Article information
Abstract
Tocilizumab (TCZ) is a humanized monoclonal antibody which targets the receptor for IL-6, developed by the Japanese pharmaceutical company Chugai and the Swiss company Roche. In Japan it is already under use for Castleman's disease, rheumatoid arthritis (RA), and juvenile idiopathic arthritis. The clinical development outside Japan is very extensive and has shown efficacy in possible RA scenarios; early RA (part of the AMBITION study), established, MTX-resistant RA (OPTION) and RA resistant to other DMARD (TOWARD), and anti-TNF-α resistant RA (RADIATE). Both monotherapy with TCZ (AMBITION) and associated to other background drugs. Radiological efficacy has also been proven (LITHE). So TCZ is probably the biologic therapy with the most extensive clinical development before marketing in the western hemisphere. In this review we will specifically deal with clinical and radiological efficacy, as wel as its safety profile.
Keywords:
Tocilizumab
Interleukin-6
Receptor interleukin-6
Rheumatoid arthritis
Anti-tumor necrosis factor alpha
Resumen
Tocilizumab (TCZ) es un anticuerpo monoclonal humanizado dirigido contra el receptor de la interleucina-6 (IL-6) desarrollado entre la farmacéutica japonesa Chugai y la suiza Roche. En Japón tiene ya indicación para la enfermedad de Castleman, artritis reumatoide (AR) y artritis idiopática juvenil. El desarrollo clínico fuera de Japón es muy extenso y ha demostrado eficacia en los escenarios posibles de la AR, AR precoz (parte del estudio AMBITION), AR establecida refractaria a metotrexato (OPTION) y a otros fármacos modificadores de enfermedad (TOWARD) y AR refractaria a anti-TNF-α (RADIATE), tanto con TCZ en monoterapia (estudio AMBITION) como asociado a fármacos de fondo. También se ha comprobado la eficacia radiológica (LITHE). En consecuencia el TCZ es probablemente el fármaco biológico con el desarrollo clínico más extenso habiéndose aprobado su comercialización por la agencia europea del medicamento con las siguientes indicaciones: TCZ en combinación con MTX está indicado para el tratamiento de la AR activa de moderada a grave en pacientes adultos que han presentado una respuesta inadecuada o fueron intolerantes a terapia previa con uno o más FAMEs o antagonistas del TNF. En estos pacientes TCZ puede ser administrado en monoterapia, en caso de intolerancia a MTX, o cuando el tratamiento prolongado con MTX es inapropiado. En esta revisión nos centraremos especialmente en la eficacia clínica, radiológica, así como en el perfil de seguridad
Palabras clave:
Tocilizumab
Interleucina-6
Receptor de interleucina-6
Artritis reumatoide
Antifactor de necrosis tumoral alfa
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