Eficacia de rituximab comparado con ciclofosfamida en pacientes con manifestaciones graves de lupus eritematoso generalizado. Estudio aleatorizado y multicéntrico / Efficacy of rituximab versus cyclophosphamide in lupus patients with severe manifestations. A randomized and multicenter study

No existen a la fecha estudios controlados que evalúen la eficacia de rituximab (RTX) comparando con un tratamiento estándar, como ciclofosfamida, en pacientes con lupus eritematoso generalizado (LEG). Objetivo. Comparar la eficacia de RTX con ciclofosfamida en pacientes con manifestaciones graves de LEG. Material y método. Estudio clínico aleatorizado, multicéntrico, controlado y abierto en adultos con LEG activo. Se administró RTX o bolos de ciclofosfamida, con mismo esquema de esteroides. Se evaluó MEX-SLEDAI, dosis de esteroide y eventos adversos, durante 12 meses. Se empleó estadística descriptiva y comparativa. Resultados. Fueron 19 pacientes, 17 mujeres, con edad de: 35,7 años ±12,1, y tiempo de evolución de 5,6 años (0,35–30,8). No hubo diferencias en género, edad, tiempo de evolución, tratamientos previos o actividad de la enfermedad al inicio entre los grupos. Se observó descenso en el MEX-SLEDAI de 12 a 3 en el grupo 1, y de 9 a 2 en el grupo 2 (p=0,80). El grupo que recibió RTX tuvo mejoría más rápida. La dosis acumulada de esteroide fue similar. En ambos grupos se observó reducción en niveles de anti-DNAds e incremento de C3. Los eventos adversos fueron semejantes. Conclusión. Este ensayo clínico comparativo muestra que RTX puede ser tan eficaz como ciclofosfamida, para el control de manifestaciones graves del LEG, con respuesta más rápida. Los eventos adversos inmediatos y mediatos no fueron diferentes. RTX puede considerarse una opción terapéutica adecuada en este tipo de pacientes (AU)

There are no controlled studies that compare the efficacy of RTX with standard treatment, such as cyclophosphamide, in patients with systemic lupus erythematosus (SLE). Objective. The objective of this study was to compare the efficacy of rituximab to that of cyclophosphamide in patients with severe manifestations of SLE. Materials and method. This is a multicenter, randomized open and controlled trial in adults with a diagnosis of active SLE. Patients were randomized into two groups; group 1: treated with RTX and group 2: cyclophosphamide pulses with the same steroid scheme. We registered MEX-SLEDAI, steroid requirements and adverse events for 12 months. Descriptive and comparative statistic analysis was performed. Results. 19 patients were included, 17 females, mean age 35.7±12.1 years and duration of disease 5.6 years (range 0.35 to 30.8 years). There were no differences at baseline regarding gender, age, duration of disease, previous treatments or disease activity between both groups. MEX-SLEDAI was reduced from 12 to 3 in group 1 and from 9 to 2 in group 2 (p=0.80). Nevertheless, patients treated with RTX had a faster improvement. There was no difference in the cumulative steroid dose. Both groups had significant reduction in antinuclear antibody levels and similar increase in C3 levels. Adverse events were similar in both groups. Conclusion. This comparative clinical study in patients with SLE shows that rituximab can be as useful as cyclophosphamide for severe manifestations, maybe showing a faster response. Adverse events were no different. Rituximab should be considered as an adequate alternative for this group of patients (AU)

[Efficacy of rituximab versus cyclophosphamide in lupus patients with severe manifestations. A randomized and multicenter study]. / Eficacia de rituximab comparado con ciclofosfamida en pacientes con manifestaciones graves de lupus eritematoso generalizado. Estudio aleatorizado y multicéntrico.

UNLABELLED: There are no controlled studies that compare the efficacy of RTX with standard treatment, such as cyclophosphamide, in patients with systemic lupus erythematosus (SLE). OBJECTIVE: The objective of this study was to compare the efficacy of rituximab to that of cyclophosphamide in patients with severe manifestations of SLE. MATERIALS AND METHOD: This is a multicenter, randomized open and controlled trial in adults with a diagnosis of active SLE. Patients were randomized into two groups; group 1: treated with RTX and group 2: cyclophosphamide pulses with the same steroid scheme. We registered MEX-SLEDAI, steroid requirements and adverse events for 12 months. Descriptive and comparative statistic analysis was performed. RESULTS: 19 patients were included, 17 females, mean age 35.7±12.1 years and duration of disease 5.6 years (range 0.35 to 30.8 years). There were no differences at baseline regarding gender, age, duration of disease, previous treatments or disease activity between both groups. MEX-SLEDAI was reduced from 12 to 3 in group 1 and from 9 to 2 in group 2 (p=0.80). Nevertheless, patients treated with RTX had a faster improvement. There was no difference in the cumulative steroid dose. Both groups had significant reduction in antinuclear antibody levels and similar increase in C3 levels. Adverse events were similar in both groups. CONCLUSION: This comparative clinical study in patients with SLE shows that rituximab can be as useful as cyclophosphamide for severe manifestations, maybe showing a faster response. Adverse events were no different. Rituximab should be considered as an adequate alternative for this group of patients.

Epidemiología, etiología y clasificación / Epidemiology, etiology and classification

Las miopatías inflamatorias idiopáticas son un grupo heterogéneo de enfermedades autoinmunitarias adquiridas del músculo estriado que se caracterizan por debilidad muscular, elevación de enzimas musculares, anormalidades electromiográficas e identificación de infiltrado inflamatorio en la biopsia muscular. En este grupo se incluyen la polimiositis, la dermatomiositis y la miositis por cuerpos de inclusión. Se consideran dentro del grupo de enfermedades autoinmunitarias poco frecuentes debido a su baja incidencia global de 2–10 casos por millón de habitantes por año, y presentan diferentes patrones de presentación por edad, sexo y raza. La etiología se considera desconocida, siendo los factores genéticos, aunados a la exposición de algunos agentes ambientales, los que pudieran desencadenar una respuesta autoinmunitaria teniendo como órgano diana el músculo esquelético (AU)

Idiopathic inflammatory myopathies are a group of heterogeneous striated muscle acquired autoimmune diseases, characterized by progressive symmetrical muscle weakness, elevated serum levels of muscle enzymes, electromyographic abnormalities and inflammatory infiltrates on muscle biopsy. This group of diseases comprises polymyositis, dermatomyositis and inclusion-body myositis. They are considered rare autoimmune diseases, with an overall incidence range of 2 to10 new cases per million persons at risk per year, with differences in distribution according to age, gender and race. Their etiology is largely unknown, but it likely involves both genetic and environmental factors that contribute to autoimmune disorders, with striated muscle as a common target (AU)

[Epidemiology, etiology and classification]. / Epidemiología, etiología y clasificación.

Idiopathic inflammatory myopathies are a group of heterogeneous striated muscle acquired autoimmune diseases, characterized by progressive symmetrical muscle weakness, elevated serum levels of muscle enzymes, electromyographic abnormalities and inflammatory infiltrates on muscle biopsy. This group of diseases comprises polymyositis, dermatomyositis and inclusion-body myositis. They are considered rare autoimmune diseases, with an overall incidence range of 2 to 10 new cases per million persons at risk per year, with differences in distribution according to age, gender and race. Their etiology is largely unknown, but it likely involves both genetic and environmental factors that contribute to autoimmune disorders, with striated muscle as a common target.