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The ITN043AD GRASS study for hay fever sufferers, conducted by Dr. Stephen Durham at Imperial College in London, recently achieved a milestone by completing randomization of 106 study participants. The goal of the GRASS study is to compare the ability of two currently approved forms of immunotherapy treatment for hay fever, Grazax® (sublingual) and Alutard SQ® (subcutaneous), to potentially induce tolerance. Inducing tolerance could reduce the symptoms of hay fever, decrease the need for anti-allergy rescue medication and improve quality of life in hay fever sufferers.

The ITN524ST-CTOT12 ARTIST study on renal transplantation and the Immune Tolerance Network (ITN) signature of tolerance, recently met the target enrollment of 250 participants. This collaborative study between the Immune Tolerance Network (ITN) and the Clinical Trials in Organ Transplantation (CTOT) consortium, led by Drs. Kenneth Newell (Emory University), Laurence Turka (Harvard University), and Anil Chandraker (Brigham and Women’s Hospital), is an observational study for people who received a kidney transplant within the past 1 to 5 years.

Data from Immune Tolerance Network (ITN) mechanistic work will be reported at the upcoming American Academy of Allergy, Asthma, and Immunology (AAAAI) meeting on March 2-6 in Orlando, FL.

The Immune Tolerance Network (ITN) is currently seeking short “Concept Proposals” for novel combination therapy clinical trials designed to induce immune tolerance in allergy and asthma. The ITN is especially interested in the following.

The ITN has invited two formal applications to be vetted by the ITN’s Network Steering Committee in April 2012 as a result of an RFP process yielding numerous high-quality submissions. This past summer the ITN issued a Request for Proposals (RFP) for clinical trials designed to induce tolerance using combined therapeutic cell transfer and solid organ transplantation. This RFP was an effort to corral innovative strategies from the transplant community to identify novel and promising clinical trials to further explore the use of mixed chimerism as a tolerance induction strategy.

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In a study recently published in PLoS ONE, researchers used specimens from the ITN RAVE trial to investigate angiopoietin-2 as a potential biomarker in ANCA-associated vasculitis (AAV), a highly variable and serious disease without reliable markers to help predict disease outcome.

Results from an ITN study published today in the Journal of the American Medical Association demonstrated successful weaning of anti-rejection drugs in pediatric liver transplant recipients (results here).  Results from this multicenter pilot study, led by Sandy Feng, MD, PhD (University of California, San Francisco), suggest that certain children undergoing liver transplantation from a parental living donor may be able to maintain their organ without the burdens of lifetime immunosuppression.

A new ITN pilot study to look at oral tolerance is now open and has enrolled its first subjects.  The pilot, led by Lloyd Mayer, MD (Mount Sinai) and called “Pilot study to determine the immunogenicity of Immucothel® and oral tolerance induction with Biosyn Native KLH in healthy subjects,” is a first step in investigating oral tolerance mechanisms and their role in autoimmunity.

In an ITN supported study recently published in the American Journal of Transplantation a new potential indicator of clinical outcome in renal transplant recipients has been identified (results here). The signature was identified from samples collected under the ITN study, “ITN registry of tolerant kidney transplant recipients” led by Kenneth Newell, MD (results reported here). The findings from this study, titled “Donor-specific indirect pathway analysis reveals a B-cell-independent signature which reflects outcomes in kidney transplant” indicate a role for indirect pathway signaling in predicting outcome.

Results from a biomarker study using clinical specimens collected from the ITN RAVE study (comparing Rituximab with cyclophosphamide in ANCA-associated Vasculitis (AAV); results here) were recently published in Arthritis and Rheumatism. AAV is a chronic disease that can be controlled with immunosuppression, but long-term management is challenging, flares are common and unpredictable, and generic inflammatory markers (proteinase 3 ANCA titers, erythrocyte sedimentation rate, C reactive protein, etc.) are unreliable predictors of disease outcomes. In the article, titled “Circulating markers of vascular injury and angiogenesis in Antineutrophil Cytoplasmic Antibody-associated Vasculitis,” Monach et al. used RAVE clinical specimens to look for better biomarkers of active disease vs. remission for AAV.