Systematic review on the use of adalimumab in autoinmune. Efficacy and safety in 54 patients

Díaz-Lagares, Cándido; Belenguer, Rafael; Ramos-Casals, Manuel

doi:10.1016/S2173-5743(10)70029-0

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Abstract

Objective

To analyze published evidence about adalimumab use in autoimmune diseases.

Methods

Systematic review of MEDLINE database of citations included from January 1990 to December 2008 employing the terms “adalimumab” and the different systemic autoimmune diseases.

Results

Our search identified 241 potentially relevant citations. 154 were retrieved for detailed evaluation. Finally, 18 were selected as relevant, including 54 patients. The reported diseases were as follow: Behçet disease in 16 patients, idiopathic uveitis in 13, sarcoidosis in 5, uveitis associated with rheumatologic diseases in 5 (psoriasis in 2, ankylosing spondylitis in 1, juvenile idiopathic arthritis in 1, Crohn disease in 1), Vogt-Koyanagi-Harada disease in 4, Birdshot uveitis in 4, vasculitis in 3 (1 temporal arteritis, 1 Takayasu's disease, 1 skin vasculitis associated with rheumatoid arthritis), adult onset Still disease in 2, relapsing polychondritis in 1 and systemic sclerosis in 1. The clinical spectrum included uveitis (39 cases), skin and/or mucosae (9), vasculitis (3), arthritis (6), lung (3). These patients were refractory to standard therapy, including corticosteroids (42 cases, 78%), immunosuppressants (42, 78%) and biologics (29, 54%). Fifty (93%) patients responded to adalimumab. The clinical response was similar in those patients who had been treated with other biologic and in those who had not received biologic therapy before adalimumab. The patients were followed for 11.9 months. Twelve (22%) patients relapsed. Five (9%) patients suffer some side effect (3 local skin reaction, 1 angioedema, 1 lung fibrosis). One patient (2%) died due to progression of her disease.

Conclusions

Available data about the use of adalimumab in autoinmune diseases come from case reports and uncontrolled studies, that include patients with severe disease and refractory to standard therapy. In this setting, it seems to be an effective and safe treatment option, especially in patients with uveitis and Behçet's disease. This initial data must be confirmed by controlled assays before extending adalimumab use.

Keywords:

Adalimumab

Autoimmune systemic diseases

Uveitis

Resumen

Objetivo

Analizar la experiencia publicada sobre el uso de adalimumab en el tratamiento de enfermedades autoinmunes en adultos.

Métodos

Se realizó una revisión sistemática de los artículos incluidos en la base de datos Medline desde el 1 de enero de 1990 al 31 de diciembre de 2008, combinando el término «adalimumab» con las diferentes enfermedades autoinmunes sistémicas. Se identificaron un total de 241 artículos, de los que 154 se revisaron a texto completo y 18 fueron finalmente seleccionados como relevantes.

Resultados

En los 18 artículos seleccionados se incluían 54 pacientes adultos con enfermedades autoinmunes tratados con adalimumab: 16 pacientes con enfermedad de Behçet; 13 con uveítis idiopática; 5 con sarcoidosis; 5 con uveítis asociadas a otras enfermedades (psoriasis en 2, espondilitis anquilosante en 1, artritis idiopática juvenil en 1, enfermedad de Crohn en 1); 4 con enfermedad de Vogt-Koyanagi-Harada; 4 con uveítis de Birdshot; 3 con vasculitis (arteritis de la temporal, enfermedad de Takayasu y una vasculitis cutánea asociada a artritis reumatoide), 2 con enfermedad de Still del adulto; uno con policondritis recidivante y un paciente con esclerosis sistémica. Las manifestaciones clínicas que motivaron la indicación fueron la uveítis (39 casos), afectación mucocutánea (9), vasculitis (3), artritis (6) y afectación pulmonar (3). En todos los casos se trataba de enfermedades refractarias a tratamiento con glucocorticoides (42 casos, 78%), inmunosupresores (42,78%) y otros biológicos (29,54%). Cincuenta (93%) pacientes respondieron a adalimumab. La respuesta fue similar tanto en aquellos que habían recibido otro biológico como en los que adalimumab era el primer biológico administrado. En 5 (9%) pacientes se describieron efectos adversos (3 reacciones cutáneas locales, un paciente con angioedema y una exacerbación de una fibrosis pulmonar). Tras un tiempo medio de seguimiento de 11,9 meses, 12 (22%) pacientes presentaron recidiva y uno (2%) falleció por exacerbación de su enfermedad de base.

Conclusiones

La evidencia del uso de adalimumab en enfermedades autoinmunes proviene de casos aislados y ensayos no controlados, que incluyen en todos los casos a pacientes graves y refractarios a tratamiento convencional. En este contexto clínico, el uso de adalimumab aparece como una opción eficaz y segura, especialmente en pacientes con uveítis y enfermedad de Behçet.

Palabras clave:

Adalimumab

Enfermedades autoinmunes sistémicas

Uveítis

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