Safety profile of repeated rituximab cycles in unselected rheumatoid arthritis patients: a long-term, prospective real-life study

Clinical and Experimental Rheumatology

Christodoulos Antoniadis¹  Dimitrios Vassilopoulos¹  Evie M. Delicha¹  Grigorios Skarantavos¹  Lazaros Sakkas¹  Vassiliki Galanopoulou¹  Loukas Settas¹  Panagiota Boura¹  Dimitrios Daoussis¹  Konstantinos Tempos¹  Spyros Aslanidis¹  Alexandros Andrianakos¹  Petros P. Sfikakis¹  Kyriaki Boki¹  Marios Katsounaros¹  Eleni Vritzali¹  Panagiotis Athanassiou¹  Fotini Skopouli¹  Sotirios Papazoglou¹ 

关键词: Rheumatoid arthritis;    rituximab;    biological therapy;    disease modifying anti-rheumatic drugs;    safety;   

DOI  :  

学科分类：医学（综合）

来源: Pacini Editore SpA

【 摘 要 】

OBJECTIVES: To evaluate the long-term safety of rituximab (RTX) in rheumatoid arthritis (RA) patients in daily clinical practice. METHODS: This was a multicentre (17 Greek Rheumatology sites), prospective, long-term, pharmacovigilance study of patients with moderate to severe RA and an inadequate response or intolerance to ≥1 anti-tumour necrosis factor (TNF) agents. Adverse events (AEs) were recorded and collected prospectively every 2-6 months. RESULTS: 234 patients (mean age: 59±12.5, 79.5% women, mean DAS28: 5.35±1.32) were included and followed for 27.7 months (median). The overall AEs, serious AE (SAEs) and serious infection (SIEs) rate were 48.36, 6.68 and 2.53/100 patient-years, respectively. Three cases of hepatitis B virus (HBV) reactivation were recorded (two in chronic and one in past HBV infection). Withdrawals due to AEs (5.6%) occurred more frequently during the first cycles of RTX therapy while repeated RTX cycles were not associated with an increased risk of AEs. There were 3 deaths with an incidence rate of 0.69/100 patient-years. Age ≥65 years was associated with a higher incidence rate ratio of AEs and SAEs as compared to

【 授权许可】

Unknown