2015 was a busy year for the ITN. Here is a roundup of highlights and accomplishments from the past year:
- The LEAP Study primary endpoint results were published in the New England Journal of Medicine and demonstrated that early consumption of peanut by high-risk infants prevents the development of peanut allergy later on. The findings were so conclusive that the American Academy of Pediatrics (in conjunction with other groups) issued interim guidelines on early introduction of peanut for the prevention of peanut allergy. To build off the success of the LEAP study, ITN is considering developing protocols to assess prophylactic immunotherapy interventions for other food allergies.
- The two-year results from the T1DAL Study were published in the Journal of Clinical Investigation and showed that a short course of a well-tolerated drug (alefacept) can interfere with immune activation in a targeted way to create sustained preservation of endogenous insulin production in certain individuals with new-onset type 1 diabetes.
- The three-year data from the HALT-MS Study were published in JAMA Neurology and showed that of 25 multiple sclerosis patients treated with high-dose immunosuppression and autologous stem cell transplantation, 90.9% had progression-free survival and 86.3% had relapse-free survival at three years.
- Long-term results from the EXIIST Study were published in the American Journal of Transplantation and demonstrate that islet transplantation with steroid-free immunosuppression (Edmonton Protocol) over a 10 year period enables good islet graft function and glucose control without serious adverse events or infections.
- Primary endpoint data from the LEAP-On Study became available in the fall of 2015 and indicate that the desensitization achieved from early peanut immunotherapy is maintained after one year of peanut avoidance, suggesting the induction of tolerance (data not yet published; results presented at the October 2015 NSC meeting).
- Primary endpoint data from the GRASS Study comparing two years of treatment with sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) for grass hayfever showed no significant differences in desensitization rates between the two treatment modes compared to a placebo following a one-year period off therapy (tolerance endpoint). Despite not meeting the primary endpoint (a comparison of nasal response to allergen challenge at three years), this well-conducted study importantly demonstrated the efficacy of both SLIT and SCIT for reducing nasal symptoms compared to placebo after two years of treatment, and specimen analyses will help identify key immunological differences between the two delivery methods (data not yet published; results presented at the October 2015 NSC meeting).
- The IMPACT Study for peanut allergy completed enrollment this year with 144 participants. IMPACT will test whether giving increasing doses of peanut protein over a two-year period can induce desensitization to peanut in young peanut-allergic children. The trial will also address whether extended oral immunotherapy can create long-lasting tolerance to peanut. The results are expected in 2019.
- Recruitment is progressing for the PAUSE Study (Efficacy of Ustekinumab followed by Abatacept for the Treatment of Psoriasis Vulgaris), the CALIBRATE Study (Combination of Antibodies in Lupus: Belimumab and Rituxan Assessment of Tolerance and Efficacy), and the CATNIP Study (Anti-TSLP plus Antigen Specific Immunotherapy for Induction of Tolerance in Individuals with Cat Allergy).
- ITN opened three new trials this year:
- The EXTEND Study (Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes)
- The CAT EEC Study [Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC)]
- The OPTIMAL Study (Operational Tolerance Biomarkers of Immune Senescence and Lymphocyte Exhaustion Following Adult Liver Transplantation)
- There are six new trials in development that are scheduled to open in 2016:
- The TEACH Study (Tolerance by Engaging Antigen During Cellular Homeostasis)
- The ALLTOL Study (Allograft Tolerance; an observational cohort study to follow tolerant liver and kidney transplant recipients from ITN trials and elsewhere)
- The EXTEND-P Study (tocilizumab in pediatric type 1 diabetes participants; to be conducted in Australia in collaboration with JDRF's Australian Clinical Research Network)
- The T1DES Study (T1D Extended Study; long-term follow-up of responders from the T1DAL and AbATE trials)
- The Cat GLA Study (combines Glucopyranosyl Lipid A (GLA) adjuvant with cat peptide immunotherapy)
- Living donor kidney transplant mixed chimerism pilot study (Protocol Chair: Tatsuo Kawai)
- ITN issued three requests for proposals (RFPs) at the end of 2015, and will assess full applications at the spring 2016 NSC meeting:
- In the past year, four new studies with associated publications were made publicly accessible on TrialShare, giving public access now to 2,500 participants with clinical and immunological assay assessment data. Since the LEAP manuscript publication in NEJM that included URL links to study data and interactive figures on TrialShare, the site has been receiving 1,500 to 2,000 page hits on a monthly basis.
- ITN carefully developed a set of 15-18 color flow cytometry panels with Dr. Alice Long which will allow comparison of T cell signatures of immune tolerance across trials and therapeutic areas. Standard panels for evaluating B cells and antigen presenting cells are currently in development.
- ITN has received over $10 million dollars from partnerships and supplemental funds for autoimmune and type 1 diabetes projects, as well as genome sequencing work for the LEAP study.
Thanks to everyone for such a productive year, and best wishes this Holiday Season!
