Corticosteroid Bursts Associated With Increased Risk of Serious Adverse Events in Children

Corticosteroid bursts are often prescribed for non-life-threatening conditions in pediatric populations and have been found to be associated with increased risk of gastrointestinal bleeding, sepsis, and pneumonia within 30 days of initiation, according to the results of research published in JAMA Pediatrics.

Currently, data about the potential harms of short-term oral corticosteroid use in children remain limited. In an effort to address this gap, researchers utilized a self-controlled case series design to conduct a nationwide, population-based study in Taiwan to evaluate the relationship between corticosteroid bursts in children and gastrointestinal bleeding, sepsis, pneumonia, and glaucoma events.

Data were collected from the National Health Insurance Research Database, which includes medical claims records and prescription data from approximately 23 million individuals covered by the Taiwanese National Health Insurance Program. Medical claims and prescription data from 2013 to 2017 were included in the study.

The total cohort included 4,542,623 children, of whom 42% (n=1,897,858) received at least 1 corticosteroid burst over the course of the 5-year study period. The inclusion cohort comprised 1,064,587 participants (51.1% boys; mean age, 9.7±5.8 years; 91% Charlson Comorbidity Index score of 0). Participants were grouped based on whether they received a single corticosteroid burst or 1 or more corticosteroids burst during the observational period, and baseline data indicate comparable characteristics between these 2 groups.

The most common indications for corticosteroid bursts were acute respiratory tract infections, including acute bronchitis and bronchiolitis; acute sinusitis; acute tonsillitis; acute laryngitis and tracheitis; acute nasopharyngitis and allergic diseases (urticaria); contact dermatitis and eczema; asthma; and allergic rhinitis.

Incidence rates per 1000 person-years across the 4 severe adverse events were higher among patients who were prescribed a single corticosteroid burst compared with those not prescribed corticosteroids. Incidence rate differences were 0.60, 0.03, 9.35, and 0.01 for gastrointestinal bleeding, sepsis, pneumonia, and glaucoma, respectively. Incidence rate ratios within 5 to 30 days following initiation of a corticosteroid burst were 1.41, 2.02, 2.19, and 0.98, respectively, for each event. Within the subsequent 31 to 90 days, rates were 1.10, 1.08, 1.09, and 0.95, respectively.

Incidence rate ratios for gastrointestinal bleeding and pneumonia were significantly higher in the 2 posttreatment periods in the single corticosteroid burst group compared with the reference period. The incidence rate ratio for sepsis was significantly higher during the first, but not the second, posttreatment period.

Study limitations include a lack of availability of lifestyle factors, potential concerns related to nonadherence to treatment, and no exploration as to whether antibiotic prescription increased following corticosteroid burst initiation.

“Treatment with corticosteroid bursts is associated with a 1.4- to 2.2-fold increased risk of [gastrointestinal] bleeding, sepsis, and pneumonia within the first month after initiation of corticosteroid therapy among children,” the researchers wrote. “Clinicians should be aware of these rare but potentially serious adverse events…particularly during the first month after corticosteroid initiation.”

“These findings provide real-world evidence for clinicians and guideline developers to implement strategies with optimal benefit to risk ratios for preventing avoidable harms,” they concluded.

Disclosure: One study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Yao T-C, Wang J-Y, Chang S-M, et al. Association of oral corticosteroid bursts with severe adverse events in children. JAMA Pediatr. Published online April 19, 2021. doi:10.1001/jamapediatrics.2021.0433