Arthritis, Autoimmune Diseases, Cancer, Cardiac Disease, Endocrine System Diseases, Myositis, Neuropathy, Ophthalmopathy
Conditions
Keywords
Anti-PD-1, Anti-PD-L1, Anti-CTLA-4, Immune checkpoint inhibitors, Immune adverse drug reactions
Brief summary
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV).
Detailed description
Immune checkpoint inhibitors (ICIs) have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, immune-related adverse events (irAEs) can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, and in the Base Nationale de PharmacoVigilance (BNPV) which is the french pharmacovigilance database, to identify cases of adverse drug reaction including arthiritis, auto-immune induced diseases, cardiac diseases, endocrinologic diseases, following treatment with ICIs.
Interventions
DRUGImmune checkpoint inhibitor
Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification) as a monotherapy or in combination: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
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 World Health Organization (WHO) database and Base Nationale de Pharmacovigilance (BNPV) of individual safety case reports to 01/05/2018 * Adverse events reported * Patients treated with ICIs, in monotherapy or combination, included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
Exclusion criteria
• Chronology not compatible between the drug and the toxicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug reactions induced by ICIs and reported in the World Health Organization (WHO) or the Base Nationale de Pharmacovigilance (BNPV) | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 | Identification and report of cases of adverse events associated with ICIs. Drugs investigated are ICIs: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32). |
Secondary
| Measure | Time frame |
|---|---|
| Description of the type of adverse drug reaction depending on the category of ICIs | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
| Description of the other immune related adverse events concomitant to the adverse drug reaction induced by ICIs | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
| Description of the duration of treatment when the toxicity happens (role of cumulative dose) | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
| Causality assessment of reported adverse drug reaction according to the WHO system | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
| Description of the population of patients having adverse event | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
| Description of the drug-drug interactions associated with adverse events | Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018 |
Countries
France
Outcome results
None listed