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Abstract：
BACKGROUND: Atopic dermatitis (AD) is a chronic immuno-inflammatory skin disease. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor approved for the treatment of mild to moderate AD. This post hoc analysis assesses the efficacy and safety of crisaborole in Chinese patients aged ≥ 2 years with mild to moderate AD.
METHODS: We evaluated the efficacy and safety of crisaborole in Chinese patients from the vehicle-controlled, phase 3 CrisADe CLEAR study. Patients were randomly assigned 2:1 to receive crisaborole or vehicle twice daily, respectively, for 28 days. The primary endpoint was percent change from baseline in Eczema Area and Severity Index (EASI) total score at day 29. Key secondary endpoints were improvement in Investigator\'s Static Global Assessment (ISGA), ISGA success, and change from baseline in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score. Adverse events were documented.
RESULTS: Of 391 patients in the overall study, 237 were from China, 157 assigned to crisaborole and 80 assigned to vehicle. A greater reduction in percent change from baseline in EASI total score at day 29 was shown in the crisaborole vs. vehicle group (least squares mean [LSM]: -66.34 [95% (confidence interval) CI -71.55 to -61.12] vs. -50.18 [95% CI -58.02 to -42.34]). Response rates for achievement of ISGA improvement (43.2% [95% CI 35.4-51.1] vs. 33.4% [95% CI 22.5-44.2]) and ISGA success (31.7% [95% CI 24.3-39.0] vs. 21.5% [95% CI 12.1-30.9]) at day 29 were higher in the crisaborole vs. vehicle group. A greater reduction in change from baseline in weekly average PP-NRS score at week 4 was observed in the crisaborole vs. vehicle group (LSM: -1.98 [95% CI -2.34 to -1.62] vs. -1.08 [95% CI -1.63 to -0.53]). No new safety signals were observed.
CONCLUSIONS: Crisaborole was effective and well tolerated in Chinese patients aged ≥ 2 years with mild to moderate AD.
BACKGROUND: ClinicalTrials.gov, NCT04360187.
METHODS: We evaluated the efficacy and safety of crisaborole in Chinese patients from the vehicle-controlled, phase 3 CrisADe CLEAR study. Patients were randomly assigned 2:1 to receive crisaborole or vehicle twice daily, respectively, for 28 days. The primary endpoint was percent change from baseline in Eczema Area and Severity Index (EASI) total score at day 29. Key secondary endpoints were improvement in Investigator\'s Static Global Assessment (ISGA), ISGA success, and change from baseline in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score. Adverse events were documented.
RESULTS: Of 391 patients in the overall study, 237 were from China, 157 assigned to crisaborole and 80 assigned to vehicle. A greater reduction in percent change from baseline in EASI total score at day 29 was shown in the crisaborole vs. vehicle group (least squares mean [LSM]: -66.34 [95% (confidence interval) CI -71.55 to -61.12] vs. -50.18 [95% CI -58.02 to -42.34]). Response rates for achievement of ISGA improvement (43.2% [95% CI 35.4-51.1] vs. 33.4% [95% CI 22.5-44.2]) and ISGA success (31.7% [95% CI 24.3-39.0] vs. 21.5% [95% CI 12.1-30.9]) at day 29 were higher in the crisaborole vs. vehicle group. A greater reduction in change from baseline in weekly average PP-NRS score at week 4 was observed in the crisaborole vs. vehicle group (LSM: -1.98 [95% CI -2.34 to -1.62] vs. -1.08 [95% CI -1.63 to -0.53]). No new safety signals were observed.
CONCLUSIONS: Crisaborole was effective and well tolerated in Chinese patients aged ≥ 2 years with mild to moderate AD.
BACKGROUND: ClinicalTrials.gov, NCT04360187.
摘要：
背景：特应性皮炎（AD）是一种慢性免疫炎症性皮肤病。Crisaborole软膏,2%,是批准用于治疗轻度至中度AD的非甾体磷酸二酯酶4抑制剂。这项事后分析评估了在年龄≥2岁的中国轻中度AD患者中使用crisaborole的疗效和安全性。
方法：我们从车辆对照，第三阶段CrisADeCLEAR研究。患者被随机分配2：1，每天两次接受crisaborole或车辆，分别,28天主要终点是第29天时湿疹面积和严重程度指数(EASI)总分相对于基线的百分比变化。关键次要终点是研究者静态全球评估(ISGA)的改善，ISGA成功,每周平均瘙痒峰数值评定量表（PP-NRS）评分与基线的变化。记录不良事件。
结果：在整个研究中的391名患者中，237来自中国，157个分配给crisaborole，80个分配给车辆。在第29天，EASI总分从基线的变化百分比降低更大。车辆组(最小二乘均值[LSM]：-66.34[95%(置信区间)CI-71.55至-61.12]vs.-50.18[95%CI-58.02至-42.34]）。实现ISGA改善的反应率(43.2%[95%CI35.4-51.1]与33.4%[95%CI22.5-44.2]）和ISGA成功率（31.7%[95%CI24.3-39.0]与21.5％[95％CI12.1-30.9]）在第29天较高车辆组。在第4周时，观察到从基线开始的每周平均PP-NRS评分的变化更大。车辆组(LSM：-1.98[95%CI-2.34至-1.62]与-1.08[95%CI-1.63至-0.53]）。没有观察到新的安全信号。
结论：Crisaborole对年龄≥2岁的中国轻中度AD患者有效且耐受性良好。
背景：ClinicalTrials.gov，NCT04360187。
方法：我们从车辆对照，第三阶段CrisADeCLEAR研究。患者被随机分配2：1，每天两次接受crisaborole或车辆，分别,28天主要终点是第29天时湿疹面积和严重程度指数(EASI)总分相对于基线的百分比变化。关键次要终点是研究者静态全球评估(ISGA)的改善，ISGA成功,每周平均瘙痒峰数值评定量表（PP-NRS）评分与基线的变化。记录不良事件。
结果：在整个研究中的391名患者中，237来自中国，157个分配给crisaborole，80个分配给车辆。在第29天，EASI总分从基线的变化百分比降低更大。车辆组(最小二乘均值[LSM]：-66.34[95%(置信区间)CI-71.55至-61.12]vs.-50.18[95%CI-58.02至-42.34]）。实现ISGA改善的反应率(43.2%[95%CI35.4-51.1]与33.4%[95%CI22.5-44.2]）和ISGA成功率（31.7%[95%CI24.3-39.0]与21.5％[95％CI12.1-30.9]）在第29天较高车辆组。在第4周时，观察到从基线开始的每周平均PP-NRS评分的变化更大。车辆组(LSM：-1.98[95%CI-2.34至-1.62]与-1.08[95%CI-1.63至-0.53]）。没有观察到新的安全信号。
结论：Crisaborole对年龄≥2岁的中国轻中度AD患者有效且耐受性良好。
背景：ClinicalTrials.gov，NCT04360187。
