Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis

Official Title
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Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study

Conditions
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Toxic Epidermal Necrolysis

Intervention / Treatment
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* Drug: Abrocitinib
* Drug: Tofacitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above. Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria. Liver and kidney function is within acceptable ranges. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment. Patients need to be capable of participating in follow-up visits and treatment plans. Exclusion Criteria: History of allergy to JAK inhibitors. Pregnant or breastfeeding women. Severe infectious conditions. History of central nervous system demyelinating diseases. History of lymphoproliferative diseases. Active and latent tuberculosis. HIV carriers with a CD4+ T cell count lower than (<200/mL). Active HBV/HCV infection. Coagulation disorders or a tendency for thrombosis. Significant abnormalities in blood routine indicators. Liver or kidney dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arocitinib-arm<br>Evaluation of the efficacy and safety of methylprednisolone combined with abrocitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with Arocitinib 200 mg daily. | Drug: Abrocitinib<br>* Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Arocitinib tablets 200 mg per day for 2 weeks<br>* Other names: Solu-Medrol®;|
| Other: Tofacitinib-arm<br>Evaluation of the efficacy and safety of methylprednisolone combined with tofacitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with tofacitinib 10 mg daily. | Drug: Tofacitinib<br>* Solu-Medrol® 1 mg/kg body weight intravenous infusion per day in combination with Tofacitinib tablets 10 mg per day for 2 weeks<br>* Other names: Solu-Medrol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reepithelization | 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). | up to 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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. | up to 12 weeks |