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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions (SCAR)

Brief 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 re-epithelization time, internal organ recovery time, mortality rate, and (2) to investigate the pathogenesis of severe cutaneous adverse reaction.

Detailed Summary:

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 highdose systemic glucocorticoids 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,6 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 re-epithelization time, internal organ recovery time, mortality rate. (2) to investigate the pathogenesis of severe cutaneous adverse reaction. This is a open-label, prospective, randomized, control study. Total 90 SCAR patients are collected.

Including criteria: Patients are diagnosed with SCAR, including SJS, TEN, DRESS. And the age of patient are above 18 year-old. Exclusive criteria: pregnancy or breast-feeding women, allergy to anti-TNF-α agent before, active tuberculosis, active infection systemic disease, active HBV or HCV hepatitis, immunocompromise patient.

Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: skin and mucosa membrane healing time [ Time Frame: one years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: July 5, 2009
Date Started: January 2009
Date Completion: December 2011
Last Updated: January 11, 2011
Last Verified: July 2009