Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

Study Overview
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Brief Summary
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Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases. The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.

Official Title
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Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab

Conditions
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Autoimmune Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient initiating treatment with RTX, delivered by the central pharmacy of Lille University Hospital Inpatient or outpatient at Lille University Hospital (in one of the following departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and monitored every three months as part of routine care (as part of the surveillance of induction of RTX treatment) Patient with one of the following autoimmune diseases, defined by international criteria Exclusion Criteria: Treatment with rituximab for a malignancy or a transplant reject Pregnant or lactating women People in emergency Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent Persons deprived of their liberty People unable to consent

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab | A serious infection event [SIE] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs | Within 12 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypogammaglobulinemia | defined by immunoglobulin (Ig) G <6g / L. | Within 12 months after inclusion | 
| Replacement therapy with immunoglobulins | Start of an immunoglobulins therapy to replace gammaglobulins | Within 12 months after inclusion | 
| Hypersensitivity skin reaction secondary to RTX injection. | Attack rate of cutaneous hypersensitivity reactions after RTX injection in patients with dysimmune disease. | Within 12 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infections, immunoglobulins, secondary immunodeficiency, rituximab