Arthritis, Capillary Leak Syndrome, Hepatitis, Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
Keywords
adverse event, arthritis, Systemic Lupus Erythematosus, Capillary Leak Syndrome, Hepatitis
Brief summary
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
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.
Interventions
DRUGdrug inducing arthritis, lupus, hepatitis, or capillary leak syndrom
Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed