Monitoring the IMmUological TOXicity of Drugs

Study Overview
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Brief Summary
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Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed Description
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Several drugs and chemotherapies seem to have an impact on the immunological system and are responsible of a wide range of rare immunological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Official Title
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Monitoring the IMmUological TOXicity of Drugs

Conditions
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Arthritis, Hepatitis, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Capillary Leak Syndrome

Intervention / Treatment
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* Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case reported in the WHO's pharmacovigilance database till 02/01/2018 Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome. Exclusion Criteria: Chronology not compatible between the drug and the toxicity

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arthritis or lupus or CLS induced by a drug<br>Case reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak syndrome of patient treated by a drug, with a chronology compatible with the drug toxicity | Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom<br>* Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms: |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 
| Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 
| Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 
| Description of the duration of treatment when the toxicity happens (role of cumulative dose) |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 
| Description of the drug-drug interactions associated with adverse events |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 
| Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adverse event, arthritis, Systemic Lupus Erythematosus, Capillary Leak Syndrome, Hepatitis