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The LEAP Trio Participant Follow-up manuscript was published today in the NEJM Evidence.  The LEAP Trial, published in 2015, demonstrated that early introduction of peanut prevented development of peanut allergy at 5 years of age. The LEAP Trio study, which follows the original LEAP Trial participants out to adolescence, shows that early peanut consumption, starting in infancy and continuing to age five years, provides lasting tolerance to peanut into adolescence irrespective of subsequent peanut consumption. This study demonstrates for the first time that long-term prevention and tolerance can be achieved in food allergy.

The results of the ITN’s Research Study of ATG and Rituximab in Renal Transplantation (RESTARRT) trial have been published in the American Journal of Transplantation.  The trial, a prospective multicenter pilot study of low immunologic risk live donor kidney transplant recipients who received anti-thymocyte globulin and rituximab, and initiated immunosuppression withdrawal (ISW) at 26 weeks, showed that six of ten subjects successfully completed ISW with one remaining immunosuppression free for 9+ years.

Jean-Francois Bach, MD, DSc 1940-2023

The CATNIP trial– a double blind randomized placebo controlled trial – tested whether treating cat allergy tested whether giving a monoclonal antibody called tezepelumab, which interferes with TSLP signaling, plus cat allergy shots to people with allergic rhinitis caused by cat allergens would safely provide better and longer-lasting symptom relief than allergy shots alone.

The Immune Tolerance Network is currently requesting proposals for the supplementary mechanistic analyses for the remaining participant samples from the Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy (GRASS) trial.

The IMPACT trial – a double blind randomized placebo controlled study – was designed to test whether young, peanut allergic children (12-48 months) could be desensitized with peanut oral immunotherapy (OIT) and ultimately remain non-responsive to peanut after discontinuation of OIT.

The EXTEND trial was a double blind randomized placebo controlled study designed to test the effect of IL-6 receptor blockade (tocilizumab) in pediatric participants (age 6-17 years) with new onset type 1 diabetes.  IL-6 pathway blockade is an effective immunotherapy in some autoimmune diseases including juvenile idiopathic arthritis and rheumatoid arthritis working, at least in part, by decreasing Th17 and increasing Treg cell frequencies.  In a paper published in JCI Insight, the study team reported that while the drug impaired IL-6 signaling in T-cells, treatment did not alter T-cell subsets and did not slow the loss of the residual beta cell function in the study participants.

Christian P. Larsen, MD, DPhil, the Immune Tolerance Network’s (ITN’s) deputy director in transplantation, transplant surgeon, and immunologist was presented with the 2021 American Medical Association (AMA) Scientific Achievement Award.

The PAUSE trial was conducted to determine whether blocking CD28/B7 costimulatory signaling with abatacept would prevent relapse of psoriasis after effective treatment with ustekinumab (an IL12/23 antagonist). In an article published in JAMA Dermatology, the study team showed that relapse following ustekinumab discontinuation was not delayed by abatacept treatment, and was associated with a pathogenic IL-23-mediated molecular signature in skin lesions, which was unaffected by blockade of the CD28-CD80/86 costimulation pathway.

In an article published today in Frontiers in Immunology, Immune Tolerance Network (ITN) leadership and clinical trial physicians review ITN's approach to the development of therapies that aim to establish tolerance in immune mediated diseases. They present concepts that have evolved from the ITN's clinical trial experience, with an emphasis on lessons learned from the mechanistic studies conducted as a part of these trials and strategies under development for the induction of tolerance.