Shinsuke Yasuda1, Tatsuya Atsumi1, Sanae Shimamura1, Kota Ono2, Keiju Hiromura3, Kenei Sada4, Masaaki Mori5, Syuji Takei6, Yasushi Kawaguchi7, Naoto Tamura8, Yoshinari Takasaki8. 1. a Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine , Hokkaido , Japan. 2. b Clinical Research and Medical Innovation Center, Hokkaido University Hospital , Hokkaido , Japan. 3. c Department of Medicine and Clinical Science , Gunma University Graduate School of Medicine , Gunma , Japan. 4. d Department of Medicine and Clinical Science , Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences , Okayama , Japan. 5. e Department of Pediatrics , Yokohama City University Medical Center , Yokohama , Japan. 6. f Kagoshima University Hospital, Children's Medical Center , Kagoshima , Japan. 7. g Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan. 8. h Department of Internal Medicine and Rheumatology , Juntendo University Faculty of Medicine , Tokyo , 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.
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.