News Journal New England Journ of Med NEJM
August 1, 2013

Therapy for Severe Vasculitis Shows Long Term-Effectiveness

ITN First to Provide Public Access to Raw Data

Results from an Immune Tolerance Network (ITN) clinical trial show that administering the drug rituximab once weekly for one month provides the same benefits as 18 months of daily immunosuppressive therapy in people with severe forms of vasculitis. Rituximab’s shorter treatment duration may decrease the risk of long-term side effects of immunosuppression, such as cancer, infertility, and infection.

The publication of the study results in the New England Journal of Medicine is the first to provide public access to the raw study data via direct links from the publication and its figures to the data sets in TrialShare. An editorial in NEJM highlights the utility of TrialShare in data sharing and transparency.

BRI Director Gerald Nepom, MD, PhD, is also director of ITN. The ITN is an international clinical research consortium sponsored by NIAID, part of the National Institutes of Health, whose mission is to accelerate the clinical development of immune tolerance therapies through a unique development model. For more information on this study visit immunetolerance.org.