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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: National Science Council, Taiwan
• Treatments: Etanercept; Prednisolone

Criteria

Inclusion Criteria:

1. Male or female patient with clinical and pathological diagnoses of severe cutaneous adverse drug reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or Durg reaction with eosinophilia and systemic symptoms.

2. Male or female patient aged more than 4 years.

3. Inform consent obtained.

Exclusion Criteria:

1. Pregnant or breastfeeding female.

2. Allergic to any anti-TNF-α biological product.

3. Active or latent tuberculosis confirmed with Chest X-ray.

4. Severe active infection and septicemia.

5. Active Hepatitis B or C carrier.

6. Suspected HIV carrier with CD4 count less than 200.

7. Patient with poor compliance or with safety concerns judged by investigator.