Long-term safety of rituximab in patients with rheumatoid arthritis

Aim: To evaluate the long-term safety of rituximab in our cohort of 173 patients with rheumatoid arthritis treated with rituximab and followed-up for longer than 1 year. Materials & Methods: Retrospective study of adverse events, including infusion reactions, neutropenia, hypogammaglobulinemia, infections, malignancies and development of autoimmune conditions. Results: Safety analysis is based on 768.4 patient-years of observation. Four patients had an episode of early-onset neutropenia; nine patients had late-onset neutropenia, although only two were severe; 27% of the patients in the cohort have experienced respiratory infections; 25% have had low IgM determinations; and 24% have had low IgG determinations. Conclusion: Long-term follow-up of rheumatoid arthritis patients on rituximab therapy has shown efficacy and safety profiles similar to clinical trials. The incidence of hypogammaglobulinemia increased after multiple cycles and could contribute to repeated infections and be a limiting factor for futu...