The indications and safety of rituximab for the treatment of pediatric autoimmune diseases: a single-center retrospective study.

Abstract

Background: Autoimmune diseases in children pose therapeutic challenges due to their refractory nature and the associated morbidity. Rituximab (RTX), a monoclonal antibody targeting CD20, has emerged as a promising steroid-sparing therapy for various autoimmune disorders by depleting B cells. However, its indications and safety in pediatric populations in our region remain insufficiently studied. This study aims to review the indications and safety of RTX in treating pediatric autoimmune diseases within a single-center setting.

Methods: A retrospective study was conducted on pediatric patients aged 18 years or younger who received RTX for different autoimmune diseases between January 2013 and March 2023 at King Abdulaziz University Hospital, Saudi Arabia. Data on demographics, indications, infusion details, adverse events, and concurrent medications were collected and analyzed.

Results: Twenty-two patients were included, with nephrotic syndrome and systemic lupus erythematosus (SLE) being the most common indications for RTX. The mean age at diagnosis and first RTX infusion was 8 and 9 years, respectively. The most commonly used protocol involved administering 2 infusions of 375 mg/m² each, given 2 weeks apart. RTX was commonly used as a second-line treatment following corticosteroids. Infusion-related adverse events occurred in 31.8% of patients, ranging from mild reactions such as chest tightness, fever, and headache to severe reactions such as anaphylaxis. No infectious related adverse events were observed.

Conclusions: This study highlights both the varied indications for which RTX was prescribed and the need for vigilance concerning infusion-related adverse events. It underscores the importance of close monitoring and appropriate management to ensure the safety of RTX therapy in pediatric patients. Further research is warranted to optimize treatment strategies and enhance patient outcomes in this population.