An interventional study of anti- TNF-a and Prednisolone in Drug Hypersensitivity, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), has a mortality rate evaluated at about 10%. The aims of this project are (1) to compare the effect of treatment between systemic steroid and anti-TNF-α. Including skin healing time, beginning of re-epithelialization time, internal organ recovery time, mortality rate, adverse events and (2) to investigate the molecular mechanism of severe cutaneous adverse reaction after anti-TNF-α treatment.
Severe cutaneous adverse drug reactions, including Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome(SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a life threatening disease. There is no gold standard in the therapy of SCAR. Treatment with high dose systemic corticosteroids is controversial. Although there have been recent reports of success with various therapies such as plasmapheresis and high-dose intravenous immunoglobulins, their efficacy is not yet proven. Assessment of these therapies is difficult because of their non-specific immunosuppressant or immunomodulating modes of action. Recent studies have shown evidence of the pathogenetic importance of tumour necrosis factor (TNF)-a, suggesting a new therapeutic approach in selective blockade of TNF-a using specific antibodies. We report successful treatment TEN using monoclonal IgG anti-TNF-antibodies. The aims of this project are (1) to compare the effect of treatment between systemic steroid and anti-TNF-α. Including skin healing time, beginning of re-epithelialization time, internal organ recovery time, mortality rate, adverse events and (2) to investigate the molecular mechanism of severe cutaneous adverse reaction after anti-TNF-α treatment.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 135 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
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Exclusion Criteria:
1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF 2. Fill out the case report form 3. Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis 4. Etanercept administration: The experimental group received the first dose of Etanercept (25 mg) i.v., followed by two doses per week and maintain 2 to 3 weeks
Drug: anti- TNF-a
1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the ICF 2. Fill out the case report form 3. Blood test and physiological assessment, and do TNF-alpha serum concentration and peripheral blood mononuclear spherical cDNA expression analysis 4. Drug administration: The control group of drug delivery: systemic intravenous steroid therapy, the dose is equivalent to prednisolone 1-1.5 mg / kg / day, according to the treatment of 3-4 days gradually decreased dose.
Drug: Prednisolone
25mg BIW, SC
Also known as: Etanercept
1-1.5 mg / kg / day
Also known as: steroid therapy
Skin Healing Time
Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.
Time frame: One to two months for SJS/TEN cases, and one to six months for DRESS cases.
SCAR patients were enrolled in the clinical trial from 2009 to 2015 at Chang Gung Memorial Hospital in Taiwan.
| Milestone | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) |
|---|---|---|---|---|
| Started | 48 | 43 | 22 | 22 |
| Completed | 38 | 33 | 18 | 17 |
| Not completed | 10 | 10 | 4 | 5 |
Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.
| days | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) |
|---|---|---|---|---|
| Skin Healing Time | 13.75 (4 to 41) | 19 (7 to 42) | 40.5 (18 to 117) | 34 (9 to 165) |
Collected over one to two months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anti- TNF-a Treatment (SJS/TEN) | — | 5/48 (10.4%) | 15/48 (31.3%) |
| Control Group (SJS/TEN) | — | 9/43 (20.9%) | 19/43 (44.2%) |
| Anti- TNF-a Treatment (DRESS) | — | 2/22 (9.1%) | 8/22 (36.4%) |
| Control Group (DRESS) | — | 5/22 (22.7%) | 8/22 (36.4%) |
| Event | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) |
|---|---|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/48 | 5/43 | 1/22 | 0/22 |
| SepsisInfections and infestations | 2/48 | 4/43 | 0/22 | 2/22 |
| Upper GI hemorrhageGastrointestinal disorders | 0/48 | 1/43 | 1/22 | 2/22 |
| HyperglycemiaMetabolism and nutrition disorders | 0/48 | 0/43 | 0/22 | 1/22 |
| Stridor, vocal cord palsyReproductive system and breast disorders | 0/48 | 1/43 | 0/22 | 0/22 |
| Bipolar disorderPsychiatric disorders | 1/48 | 0/43 | 0/22 | 0/22 |
| Event | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) |
|---|---|---|---|---|
| HyperglycemiaMetabolism and nutrition disorders | 8/48 | 8/43 | 4/22 | 3/22 |
| GI hemorrhage (grade 2)Gastrointestinal disorders | 1/48 | 6/43 | 1/22 | 3/22 |
| HypertensionVascular disorders | 6/48 | 5/43 | 3/22 | 2/22 |
A total of 135 SCAR patients (including 91 SJS/TEN cases and 44 DRESS cases) were enrolled to analyze.
| Age, Categorical(Participants) | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 5 | 0 | 0 | 6 |
| Between 18 and 65 years | 35 | 15 | 17 | 11 | 78 |
| >=65 years | 12 | 23 | 5 | 11 | 51 |
| Age, Continuous(years) | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) | Total |
|---|---|---|---|---|---|
| Mean | 52.73 ± 16.78 | 59.84 ± 24.20 | 53.95 ± 17.41 | 60.95 ± 20.39 | 56.53 ± 20.20 |
| Sex: Female, Male(Participants) | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) | Total |
|---|---|---|---|---|---|
| Female | 28 | 23 | 14 | 15 | 80 |
| Male | 20 | 20 | 8 | 7 | 55 |
| Region of Enrollment(Participants) | Anti- TNF-a Treatment (SJS/TEN) | Control Group (SJS/TEN) | Anti- TNF-a Treatment (DRESS) | Control Group (DRESS) | Total |
|---|---|---|---|---|---|
| Taiwan | 48 | 43 | 22 | 22 | 135 |
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Chang Gung Memorial Hospital