RESUMO
INTRODUCTION: The combination of methotrexate (MTX) + leflunomide (LFN) has been shown to be effective in the treatment of RA. Its safety has been questioned. OBJECTIVE: To evaluate the effectiveness and safety of the combination of MTX + LFN in patients with active RA. METHODS: This was a 24-week multicenter study, which included 88 patients with active disease despite consistent treatment with methotrexate and prednisolone. RESULTS: We included 78 women (88%) and 10 men. The age was 51.3 ± 12.4 years, and the evolution of disease was 8 ± 6.8 years. Patients had active disease, which was indicated by a median of IQR of 10.0 (7.0-13.0) for swollen and of 14.0 (18.0-10.0) for tender joints for the whole group. The ACR responses achieved at week 24 were: ACR20: 76.0%; ACR50: 67.1%; ACR70: 23.9%. There was improvement in the activity of disease: DAS-28 score: 5.8 ± 1.2 at baseline vs. 3.8 ± 1.6 at week 24 (P = 0.000). The most significant adverse event was elevation of transaminases in eight patients (26%). Eight patients were withdrawn due to adverse events: four due to the elevation of transaminases, and one each due to diabetes insipidus, rash, diabetes mellitus and osteomuscular pain. CONCLUSION: The combination of MTX + LFN is effective for treating RA in patients for whom conventional treatment has failed. Strict medical and laboratory control is to be enforced for safety.
Assuntos
Artrite Reumatoide/tratamento farmacológico , Isoxazóis/uso terapêutico , Metotrexato/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Colômbia , Quimioterapia Combinada , Feminino , Humanos , Isoxazóis/efeitos adversos , Leflunomida , Masculino , Metotrexato/efeitos adversos , Pessoa de Meia-Idade , Adulto JovemRESUMO
INTRODUÇÃO: A combinação de metotrexato (MTX) + leflunomida (LFN) demonstrou ser efetiva no tratamento da artrite reumatoide (AR), mas sua segurança tem sido questionada. OBJETIVO: Avaliar a eficácia e a segurança terapêutica da combinação de MTX + LFN em pacientes com AR ativa. MÉTODOS: Estudo multicêntrico com 24 semanas de duração envolvendo 88 pacientes com doença ativa, apesar do tratamento regular com MTX e prednisolona. RESULTADOS: Participaram do estudo 78 mulheres (88%) e 10 homens. A idade foi de 51,3 ± 12,4 anos, e o tempo de evolução da doença, 8,0 ± 6,8 anos. Os pacientes tinham doença ativa evidenciada por IQR média de 10 (7,0-13,0) nas articulações inflamadas e 14,0 (18,0-10,0) nas articulações dolorosas. As respostas ACR obtidas na semana 24 foram: ACR20: 76%; ACR50: 67,1%; e ACR70: 23,9%. Houve melhora na atividade da doença, medida pelo escore DAS-28: 5,8 ± 1,2 no início do estudo vs. 3,8 ± 1,6 na semana 24 (P = 0,000). O evento adverso mais significativo foi elevação das transaminases, ocorrida em oito (26%) pacientes. Oito pacientes descontinuaram o estudo devido a eventos adversos: quatro por elevação das transaminases, um por diabetes insípido, um por erupção cutânea, um por diabetes mellitus e um por dor osteomuscular. CONCLUSÃO: A combinação de MTX + LFN é efetiva para o tratamento de AR em pacientes que não obtiveram sucesso com o tratamento convencional. Há necessidade de rígido controle médico e laboratorial para segurança terapêutica.
INTRODUCTION: The combination of methotrexate (MTX) + leflunomide (LFN) has been shown to be effective in the treatment of RA. Its safety has been questioned. OBJECTIVE: To evaluate the effectiveness and safety of the combination of MTX + LFN in patients with active RA. METHODS: This was a 24-week multicenter study, which included 88 patients with active disease despite consistent treatment with methotrexate and prednisolone. RESULTS: We included 78 women (88%) and 10 men. The age was 51.3 ± 12.4 years, and the evolution of disease was 8 ± 6.8 years. Patients had active disease, which was indicated by a median of IQR of 10.0 (7.0-13.0) for swollen and of 14.0 (18.0-10.0) for tender joints for the whole group. The ACR responses achieved at week 24 were: ACR20: 76.0%; ACR50: 67.1%; ACR70: 23.9%. There was improvement in the activity of disease: DAS-28 score: 5.8 ± 1.2 at baseline vs. 3.8 ± 1.6 at week 24 (P = 0.000). The most significant adverse event was elevation of transaminases in eight patients (26%). Eight patients were withdrawn due to adverse events: four due to the elevation of transaminases, and one each due to diabetes insipidus, rash, diabetes mellitus and osteomuscular pain. CONCLUSION: The combination of MTX + LFN is effective for treating RA in patients for whom conventional treatment has failed. Strict medical and laboratory control is to be enforced for safety.