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

Completed

• Conditions: Immune Checkpoint Inhibitor-Induced Dermatitis; Stevens-Johnson Syndrome, Drug-Induced; Toxic Epidermal Necrolysis Due to Drug
• Interventions: Other: Observational studies do not require intervention

• Registration Number: NCT06522048
• Lead Sponsor: Chao Ji

Brief 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2024-05
• Study Completion: 2024-05
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinical diagnosis of SJS/TEN induced by any drugs
• Have the immune-related cutaneous adverse events

Exclusion Criteria

• Incomplete medical records
• Unknown the specific culprit drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immune checkpoint inhibitor (ICIs) group	Observational studies do not require intervention	Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by immune checkpoint inhibitor (ICIs)
Non-immune checkpoint inhibitor (non-ICI) drugs group	Observational studies do not require intervention	Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by non-immune checkpoint inhibitor (non-ICI) drugs

Primary Outcome Measures

Name	Time	Method
Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications	January 2015 to May 2024	Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

Trial Locations

Locations (1)

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China