Toxic Epidermal Necrolysis
Conditions
Brief summary
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
Interventions
DRUGAbrocitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks
DRUGTofacitinib
Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks
Sponsors
Peng Zhang
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 and above. 2. Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria. 3. Liver and kidney function is within acceptable ranges. 4. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges. 5. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment. 6. Patients need to be capable of participating in follow-up visits and treatment plans.
Exclusion criteria
1. History of allergy to JAK inhibitors. 2. Pregnant or breastfeeding women. 3. Severe infectious conditions. 4. History of central nervous system demyelinating diseases. 5. History of lymphoproliferative diseases. 6. Active and latent tuberculosis. 7. HIV carriers with a CD4+ T cell count lower than (\<200/mL). 8. Active HBV/HCV infection. 9. Coagulation disorders or a tendency for thrombosis. 10. Significant abnormalities in blood routine indicators. 11. Liver or kidney dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reepithelization | up to 8 week | duration from initiation of treatment to the point when skin detachment and erosions were no longer observed (negative Nikolsky's sign). Meanwhile, skin islands started to regenerate and replace the damaged superficial epithelia in local skin or mucous lesions (approximately 20% of the maximum BSA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | up to 12 weeks | The common adverse effects associated with treatments including elevated blood pressure, elevated blood glucose, gastrointestinal bleeding, electrolyte disturbance, and mucocutaneous infections were closely monitored during their hospitalization. All patients in both groups were followed up for 4 weeks to monitor the associated adverse effects. |
Countries
China
Contacts
Primary ContactChao Ji
Backup ContactPeng Zhang
Outcome results
None listed