Real-Life Experience of Safety Profile of a Rituximab Biosimilar (Reditux®) in Patients at a Rheumatology Center in India

Abstract

AIM: The aim of this study was to study the safety profile of a rituximab (RTX) biosimilar Reditux® in patients of rheumatological disorders at a tertiary care hospital in North India. Methodology: An observational study was carried out to ascertain the safety of RTX in rheumatology patients. A total of 60 patients initiated on RTX were followed up for a mean duration of 14 months for adverse events. Results: A total of seven mild infusion reactions were recorded during the first infusion of RTX. Eighteen infective events were recorded including a case of extrapulmonary tuberculosis (TB), three cases of hepatitis B virus (HBV) reactivation, four cases of herpes zoster, and a fatal case of disseminated varicella infection. There were no cases of JC virus infection or malignancies in our study. Conclusion: This study highlights a much higher incidence of infections following the use of RTX in India as compared to international studies published so far. We also observed a higher rate of reactivation of HBV, varicella zoster virus, and TB in our cohort. This emphasizes the need for revising protocols for screening, vaccination, and chemoprophylaxis for chronic infections in countries with high burden of infections.

Keywords

• biosimilar
• hepatitis b
• herpes
• rituximab
• tuberculosis