Wang 2018.
Study characteristics | ||
Methods |
Study Design: open‐label randomised controlled trial Study Duration: participants were followed for an additional 3 weeks after hospital discharge Number of Participants Randomised: 91 Study Dates: 2009 to 2015 |
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Participants |
Setting: the study was undertaken at Chuang Gung Memorial Hospital, the largest medical health system in Taiwan, which receives SJS‐TEN referral cases from other hospitals in northern Taiwan. Inclusion Criteria: patients over 4 years of age diagnosed with "probable" or "definite" SJS‐TEN using the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) phenotypic criteria, and for most patients histopathological analysis including direct immunofluorescence and blister granulysin levels. All patients were also "assessed and diagnosed by at least two experienced dermatologists". Exclusion Criteria: (a) pregnant or breastfeeding women; (b) patients with a previous allergy to any TNF‐α biological product; (c) patients with active or latent tuberculosis confirmed by chest x‐ray; (d) patients with severe, active infection and septicaemia; (e) carriers of active hepatitis B or C; (f) suspected carriers of HIV with a CD4+ T cell count below 200; and (g) patients with poor compliance or safety concerns, as judged by an investigator Baseline Data: Overall study group:
Intervention:
Comparator:
Data not reported:
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Interventions |
Intervention: Etanercept 25 mg (50 mg if weight > 65 kg) subcutaneous twice weekly "until skin lesions healed" (n = 48) Comparator: Prednisolone 1 to 1.5 mg/kg/day intravenous "until skin lesions healed" (n = 43) Supportive Care Measures (for all): No details provided. |
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Outcomes | Disease‐specific mortality Other adverse events Days to full skin healing, median (mean and SD not provided) |
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Funding source | This work was supported by grants from the National Science Council of Taiwan (MOST101‐2320‐B‐010‐072‐MY3, MOST101‐2321‐B‐010‐027, MOST101‐2628‐B‐182‐001‐MY3, MOST101‐2321‐B‐182‐008, MOST102‐2314‐B‐010‐014‐MY3, MOST102‐2321‐B‐182‐006, and MOST103‐2321‐B‐182‐001); the CGMH (BMRPG‐290011, OMRPG‐2C0011, OMRPG‐2C0021, CMRPG‐290051‐3, CMRPG‐3D0351‐2, CMRPG‐3D0361‐2, CORPG3F0041‐2, and CLRPG‐2E0051); and the Ministry of Health and Welfare of Taiwan (DOHW103‐TDU‐B‐212‐113003, DOHW104‐TDU‐B‐212‐113003, and DOHW105‐TDU‐B‐212‐113003). | |
Declarations of interest | The authors declare that they have no conflicts of interest. | |
Notes |