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

NCT06522048 | Completed

• 1 other identifier: Ethical Number [2021]261
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications

  Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.

  January 2015 to May 2024

Study Arms (2)

Non-immune checkpoint inhibitor (non-ICI) drugs group

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by non-immune checkpoint inhibitor (non-ICI) drugs

Other: Observational studies do not require intervention

Immune checkpoint inhibitor (ICIs) group

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by immune checkpoint inhibitor (ICIs)

Other: Observational studies do not require intervention

Interventions

Observational studies do not require intervention OTHER

This is an observational retrospective study and does not require any intervention.

Immune checkpoint inhibitor (ICIs) group; Non-immune checkpoint inhibitor (non-ICI) drugs group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Detailed patient records for SJS/TEN were available in the dermatology inpatient department according to inclusion criteria.

You may qualify if:

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

You may not qualify if:

• Incomplete medical records
• Unknown the specific culprit drugs

Sponsors & Collaborators

• Chao Ji: lead

Study Sites (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

Related Publications (5)

• Gerull R, Nelle M, Schaible T. Toxic epidermal necrolysis and Stevens-Johnson syndrome: a review. Crit Care Med. 2011 Jun;39(6):1521-32. doi: 10.1097/CCM.0b013e31821201ed.

  PMID: 21358399 BACKGROUND

• Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.

  PMID: 29442540 BACKGROUND

• Zimmermann S, Sekula P, Venhoff M, Motschall E, Knaus J, Schumacher M, Mockenhaupt M. Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jun 1;153(6):514-522. doi: 10.1001/jamadermatol.2016.5668.

  PMID: 28329382 BACKGROUND

• Van Wilpe S, Koornstra R, Den Brok M, De Groot JW, Blank C, De Vries J, Gerritsen W, Mehra N. Lactate dehydrogenase: a marker of diminished antitumor immunity. Oncoimmunology. 2020 Feb 26;9(1):1731942. doi: 10.1080/2162402X.2020.1731942. eCollection 2020.

  PMID: 32158624 BACKGROUND

• Lin CC, Chen CB, Wang CW, Hung SI, Chung WH. Stevens-Johnson syndrome and toxic epidermal necrolysis: risk factors, causality assessment and potential prevention strategies. Expert Rev Clin Immunol. 2020 Apr;16(4):373-387. doi: 10.1080/1744666X.2020.1740591. Epub 2020 Apr 2.

  PMID: 32154748 BACKGROUND

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of the Dermatology Branch of the First Affiliated Hospital of Fujian Medical University

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: January 1, 2015
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)