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Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial
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Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial
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Journal Article
Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial
2019
Overview
ObjectiveRegulatory T cells (Tregs) prevent autoimmunity and control inflammation. Consequently, any autoimmune or inflammatory disease reveals a Treg insufficiency. As low-dose interleukin-2 (ld-IL2) expands and activates Tregs, it has a broad therapeutic potential.AimWe aimed to assess this potential and select diseases for further clinical development by cross-investigating the effects of ld-IL2 in a single clinical trial treating patients with 1 of 11 autoimmune diseases.MethodsWe performed a prospective, open-label, phase I–IIa study in 46 patients with a mild to moderate form of either rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Behcet’s disease, granulomatosis with polyangiitis, Takayasu’s disease, Crohn’s disease, ulcerative colitis, autoimmune hepatitis and sclerosing cholangitis. They all received ld-IL2 (1 million IU/day) for 5 days, followed by fortnightly injections for 6 months. Patients were evaluated by deep immunomonitoring and clinical evaluation.Resultsld-IL2 was well tolerated whatever the disease and the concomitant treatments. Thorough supervised and unsupervised immunomonitoring demonstrated specific Treg expansion and activation in all patients, without effector T cell activation. Indication of potential clinical efficacy was observed.ConclusionThe dose of IL-2 and treatment scheme used selectively activate and expand Tregs and are safe across different diseases and concomitant treatments. This and preliminary indications of clinical efficacy should licence the launch of phase II efficacy trial of ld-IL2 in various autoimmune and inflammatory diseases.Trial registration numberNCT01988506.
Publisher
Elsevier Limited,BMJ Publishing Group
Subject
/ Autoimmune Diseases - drug therapy
/ Autoimmune Diseases - immunology
/ Diabetes
/ Female
/ Humans
/ Immunologic Factors - administration & dosage
/ Immunologic Factors - immunology
/ Interleukin-2 - administration & dosage
/ Lupus
/ Male
/ Patients
/ Systemic lupus erythematosus
/ T-Lymphocytes, Regulatory - drug effects
