N/A
Completed N=135
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
Source: ClinicalTrials.gov NCT01276314 ↗Enrolled (actual)
135
Serious AEs
15.6%
Results posted
Dec 2017
Primary outcomePrimary: Skin Healing Time — 13.75; 19; 40.5; 34 days — p=0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Healing Time |
13.75; 19; 40.5; 34 | 0.01 sig |
Eligibility Criteria
Inclusion Criteria
- 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.
- Male or female patient aged more than 4 years.
- Inform consent obtained.
Exclusion Criteria
- Pregnant or breastfeeding female.
- Allergic to any anti-TNF-α biological product.
- Active or latent tuberculosis confirmed with Chest X-ray.
- Severe active infection and septicemia.
- Active Hepatitis B or C carrier.
- Suspected HIV carrier with CD4 count less than 200.
- Patient with poor compliance or with safety concerns judged by investigator.
Data sourced from ClinicalTrials.gov (NCT01276314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.