巴瑞替尼对特应性皮炎患者瘙痒及睡眠的改善作用：三项3期研究的事后分析
Itch and Sleep Improvements with Baricitinib in Patients with Atopic Dermatitis: A Post Hoc Analysis of 3 Phase 3 Studies.
作者信息
Buhl Timo, Rosmarin David, Serra-Baldrich Esther, Fernandez-Peñas Pablo, Igarashi Atsuyuki, Konstantinou Maria Polina, Chen Sherry, Lu Na, Pierce Evangeline, Casillas Marta
机构信息
Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.
Department of Dermatology, Tufts Medical Center, Boston, MA, USA.
出版信息
Dermatol Ther (Heidelb). 2021 Jun;11(3):971-982. doi: 10.1007/s13555-021-00534-8. Epub 2021 Apr 25.
INTRODUCTION
Burdensome symptoms of atopic dermatitis include itch and sleep disturbance. This post hoc analysis reports the effect of baricitinib on itch and sleep disturbance during the first week of treatment in 3 phase 3 studies.
METHODS
Patients were randomized 2:1:1:1 to once-daily placebo or baricitinib 1 mg, 2 mg, or 4 mg in the BREEZE-AD1 and -AD2 studies and 1:1:1 to once-daily placebo or baricitinib 2 mg or 4 mg in the BREEZE-AD7 study. Topical corticosteroids were only allowed in BREEZE-AD7. Patients completed the itch numerical rating scale and atopic dermatitis sleep scale (ADSS) items 1-3 using an electronic daily diary. Data were analyzed by study as least squares mean percent change from baseline in daily scores for the randomized patients. Mixed model repeated measures analysis was used to analyze change from baseline values.
RESULTS
A total of 624, 615, and 329 patients were randomized in BREEZE-AD1, -AD2, and -AD7, respectively. Itch severity significantly improved with baricitinib 2 mg and 4 mg versus placebo starting at day 2 (1 day after first dose) in BREEZE-AD1 and -AD7 and at day 1 in BREEZE-AD2. Patients' ability to fall asleep (ADSS item 1) significantly improved with baricitinib 2 mg and 4 mg versus placebo starting at day 2 in all three studies. There were significant improvements in patients waking due to itch (ADSS item 2) with baricitinib 4 mg versus placebo starting at day 2 in all three studies. Patients' ability to return to sleep after being woken by itch (ADSS item 3) was significantly improved with baricitinib 4 mg versus placebo starting at day 2 in BREEZE-AD1 and -AD2 and at day 4 in BREEZE-AD7.
CONCLUSION
Rapid onset of action, typically 1 day after taking the first dose of baricitinib, was observed consistently for the burdensome symptoms of itch and sleep disturbance. CLINICALTRIALS.
GOV IDENTIFIERS
BREEZE-AD1, NCT03334396; BREEZE-AD2, NCT03334422; BREEZE-AD7, NCT03733301.
引言
特应性皮炎的沉重症状包括瘙痒和睡眠障碍。这项事后分析报告了巴瑞替尼在3项3期研究治疗的第一周对瘙痒和睡眠障碍的影响。
方法
在BREEZE - AD1和 - AD2研究中，患者按2:1:1:1随机分为每日一次的安慰剂组或1毫克、2毫克或4毫克巴瑞替尼组；在BREEZE - AD7研究中，患者按1:1:1随机分为每日一次的安慰剂组或2毫克或4毫克巴瑞替尼组。仅在BREEZE - AD7中允许使用外用皮质类固醇。患者使用电子每日日记完成瘙痒数字评定量表和特应性皮炎睡眠量表（ADSS）的第1 - 3项。数据按研究进行分析，为随机分组患者每日评分相对于基线的最小二乘均值百分比变化。采用混合模型重复测量分析来分析相对于基线值的变化。
结果
在BREEZE - AD1、 - AD2和 - AD7中分别有624、615和329例患者被随机分组。在BREEZE - AD1和 - AD7中，从第2天（首次给药后1天）起，2毫克和4毫克巴瑞替尼组的瘙痒严重程度相对于安慰剂组显著改善；在BREEZE - AD2中，从第1天起显著改善。在所有三项研究中，从第2天起，2毫克和4毫克巴瑞替尼组相对于安慰剂组患者入睡能力（ADSS第1项）显著改善。在所有三项研究中，从第2天起，4毫克巴瑞替尼组相对于安慰剂组因瘙痒醒来的患者（ADSS第2项）有显著改善。在BREEZE - AD1和 - AD2中，从第2天起，在BREEZE - AD7中从第4天起，4毫克巴瑞替尼组相对于安慰剂组患者因瘙痒醒来后恢复睡眠的能力（ADSS第3项）显著改善。
结论
对于瘙痒和睡眠障碍这些沉重症状，一致观察到巴瑞替尼起效迅速，通常在服用首剂后的第1天。临床试验。
美国国立医学图书馆临床试验标识符
BREEZE - AD1，NCT03334396；BREEZE - AD2，NCT03334422；BREEZE - AD7，NCT03733301。
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