| Autor: |
Michelle Rosenzwajg, Roberta Lorenzon, Patrice Cacoub, Arsène Mekinian, Anne Daguenel-Nguyen, Eric Vicaut, David Klatzmann, Sébastien Rivière, Olivier Fain, François Barde, Carlotta Cacciatore |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
RMD Open, Vol 10, Iss 2 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2056-5933 |
| DOI: |
10.1136/rmdopen-2023-003500 |
| Popis: |
Background Systemic sclerosis (SSc) is a chronic autoimmune disease, with impaired immune response, increased fibrosis and endothelial dysfunction. Regulatory T cells (Tregs), which are essential to control inflammation, tissue repair and autoimmunity, have a decreased frequency and impaired function in SSc patients. Low-dose interleukin-2 (IL-2LD) can expand and activate Tregs and has, therefore, a therapeutic potential in SSc.Objective We aimed to assess the safety and biological efficacy of IL-2LD in patients with SSc.Methods As part of the TRANSREG open-label phase IIa basket trial in multiple autoimmune diseases, we studied nine patients with SSc without severe organ involvement. Patients received 1 million international units (MIU)/day of IL-2 for 5 days, followed by fortnightly injections for 6 months. Laboratory and clinical evaluations were performed between baseline and month 6.Results At day 8, the primary endpoint (Treg frequency) was reached with a 1.8±0.5-fold increase of Treg levels among CD4+ T lymphocytes (p=0.0015). There were no significant changes in effector T cells nor in B cells. IL-2LD was well tolerated, and no serious adverse events related to treatment occurred. There was a globally stable measurement in the modified Rodnan skin score and Valentini score at month 6. Disease activity and severity measures, the quality of life evaluated by EuroQL-5D-5L and pulmonary function test parameters remained stable during the study period.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. This opens the door to properly powered phase II efficacy trials investigating IL-2LD therapeutic efficacy in SSc. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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