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November 24, 2018

Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial

Annals of the Rheumatic Diseases - 2018



Authors: Michelle Rosenzwajg, Roberta Lorenzon, Patrice Cacoub, Hang Phuong Pham, Fabien Pitoiset, Karim El Soufi, Claire RIbet, Claude Bernard, Selim Aractingi, Beatrice Banneville, Laurent Beaugerie, Francis Berenbaum, Julien Champey, Olivier Chazouilleres, Christophe Corpechot, Bruno Fautrel, Arsène Mekinian, Elodie Regnier, David Saadoun, Joe-Elie Salem, Jérémie Sellam, Philippe Seksik, Anne Daguenel-Nguyen, Valérie Doppler, Jéremie Mariau, Eric Vicaut, David Klatzmann.

  • puce

    Purpose: Regulatory 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. Aim We 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.

  • puce

    Experimental Design: We 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.

  • puce

    Results: ld-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.

  • puce

    Conclusions: The 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.

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