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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.

In April 2011, the FDA approved Rituximab (anti-CD20; Genentech) for use in granulomatosis and microscopic polyangiitis based on results from the ITN RAVE study. Before the Rituximab label extension, the standard of care for this disease was cyclophosphamide, a potent immunosuppressant that although effective is very toxic when used long-term. The RAVE study was able to successfully compare a potentially safer biologic therapy for a rare and challenging disease against the long-accepted standard of care treatment. Designing such a study required creative approaches which are described in the November 2011 publication in the Open Arthritis Journal, “Design of the Rituximab in ANCA-Associated Vasculitis (RAVE) Trial” (Specks et al.). In this paper, the authors “illuminate the unique challenges involved in comparing a new treatment approach against an entrenched standard of care.”

Richard Nash, MD (Colorado Blood Cancer Institute) will be presenting early results from the Immune Tolerance Network (ITN) HALT MS clinical trial on December 11, 2011 at the American Society of Hematology (ASH) annual meeting in San Diego, CA. The abstract is titled.

The Immune Tolerance Network's (ITN's) T1DAL research trial for recently diagnosed type 1 diabetes has recently received the approval of its Data Safety Monitoring Board (DSMB) to begin accepting patients in the younger cohort, ages 12-15 years, into the study. The decision was made after a review of safety data from the initial group of 10 adult-age subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with type 1 diabetes within the past 3 months.

Data from an Immune Tolerance Network (ITN) hayfever pilot study will be presented at the World Allergy Congress on December 7, 2011 in Cancun, Mexico.

18-month data from the Immune Tolerance Network's (ITN’s) RAVE trial comparing rituximab (anti-CD20) against cyclophosphamide in ANCA-associated Vasculitis will be reported on November 8^th at the 2011 American College of Rheumatology (ACR) meeting in Chicago, IL.  Protocol Chair Ulrich Specks, MD (Mayo Clinic) will be presenting the following abstract.

The Immune Tolerance Network (ITN) is currently seeking Concept Proposals for novel clinical trials designed to induce immune tolerance in combined allogeneic solid organ transplantation plus therapeutic cell transfer.

The Immune Tolerance Network is conducting a portfolio of innovative intervention research trials in new-onset type 1 diabetes.

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