Klinikum der Universität München, Department of Dermatology and Allergy, Munich, Germany
Medical Dermatology Associates, Chicago IL, USA
Eur J Dermatol. 2022 Jul 1;32(4):522-529. doi: 10.1684/ejd.2022.4280.
In adults with atopic dermatitis (AD), head and/or neck involvement is frequent, bothersome, and impacts quality of life, however, long-term topical corticosteroids (TCS) are contraindicated for this difficult-to-treat region. Baricitinib, an oral, selective, reversible inhibitor of Janus kinase 1/2 has demonstrated efficacy in adult patients with moderate-to-severe AD.
For this post hoc analysis, data from five Phase III trials were used to investigate the efficacy of baricitinib in patients with head and neck involvement.
MATERIALS & METHODS: Data were obtained from BREEZE-AD1, -AD2, -AD4, -AD5, and -AD7; Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in patients ≥18 years with moderate-to-severe AD. BREEZE-AD1, -AD2, and -AD5 evaluated baricitinib as monotherapy, and BREEZE-AD4 and -AD7 evaluated baricitinib in combination with TCS, topical calcineurin inhibitors, or topical PDE-4 inhibitors, where available. The proportion of patients with improvement of Eczema Area and Severity Index (EASI) total score from baseline of ≥50% (EASI50) and ≥75% (EASI75), as well as head/neck EASI50 and EASI75 and erythema head/neck EASI50 and EASI75 response rates were assessed up to Week 16.
Across the studies, 93-98% of patients had head/neck involvement at baseline (EASI head/neck score ≥1). Baricitinib was similarly effective based on EASI total score for the entire body in all studies. In the monotherapy studies, the proportion of patients achieving head/neck EASI50 and EASI75 scores was significantly higher for baricitinib 2-mg and 4-mg versus placebo at Weeks 1 and 16.
Baricitinib 2-mg and 4-mg treatment showed rapid and substantial reduction in AD head and neck severity, including erythema.
在患有特应性皮炎（AD）的成年人中，头部和/或颈部受累较为常见，令人困扰，并影响生活质量，但长期局部使用皮质类固醇（TCS）对此类难以治疗的区域是禁忌。巴瑞替尼是一种口服、选择性、可逆的 Janus 激酶 1/2 抑制剂，已证明在中重度 AD 成年患者中有效。
本事后分析使用五项 III 期试验的数据，调查巴瑞替尼治疗头颈部受累患者的疗效。
数据来自 BREEZE-AD1、-AD2、-AD4、-AD5 和 -AD7 试验；这是五项在≥18 岁中重度 AD 患者中进行的多中心、随机、双盲、安慰剂对照的 III 期研究。BREEZE-AD1、-AD2 和 -AD5 评估了巴瑞替尼作为单药治疗，BREEZE-AD4 和 -AD7 评估了巴瑞替尼联合 TCS、局部钙调磷酸酶抑制剂或局部 PDE-4 抑制剂（如适用）的疗效。评估了从基线改善≥50%（EASI50）和≥75%（EASI75）的患者比例（EASI 总评分），以及头/颈部 EASI50 和 EASI75 和头/颈部红斑 EASI50 和 EASI75 的反应率，直至第 16 周。
在所有研究中，93-98%的患者基线时存在头/颈部受累（EASI 头/颈部评分≥1）。在所有研究中，基于全身 EASI 总评分，巴瑞替尼治疗均同样有效。在单药治疗研究中，巴瑞替尼 2mg 和 4mg 治疗组在第 1 周和第 16 周时达到头/颈部 EASI50 和 EASI75 评分的患者比例明显高于安慰剂组。
巴瑞替尼 2mg 和 4mg 治疗可迅速显著减轻 AD 头颈部严重程度，包括红斑。
