Radi Giulia, Simonetti Oriana, Rizzetto Giulio, Diotallevi Federico, Molinelli Elisa, Offidani Annamaria
Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Via Conca 71, 60020 Ancona, Italy.
Healthcare (Basel). 2021 Nov 18;9(11):1575. doi: 10.3390/healthcare9111575.
: Atopic dermatitis (AD) is an inflammatory skin disease characterized by a wide phenotypic variety with a very complex pathophysiological mechanism that has led to the identification of new therapeutic targets, such as janus kinasis (JAK) inhibitors. : To evaluate the efficacy and safety of baricitinib, the first JAK 1 and 2 inhibitor approved in Europe for the treatment of adult patients with moderate-to-severe AD. : The efficacy and safety data available from the Phase III studies belonging to the BREEZE AD program are presented. Results from BREEZE-AD1, AD2, AD4, and AD7 showed the efficacy of Baricitib 4 mg, administered orally, once daily, as monotherapy or in combination with topical corticosteroid (TCS), with a significant proportion of patients achieving primary endpoints IGA 0-1 (16.4% vs. 4.8%; 13.8% vs. 4.5%; 21.7% vs. 9.7%; 30.6% vs. 14.7%) and EASI75 (24.8% vs. 8.8%; 21.1% vs. 6.1%; 31.5% vs. 17.2%; 47.7% vs. 22.9%) at week 16 (W16) compared to placebo, respectively. Baricitinib showed rapid improvement in symptoms, starting from week 1 of treatment at 4 mg dosage, with a good safety profile. Nasopharyngitis, upper respiratory tract infections (URIs), creatine phosphokinase (CPK) elevations, and headache were the most frequently reported adverse events. : Following the efficacy and safety data on W 16 from the phase III BREEZE-AD studies, baricitinib has recently been approved in Europe for the treatment of moderate to severe AD in adult patients. Further data to evaluate long-term efficacy and safety in a real-life setting are needed.
特应性皮炎（AD）是一种炎症性皮肤病，其表型多样，病理生理机制非常复杂，这促使人们确定了新的治疗靶点，如 Janus 激酶（JAK）抑制剂。为了评估巴瑞替尼的疗效和安全性，它是欧洲首个获批用于治疗中度至重度 AD 成年患者的 JAK1 和 JAK2 抑制剂。本文展示了 BREEZE AD 项目中 III 期研究的疗效和安全性数据。BREEZE-AD1、AD2、AD4 和 AD7 的结果显示，口服 4mg 巴瑞替尼，每日一次，作为单一疗法或与外用糖皮质激素（TCS）联合使用，与安慰剂相比，在第 16 周（W16）时有相当比例的患者达到主要终点，即 IGA 0-1（分别为 16.4%对 4.8%；13.8%对 4.5%；21.7%对 9.7%；30.6%对 14.7%）和 EASI75（分别为 24.8%对 8.8%；21.1%对 6.1%；31.5%对 17.2%；47.7%对 22.9%）。巴瑞替尼在 4mg 剂量治疗第 1 周开始症状就迅速改善，安全性良好。鼻咽炎、上呼吸道感染（URIs）、肌酸磷酸激酶（CPK）升高和头痛是最常报告的不良事件。根据 III 期 BREEZE-AD 研究第 16 周的疗效和安全性数据，巴瑞替尼最近在欧洲获批用于治疗成年中度至重度 AD 患者。还需要进一步的数据来评估其在实际应用中的长期疗效和安全性。
