Evidence map›Paper›PMID 29400697›Full record

Trial reportThe Journal of clinical investigation2018

Randomized, controlled trial of TNF-α antagonist in CTL-mediated severe cutaneous adverse reactions.

Chuang-Wei Wang, Lan-Yan Yang, Chun-Bing Chen, Hsin-Chun Ho, Shuen-Iu Hung, Chih-Hsun Yang, Chee-Jen Chang, Shih-Chi Su, Rosaline Chung-Yee Hui, See-Wen Chin and 10 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01276314 (Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions), which is not on this map. Cited by 119 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 6 pooled it
19.6field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01276314 nacompletednot on this map

Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions (SCAR)

TypeinterventionalSponsorChang Gung Memorial HospitalRan2009 to 2015Enrolled135ConditionsDrug HypersensitivityArmsanti- TNF-a, Prednisolone
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 6 syntheses or guidelines pooled it, 271 citations in OpenAlex.

  1. Pooled it
  2. Systemic immunomodulating therapies for epidermal necrolysis (Stevens-Johnson syndrome/toxic epidermal necrolysis): A systematic review and meta-analysis.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2026
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59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 5 institutions in 2 countries.

Chuang-Wei WangDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Lan-Yan YangClinical Trial Center, CGMH, Linkou, Taiwan.
Chun-Bing ChenDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Hsin-Chun HoDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Shuen-Iu HungDepartment and Institute of Pharmacology, School of Medicine, Infection and Immunity Research Center, National Yang-Ming University, Taipei, Taiwan.
Chih-Hsun YangDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Chee-Jen ChangGraduate Institute of Clinical Medical Science, Clinical Informatics and Medical Statistics Research Center, Chang Gung University, Taoyuan, Taiwan.
Shih-Chi SuDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Rosaline Chung-Yee HuiDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
See-Wen ChinDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Li-Fang HuangClinical Trial Center, CGMH, Linkou, Taiwan.
Yang Yu-Wei LinDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Wei-Yang ChangClinical Trial Center, CGMH, Linkou, Taiwan.
Wen-Lang FanWhole-Genome Research Core Laboratory of Human Diseases, CGMH, Keelung, Taiwan.
Chin-Yi YangDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Ji-Chen HoCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.
Ya-Ching ChangDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Chun-Wei LuDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
Wen-Hung ChungDepartment of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital (CGMH), Linkou, Taipei and Keelung, Taiwan.
the Taiwan Severe Cutaneous Adverse Reaction (TSCAR) Consortium
Chang Gung University · TWHuman Genome Sciences (United States) · USLinkou Chang Gung Memorial Hospital · TWChang Gung Memorial Hospital · TWNational Yang Ming Chiao Tung University · TW

Funding

NTP INFORMATION SYSTEMS SUPPORT27305C0011 · NIEHS · Z-TECH CORPORATION · 2007 to 2009
$4.3M
PROVIDE RABBITS, RATS, MICE, HAMSTERS, GERBILS, GUINEA PIGS27307C0011 · NIEHS · PI BOLEN, WAYNE · 2007 to 2007
$500k
NIEHS NIH HHS 27305C0011NIEHS NIH HHS 27307C0011NIEHS NIH HHS 27398C0011
6 · The paper itself

Abstract

backgroundCytotoxic T lymphocyte-mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare but life-threatening adverse reactions commonly induced by drugs. Although high levels of CTL-associated cytokines, chemokines, or cytotoxic proteins, including TNF-α and granulysin, were observed in SJS-TEN patients in recent studies, the optimal treatment for these diseases remains controversial. We aimed to evaluate the efficacy, safety, and therapeutic mechanism of a TNF-α antagonist in CTL-mediated SCARs.

methodsWe enrolled 96 patients with SJS-TEN in a randomized trial to compare the effects of the TNF-α antagonist etanercept versus traditional corticosteroids.

resultsEtanercept improved clinical outcomes in patients with SJS-TEN. Etanercept decreased the SCORTEN-based predicted mortality rate (predicted and observed rates, 17.7% and 8.3%, respectively). Compared with corticosteroids, etanercept further reduced the skin-healing time in moderate-to-severe SJS-TEN patients (median time for skin healing was 14 and 19 days for etanercept and corticosteroids, respectively; P = 0.010), with a lower incidence of gastrointestinal hemorrhage in all SJS-TEN patients (2.6% for etanercept and 18.2% for corticosteroids; P = 0.03). In the therapeutic mechanism study, etanercept decreased the TNF-α and granulysin secretions in blister fluids and plasma (45.7%-62.5% decrease after treatment; all P < 0.05) and increased the Treg population (2-fold percentage increase after treatment; P = 0.002), which was related to mortality in severe SJS-TEN.

conclusionsThe anti-TNF-α biologic agent etanercept serves as an effective alternative for the treatment of CTL-mediated SCARs.

trial registrationClinicalTrials.gov NCT01276314.

fundingMinistry of Science and Technology of Taiwan.

Indexed as

Administration, CutaneousAdrenal Cortex HormonesAdultAgedAntigens, Differentiation, T-LymphocyteChemokinesCytokinesEtanerceptFemaleGastrointestinal HemorrhageHumansImmunophenotypingMaleMiddle AgedSkinStevens-Johnson SyndromeAdrenal Cortex HormonesAntigens, Differentiation, T-LymphocyteChemokinesCytokinesEtanerceptGNLY protein, humanTNF protein, humanTumor Necrosis Factor-alphaAllergyClinical TrialsImmunologyImmunotherapy

Identifiers

PMID29400697
PMCPMC5824923
OpenAlexW2787407277

What OpenQuestion holds

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Read underepoch 390

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.