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

Yasuda, Shinsuke; Atsumi, Tatsuya; Shimamura, Sanae; Ono, Kota; Hiromura, Keiju; Sada, Ken‐ei; Mori, Masaaki; Takei, Syuji; Kawaguchi, Yasushi; Tamura, Naoto; Takasaki, Yoshinari

doi:10.3109/14397595.2015.1031444

Cited by 12 publications

(8 citation statements)

References 19 publications

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“…The dose of MMF initially used, according to the study design, was based on previous work in autoimmunity . From our previous pilot study, we observed that even low doses of MMF (1000 mg/d) were effective at suppressing orbital inflammation .…”

Section: Discussionmentioning

confidence: 99%

Retracted: Efficacy and safety of mycophenolate mofetil in patients with active moderate‐to‐severe Graves’ orbitopathy

et al. 2016

Clinical Endocrinology

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Section: Discussionmentioning

confidence: 99%

Retracted: Efficacy and safety of mycophenolate mofetil in patients with active moderate‐to‐severe Graves’ orbitopathy

et al. 2016

Clinical Endocrinology

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“…In the present surveillance study, the efficacy of MZR was confirmed based on composite indicators. Numerous reports have been published recently showing that MMF and tacrolimus are effective in terms of providing satisfactory improvements in urine protein [17][18][19]. In the present study, decreases in urine protein levels were also confirmed, and the efficacy of MZR was demonstrated.…”

Section: Efficacysupporting

confidence: 81%

“…In Japan, a multicenter surveillance study (2008-2013) conducted in 137 adult patients with LN by the Japanese College of Rheumatology on the status of MMF use in everyday medical practice reported that MMF has acceptable efficacy and safety, and that it was used in combination with another immunosuppressant in nearly half of the patients; specifically, it was used concomitantly with tacrolimus in 35.7% of the patients [18]. Furthermore, it has been reported that MZR can be used with tacrolimus [26,27].…”

Section: Multi-target Therapymentioning

confidence: 99%

Post-marketing surveillance study of the long-term use of mizoribine for the treatment of lupus nephritis: 2-Year results

Takeuchi

Okada

Yoshida

et al. 2017

Modern Rheumatology

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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.ARTICLE HISTORY

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“…The dose can be adjusted according to age and symptoms, but the maximum daily dose is 3000 mg for adults and 2000 mg for children. The dosage is based on the results of a survey conducted in Japan [ 13 , 14 ] prior to the approval. The doses of MMF used in patients with primary nephrotic syndrome in the database were generally within the approved dose range for lupus nephritis and transplant-related diseases in Japan, and most patients were treated with a daily dose of 2000 mg or less.…”

Section: Discussionmentioning

confidence: 99%

Use of mycophenolate mofetil in patients with pediatric and adult primary nephrotic syndrome: information from a Japanese hospital claims database

Funatogawa¹,

Narita²,

Tamura³

et al. 2022

Clin Exp Nephrol

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Background Current treatment for frequently relapsing, steroid-dependent, or steroid-resistant nephrotic syndrome focuses on immunosuppressive therapies. Although the clinical guideline suggests the use of mycophenolate mofetil (MMF), limited information is available on patients with primary nephrotic syndrome who receive off-label treatment with MMF in Japan. Method The dose, treatment duration, previous treatment, and characteristics of primary nephrotic syndrome patients receiving MMF were investigated using data from a Japanese hospital claims database (April 2008–September 2021). Results Data on 424 primary nephrotic syndrome patients receiving MMF (146 patients < 18 years old; 278 patients ≥ 18 years old) were captured. The most common initial daily doses of MMF capsules (% of patients < 18 and ≥ 18 years old) were 1000 mg (31.9%, 36.8%), 1500 mg (16.0%, 23.8%), and 500 mg (23.6%, 17.3%), and the most common maximum daily doses were 1000 mg (43.8%, 32.9%), 1500 mg (23.6%, 28.9%), and 2000 mg (6.3%, 16.2%). Most patients (97.9%, 99.3%) were treated with a daily dose of 2000 mg or less. Among patients < 18 years old, the younger the patient, the lower the dose. MMF was used for more than 1 year in 30.8% of patients < 18 years old and in 28.8% of patients ≥ 18 years old. Conclusions Our study suggested that off-label use of MMF for primary nephrotic syndrome has increased since 2012 in Japan. The dose of MMF used in patients with primary nephrotic syndrome was generally within the approved dose range for lupus nephritis and transplant-related diseases in Japan.

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

Abstract: MMF was commonly used for the treatment of adult LN patients with acceptable efficacy and safety in Japan.

Cited by 12 publications

References 19 publications

Retracted: Efficacy and safety of mycophenolate mofetil in patients with active moderate‐to‐severe Graves’ orbitopathy

Retracted: Efficacy and safety of mycophenolate mofetil in patients with active moderate‐to‐severe Graves’ orbitopathy

Post-marketing surveillance study of the long-term use of mizoribine for the treatment of lupus nephritis: 2-Year results

Use of mycophenolate mofetil in patients with pediatric and adult primary nephrotic syndrome: information from a Japanese hospital claims database

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