よむ、つかう、まなぶ。
資料3-1 ミコフェノール酸モフェチル (23 ページ)
出典
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| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議（第57回 ） |
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3)
Denton CP et al. BSR and BHPR guideline for the treatment of systemic sclerosis. Rheumatology
(Oxford) 2016; 55: 1906-10
4)
Tashkin DP et al. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related
interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial.
Lancet Respir Med 2016; 4: 708-19
5)
米国添付文書（CELLCEPT®）
6)
英国添付文書（CellCept 250 mg hard capsules、CellCept 1 g/5 ml powder for oral suspension）
7)
加国添付文書（CELLCEPT®）
8)
豪州添付文書（CELLCEPT®）
9)
Raghu G et al. Treatment of Systemic Sclerosis-associated Interstitial Lung Disease: Evidencebased Recommendations. Am J Respir Crit Care Med 2023 Sep 29. doi: 10.1164/rccm.2023061113ST
10) Shenoy PD et al. Cyclophospamide versus mycophenolate mofetil in scleroderma interstitial
lung disease (SSc-ILD) as induction therapy: a single-centre, retrospective analysis. Arthritis Res
Ther 2016; 18: 123
11) Panopoulos ST et al. Mycophenolate versus cyclophosphamide for progressive interstitial lung
disease associated with systemic sclerosis: a 2-year case control study. Lung 2013; 191: 483-9
12) Goldin JG et al. Longitudinal changes in quantitative interstitial lung disease on computed
tomography after immunosuppression in the Scleroderma Lung Study II. Ann Am Thorac Soc
2018; 15: 1286-95
13) Naidu GSRSNK et al. Effect of mycophenolate mofetil (MMF) on systemic sclerosisrelated
interstitial lung disease with mildly impaired lung function: a double-blind, placebo-controlled,
randomized trial. Rheumatol Int 2020; 40: 207–16
14) Volkmann ER et al. Treatment with mycophenolate and cyclophosphamide leads to
clinically meaningful improvements in patient-reported outcomes in scleroderma lung disease:
Results of Scleroderma Lung Study II. ACR Open Rheumatol 2020; 2: 362-70
15) Volkmann ER et al. Mycophenolate mofetil versus placebo for systemic sclerosis-related
interstitial lung disease: an analysis of scleroderma lung studies I and II. Arthritis Rheumatol
2017; 69: 1451-60
16) Mendoza FA et al. A prospective observational study of mycophenolate mofetil treatment in
progressive diffuse cutaneous systemic sclerosis of recent onset. J Rheumatol 2012; 39: 1241-7
17) Hachulla E et al. French recommendations for the management of systemic sclerosis. Orphanet
J Rare Dis 2021; 16: 322
18) Li N et al. Joint analysis of bivariate longitudinal ordinal outcomes and competing risks survival
times with nonparametric distributions for random effects. Stat Med 2012; 31: 1707-21
19) Tashkin DP et al. Improved cough and cough-specific quality of life in patients treated for
scleroderma-related interstitial lung disease: results of scleroderma lung study II. Chest 2017;
23
Denton CP et al. BSR and BHPR guideline for the treatment of systemic sclerosis. Rheumatology
(Oxford) 2016; 55: 1906-10
4)
Tashkin DP et al. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related
interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial.
Lancet Respir Med 2016; 4: 708-19
5)
米国添付文書（CELLCEPT®）
6)
英国添付文書（CellCept 250 mg hard capsules、CellCept 1 g/5 ml powder for oral suspension）
7)
加国添付文書（CELLCEPT®）
8)
豪州添付文書（CELLCEPT®）
9)
Raghu G et al. Treatment of Systemic Sclerosis-associated Interstitial Lung Disease: Evidencebased Recommendations. Am J Respir Crit Care Med 2023 Sep 29. doi: 10.1164/rccm.2023061113ST
10) Shenoy PD et al. Cyclophospamide versus mycophenolate mofetil in scleroderma interstitial
lung disease (SSc-ILD) as induction therapy: a single-centre, retrospective analysis. Arthritis Res
Ther 2016; 18: 123
11) Panopoulos ST et al. Mycophenolate versus cyclophosphamide for progressive interstitial lung
disease associated with systemic sclerosis: a 2-year case control study. Lung 2013; 191: 483-9
12) Goldin JG et al. Longitudinal changes in quantitative interstitial lung disease on computed
tomography after immunosuppression in the Scleroderma Lung Study II. Ann Am Thorac Soc
2018; 15: 1286-95
13) Naidu GSRSNK et al. Effect of mycophenolate mofetil (MMF) on systemic sclerosisrelated
interstitial lung disease with mildly impaired lung function: a double-blind, placebo-controlled,
randomized trial. Rheumatol Int 2020; 40: 207–16
14) Volkmann ER et al. Treatment with mycophenolate and cyclophosphamide leads to
clinically meaningful improvements in patient-reported outcomes in scleroderma lung disease:
Results of Scleroderma Lung Study II. ACR Open Rheumatol 2020; 2: 362-70
15) Volkmann ER et al. Mycophenolate mofetil versus placebo for systemic sclerosis-related
interstitial lung disease: an analysis of scleroderma lung studies I and II. Arthritis Rheumatol
2017; 69: 1451-60
16) Mendoza FA et al. A prospective observational study of mycophenolate mofetil treatment in
progressive diffuse cutaneous systemic sclerosis of recent onset. J Rheumatol 2012; 39: 1241-7
17) Hachulla E et al. French recommendations for the management of systemic sclerosis. Orphanet
J Rare Dis 2021; 16: 322
18) Li N et al. Joint analysis of bivariate longitudinal ordinal outcomes and competing risks survival
times with nonparametric distributions for random effects. Stat Med 2012; 31: 1707-21
19) Tashkin DP et al. Improved cough and cough-specific quality of life in patients treated for
scleroderma-related interstitial lung disease: results of scleroderma lung study II. Chest 2017;
23