Surveillance for the use of mycophenolate mofetil for adult patients with lupus nephritis in Japan

Abstract

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.

Keywords:

• Induction therapy
• Mycophenolate mofetil
• Mycophenolic acid
• Proliferative lupus nephritis
• Systemic lupus erythematosus

Acknowledgments

We appreciate Drs. Hitoshi Kohsaka (Department of Medicine and Rheumatology, Graduate School of Medicine and Dental Science, Tokyo Medical and Dental University), Akio Mimori (Division of Rheumatic Diseases, National Center for Global Health and Medicine), Tsuneyo Mimori (Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine), Hajime Sano (Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine), Yoshiya Tanaka (The First Department of Internal Medicine, University of Occupational and Environmental Health), and Hidehiro Yamada (Division of Rheumatology, Department of Internal Medicine, St. Marianna University School of Medicine) for supporting surveillance of the patients treated with MMF.

Conflict of interest

S.Y. has received research grant and/or speaking fee from Bristol Myers Squibb, Astellas Pharma Inc. and Chugai Pharmaceutical Co.

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.

K.H. has received grant and/or speaking fee from Astellas Pharma Inc. and Chugai Pharmaceutical Co.

M.M has received lecture fees from MSD, Sumitomo Dainippon Pharma, and Pfizer Japan Inc, and has served as a consultant adviser to Bristol-Myers Squibb and Astellas Pharma.

S.T. has received research grant and/or speaking fee from Chugai Pharmaceutical Co., and Takeda Pharmaceutical Co. Ltd.

N.T. has received research grant and/or speaking fee from Chugai Pharmaceutical Co. and Astellas Pharma Inc.

Y.K. has received research grant and/or speaking fee from Santen Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Bristol-Myers Squibb, AstraZeneca plc, Astellas Pharma Inc., MSD K.K., Chugai Pharmaceutical Co, Asahi Kasei Pharma Corporation, Eisai Co. Ltd., and Janssen Pharmaceutical K.K.

S.S., K.O., K.S., and Y.K. have no conflict of interest.