Adverse drug reactions associated with treatment in patients with chronic rheumatic diseases in childhood: a retrospective real life review of a single center cohort

Abstract

Background Adverse drug reactions (ADRs) are the sixth leading causes of death worldwide; monitoring them is fundamental, especially in patients with disorders like chronic rheumatic diseases (CRDs). The study aimed to describe the ADRs investigating their severity and associated factors and resulting interventions in pediatric patients with CRDs. Methods A retrospective, descriptive and analytical study was conducted on a cohort of children and adolescents with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM). The study evaluated medical records of the patients to determine the causality and the management of ADRs. In order to investigate the risk factors that would increase the risk of ADRs, a logistic regression model was carried out on a group of patients treated with the main used drug. Results We observed 949 ADRs in 547 patients studied. Methotrexate (MTX) was the most frequently used medication and also the cause of the most ADRs, which occurred in 63.3% of patients, followed by glucocorticoids (GCs). Comparing synthetic disease-modifying anti-rheumatic drugs (sDMARDs) vs biologic disease-modifying anti-rheumatic drugs (bDMARDs), the ADRs attributed to the former were by far higher than the latter. In general, the severity of ADRs was moderate and manageable. Drug withdrawal occurred in almost a quarter of the cases. In terms of risk factors, most patients who experienced ADRs due to MTX, were 16 years old or younger and received MTX in doses equal or higher than 0.6 mg/kg/week. Patients with JIA and JDM had a lower risk of ADRs than patients with JSLE. In the multiple regression model, the use of GCs for over 6 months led to an increase of 0.5% in the number of ADRs. Conclusions Although the ADRs highly likely affect a wide range of children and adolescents with CRDs they were considered moderate and manageable cases mostly. However, triggers of ADRs need further investigations.

Gastrointestinal Involvement in Children with Systemic Lupus Erythematosus

“…Different drugs that are usually prescribed in SLE such as methotrexate, hydroxychloroquine, and azathioprine can be responsible for liver damage [34]. Even if not directly comparable to the pediatric population, data that are related to a large cohort of 1533 adult SLE patients reported by Huang et al, suggested that metabolic abnormalities such as obesity, hypertension, and drug-related toxicity may provide hepatotoxicity more than SLE-related factors [35].…”

Pharmacovigilance study in geriatric patients of a tertiary care hospital

“…The rate of fatal ADRs in US hospitals was found to be extremely high, close to the 5% estimate based on data from multiple studies around the world, placing these reactions between the fourth and sixth leading causes of death. (Said et al, 2020;Lazarou et al, 1998). The prevalence of ADR is higher among geriatric (5 %) as compared to adults.…”