PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：已知对Janus激酶（JAK）1/2抑制剂baricitinib（BARI）最有可能反应的中度至重度特应性皮炎（AD）患者的体表面积（BSA）≤40％和严重瘙痒（数字等级量表[NRS]≥7]，统称为“BARI瘙痒为主”患者。我们的目标是在我们以前的工作的基础上，通过提供一个特定的身体区域，基线时BARI瘙痒为主患者的临床特征及其对BARI4mg的反应。
方法：BREEZE-AD7是一项针对中度至重度AD成人的3期试验，接受安慰剂或2mg或4mgBARI联合外用皮质类固醇。仅评估BARI瘙痒为主患者的数据，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,以报告该亚型患者对安慰剂和BARI4mg的反应.
结果：BARI4mg在所有身体区域均非常有效；在第16周时，EASI评分（EASI75）改善了75％，和BARI4mg的反应率(头/颈部，58.3%;树干,69.2%;上肢,61.5%;下肢,87.5％）全部超过安慰剂组（头/颈部：37.5％；躯干，40.6%；上肢；18.8%;下肢,40.6%)以及意向治疗(ITT)人群的整体EASI75率(BARI，48.0%；安慰剂，23.0%）。在基线,大多数以BARI瘙痒为主的患者出现所有区域的受累（平均区域BSA22.7%-40.3%），在头部和颈部最高，EASI地区平均得分为15.7-24.0分，以及相当严重的体征评分（平均EASI子得分：1.4-2.3分，共3分），尤其是红斑.
结论：BARI瘙痒为主的患者在所有身体部位均表现出AD受累，体征严重程度相当高，尤其是红斑.对BARI4毫克的反应，EASI在各地区迅速改善，在这种亚型中比在ITT群体中更明显。
方法：BREEZE-AD7是一项针对中度至重度AD成人的3期试验，接受安慰剂或2mg或4mgBARI联合外用皮质类固醇。仅评估BARI瘙痒为主患者的数据，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,以报告该亚型患者对安慰剂和BARI4mg的反应.
结果：BARI4mg在所有身体区域均非常有效；在第16周时，EASI评分（EASI75）改善了75％，和BARI4mg的反应率(头/颈部，58.3%;树干,69.2%;上肢,61.5%;下肢,87.5％）全部超过安慰剂组（头/颈部：37.5％；躯干，40.6%；上肢；18.8%;下肢,40.6%)以及意向治疗(ITT)人群的整体EASI75率(BARI，48.0%；安慰剂，23.0%）。在基线,大多数以BARI瘙痒为主的患者出现所有区域的受累（平均区域BSA22.7%-40.3%），在头部和颈部最高，EASI地区平均得分为15.7-24.0分，以及相当严重的体征评分（平均EASI子得分：1.4-2.3分，共3分），尤其是红斑.
结论：BARI瘙痒为主的患者在所有身体部位均表现出AD受累，体征严重程度相当高，尤其是红斑.对BARI4毫克的反应，EASI在各地区迅速改善，在这种亚型中比在ITT群体中更明显。
