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

Autor:	Vassilopoulos D; 2nd Department of Internal Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, Hippokration General Hospital; and Joint Rheumatology Program, National and Kapodistrian University of Athens Medical School, Greece., Delicha EM; 1st Department of Propedeutic & Internal Medicine, Laikon Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece., Settas L; Rheumatology Unit, AHEPA Hospital, University of Thessaloniki, Thessaloniki, Greece., Andrianakos A; Hellenic Foundation of Rheumatology, Athens, Greece., Aslanidis S; 2nd Department of Internal Medicine, Hippokratio Hospital, Thessaloniki, Greece., Boura P; 2nd Department of Internal Medicine, University of Thessaloniki, Thessaloniki, Greece., Katsounaros M; 2nd Department of Internal Medicine, Papanikolaou Hospital, Thessaloniki, Greece., Athanassiou P; Rheumatology Division, St. Paul Hospital, Thessaloniki, Greece., Tempos K; Rheumatology Division, KAT Hospital, Athens, Greece., Skarantavos G; Rheumatology and Bone Metabolic Diseases Clinic, Attikon Hospital, Athens, Greece., Antoniadis C; Rheumatology Division, Asclepieion Hospital, Athens, Greece., Papazoglou S; Rheumatology Division, Georgios Gennimatas General Hospital, Athens, Greece., Sakkas L; Rheumatology Division, University Hospital of Thessaly, Larissa, Greece., Galanopoulou V; 1st Internal Medicine Department, Department of Rheumatology, Papageorgiou Hospital, Thessaloniki, Greece., Skopouli F; 2nd Department of Internal Medicine, Euroclinic Hospital, Athens, Greece., Boki K; Rheumatology Clinic, Sismanoglio Hospital, Athens, Greece., Daoussis D; Patras University Rheumatology Department, Patra, Greece., Vritzali E; Immunology Franchise, Medical Department, Roche Hellas SA, Greece., Sfikakis PP; Joint Rheumatology Program, National and Kapodistrian University of Athens Medical School; and 1st Department of Propedeutic & Internal Medicine, Laikon Hospital, National and Kapodistrian University of Athens Medical School, Greece.
Jazyk:	angličtina
Zdroj:	Clinical and experimental rheumatology [Clin Exp Rheumatol] 2016 Sep-Oct; Vol. 34 (5), pp. 893-900. Date of Electronic Publication: 2016 Jul 05.
Abstrakt:	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 <65 years (1.53, p=0.002 and 2.88, p=0.005, respectively). Drug retention rate during 434.28 patient-years of follow-up was 57.3%. Factors associated with drug discontinuation by multivariate analysis included age, baseline swollen joint count and no use of concomitant methotrexate therapy. Conclusions: Long-term RTX therapy in a real-life RA cohort, did not reveal any new safety issues. Advanced age was associated with increased risk of AEs and premature drug discontinuation.
Databáze:	MEDLINE
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