Comparative efficacy of three regimens (cyclosporine, tacrolimus, and cyclophosphamide) combined with steroids for the treatment of idiopathic membranous nephropathy.

INTRODUCTION AND OBJECTIVES: To investigate the efficacy of combined immunosuppressive regimens of cyclosporine (CsA), tacrolimus (TAC), or cyclophosphamide (CTX) combined with steroids in the treatment of idiopathic membranous nephropathy (IMN). MATERIALS AND METHODS: A total of 150 biopsy-proven IMN patients were divided into three groups: CTX, TAC, and CsA groups (50 cases each). Patients received a selected regimen for 48 weeks. The efficacy (remission rate, 24h urinary protein, and serum albumin and creatinine) and safety (adverse events) profiles of administered regimens were evaluated at 12, 24 and 48 weeks. RESULTS: At 12 weeks, the response rates for CsA, TAC, and CTX groups were 14%, 50%, and 22%, respectively. This increased to 74%, 84%, and 82%, respectively at 48 weeks. During follow-up, 24h urinary protein significantly reduced from baseline in all regimens (P<0.05), while serum albumin increased in TAC and CTX groups after 12 weeks (P<0.05), and CsA group at 48 weeks (P<0.05). No significant changes in serum creatinine levels were noted in all three regimens (P>0.05). Safety was comparable in all groups, with lower respiratory tract infection being the most frequent adverse event. CONCLUSIONS: The combined regimens (i.e., TAC, CsA, and CTX) are effective in the treatment of patients with IMN at 48 weeks, while TAC and CTX might be more beneficial in terms of shortened time to remission and increased complete response rate.

Comparative efficacy of three regimens (cyclosporine, tacrolimus, and cyclophosphamide) combined with steroids for the treatment of idiopathic membranous nephropathy / Eficacia comparativa de 3 regímenes (ciclosporina, tacrolimús y ciclofosfamida) combinados con esteroides para el tratamiento de la nefropatía membranosa idiopática

Introduction and objectives: To investigate the efficacy of combined immunosuppressive regimens of cyclosporine (CsA), tacrolimus (TAC), or cyclophosphamide (CTX) combined with steroids in the treatment of idiopathic membranous nephropathy (IMN). Materials and methods: A total of 150 biopsy-proven IMN patients were divided into three groups: CTX, TAC, and CsA groups (50 cases each). Patients received a selected regimen for 48 weeks. The efficacy (remission rate, 24h urinary protein, and serum albumin and creatinine) and safety (adverse events) profiles of administered regimens were evaluated at 12, 24 and 48 weeks. Results: At 12 weeks, the response rates for CsA, TAC, and CTX groups were 14%, 50%, and 22%, respectively. This increased to 74%, 84%, and 82%, respectively at 48 weeks. During follow-up, 24h urinary protein significantly reduced from baseline in all regimens (P<0.05), while serum albumin increased in TAC and CTX groups after 12 weeks (P<0.05), and CsA group at 48 weeks (P<0.05). No significant changes in serum creatinine levels were noted in all three regimens (P>0.05). Safety was comparable in all groups, with lower respiratory tract infection being the most frequent adverse event. Conclusions: The combined regimens (i.e., TAC, CsA, and CTX) are effective in the treatment of patients with IMN at 48 weeks, while TAC and CTX might be more beneficial in terms of shortened time to remission and increased complete response rate. (AU)

Introducción y objetivos: Investigar la eficacia de los regímenes inmunosupresores combinados de ciclosporina (CsA), tacrolimús (TAC) o ciclofosfamida (CTX) combinados con esteroides en el tratamiento de la nefropatía membranosa idiopática (NMI). Materiales y métodos: Un total de 150 pacientes con NMI comprobada por biopsia se dividieron en 3 grupos: grupos CTX, TAC y CsA (50 casos cada uno). Los pacientes recibieron un régimen seleccionado durante 48 semanas. Se evaluaron los perfiles de eficacia (tasa de remisión, proteína en orina de 24h y albúmina y creatinina séricas) y seguridad (eventos adversos) de los regímenes administrados a las 12, 24 y 48 semanas. Resultados: A las 12 semanas, las tasas de respuesta para los grupos CsA, TAC y CTX fueron del 14, el 50 y el 22%, respectivamente. Esto aumentó al 74, el 84 y el 82%, respectivamente, a las 48 semanas. Durante el seguimiento, la proteína urinaria de 24h se redujo significativamente desde el inicio en todos los regímenes (p <0,05), mientras que la albúmina sérica aumentó en los grupos TAC y CTX después de 12 semanas (p <0,05) y el grupo CsA a las 48 semanas (p <0,05). No se observaron cambios significativos en los niveles de creatinina sérica en los 3 regímenes (p> 0.05). La seguridad fue comparable en todos los grupos, siendo la infección del tracto respiratorio inferior el evento adverso más frecuente. Conclusiones: Los regímenes combinados (es decir, TAC, CsA y CTX) son eficaces en el tratamiento de pacientes con NMI a las 48 semanas, mientras que TAC y CTX podrían ser más beneficiosos en términos de reducción del tiempo de remisión y aumento de la tasa de respuesta completa. (AU)