Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Detailed Description
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There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, the investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Official Title
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Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus

Conditions
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Autoimmune Hemolytic Anemia, Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Mycophenolate Mofetil 500mg
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of erythematosus (SLE) according to The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) guidelines. secondary autoimmune hemolytic anemia (AIHA) that does not respond properly to corticosteroid or when the patients are intolerant to treatment, or refuse standard treatment. Exclusion Criteria: Pregnant or breastfeeding women. any contraindication of the used drugs. any known hypersensitivity of the used drugs. congenital hemolytic anemia. chronic renal failure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MMF arm<br> | Drug: Mycophenolate Mofetil 500mg<br>* MMF 2gram/day orally for 12 weeks<br>|
| Active Comparator: Rituximab arm<br> | Drug: Rituximab<br>* 375 mg/m2 of rituximab given intravenously weekly for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response (CR) proportion | CR defined as hemoglobin > 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers. | 12 weeks | 
| partial response (PR) proportion | PR defined as hemoglobin 10-12 g/dL or at least ≥ 2 g/dL increase from baseline not attributed to transfusion effect and the normalization of hemolytic markers. | 12 weeks | 
| rate of Adverse events | rate of occurrence of adverse events of the both drugs | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness | Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) sub-scale questionnaire | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune hemolytic anemia, systemic lupus erythematosus, mycophenolate mofetil