Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors

Johns Hopkins University

Status: Completed

Conditions: Cutaneous Toxicity From ICI Therapy

Treatments: Drug: Immune checkpoint inhibitor (ICI)

Study type: Observational

Funder types: Other

Identifiers

NCT04898751

JH IRB00210048

Details and patient eligibility

About

Immune checkpoint inhibitors (ICIs) are associated with a wide variety of cutaneous immune-related adverse events (cirAEs). These cirAEs are reported to be the most common immune-related adverse events (irAEs) and the first to appear. This study examines the appearance of cirAEs within the World Health Organization (WHO) pharmacovigilance database, VigiBase.

Full description

ICIs have revolutionized clinical oncologic care. The ICIs that are currently FDA approved fall into three main categories: those that block the cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4; ipilimumab), block the programmed cell death protein-1 (anti-PD-1; nivolumab, pembrolizumab, cemiplimab), and block the programmed cell death ligand-1 (anti-PD-L1; atezolizumab, avelumab, durvalumab) pathway. There is a considerable diversity of cirAEs that have been reported with these ICIs in both monotherapy and combination therapy.

VigiBase is the WHO pharmacovigilance database that monitors individual case safety reports associated with certain drugs. The largest database of its kind in the world, VigiBase is managed by the Uppsala Monitoring Center (UMC) in Sweden, and since its inception in 1967 has received over 19 million individual case safety reports (ICSRs) from over 130 contributing countries. In this study, the investigators examine the appearance of cutaneous immune related adverse events in the setting of immunotherapy within VigiBase.

Enrollment: 2,214 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with either Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), and Cemiplimab (L01XC33).
• Developed an adverse reaction that was submitted to a pharmacovigilance center and was determined to be related to aforementioned immune checkpoint inhibitors.
• Adverse reaction was determined to be within the System Organ Class (SOC) "Skin and subcutaneous disorder".

Exclusion criteria

• Adverse event was determined not to be immune-related (for example, infectious etiology) or was a symptom (e.g., edema).
• Adverse event developed before the administration of ICI.

Trial design

2,214 participants in 1 patient group

Cutaneous toxicity

Description:

Patients who reported a cutaneous immune related adverse event following ICI initiation with appropriate chronology that indicates drug toxicity.

Treatment:

Drug: Immune checkpoint inhibitor (ICI)