2016 Year-End Summary

December 21, 2016

2016 was a very busy year for the ITN, with a total of 212 new participants in actively-enrolling trials, up from 175 new participants in 2015, and over 5000 participant study visits, the largest number ever.  This robust number resulted from significant gains for PAUSE (completing enrollment in April), CATNIP, OPTIMAL, EXTEND, and CALIBRATE. A better indicator of the overall level of activity this year, there were 387 screened participants for active trials, a testament to all the hard work put in by site staff and ITN internal teams to meet enrollment targets.

Following a few concept-heavy steering committee meetings, the ITN's pipeline is very full with lots of projects to get off the ground in 2017. As of December 2016 there are 12 trials in development (TEACH, EXTEND-P, REMIX-B, LEAP-TRIO, GLASS GLA, LiTTMUS at MGH and UCSF, BRAVOS, FEAST, aHSCT-MS, C-section Microbiome, belimumab + rituximab in membranous glomerulonephritis), 8 trials in enrollment (CALIBRATE, OPTIMAL, CATNIP, EXTEND, ALLTOL, T1DES, deLTa, TILT), plus 19 trials in follow-up or analysis.

ITN had 30 publications in 2016;  Highlights this year included:

  • The LEAP-On primary manuscript, which found that after 12 months of peanut avoidance, only 4.8% of the original peanut consumers from the LEAP study were found to be allergic, compared to 18.6% of the original peanut avoiders. These findings strongly suggest that four years of early peanut consumption provided stable and sustained protection against the development of peanut allergy in at-risk children.
  • The two-year data from the START study (antithymocyte globulin (ATG) for type 1 diabetes) found in a post-hoc analysis that older participants (ages 22-35) treated with ATG maintained better C-peptide production throughout the course of the trial; these findings may warrant further studies to assess the benefits of ATG in older populations.
  • An analysis of samples from the AbATE study (anti-CD3 in type 1 diabetes) identified a population of CD8 T cells that resemble exhausted T cells and is associated with the best treatment outcome, suggesting T cell exhaustion as a potential target for therapy in type 1 diabetes.

Other publications included the primary results from the ACCLAIM study (abatacept in multiple sclerosis), five-year outcomes from the WISP-R study (immunosuppression withdrawal in pediatric liver transplant recipients), and an analysis of glycemic variability and C-peptide preservation from the T1DAL study (alefacept in type 1 diabetes).

ITN also rolled out a new specimen tracking system, LabVantage, at 107 clinical sites with no major issues to date, a huge accomplishment. So far the feedback from site users has been very positive.

Thanks to the entire ITN team for significant progress in all areas of the portfolio, and we look forward to another productive and exciting year in 2017.

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