Carrascosa José-Manuel, Narcisi Alessandra, Nomura Toshifumi, Ständer Sonja, Vestergaard Christian, Sabatino Silvia, Grond Susanne, Koppelhus Uffe, Elrayes Mohamed, Chen Yun-Fei, Liu Chunyuan, Wollenberg Andreas
Department of Dermatology, Hospital Universitari Germans Trias i Pujol, IGTP, Universitat Autònoma of Barcelona, Carretera de Canyet, s/n, 08916, Badalona, Barcelona, Spain.
Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy.
Dermatol Ther (Heidelb). 2024 Jun;14(6):1561-1573. doi: 10.1007/s13555-024-01171-7. Epub 2024 May 22.
Patients with moderate-to-severe atopic dermatitis (AD) who are most likely to respond to the Janus kinase (JAK) 1/2 inhibitor baricitinib (BARI) are known to have an impacted body surface area (BSA) ≤ 40% and severe itch (numerical rating scale [NRS] ≥ 7], collectively termed 'BARI itch-dominant' patients. Our objective is to build on our previous work by providing a body region-specific, clinical characterization of the BARI itch-dominant patient at baseline and their response to BARI 4 mg.
BREEZE-AD7 was a phase 3 trial in adults with moderate-to-severe AD receiving placebo or 2 mg or 4 mg BARI in combination with topical corticosteroids. Assessing only data from BARI itch-dominant patients, we summarized the baseline characteristics and conducted body region-specific analyses on Eczema Area and Severity Index (EASI) data in order to report the response to placebo versus BARI 4 mg within this patient subtype.
BARI 4 mg was highly effective across all body regions; at week 16, 75% improvement was seen in EASI scores (EASI75), and response rates with BARI 4 mg (head/neck, 58.3%; trunk, 69.2%; upper extremities, 61.5%; lower extremities, 87.5%) all exceeded those with placebo (head/neck: 37.5%; trunk, 40.6%; upper extremities, 18.8%; lower extremities, 40.6%) as well as the overall EASI75 rates of the intent-to-treat (ITT) population (BARI, 48.0%; placebo, 23.0%). At baseline, most BARI itch-dominant patients presented with involvement of all regions (mean regional BSA 22.7%-40.3%), highest in the head and neck, mean EASI region scores of 15.7-24.0, and considerably severe sign ratings (mean EASI sub-scores: 1.4-2.3, out of 3), especially for erythema.
BARI itch-dominant patients exhibit AD involvement across all body regions and considerable sign severity, especially erythema. In response to BARI 4 mg, EASI quickly improved across regions, substantially more so in this subtype than in the ITT population.
已知最有可能对Janus激酶（JAK）1/2抑制剂巴瑞替尼（BARI）产生反应的中度至重度特应性皮炎（AD）患者的受累体表面积（BSA）≤40%且瘙痒严重（数字评分量表[NRS]≥7），统称为“BARI瘙痒主导型”患者。我们的目标是在之前工作的基础上，对BARI瘙痒主导型患者在基线时进行身体区域特异性的临床特征描述，并分析他们对4毫克巴瑞替尼的反应。
BREEZE - AD7是一项针对中度至重度AD成人患者的3期试验，患者接受安慰剂或2毫克或4毫克巴瑞替尼联合外用糖皮质激素治疗。仅评估BARI瘙痒主导型患者的数据，我们总结了基线特征，并对湿疹面积和严重程度指数（EASI）数据进行了身体区域特异性分析，以便报告该患者亚组中对安慰剂与4毫克巴瑞替尼的反应。
4毫克巴瑞替尼在所有身体区域均具有高效性；在第16周时，EASI评分（EASI75）改善了75%，4毫克巴瑞替尼的有效率（头颈部，58.3%；躯干，69.2%；上肢，61.5%；下肢，87.5%）均超过安慰剂组（头颈部：37.5%；躯干，40.6%；上肢，18.8%；下肢，40.6%）以及意向性治疗（ITT）人群的总体EASI75率（巴瑞替尼，48.0%；安慰剂，23.0%）。在基线时，大多数BARI瘙痒主导型患者所有区域均受累（平均区域BSA为22.7% - 40.3%），头颈部受累程度最高，平均EASI区域评分为15.7 - 24.0，体征评分相当严重（平均EASI子评分：满分3分，为1.4 - 2.3），尤其是红斑。
BARI瘙痒主导型患者全身各区域均有AD累及，体征严重程度较高，尤其是红斑。对于4毫克巴瑞替尼的治疗反应，各区域的EASI评分迅速改善，在该亚组中的改善程度显著高于ITT人群。
