Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Study Overview
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Brief Summary
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This is a prospective, multicenter cohort observational; study to compare treatment outcomes in patients admitted to the hospital with Stevens-Johnsons Syndrome/Toxic Epidermolysis, aiming to assess the utility of medical management. The hypothesis of this study is that one or more treatment options will demonstrate improved patient outcomes. The primary objectives are cessation of progression of disease, time to complete re-epithelialization, length of stay, and mortality rate in the treatment groups as compared to those receiving supportive care alone. Exploratory analyses will assess the cause, risk factors, and severity prediction factors associated with the disease.

Official Title
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A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Conditions
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Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction

Intervention / Treatment
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* Drug: Site specific standard of care comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of Stevens Johnsons Syndrome/Toxic Epidermal Necrolysis confirmed by examination of a dermatologist and/or skin biopsy plus described appropriate clinical findings (epidermal necrosis plus two involved mucosal surfaces) presenting within one week of disease onset Exclusion Criteria: Pregnancy Age <18y Decisional impairment Incarceration Onset of skin separation >7d

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cyclosporine<br> | Drug: Site specific standard of care comparison<br>* Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.<br>|
| Intravenous Immunoglobulin<br> | Drug: Site specific standard of care comparison<br>* Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.<br>|
| Etanercept<br> | Drug: Site specific standard of care comparison<br>* Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.<br>|
| Steroids<br> | Drug: Site specific standard of care comparison<br>* Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Percent of deaths in each group | 3 years | 
| Time to cessation of new lesion formation | Days until no new lesions arise from time of initiation of therapy | 3 years | 
| Time to re-epithelialization | Days until skin has completely healed | 3 years | 
| Hospital length of stay | Time from hospital admission to discharge | 3 years |