TY - JOUR
T1 - Post-marketing surveillance study of the long-term use of mizoribine for the treatment of lupus nephritis
T2 - 2-Year results
AU - Takeuchi, Tsutomu
AU - Okada, Kenya
AU - Yoshida, Hisao
AU - Yagi, Nobuyuki
N1 - Funding Information:
This study was funded by Asahi Kasei Pharma Corporation, Tokyo, Japan. The authors wish to express their deepest gratitude to all physicians who participated in this surveillance study for their cooperation and for providing valuable data.
Publisher Copyright:
© 2017 Japan College of Rheumatology. Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2018/1/2
Y1 - 2018/1/2
N2 - 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.
AB - 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.
KW - Lupus nephritis
KW - mizoribine
KW - multi-target therapy
KW - post-marketing surveillance
KW - tacrolimus
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U2 - 10.1080/14397595.2017.1349573
DO - 10.1080/14397595.2017.1349573
M3 - Article
C2 - 28722500
AN - SCOPUS:85025166825
SN - 1439-7595
VL - 28
SP - 85
EP - 94
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
IS - 1
ER -