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

Launched by PENG ZHANG · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a combination treatment for people with Toxic Epidermal Necrolysis (TEN), a serious skin condition. The treatment includes methylprednisolone, a type of steroid that helps reduce inflammation, along with two medications called JAK inhibitors, abxitinib and tofacitinib. The goal is to see if this combination can help patients recover more effectively.

To participate in the trial, individuals must be at least 18 years old and diagnosed with TEN based on specific medical criteria. They should also have normal liver and kidney function and be able to attend follow-up visits. However, people with certain conditions, like severe infections or specific allergies, may not be eligible. Those who join the trial will receive close monitoring and care while they undergo this new treatment. Overall, this study aims to find better ways to treat this challenging condition and improve patient outcomes.

Gender

ALL

Eligibility criteria

• 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.