Monitoring the IMmUological TOXicity of Drugs

Groupe Hospitalier Pitie-Salpetriere662 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

662

Conditions

Arthritis Systemic Lupus Erythematosus Rheumatoid Arthritis Capillary Leak Syndrome Hepatitis

Interventions

drug inducing arthritis, lupus, hepatitis, or capillary leak syndromDRUG

Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, France

Rhumatology department, CHU Strasbourg, Hautepierre hospital

Strasbourg, France

Outcomes

Primary Outcomes

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: