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Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases.
Ramos-Casals, M; García-Hernández, F J; de Ramón, E; Callejas, J L; Martínez-Berriotxoa, A; Pallarés, L; Caminal-Montero, L; Selva-O'Callaghan, A; Oristrell, J; Hidalgo, C; Pérez-Alvarez, R; Micó, M L; Medrano, F; Gómez de la Torre, R; Díaz-Lagares, C; Camps, M; Ortego, N; Sánchez-Román, J.
Afiliación
  • Ramos-Casals M; Laboratorio de Enfermedades Autoinmunes Josep Font, IDIBAPS, Hospital Clínic, Barcelona. Spain. mramos@clinic.ub.es
Clin Exp Rheumatol ; 28(4): 468-76, 2010.
Article en En | MEDLINE | ID: mdl-20525449
OBJECTIVES: To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases. METHODS: In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents). RESULTS: One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases). CONCLUSIONS: Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Autoinmunes / Índice de Severidad de la Enfermedad / Uso Fuera de lo Indicado / Anticuerpos Monoclonales de Origen Murino / Factores Inmunológicos Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Clin Exp Rheumatol Año: 2010 Tipo del documento: Article Pais de publicación: Italia
Buscar en Google
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Imprimir
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PubMed Links

Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Autoinmunes / Índice de Severidad de la Enfermedad / Uso Fuera de lo Indicado / Anticuerpos Monoclonales de Origen Murino / Factores Inmunológicos Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Clin Exp Rheumatol Año: 2010 Tipo del documento: Article Pais de publicación: Italia