TY - JOUR
T1 - Surveillance for the use of mycophenolate mofetil for adult patients with lupus nephritis in Japan
AU - Yasuda, Shinsuke
AU - Atsumi, Tatsuya
AU - Shimamura, Sanae
AU - Ono, Kota
AU - Hiromura, Keiju
AU - Sada, Kenei
AU - Mori, Masaaki
AU - Takei, Syuji
AU - Kawaguchi, Yasushi
AU - Tamura, Naoto
AU - Takasaki, Yoshinari
N1 - Funding Information:
S.Y. has received research grant and/or speaking fee from Bristol Myers Squibb, Astellas Pharma Inc. and Chugai Pharmaceutical Co.
Funding Information:
N.T. has received research grant and/or speaking fee from Chugai Pharmaceutical Co. and Astellas Pharma Inc.
Funding Information:
T.A. has received research grant and/or speaking fees from Astellas Pharma Inc., Bristol Myers Squibb Co., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., and Mitsubishi-Tanabe Pharma Co.
Funding Information:
S.T. has received research grant and/or speaking fee from Chugai Pharmaceutical Co., and Takeda Pharmaceutical Co. Ltd.
Funding Information:
Supported by the Japanese Ministry of Health, Labour and Welfare.
Publisher Copyright:
© 2015 Japan College of Rheumatology.
PY - 2015/9/8
Y1 - 2015/9/8
N2 - Objectives. Mycophenolate mofetil (MMF) is used as one of the standard induction/maintenance protocols for lupus nephritis (LN). However, MMF has not been approved for treating LN in any country, resulting in worldwide off-label use of this immunosuppressant. In order to clarify the real-world use of MMF as a treatment for LN in Japan, Japan College of Rheumatology surveyed the use of MMF in daily clinical practice. Methods. Adult patients with LN who visited enrolled hospitals from October 2008 to September 2013 were surveyed for the initial, maximum, and maintenance doses of MMF. The safety and efficacy of MMF were retrospectively evaluated. Results. One hundred and thirty-seven LN patients including 116 females were enrolled. The median of initial, maximum, and maintenance doses of MMF were 1.0 g/day, 1.5 g/day, and 1.0 g/day, respectively. Sixty-one adverse events were reported in 39 patients during the follow-up period. Median urine protein level decreased from 1.89 g/gCr to 0.21 g/gCr, meanC3 level increased from 66.4 mg/dl to 80.3 mg/dl, and median anti-DNA antibody titer decreased from 40.6 IU/ml to 10.6 IU/ml. Conclusion. MMF was commonly used for the treatment of adult LN patients with acceptable efficacy and safety in Japan.
AB - Objectives. Mycophenolate mofetil (MMF) is used as one of the standard induction/maintenance protocols for lupus nephritis (LN). However, MMF has not been approved for treating LN in any country, resulting in worldwide off-label use of this immunosuppressant. In order to clarify the real-world use of MMF as a treatment for LN in Japan, Japan College of Rheumatology surveyed the use of MMF in daily clinical practice. Methods. Adult patients with LN who visited enrolled hospitals from October 2008 to September 2013 were surveyed for the initial, maximum, and maintenance doses of MMF. The safety and efficacy of MMF were retrospectively evaluated. Results. One hundred and thirty-seven LN patients including 116 females were enrolled. The median of initial, maximum, and maintenance doses of MMF were 1.0 g/day, 1.5 g/day, and 1.0 g/day, respectively. Sixty-one adverse events were reported in 39 patients during the follow-up period. Median urine protein level decreased from 1.89 g/gCr to 0.21 g/gCr, meanC3 level increased from 66.4 mg/dl to 80.3 mg/dl, and median anti-DNA antibody titer decreased from 40.6 IU/ml to 10.6 IU/ml. Conclusion. MMF was commonly used for the treatment of adult LN patients with acceptable efficacy and safety in Japan.
KW - Induction therapy
KW - Mycophenolate mofetil
KW - Mycophenolic acid
KW - Proliferative lupus nephritis
KW - Systemic lupus erythematosus
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U2 - 10.3109/14397595.2015.1031444
DO - 10.3109/14397595.2015.1031444
M3 - Article
C2 - 25800636
AN - SCOPUS:84946838972
VL - 25
SP - 854
EP - 857
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 6
ER -