Trial results for the Phase 1 study (NCT05048238) evaluating tofacitinib in the prevention of photosensitivity in cutaneous lupus were posted on ClinicalTrials.gov on 2025-03-21. The study observed mean changes in UVB-induced apoptotic epidermal cells, including a reduction of up to -18.06%.
Background
Tofacitinib is the drug investigated in this study, which focused on its potential role in managing cutaneous lupus, specifically in preventing photosensitivity.
Trial design
The study (NCT05048238) was a Phase 1, single-arm, multi-site, proof-of-concept trial that enrolled 7 participants. It investigated tofacitinib for the prevention of photosensitivity in individuals with cutaneous lupus. The study evaluated the treatment of participants with tofacitinib. No primary outcomes were listed for this study.
Key results
The trial results included measurements for changes in UVB-induced apoptotic epidermal cells and minimal erythema dose due to UVB exposure.
- For "Change in Percentage of UVB-induced Apoptotic Epidermal Cells" in the Tofacitinib group, the following mean values and standard deviations were reported:
- 20.06% (Standard Deviation: 9.587)
- 3.03% (Standard Deviation: 2.349)
- -17.03% (Standard Deviation: 8.355)
- 21.51% (Standard Deviation: 12.334)
- 3.45% (Standard Deviation: 2.976)
- -18.06% (Standard Deviation: 11.182)
- For "Change in Minimal Erythema Dose (MED) Due to UVB" in the Tofacitinib group, the following counts of participants were reported:
- 0 participants
- 0 participants
- 1 participant
- 3 participants
- 0 participants
- 1 participant
What this means
As a Phase 1, single-arm, proof-of-concept study with a small enrollment of 7 participants, these results provide initial data on tofacitinib's effects on photosensitivity in cutaneous lupus. The observed reductions in UVB-induced apoptotic epidermal cells, such as -17.03% and -18.06%, suggest a potential effect that warrants further investigation. The varied changes in apoptotic cells and the limited number of participants showing a change in Minimal Erythema Dose (MED) indicate the preliminary nature of these findings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05048238, titled "Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus," were posted on 2025-03-21 on clinicaltrials.gov.