Systemic sclerosis & Raynaud's
Induction of regulatory T cells and efficacy of low-dose interleukin-2 in systemic sclerosis: interventional open-label phase 1–phase 2a study
Authors' conclusion
IL-2LD at a dosage of 1 MIU/day safely and selectively activates and expands Tregs. Clinical signs remain stable during the study period.
Study context
- Population
- Patients with systemic sclerosis (SSc) without severe organ involvement
- Participants
- 9 patients
- Outcome
- Treg frequency
- Follow-up
- Day 8
Methodological detailssingle-group, part of TRANSREG phase IIa basket trial in multiple autoimmune diseases
- Single-group
- Part of TRANSREG phase IIa basket trial in multiple autoimmune diseases
Main finding
As reported in the abstract
Treg frequency among CD4+ T lymphocytes, fold increase
Primary endpoint (Treg frequency) reached: fold increase of Treg levels among CD4+ T lymphocytes
1.8±0.5-fold increase
p=0.0015
Further findings
Effector T cells and B cells
- No significant changes
Modified Rodnan skin score and Valentini score · month 6
- Globally stable
Disease activity and severity, quality of life (EuroQL-5D-5L), pulmonary function tests · study period
- Remained stable
Safety
| Outcome | Values |
|---|---|
| Serious adverse events related to treatment | IL-2LD 0 events |
Serious adverse events related to treatment
- IL-2LD was well tolerated
Original publication
Induction of regulatory T cells and efficacy of low-dose interleukin-2 in systemic sclerosis: interventional open-label phase 1–phase 2a study. RMD Open. Published 4 April 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →