Adverse Events and Safety of Oral Cyclosporine for Dermatoses among Children and Adolescents: A Single Center Study

Abstract

Background: Cyclosporine (CS) is widely used in various dermatological diseases, and its range of usage has been expanded to younger patients. However, data on the safety of CS in children and adolescents are limited. Objective: This study aimed to investigate the adverse events and safety of CS in pediatric and adolescent patients with dermatologic diseases. Methods: This retrospective study included 992 pediatric patients (> 12 and < 19 years of age) having administered oral CS for dermatological reasons between 2010 and 2021. Results: Among the 992 patients, 57 (5.7%) reported adverse events at the clinic. Gastrointestinal symptoms were the most common adverse events (2.6%). Other adverse events included hypertrichosis (1.4%) and headaches (0.6%). During subgroup analysis, hypertrichosis was found more frequently in pediatric patients (age < 12 years), and the cumulative dose of CS was higher (≥420 mg/kg). Of the 150 patients who underwent laboratory tests, 28 (18.7%) showed abnormal results, including an increase in serum creatinine (8.0%), hypercholesterolemia (6.7%), and urea (2.7%). Conclusion: The use of CS in pediatric dermatoses resulted in a low frequency of adverse events, and all the patients showed reversible courses without serious complications. The study suggest that dermatologists should safely administer oral CS with detailed history taking and periodic laboratory tests.