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The aim of this study is to conduct a pharmacoeconomic analysis to compare the use of Mycophenolate Mofetil or i.v. Cyclophosphamide as induction therapy from a third party payer perspective in LN patients in the Egyptian context
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyc group |
| ||
| MMF group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoxan | Drug | Immunosuppressant |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical outcomes | renal remission | 6 months - 12 months |
| pharmacoeconomic outcomes | comparison of Direct medical costs between both regimens | 12 months |
| Quality of life outcomes | SF36 Survey comparison between both groups | baseline and after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | percentage of adverse events in each group | 12 months |
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Inclusion Criteria:
- LN patients between 18 and 65 years of age who were followed up in the Department of Rheumatology and Rehabilitation were included during the study period. All patients fulfilled at least 4 of the 11 American College of Rheumatology (ACR) revised criteria for the classification of SLE 21. Patients were included if they had active lupus nephritis LN(LN) that was confirmed by Class III, or Class IV, or Class V renal biopsy and which was performed within six months of enrolment. Furthermore, laboratory tests must show active nephritis demonstrated by a clinically significant high level of proteinuria, which might indicate a recent decline in renal function 22. Patients with class III or V LN must have either proteinuria (≥ 2 gm/day) or serum creatinine > 1.3 mg/dl. Patients with class IV must have either proteinuria ≥ 1 gm/day or serum creatinine > 1.3 mg/dl 23. Newly diagnosed patients who were given either IV CYC or oral MMF as induction therapy or patients who needed to be induced when flared up were included in the study.
All patients signed a written informed consent form. For those below the age of 21, written informed consent was obtained from the parents.
Exclusion Criteria:
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Newly diagnosed patients who were given either IV CYC or oral MMF as induction therapy or patients who needed to be induced when flared up were included in the study.
All patients signed a written informed consent form. For those below the age of 21, written informed consent was obtained from the parents.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Aini Hospital | Cairo | 11787 | Egypt |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| cellcept | Drug | Immunosuppressant |
|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |