Intensive Safety Monitoring of Rituximab (Biosimilar Novex ® and the Innovator) in Pediatric Patients With Complex Diseases

NATALIA RIVA ; MANUEL MOLINA ; ANDREA SAVRANSKY ; SILVIA TENEMBAUM ; MARÍA M KATSICAS; MARTA MONTEVERDE; RAQUEL STACIUK; PEDRO ZUBIZARRETA; LAGOMARSINO E; PAULA SCHAIQUEVICH

Frontiers in Pharmacology

Nature

Año: 2022

1663-9812

Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex® and innovator, and to identify risk factors for the development of ADR in a real-life follow-up cohort of pediatric patients with complex diseases. We conducted a prospective, longitudinal, observational, single-centre study in patients that received rituximab for any complex disease, and as part of an intensive pharmacovigilance program. Demographic, pharmacological, clinical, and drug-related data were collected for all patients. ADR-free survival, including infusion-related reactions (IRR) and delayed ADR (dADR), was estimated using Kaplan-Meier curves. Risk factors were evaluated by multivariable Cox regression models. In total, 77 patients (