The universal effects of low-dose interleukin-2 across 13 autoimmune diseases in a basket clinical trial

医学 免疫学 自身免疫 临床试验 白细胞介素 内科学 细胞因子 免疫系统
作者
Roberta Lorenzon,Claire Ribet,Fabien Pitoiset,S. Aractingi,Beatrice Banneville,Laurent Beaugerie,Françis Berenbaum,P. Cacoub,Julien Champey,Olivier Chazouillères,Christophe Corpechot,Bruno Fautrel,A. Mékinian,Elodie Régnier,David Saadoun,Joe‐Elie Salem,Jérémie Sellam,Philippe Seksik,Éric Vicaut,Michèlle Rosenzwajg
出处
期刊:Journal of Autoimmunity [Elsevier BV]
卷期号:144: 103172-103172 被引量:19
标识
DOI:10.1016/j.jaut.2024.103172
摘要

A Tregs insufficiency is central to autoimmune and inflammatory diseases pathophysiology and low dose interleukin-2 (IL-2LD) can specifically activate Tregs. To assess IL-2LD therapeutic potential and select diseases for further clinical development, we performed an open-label, phase 2a, disease-finding, "basket trial" involving patients with one of 13 different autoimmune diseases. 81 patients treated with IL-2LD (1 million IU/day) for 5 days, followed by fortnightly injections. The first 48 patients received diluted Proleukin®, while the subsequent 33 received ready-to-use ILT-101®. The primary endpoint was the change in Tregs at day-8 compared to baseline. Key secondary endpoints included clinical efficacy assessments using the Clinical Global Impression (CGI) scale, disease-specific scores, and EuroQL-5D-5L. Our study unveiled a universal and significant expansion and activation of Tregs, without concomitant Teffs activation, across all 13 autoimmune diseases. Both Proleukin® and ready-to-use ILT-101® demonstrated identical effects on Tregs. CGI scores reflecting activity, severity, and efficacy were significantly reduced in the overall patient population. Disease-specific clinical scores improved in five of the six disease cohorts with at least six patients, namely ankylosing spondylitis, systemic lupus erythematosus, Behçet's disease, Sjögren's syndrome, and systemic sclerosis. Urticaria was the only severe adverse event related to treatment. IL-2LD was well-tolerated, exhibiting specific Treg activation and clinical improvements across the 13 autoimmune diseases. Tregs stimulation by IL-2LD is a promising therapeutic strategy and IL-2LD holds considerable promise for integration into combinatorial therapeutic approaches.
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