SAT0127 Long-Term Safety and Efficacy Following the Administration of Multiple Rituximab Cycles in Rheumatoid Arthritis (RA) Patients: The Multicenter, Prospective Launch Study
| Autor: | Kyriaki A. Boki, L. Settas, C. Antoniadis, Dimitrios Vassilopoulos, E. Vritzali, Lazaros I. Sakkas, Andrew P. Andonopoulos, P.P. Sfikakis, V Galanopoulou, Spyros Aslanidis, A Andrianakos, K. Tempos, F. Solioti, Panagiota Boura, M Katsounaros, Panagiotis Athanassiou, G. Skarantavos |
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| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
business.industry Immunology medicine.disease General Biochemistry Genetics and Molecular Biology Rheumatology Surgery Safety profile Internal medicine Rheumatoid arthritis medicine Immunology and Allergy In patient Rituximab Long term safety Adverse effect business Prospective cohort study medicine.drug |
| Zdroj: | Annals of the Rheumatic Diseases. 72:A624.1-A624 |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/annrheumdis-2013-eular.1853 |
| Popis: | Background About one third of RA patients do not initially respond to treatment with an anti-TNF agent whereas a similar rate demonstrates lack of efficacy over time. Rituximab/Mabthera administration (temporary B-lymphocyte depletion) is one of the therapeutic options for them. Objectives The LAUNCH prospective study aimed at the evaluation of long-term efficacy and safety data following rituximab administration in standard clinical practice Methods 17 Rheumatology sites in Greece enrolled 234 adult patients (63.0±12.4 years, 79.5% women) with severe RA and an inadequate response or non-tolerance to anti-TNF treatment. Rituximab (1gr) was administered IV on days 1 and 14 of each cycle, repeated every 6-12 months, for up to 7 cycles. Of these patients 41.2% and 56.2% had received one, or more, anti-TNF agent(s), respectively. Adverse events, DAS28, and the quality of life evaluation indices (Euroqol) were collected every 2 to 6 months for 5 years according to each site’s standard clinical practice Results During 496 patient/years, 28 adverse events /100 pt-yrs (including9.9 serious adverse events and 7.7 serious infectious per 100pt-yrs, respectively) were observed. Of the total number of adverse events a 46.7% was not related to rituximab. The mean number of adverse events per patient remained stable during repeated treatment cycles. Disease activity at baseline (mean±SD DAS28 of 5.36±1.40) was significantly reduced in cycles 1,2, 3, 4, 5, and 6 by 1.34, 2.12, 2.25, 2,56, 2.42 and 2.79, respectively (p Conclusions Rituximab administration in clinical practice for up to 5 years demonstrated an acceptable safety profile which was maintained over time. Likewise, maintenance and/or improvement of efficacy with repeated treatment cycles in patients with severe RA not responding to anti-TNF were evident Disclosure of Interest L. Settas: None Declared, A. Andrianakos: None Declared, S. Aslanidis: None Declared, P. Boura: None Declared, M. Katsounaros: None Declared, D. Vassilopoulos: None Declared, P. Athanassiou: None Declared, K. Tempos: None Declared, G. Skarantavos: None Declared, C. Antoniadis : None Declared, L. Sakkas: None Declared, A. Andonopoulos: None Declared, V. Galanopoulou: None Declared, F. Solioti: None Declared, K. Boki: None Declared, E. Vritzali Employee of: Roche Hellas SA, P. Sfikakis: None Declared |
| Databáze: | OpenAIRE |
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