A Prospective Observational Study to Evaluate the Actual Use of 1% Pimecrolimus in Chinese Patients with Mild-to-Moderate Atopic Dermatitis Affecting Sensitive Skin Areas

Zhiqiang Xie,1 Jianmin Chang,2 Lin Ma,3 Chunping Shen,3 Li Zhang,4 Qian An,5 Hua Wang,6 Xia Dou,7 Yue Zheng,8 Congxiu Ye,8 Ying Gao9 1Department of Dermatology, Peking University Third Hospital, Beijing, People’s Republic of China; 2Department of Dermatology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 3Department of Dermatology, Beijing Children’s Hospital, Capital Medical University, National Key Discipline of Pediatrics, Key Laboratory of Major Diseases in Children, Ministry of Education, National Center for Children‘s Health, Beijing, People’s Republic of China; 4Department of Dermatology, The First Hospital of China Medical University; NHC Key Laboratory of Immunodermatology; National and Local Joint Engineering Research Center of Immunodermatological Theranostics, Shenyang, People’s Republic of China; 5Department of Dermatology, The First Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of China; 6Department of Dermatology, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of China; 7Department of Dermatology, Peking University Shenzhen Hospital, Shenzhen, People’s Republic of China; 8Department of Dermato-Venereology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, People’s Republic of China; 9Department of Dermatology, Capital Institute of Pediatrics, Beijing, People’s Republic of ChinaCorrespondence: Zhiqiang Xie, Peking University Third Hospital, Beijing, People’s Republic of China, Email [email protected]: Atopic dermatitis (AD) is a common inflammatory skin disorder that affects both children and adults, characterized by pruritus and scaly, dry eczematous lesions. This study aimed to gather knowledge on the actual use and effectiveness of Pimecrolimus (PIM) in Chinese patients with mild-to-moderate AD affecting sensitive skin areas in routine clinical practice.Methods: This multicentre and non-interventional study included 130 subjects from China, divided into two age groups (2– 12 years and ≥ 12 years). The primary endpoint was the change in SCORAD index, in AD areas from inclusion to the end of the PIM treatment period.Results: The primary efficacy analysis showed a significant reduction in the SCORAD index from baseline to the end of the PIM treatment period (p < 0.0001). The mean change in SCORAD index (SD) from baseline at visit 2 and visit 3 was − 15.4 (10.50) and − 18.6 (11.57), respectively. The mean Investigator’s Global Assessment (IGA) score decreased from 2.3 at baseline to 0.7 at the end of the study, while the mean itching score decreased from 4.7 at baseline to 0.9 at the end of the study. The mean duration of PIM use was 38.3 days, with similar durations for patients above and below 12 years. There was progressive improvement in the quality of life of the patients with PIM treatment. The median time to first flare was 100 days and no adverse drug reactions or significant adverse events were reported during the study.Discussion: This study provides robust real-world evidence that PIM 1% cream is effective for the treatment of mild-to-moderate AD in Chinese patients, particularly in sensitive skin areas and paediatric population. PIM also offers a TCS-sparing approach, making it a valuable option for managing mild-to-moderate AD.Keywords: atopic dermatitis, pimecrolimus, China, SCORAD index, non-interventional study