Adverse events of biological agents in pediatric rheumatologic diseases.

OBJECTIVES: To evaluate adverse events (AEs) in pediatric patients with rheumatologic diseases being treated with approved or off-label biologic agents (BAs). METHODS: This observational, retrospective, multicenter study was conducted from 2010 to 2022 in patients under 18 years of age with rheumatic diseases who were receiving interleukin-1 antibodies (Anti-IL1), interleukin-6 antibodies (Anti-IL6), and tumor necrosis factor alpha inhibitors (anti-TNF). Efficacy, AEs, and timing of AEs were collected from electronic medical records. RESULTS: Three hundred and fifteen BAs were prescribed to 237 patients. Fifty AEs occurred in 44 patients (18.6%). Anti-TNF exposure was present in 8 (72.2%) of 11 patients with latent tuberculosis (TB) and in all 7 patients with herpes infections. Four of 6 patients (66.7%) with recurrent upper respiratory tract infections and 7 of 8 patients (87.5%) with local skin reactions were on Anti-IL1. The cutoff value for latent TB development was determined as 23.5 months by ROC analysis (AUC: 0.684 ± 0.072, p = 0.038, 95% CI: 0.54-0.82). In patients who used BA for 23.5 months or more, the risk of latent TB was 5.94-fold (p = 0.024, 95% CI: 1.26-27.97). Drug rash with eosinophilia and systemic symptoms (DRESS) occurred in 2 patients on anakinra, and anaphylaxis occurred in 1 patient on anti-IL6. There were no cases of malignancy or death in any patient. CONCLUSION: The physician should be vigilant for latent TB in patients exposed to BA for more than 2 years. While local skin reactions are more prevalent in patients receiving anti-IL1, severe skin reactions such as DRESS may also occur.

Complications of epicutaneo-caval catheters: Pericardial effusion and cardiac tamponade in three preterm infants.

In the neonatal intensive care units (NICU), epicutaneo-caval catheters (ECCs) are common alternative vascular routes. Pericardial effusion (PCE) and cardiac tamponade (CT) are rare but serious complications in infants with ECCs. It may be asymptomatic or present with a variety of significant clinical signs, including dyspnea, bradycardia, sudden asystole, and hypotension. If untreated, PCE can be fatal. This report presents, three cases of ECC-associated PCE/CT during NICU stay. All three patients were born before 30 weeks of gestation and weighed less than 1500 g. Echocardiography was used for diagnosis all patients. PCE/CT was detected incidentally in one patient and after hemodynamic deterioration in the other two. In one patient, CT was developed due to catheter malposition, and the other two patient, the catheter tip was found in the right atrium. PCE did not recur in any of the patients after pericardial fluid was drained and the catheters were removed. No PCE/CT-related deaths were observed. In all three patients, X-ray was used to evaluate the location of the catheter tips. However, after clinical deterioration, echocardiography showed that in the first two cases the tips were actually in the right atrium. Real-time ultrasound was suggested with strong evidence to evaluate the location of the catheter tip and to detect secondary malapposition. PCE/CT should be considered in the presence of unexplained and refractory respiratory distress, abnormal heart rate and blood pressure, and metabolic acidosis in a neonate with ECC. Early diagnosis and prompt pericardiocentesis are essential to reduce mortality and improve prognosis. Prospective studies with educational interventions should be designed to demonstrate that the use of point-of-care ultrasound (POCUS) can be easily acquired and may reduce complications.