NCT06522048

SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs

SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) Versus Non-ICIs in Chinese Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Chao Ji · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction, characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs), versus other types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

Detailed description

Introduction: Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs) versus other type drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life. Methods: * Study Design: Retrospective cohort study or cross-sectional study. * Participants: 60 patients with ICI-induced SJS/TEN and 100 to 500 patients with other drug-induced SJS/TEN. * Data Collection: Detailed medical records were reviewed to extract information. * Statistical Analysis: analysis using appropriate statistical tests (e.g., t-test, chi-square test). Results: Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings. Conclusion: We discuss the clinical implications of the findings, potential mechanisms underlying the observed differences, and the relevance to patient management. Summarize the main findings and their significance for clinical practice. Emphasize the need for tailored treatment approaches based on the type of drug causing SJS/TEN.

Conditions

• Immune Checkpoint Inhibitor-Induced Dermatitis
• Stevens-Johnson Syndrome, Drug-Induced
• Toxic Epidermal Necrolysis Due to Drug

Interventions

Type	Name	Description
OTHER	Observational studies do not require intervention	This is an observational retrospective study and does not require any intervention.

Timeline

• Start date: 2015-01-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2024-07-26
• Last updated: 2024-07-29

Locations

1 site across 1 country: China