的需求。目的评估dupilumab在AD患者中的长期安全性和有效性。方法这项正在进行的，多中心，开放标签的扩展研究（NCT01949311）评价了成人dupilumab的长期治疗，该成人先前曾参与过dupilumab AD的1至3期临床试验。这项分析检查了在数据截止日期（2016年4月）每周服用300 mg dupilumab的患者，长达76周。安全是主要结果；疗效也进行了评估。结果在1491名登记患者（1042.9患者-年）中，92.9％的患者在截断时接受了治疗。安全性与先前报道的试验一致（420.4不良事件/ 100患者-年和8.5严重不良事件/ 100患者-年），没有新的安全信号；常见的不良事件包括鼻咽炎，结膜炎和注射部位反应。在所有功效结果中，包括皮肤炎症，瘙痒和生活质量的测量结果，均可观察到持续改善长达76周。局限性：缺乏对照组，接受治疗76周或更长时间（中位随访期为24周）的患者数量有限，并且每两周未接受批准的300 mg剂量治疗方案的患者。结论本研究的安全性和有效性概况支持dupilumab作为中重度AD患者连续长期治疗的作用。瘙痒和生活质量。局限性：缺乏对照组，接受治疗76周或更长时间（中位随访期为24周）的患者数量有限，并且每两周未接受批准的300 mg剂量治疗方案的患者。结论本研究的安全性和有效性概况支持dupilumab作为中重度AD患者连续长期治疗的作用。瘙痒和生活质量。局限性：缺乏对照组，接受治疗76周或更长时间（中位随访期为24周）的患者数量有限，并且每两周未接受批准的300 mg剂量治疗方案的患者。结论本研究的安全性和有效性概况支持dupilumab作为中重度AD患者连续长期治疗的作用。