Etanercept therapy for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cases of refractory to systemic steroid therapy

JRCT ID: jRCTs031210325

Registered date:17/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: stevens-johnson syndrome, toxic epidermal necrosis
• Date of first enrollment: 01/10/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Etanercept 50 mg / day is subcutaneously administered on the first day (Day 1). If epithelialization is not complete, administer once on day 8 (Day 8) and day 15 (Day 15) as needed.

Outcome(s)

Primary Outcome

Period until re-epithelialization is completed (day)
The number of days from the first administration day (Day 1) to the completion date of re-epithelialization when the skin peeling area becomes 0% is totaled and evaluated.

Secondary Outcome

1. Period until the progress of skin symptoms stops (day)
The progress of the skin symptoms stop from the first day of administration (Day 1) to aggregate the number of days until the (new blisters / skin peeling, flaking and state not recognized is likely to skin) evaluation.

2. Hospitalization period (day)
The number of days from Day 1 to the discharge date is totaled and evaluated.

3. Mortality rate until Day 29
Aggregate the deaths from Day 1 to Day 29 and evaluate the mortality rate.

4. Severity-of-illness evaluation
The severity-of-illness score at each evaluation point and amount of change from baseline for each item are evaluated.

5. Corneal epithelial defect score
Evaluate the amount of change from baseline.

6. Presence or absence of re-epithelialization
The presence or absence of re-epithelialization is confirmed every week, and the re-epithelialization rate is evaluated.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who meet the SJS diagnostic criteria or the TEN diagnostic criteria.
2.Patients treated with systemic steroid therapy (predonisolone equivalent administrated 20 mg/day or more) for 2 days or more.
3. Patients with progressing or unchanged symptoms after steroid therapy.
4. Patients aged 20 years or older who gave written consent to participate in the study.

Exclude criteria

1. Patients whose dose of systemic steroid therapy has been changed within 2 days (excluding cases where dose reduction is necessary due to worsening complications, etc.)
2. Patients who received steroid pulse therapy within 2 days
3. Patients who received IVIg therapy within 2 days
4. Patients who received plasma exchange therapy within 2 days
5. Patients who need to use the concomitant prohibited drugs and therapies in this study
6. Patients with a total SCORTEN score of 4 points or more
7. Patients with DIHS
8. Patients with multiple organ failure
9. Patients with serious infection and sepsis
10. Patients with demyelinating disease (multiple sclerosis, etc.)
11. Patients with serious respiratory illness (active or latent tuberculosis, etc. )
12. Patients infected with hepatitis B virus or hepatitis C virus
13. Patients with severe cerebral and cardiovascular disorders
14. Patients with severe deterioration of cardiac function
15. Patients at high risk of thrombosis embolus
16. Patients with hemolytic and blood loss anemia
17. Patients with platelet count less than 75,000 /microL
18. Patients with serum creatinine of 2 mg/dL or more
19. Patients with a history of shock and hypersensitivity to ETN
20. Patients who have been treated with ETN or other TNF-alpha inhibitors within 168 days ( 24 weeks )
21. Patients treated with other unapproved drugs within 168 days ( 24 weeks )
22. Pregnant, expected pregnant, lactating patients, or patients who disagree with contraception until the end of observation
23. Patients who are judged to be inappropriate by the responsible doctor or the sharing doctor

Related Information

• Primary Sponsor: Abe Riichirou
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development