Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged ≥ 2 Years with Mild to Moderate Atopic Dermatitis

Lin Ma; Xiaohua Tao; Sujun Liu; Hao Cheng; Ruihua Fang; Yan Zhao; Amy Cha; Gerardo A Encinas; Yangmei Zhou; Yujie Deng; Jianzhong Zhang

doi:10.1007/s13555-024-01156-6

Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged ≥ 2 Years with Mild to Moderate Atopic Dermatitis

Dermatol Ther (Heidelb). 2024 May;14(5):1229-1243. doi: 10.1007/s13555-024-01156-6. Epub 2024 May 15.

Authors

Lin Ma¹, Xiaohua Tao², Sujun Liu³, Hao Cheng⁴, Ruihua Fang⁵, Yan Zhao⁶, Amy Cha⁷, Gerardo A Encinas⁸, Yangmei Zhou⁹, Yujie Deng¹⁰, Jianzhong Zhang¹¹

Affiliations

¹ Department of Dermatology, Beijing Children's Hospital, National Center for Children's Health, Capital Medical University, Beijing, China.
² Department of Dermatology, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.
³ Department of Dermatology, Hangzhou Third People's Hospital, Hangzhou, Zhejiang, China.
⁴ Department of Dermatology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
⁵ Department of Dermatology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China.
⁶ Department of Dermatology, Peking University People's Hospital, Beijing, 100044, China.
⁷ Pfizer Inc., New York, NY, USA.
⁸ Pfizer SA DE CV, Mexico City, Mexico.
⁹ Clinical Development, Pfizer R&D China, Shanghai, China.
¹⁰ Pfizer Beijing, Beijing, China.
¹¹ Department of Dermatology, Peking University People's Hospital, Beijing, 100044, China. rmzjz@126.com.

Abstract

Introduction: 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.

Conclusion: Crisaborole was effective and well tolerated in Chinese patients aged ≥ 2 years with mild to moderate AD.

Trial registration: ClinicalTrials.gov, NCT04360187.

Keywords: Atopic dermatitis; Chinese patients; Crisaborole; Eczema Area and Severity Index; Infant; Phosphodiesterase 4 inhibitors.

Associated data

ClinicalTrials.gov/NCT04360187