Post-marketing surveillance study of the long-term use of mizoribine for the treatment of lupus nephritis: 2-Year results.
Mod Rheumatol
; 28(1): 85-94, 2018 Jan.
Article
en En
| MEDLINE
| ID: mdl-28722500
ABSTRACT
OBJECTIVES:
To understand the status of mizoribine use in patients with lupus nephritis (LN) and to collect safety- and efficacy-related data on 2-year treatment with mizoribine.METHODS:
A continuous survey was conducted between March 2010 and July 2015.RESULTS:
The analysis set included 559 patients (mean age 39.5 years, females 82.6%, mean duration of systemic lupus erythematosus (SLE) 8.4 years, mean duration of LN 5.9 years). Renal function was satisfactory for 6 months, but worsened from 12 months, with significant worsening at 24 months. By the ACR 2006 remission criteria (eGFR >60), at 24 months, 26.5% of patients achieved complete remission, and 63.3% achieved complete or partial remission. The urine protein to creatinine ratio decreased significantly. The SLE Disease Activity Index 2000 score decreased significantly at 12 and 24 months. Overall, 98 (17.5%) patients experienced 124 adverse drug reactions (ADRs); 3.6% experienced serious ADRs. Mizoribine was used with a steroid in 99.3% and an immunosuppressant in 51.2%; tacrolimus was used in 43.8%. The oral steroid dosage decreased from baseline to 24 months. The incidence of ADRs was not significantly different with concomitant tacrolimus use.CONCLUSIONS:
The results suggest that long-term mizoribine is safe and effective, even when used with tacrolimus.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
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Ribonucleósidos
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Nefritis Lúpica
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Inmunosupresores
Tipo de estudio:
Screening_studies
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Mod Rheumatol
Año:
2018
Tipo del documento:
Article
País de afiliación:
Japón