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1.
Audiol Neurootol ; 16(4): 214-21, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-20980741

RESUMEN

Immune-mediated inner ear disease (IMED) is a cause of rapidly progressive auditory dysfunction. Patients are often responsive to high-dose corticosteroids and the disease is believed to be mediated by an antibody to inner ear proteins. To date, no therapies have proven effective as corticosteroid-sparing agents. Rituximab is a monoclonal antibody that depletes B cells, resulting in a reduction in autoantibody production. For that reason, rituximab was evaluated in a small pilot study in patients with IMED to see if there was a signal suggesting benefit. In all, 5/7 patients met the primary endpoint of an improvement in pure tone average (500-3000 Hz) by 10 dB in at least one ear, or an improvement in word identification score by at least 12% at 24 weeks, both relative to screening precorticosteroid values after 1 course of treatment. No significant adverse events were reported. The results of this study suggest further evaluation of rituximab as a treatment for IMED is indicated.


Asunto(s)
Anticuerpos Monoclonales de Origen Murino/uso terapéutico , Enfermedades Autoinmunes/terapia , Pérdida Auditiva Sensorineural/terapia , Factores Inmunológicos/uso terapéutico , Enfermedades del Laberinto/terapia , Adulto , Audiometría de Tonos Puros , Enfermedades Autoinmunes/inmunología , Enfermedades Autoinmunes/fisiopatología , Femenino , Pérdida Auditiva Sensorineural/inmunología , Pérdida Auditiva Sensorineural/fisiopatología , Humanos , Enfermedades del Laberinto/inmunología , Enfermedades del Laberinto/fisiopatología , Masculino , Persona de Mediana Edad , Proyectos Piloto , Rituximab , Resultado del Tratamiento
2.
Arthritis Rheum ; 58(9): 2652-61, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18759293

RESUMEN

OBJECTIVE: Ocrelizumab, a humanized anti-CD20 monoclonal antibody, was studied in a first-in-human trial in rheumatoid arthritis (RA) patients receiving concomitant methotrexate (MTX). METHODS: The ACTION trial was a combined phase I/II study of placebo plus MTX versus ocrelizumab plus MTX in 237 RA patients (intent-to-treat population). During phase I, 45 patients were treated with 1 of 5 escalating doses of study drug (infusions on days 1 and 15, 10-1,000 mg per each infusion). An additional 192 patients were randomized during phase II. Eligible patients had active disease, an inadequate response to treatment with at least MTX, rheumatoid factor positivity, and elevated levels of acute-phase reactants. The total study duration was 72 weeks. B cell pharmacodynamics over time was investigated. RESULTS: Baseline demographics were similar among the treatment groups. Based on the entire 72-week data set, the incidence of serious adverse events in the ocrelizumab-treated patients was 17.9%, as compared with 14.6% in placebo-treated patients. The incidence of serious infections was 2.0% in all ocrelizumab-treated patients and 4.9% in placebo-treated patients. Infusion-associated adverse events were mostly grade 1 or grade 2 and were more frequent around the time of the first infusion. No serious infusion-associated adverse events were reported in the ocrelizumab group. Evidence of clinical activity was observed at all doses evaluated. Peripheral B cell depletion after infusion was rapid at all doses, with earlier repletion of B cells at doses of 10 mg and 50 mg. Human anti-human antibodies were detected in 19% and 10%, respectively, of those receiving 10 mg and 50 mg of ocrelizumab, compared with 0-5% of those receiving 200, 500, and 1,000 mg. CONCLUSION: Ocrelizumab therapy in combination with MTX was well tolerated. Doses of 200 mg (2 infusions) and higher showed better clinical responses, better reduction of C-reactive protein levels, and very low immunogenicity.


Asunto(s)
Anticuerpos Monoclonales/administración & dosificación , Artritis Reumatoide/terapia , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales Humanizados , Antirreumáticos/administración & dosificación , Artritis Reumatoide/inmunología , Linfocitos B/inmunología , Proteína C-Reactiva/inmunología , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Quimioterapia Combinada , Femenino , Humanos , Inmunoglobulina M/inmunología , Factores Inmunológicos/administración & dosificación , Análisis de Intención de Tratar , Masculino , Metotrexato/administración & dosificación , Persona de Mediana Edad , Selección de Paciente , Inducción de Remisión , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
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