Trial results for the study investigating tofacitinib in patients with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) were posted on ClinicalTrials.gov on 2025-09-16. The study reported a median complete skin healing time of 10.0 days and 0 participant mortalities.
Background
The study aimed to evaluate the effect of tofacitinib in patients with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These conditions are severe, life-threatening dermatologic emergencies.
Trial design
This study (NCT06474078) was completed with an overall status of COMPLETED and enrolled 20 participants. The phase was not specified. It investigated tofacitinib in patients diagnosed with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. The primary outcome of the study was the time to complete re-epithelialization. Secondary outcomes included mortality, length of hospitalization, adverse events, time to beginning of epithelization, time to halting of progression of SJS/TEN, ocular complications, and infections.
Key results
Key measurements from the tofacitinib treatment group were reported:
- For "Complete Skin Healing Time, Day":
- The median time was 10.0 days (Full Range).
- The mean time was 10.1 days (Full Range).
- For "Length of Hospitalization":
- The mean length was 22.4 days (Standard Deviation: 15.6).
- For "Mortality":
- 0 participants experienced mortality.
What this means
The results from this study suggest that tofacitinib may offer a beneficial effect in patients with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, particularly regarding skin healing time and patient survival. A median complete skin healing time of 10.0 days and no reported mortalities among the 20 participants are notable findings for these severe conditions. These data provide initial insights into the potential role of tofacitinib in managing SJS/TEN, warranting further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06474078, titled "Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN," were posted on 2025-09-16 on clinicaltrials.gov.