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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthritis or lupus or CLS induced by a drug | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom | Drug | Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM. | Paris | 75013 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29724725 | Result | Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3. No abstract available. | |
| 30244023 | Result | Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20. No abstract available. |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| D019559 | Capillary Leak Syndrome |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| 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 |
| Rhumatology department, CHU Strasbourg, Hautepierre hospital |
| Strasbourg |
| 67098 |
| France |
| 30793701 | Result | Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012216 | Rheumatic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |