Abstract
CONTEXT: Despite the clinical benefits, the administration of biologics in asthma is not without adverse effects. However, there is a lack of information on the safety profile, particularly in children. OBJECTIVE: To provide a systematic review of the range of reported adverse events (AEs) of biologic treatments approved for paediatric asthma (Xolair, Nucala, Dupixent, Fasenra and Tezspire). DATA SOURCES: Databases (MEDLINE, CENTRAL, Scopus and Web of Science) and one registry (ClinicalTrials.gov). STUDY SELECTION: This review included randomised clinical trials, prospective clinical studies, real-world studies, exploratory studies, registry analyses, case series and case reports, which met predefined inclusion criteria. DATA EXTRACTION: Study characteristics and AEs were extracted into predefined forms and then summarised in terms of their frequency and study duration. RESULTS: Overall, 45 reports and 13 clinical trials met the inclusion criteria for data evaluation, of which eight studies were placebo-controlled. Overall, paediatric asthma patients' most frequently reported AEs were headache, injection site reactions, upper respiratory tract infections, pyrexia and urticaria. The systematic analysis revealed a similar safety profile of the biologics to that reported on the product labels. LIMITATIONS: The small number of paediatric patients, missing placebo control groups, variant definitions of AEs and a lack of statistical evaluation limited the validation of specific AEs to individual biologics. CONCLUSIONS: In this systematic review, no new safety concerns regarding the use of biologics in paediatric asthma were identified, even after an observation period of up to 7 years. In order to record rare side-effects and possible long-term consequences, further data from paediatric study cohorts are needed.