Safety of biologics for the treatment of asthma in children and adolescents: a systematic review
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…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.