A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt

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

Study Overview

• Status: Completed
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: endoxan; Drug: cellcept

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11787
    • Kasr El Aini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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:

• Patients were excluded from the study if they had a history of known allergy to study drugs, received previous kidney transplantation, or were on continuous dialysis for more than two weeks before the study. Patients with combinations of membranous and proliferative glomerulonephritis (i.e., class III + V or class IV + V) renal biopsies were not included. Other reasons for exclusion were pregnancy and lactation, pancreatitis, current infection episode requiring IV antibiotics, severe viral infection, history of cancer, or overlapping autoimmune condition.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cyc group	Drug: endoxan; Immunosuppressant; Other Names: Cyclophosphamide
MMF group	Drug: cellcept; Immunosuppressant; Other Names: Mycophenolate Mofetil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	percentage of adverse events in each group	12 months

Collaborators and Investigators

• Sponsor: Nada Magdy Mansour

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): June 5, 2021

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Lupus Nephritis, immunosuppressive agents, Mycophenolic acid, Cyclophosphamide, healthcare costs, cost saving regimen, resource-limited setting, Egypt.
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Cyclophosphamide; Mycophenolic Acid
• Other Study ID Numbers: CP3.4.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes