Latest News

The Immune Tolerance Network (ITN) completed enrollment this week for the IMPACT Study in peanut allergy. There are 144 participants enrolled in the IMPACT Study (Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children), which tests whether giving increasing doses of peanut protein (oral immunotherapy) over a two-year period can induce desensitization to peanut.  The trial will also address whether extended oral immunotherapy can create long-lasting tolerance to peanut. While other smaller trials have suggested that peanut immunotherapy may successfully desensitize peanut-allergic individuals, it is not known whether these effects can last without the continued consumption of peanut.  The IMPACT study will help answer this question by assessing participants after they have avoided peanut for 26 weeks following completion of immunotherapy.

Long-term safety and efficacy results of the Edmonton Protocol for islet transplantation were reported October 3, 2015 in the American Journal of Transplantation. Data from the Immune Tolerance Network’s (ITN) EXIIST Study (Extended Immunosuppression in Islet Transplantation), led by Dr. Daniel Brennan (Washington University), demonstrate that islet transplantation with steroid-free immunosuppression over a 10 year period enables good islet graft function and glucose control without serious adverse events or infections.

Jerry Nepom, MD, PhD, director of the Immune Tolerance Network (ITN) and Jonathan Corren, MD, protocol chair for the ITN’s CATNIP Study, were recently interviewed by Tracie Hotchner from the Radio Pet Lady Network.

On August, 31, 2015, interim guidance on the early introduction of peanut for the prevention of peanut allergy based on ITN’s “Learning Early About Peanut Allergy” LEAP Study was published in The Journal of Allergy and Clinical Immunology. The consensus communication was endorsed by the American Academy of Pediatrics and based on consensus among the following organizations: American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American College of Allergy, Asthma & Immunology, Australasian Society of Clinical Immunology and Allergy, Canadian Society of Allergy and Clinical Immunology, European Academy of Allergy and Clinical Immunology, Israel Association of Allergy and Clinical Immunology, Japanese Society for Allergology, Society for Pediatric Dermatology, and World Allergy Organization.

The ITN is currently inviting proposals for novel clinical trials with the aim of inducing tolerance in patients who receive gene/protein-replacement (e.g. hemophilia, Gaucher’s disease) or other exogenous protein therapy, in which the patients are at risk for developing an immune response to the biologic agent. The ideal proposal would have a testable mechanism of tolerance induction and a strategy for assays investigating this mechanism.

Individuals with new-onset type 1 diabetes who took two courses of alefacept (Amevive®, Astellas Pharma Inc.) soon after diagnosis show preserved beta cell function after two years compared to those who received a placebo. The positive results of the Immune Tolerance Network’s (ITN) T1DAL study [Inducing Remission in New Onset T1DM with Alefacept (Amevive®)], led by Mark Rigby, MD, PhD, of Indiana University were published today in the Journal of Clinical Investigation.

The results of the Immune Tolerance Network’s (ITN) “Learning Early About Peanut” (LEAP) study published today in the New England Journal of Medicine demonstrate that consumption of a peanut-containing snack by infants who are at high-risk for developing peanut allergy prevents the subsequent development of allergy. The LEAP study, designed and conducted by the ITN with additional support from FARE and led by Professor Gideon Lack at Kings College London, is the first randomized trial to prevent food allergy in a large cohort of high-risk infants.

On Monday the ITN opened a new pilot study to compare two different methods for assessing allergic responses: environmental exposure chambers and nasal allergen challenges. The CAT EEC study, “Cat Pilot Study – Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC),” is being conducted at Inflamax Research, Inc. in Ontario, Canada and led by Drs. Stephen Durham (Imperial College London) and Piyush Patel (Inflamax Research, Inc.).

A new ITN type 1 diabetes trial opened today at the first site, Sanford Health in Sioux Falls, SD. The EXTEND trial (Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes) will test whether tocilizumab (ACTEMRA®; Genentech), an antibody that targets the interleukin-6 (IL-6) receptor, can slow disease progression and help maintain natural insulin production in adults with new-onset type 1 diabetes.

The ITN has an interest in antigen-specific T cell tolerance in multiple sclerosis, an autoimmune disease in which autoreactive T cells specific for myelin-associated antigens are thought to play a role in pathogenesis. Assessment of antigen-specific tolerance in multiple sclerosis will require reliable assays to detect and phenotype T cell responses to myelin-associated antigens in a clinical trial setting. To this end, the ITN is seeking assays for assessing functional tolerance and biomarkers of tolerance in antigen-specific CD4 and CD8 effector and regulatory T cells.