Eficacia de leflunomida 100 mg semanales comparado con dosis bajas de metotrexate en pacientes con artritis reumatoide activa. Estudio clínico doble ciego aleatorizado / Efficacy of leflunomide 100 mg weekly compared to low dose methotrexate in patients with active rheumatoid arthritis. Double blind, randomized clinical trial

Objetivos. Estudio clínico aleatorizado para determinar la eficacia y seguridad de leflunomida (LFN) 100mg/semana en artritis reumatoide (AR), comparado con dosis bajas de metotrexate (MTX) 10mg/semana a 52 semanas. Pacientes y métodos. Se incluyeron pacientes con criterios de AR activa (ACR1987). Fueron realizados estudios de laboratorio, radiografías de manos y determinaciones clinimétricas para establecer criterios de respuesta clínica de ACR y EULAR. El análisis estadístico se obtuvo a través de mejoría ACR20. La eficacia se estableció por análisis de ANOVA de muestras independientes entre ambos grupos (p<=0,05). La seguridad fue analizada con porcentaje de eventos adversos. Resultados. De 90 pacientes evaluados, 5 fueron eliminados; 85 aleatorizados e incluidos en 2 grupos: 43 (LFN) y 42 (MTX). Completaron el estudio con LFN el 72% y con MTX el 74,4%. El criterio de mejoría de ACR20 al final del estudio fue alcanzado para LFN en 90,3% y para MTX 78,1%, p=0,14. El valor DAS28 al final para LFN fue de 3,45, y para MTX de 3,67, no existiendo diferencias significativas (p=0,43). Los pacientes excluidos para LFN fueron 11, y 10 para MTX. La falla terapéutica se definió en 5,2% para LFN, y 12,1 en el caso de MTX. No se reportaron eventos adversos graves que pusieran en riesgo la vida de los pacientes. Conclusiones. Los resultados confirman que LFN usada en dosis semanales de 100mg, ofrece una adecuada y sostenida mejoría de las manifestaciones clínicas de AR, al compararlo con una dosis baja de MTX. Pudiendo ser una opción terapéutica en algunos pacientes como monoterapia o en combinación con otros antirreumáticos (AU)

Objective: To determine the clinical efficacy and safety of Leflunomide (LFN) 100 mg/week compared to low dose Methotrexate (MTX) 10 mg/week in a double-blind, randomized, controlled trial with 52 weeks of follow up in Rheumatoid Arthritis (RA) patients. Patients and methods: Patients who met ARC1987 criteria for RA were included. All patients had medical records, including laboratory tests and hand X-rays. Clinical evaluations for improvement and ACR and EULAR response criteria were performed. Statistical analysis for independent’s samples between both groups defined a P value of <= .05. Safety was evaluated by comparing the proportion of adverse events (AE) registered. Results: Of 90 patients screened; five were withdrawn; the remaining 85 patients were randomised: 43 LFN and 42 MTX. Sixty-three patients completed the study; 72% in the LFN group and 74.4% in the MTX group. ACR20 improvement criteria were achieved by LFN group in 90.3%, and in MTX 78.1% (P = .14) at week 52. EULAR improvement criteria applied at the end point showed a DAS28 score for the LFN group of 3.45, and for the MTX group was 3.67(P = .43). Total withdrawals, including loss during follow up, AE and lack of efficacy for each group was 12 patients in the LFN group, and 10 patients in the MTX group. Regarding safety, no serious AE of a life threatening nature were reported. Conclusions: These outcomes confirm that LFN 100 mg/week offers an adequate and sustained improvement effect on the clinical manifestations of RA, similar to low dose treatment with MTX 10 mg/every week after 52 weeks of follow up; it may be a good therapeutic option alone or in combination with others anti-rheumatic drugs (AU)

Efficacy of leflunomide 100mg weekly compared to low dose methotrexate in patients with active rheumatoid arthritis. Double blind, randomized clinical trial.

OBJECTIVE: To determine the clinical efficacy and safety of Leflunomide (LFN) 100 mg/week compared to low dose Methotrexate (MTX) 10 mg/week in a double-blind, randomized, controlled trial with 52 weeks of follow up in Rheumatoid Arthritis (RA) patients. PATIENTS AND METHODS: Patients who met ARC1987 criteria for RA were included. All patients had medical records, including laboratory tests and hand X-rays. Clinical evaluations for improvement and ACR and EULAR response criteria were performed. Statistical analysis for independent's samples between both groups defined a P value of ≤.05. Safety was evaluated by comparing the proportion of adverse events (AE) registered. RESULTS: Of 90 patients screened; five were withdrawn; the remaining 85 patients were randomised: 43 LFN and 42 MTX. Sixty-three patients completed the study; 72% in the LFN group and 74.4% in the MTX group. ACR20 improvement criteria were achieved by LFN group in 90.3%, and in MTX 78.1% (P=.14) at week 52. EULAR improvement criteria applied at the end point showed a DAS28 score for the LFN group of 3.45, and for the MTX group was 3.67(P=.43). Total withdrawals, including loss during follow up, AE and lack of efficacy for each group was 12 patients in the LFN group, and 10 patients in the MTX group. Regarding safety, no serious AE of a life threatening nature were reported. CONCLUSIONS: These outcomes confirm that LFN 100 mg/week offers an adequate and sustained improvement effect on the clinical manifestations of RA, similar to low dose treatment with MTX 10 mg/every week after 52 weeks of follow up; it may be a good therapeutic option alone or in combination with others anti-rheumatic drugs.

Neumonía eosinofílica crónica: ¿fenómeno autoinmune o enfermedad inmunoalérgica. Reporte de un caso y revisión de literatura / Chronic eosinophilic pneumonia: Autoimmune phenomenon or immunoallergic disease. Case report and literature review

Las neumonía eosinofílica se clasifica por su presentación en aguda o crónica; las características distintivas se basan en la presencia de tos, disnea, fiebre e infiltrados pulmonares con acumulación de células inflamatorias, predominante de eosinófilos. La asociación de eosinofilia y padecimientos reumatológicos es bien conocida, como en el caso de la fascitis eosinofílica y el síndrome de Churg-Strauss. La coexistencia de neumonía eosinofílica crónica y artritis reumatoide ha sido reportada, ya sea de inicio coincidente o en artritis reumatoide establecida. El papel fisiopatológico de los eosinófilos en las enfermedades autoinmunes no está bien definido, sin embargo se ha demostrado que la producción de citocinas proinflamatorias estimulan y activan diferentes grupos celulares, pudiendo en forma simultánea inducir autoanticuerpos e incremento y/o infiltración de eosinófilos en diversos tejidos, sin tener una enfermedad autoinmune subyacente. Presentamos el caso de una mujer joven con neumonía eosinofílica crónica con manifestaciones clínicas reumatológicas y presencia de autoanticuerpos, que se resolvió en forma espontánea (AU)

Eosinophilic pneumonia is classified by its acute or chronic presentation, the distinguishing characteristics of which are based on the presence of cough, dyspnea, fever and pulmonary infiltrates with accumulation of inflammatory cells, predominantly eosinophils. The association of eosinophilia and rheumatologic disorders is well known, as in the case of eosinophilic fasciitis and the Churg-Strauss syndrome. The coexistence of chronic eosinophilic pneumonia and rheumatoid arthritis has been reported, either early rheumatoid arthritis of definitive disease. The pathophysiological role of eosinophils in autoimmune diseases is not well defined, however it has been shown that the production of pro-inflammatory cytokines stimulate and activates different cell groups, and can simultaneously induce autoantibodies and/or increased infiltration of eosinophils in various tissues, without an underlying autoimmune disease. The case of a young woman with rheumatic chronic eosinophilic pneumonia manifestations and the presence of autoantibodies, which resolved spontaneously, is presented here (AU)

Chronic eosinophilic pneumonia: autoimmune phenomenon or immunoallergic disease? Case report and literature review.

Eosinophilic pneumonia is classified by its acute or chronic presentation, the distinguishing characteristics of which are based on the presence of cough, dyspnea, fever and pulmonary infiltrates with accumulation of inflammatory cells, predominantly eosinophils. The association of eosinophilia and rheumatologic disorders is well known, as in the case of eosinophilic fasciitis and the Churg-Strauss syndrome. The coexistence of chronic eosinophilic pneumonia and rheumatoid arthritis has been reported, either early rheumatoid arthritis of definitive disease. The pathophysiological role of eosinophils in autoimmune diseases is not well defined, however it has been shown that the production of pro-inflammatory cytokines stimulate and activates different cell groups, and can simultaneously induce autoantibodies and/or increased infiltration of eosinophils in various tissues, without an underlying autoimmune disease. The case of a young woman with rheumatic chronic eosinophilic pneumonia manifestations and the presence of autoantibodies, which resolved spontaneously, is presented here.

Fascitis eosinofílica, respuesta favorable al tratamiento con ciclosporina A / Eosynophilic fasciitis. Favorable response to treatment with Cyclosporin A

Introducción: La fascitis eosinofílica (FE) es una enfermedad de origen desconocido, caracterizada por induración de la piel, debido a inflamación de las fascias del tejido conjuntivo. Afecta principalmente a las extremidades y se acompaña de elevación de inmunoglobulinas y eosinofilia periférica. Objetivo: Evaluar la eficacia de ciclosporina A en pacientes con FE con resistencia al tratamiento convencional con glucocorticoides. Pacientes y método: Presentamos 3 pacientes con manifestaciones clínicas y serológicas de FE que tuvieron resistencia al tratamiento estándar con glucocorticoides (30 a 50 mg/día, durante un período de hasta 8 meses). Las manifestaciones clínicas principales fueron: induración de la piel de las extremidades y el tronco que se acompañó de eosinofilia periférica y elevación de la creatincinasa. Histológicamente se observó un engrosamiento con intensa inflamación linfocitaria de las fascias. Resultados: Todos los pacientes fueron tratados con ciclosporina A, a dosis de 5 a 7 mg/kg/día con una rápida mejoría clínica (2 meses). El tratamiento condujo, en todos los casos, a una remisión clínica que permitió reducir e incluso retirar la ciclosporina A durante el seguimiento. Conclusiones: La ciclosporina A parece una alternativa terapéutica eficaz en el tratamiento de pacientes con FE resistente a glucocorticoides (AU)

Introduction: Eosinophilic fasciitis (EF) is a disease of unknown aetiology characterized by cutaneous swelling and indurations. The disease affects predominantly the extremities and usually show an elevation of serum immunoglobulins, and eosinophilia. Objective: Evaluation of the efficacy of cyclosporine A as a therapeutic alternative in patients with EF refractory to steroids. Patients and method: We report 3 patients with clinical, laboratory and pathologic characteristics of EF who did not show a satisfactory response to steroids treatment. All patients disclosed scleroderma-like signs with orange skin, groove sign, and indurations of the affected extremities associated to peipheral eosinophilia and increased creatine-kinase. Epidermis histological findings were normal and intense linfocitary inflammation of the fascia was observed in all patients’ biopsies. All patients were treated for average of 8 months with prednisone 30-50 mg daily with an insufficient clinical response. Results: Patients started on cyclosporine A 5-7 mg/kg/day, showing a fast improvement (2 months). The treatment induces a clinical remission that permits to reduce or even stops the cyclosporine A treatment during follow-up. Conclusions: It seems that cyclosporine A may be a effective therapeutic alternative in patients with EF refractory to steroids (AU)

[Eosynophilic fasciitis. Favorable response to treatment with cyclosporin a]. / Fascitis eosinofílica, respuesta favorable al tratamiento con ciclosporina A.

INTRODUCTION: Eosinophilic fasciitis (EF) is a disease of unknown aetiology characterized by cutaneous swelling and indurations. The disease affects predominantly the extremities and usually show an elevation of serum immunoglobulins, and eosinophilia. OBJECTIVE: Evaluation of the efficacy of cyclosporine A as a therapeutic alternative in patients with EF refractory to steroids. PATIENTS AND METHOD: We report 3 patients with clinical, laboratory and pathologic characteristics of EF who did not show a satisfactory response to steroids treatment. All patients disclosed scleroderma-like signs with orange skin, groove sign, and indurations of the affected extremities associated to peipheral eosinophilia and increased creatine-kinase. Epidermis histological findings were normal and intense linfocitary inflammation of the fascia was observed in all patients' biopsies. All patients were treated for average of 8 months with prednisone 30-50 mg daily with an insufficient clinical response. RESULTS: Patients started on cyclosporine A 5-7mg/kg/day, showing a fast improvement (2 months). The treatment induces a clinical remission that permits to reduce or even stops the cyclosporine A treatment during follow-up. CONCLUSIONS: It seems that cyclosporine A may be a effective therapeutic alternative in patients with EF refractory to steroids.