在轻度至中度特应性皮炎患者中，每日一次使用crisaborole维持研究者的静态整体评估反应。
Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis.
作者信息
Eichenfield Lawrence F, Stein Gold Linda F, Lynde Charles, Guenther Lyn, Greenberger Shoshana, Chu Chia-Yu, Ghodsi Zara, Vlahos Bonnie, Sanders Paul, Cha Amy, Canosa Juliana M
机构信息
UC San Diego and Rady Children's Hospital, 3020 Children's Way, Mail Code 5062, San Diego, CA, 92123, USA.
Henry Ford Hospital, Detroit, MI, USA.
出版信息
Dermatol Ther (Heidelb). 2024 Apr;14(4):875-892. doi: 10.1007/s13555-024-01129-9. Epub 2024 Mar 28.
INTRODUCTION
Treatments for atopic dermatitis (AD) often fail to achieve lasting disease control. In the CrisADe CONTROL phase III study (ClinicalTrials.gov: NCT04040192), participants aged ≥ 3 months with mild to moderate AD treated with once-daily (QD) crisaborole, following initial treatment success with crisaborole twice daily (BID), had longer periods of flare-free maintenance, a higher number of flare-free days, and a lower number of flares compared with those who received vehicle. The study was an exploratory analysis of data on the maintenance of response per Investigator's Static Global Assessment (ISGA; ISGA score of 0 [clear] or 1 [almost clear]) during the CrisADe CONTROL study through week 52.
METHODS
Exploratory endpoints were the time to ISGA response during the open-label run-in period, and the maintenance of ISGA response and the severity and duration of flares during the double-blind maintenance period. Outcomes were stratified by age (participants aged 3 months to < 12 years and ≥ 12 years) and duration of crisaborole BID treatment (< 4 weeks or ≥ 4 weeks) during the open-label run-in period.
RESULTS
During the open-label run-in period, the median time to ISGA response was 41.5 days. From week 4 to week 52 of the double-blind maintenance period, the proportion of participants who maintained ISGA response was greater with crisaborole versus vehicle, and this difference was statistically significant up to week 36 (P < 0.05). Duration of flare periods during the maintenance period were 54.1 and 54.0 days for the vehicle and crisaborole-treated groups, respectively. Numerically fewer crisaborole-treated participants experienced a flare with an ISGA score of ≥ 2 compared with vehicle-treated participants (64.8% vs. 74.4%, respectively). Findings were comparable across most subgroups.
CONCLUSIONS
Adult and pediatric participants with mild to moderate AD at baseline who had achieved responder criteria (treatment success) with crisaborole BID during the run-in period maintained response per ISGA with crisaborole QD during the double-blind maintenance period through week 52.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT04040192.
引言
特应性皮炎（AD）的治疗往往无法实现对疾病的持久控制。在CrisADe CONTROL III期研究（ClinicalTrials.gov：NCT04040192）中，年龄≥3个月的轻至中度AD患者，在初始每日两次（BID）使用克立硼罗治疗成功后，改为每日一次（QD）使用克立硼罗治疗，与接受赋形剂治疗的患者相比，无发作维持期更长、无发作天数更多且发作次数更少。该研究是对CrisADe CONTROL研究中至第52周时根据研究者静态整体评估（ISGA；ISGA评分为0[清除]或1[几乎清除]）维持反应的数据进行的探索性分析。
方法
探索性终点为开放标签导入期至ISGA反应的时间，以及双盲维持期ISGA反应的维持情况、发作的严重程度和持续时间。结果按年龄（3个月至<12岁和≥12岁的参与者）和开放标签导入期克立硼罗BID治疗的持续时间（<4周或≥4周）进行分层。
结果
在开放标签导入期，至ISGA反应的中位时间为41.5天。在双盲维持期的第4周至第52周，与赋形剂相比，使用克立硼罗维持ISGA反应的参与者比例更高，且直至第36周这种差异具有统计学意义（P<0.05）。维持期发作期的持续时间，赋形剂治疗组和克立硼罗治疗组分别为54.1天和54.0天。与赋形剂治疗的参与者相比，使用克立硼罗治疗且ISGA评分≥2的发作参与者在数量上更少（分别为64.8%和74.4%）。大多数亚组的结果具有可比性。
结论
基线时患有轻至中度AD的成人和儿童参与者，在导入期使用克立硼罗BID达到反应标准（治疗成功），在双盲维持期至第52周时，每日一次使用克立硼罗可根据ISGA维持反应。
试验注册
ClinicalTrials.gov：NCT04040192。
Zotero 插件