ArticleEClinicalMedicine2021
Stevens-Johnson syndrome/toxic epidermal necrolysis in patients treated with immune checkpoint inhibitors: A safety analysis of clinical trials and FDA pharmacovigilance database.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Concurrent moxifloxacin-induced liver injury and toxic epidermal necrolysis after immune checkpoint inhibition: a case report and literature review.Frontiers in immunology · 2026Pooled it
- Risk factors of immune checkpoint inhibitor-associated acute kidney injury: evidence from clinical studies and FDA pharmacovigilance database.BMC nephrology · 2023Pooled it
- Severe Cutaneous Adverse Reactions Associated With Newer-Generation Antiseizure Medications: A Real-World Pharmacovigilance Study Based on FAERS and JADER.CNS neuroscience & therapeutics · 2026Article
- Article
- Rapid progression to toxic epidermal necrolysis following switch of PD-1 inhibitors: a case report.Frontiers in medicine · 2026Article
- Sintilimab-induced delayed-onset toxic epidermal necrolysis in a patient with gastric carcinoma: a case report and literature review.Frontiers in oncology · 2026Article
- Pharmacovigilance analysis of severe cutaneous adverse reactions associated with antiseizure medications: a FAERS database study with time-to-onset evaluation.Frontiers in pharmacology · 2026Article
- Successful management of pembrolizumab-associated Stevens-Johnson syndrome/toxic epidermal necrolysis in a patient with uterine serous carcinoma: a case report.Frontiers in immunology · 2026Article
- Review
- Real-World Data on Severe Cutaneous Adverse Reactions to Drugs.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Astellas article: UK multidisciplinary recommendations on use of combination first-line enfortumab vedotin▼ and pembrolizumab in advanced urothelial carcinoma.The oncologist · 2025Article
- Stevens-Johnson syndrome-toxic epidermal necrolysis spectrum reactions to immune checkpoint inhibitor therapy and safety of rechallenge: A retrospective review.JAAD case reports · 2025Article
- Lamotrigine Therapy: Relation Between Treatment of Bipolar Affective Disorder and Incidence of Stevens-Johnson Syndrome-A Narrative Review of the Existing Literature.Journal of clinical medicine · 2025Review
- Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database.Therapeutic innovation & regulatory science · 2025Article
- Treatment of Tislelizumab-Induced Toxic Epidermal Necrolysis and Agranulocytosis: A Case Report and Literature Review.Current drug safety · 2025Review
- Atezolizumab combined with immunogenic salvage chemoimmunotherapy in patients with transformed diffuse large B-cell lymphoma.Haematologica · 2025Article
- Emerging causes of anticancer therapies-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: evidence from disproportionality analysis of the FDA adverse event reporting system.Frontiers in immunology · 2025Article
- Severe cutaneous adverse reactions to anti-osteoporosis drugs: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database and a review of published cases.Frontiers in pharmacology · 2025Article
- Article
- From tumor to tolerance: A comprehensive review of immune checkpoint inhibitors and immune-related adverse events.Asia Pacific allergy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe association between immune checkpoint inhibitors (ICIs) and Stevens-Johnsons syndrome (SJS) /toxic epidermal necrolysis (TEN) is unclear. We assessed the risk of SJS and TEN related to ICIs, via a systematic analysis of SJS/TEN cases reported in clinical trials and the FDA Adverse Event Reporting System (FAERS).
methodsWe explored ICIs related SJS/TEN events in randomized control trials available in ClinicalTrials.gov and electronic databases (Pubmed, Embase, the Cochrane Central Register of Controlled Trials) up to 12 January 2021. Meta-analysis was performed by using Peto odds ratios (ORs) with 95% CIs. In a separate retrospective pharmacovigilance study of FAERs, cases of ICIs related SJS/TEN were extracted between the first quarter (Q1) of 2004 and Q4 of 2020. Disproportionality was analyzed using the proportional reports reporting odds ratio (ROR) and information components (IC). PROSPERO registration number: CRD42021232399.
findingsA total of 20 RCTs (11597 patients) were included. ICIs were associated with an increased risk of SJS/TEN (OR= 4.33, 95%CI:1.90-9.87). FAERS pharmacovigilance data identified 411 cases of SJS (
interpretationThese data suggest that ICIs were significantly associated with increased risk of SJS/TEN.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.