ImproveCareNow awarded $2.5 million grant by the Helmsley Charitable Trust to implement key research findings for pediatric Crohn's disease

The ImproveCareNow (ICN) Network has been awarded a three-year, 2.5-million-dollar grant by The Leona M. and Harry B. Helmsley Charitable Trust. The project will support the implementation of key findings from the landmark clinical trial, COMBINE (Clinical Outcomes of Methotrexate Binary treatment with INfliximab or adalimumab in practice).

The COMBINE trial under the direction of Michael Kappelman, MD, MPH, professor of pediatrics at UNC School of Medicine, found that pediatric patients with moderate to severe Crohn’s disease being treated with the tumor necrosis factor inhibitor (TNFi) adalimumab combined with a low dose of methotrexate did better than those treated with adalimumab alone. However, children initiating infliximab, another tumor necrosis factor inhibitor, had similar outcomes with or without methotrexate.  ¹

Current published guidelines recommend combination therapy with an immunomodulator, low-dose methotrexate (MTX), for adults and for pediatric patients on infliximab (IFX), but there is no such recommendation for children on adalimumab (ADA). With funding support from the Helmsley Charitable Trust, ICN aims to integrate the key findings from the COMBINE trial into clinical care by promoting, when appropriate, combination therapy with methotrexate for children with Crohn's disease initiating ADA and not starting it in children initiating IFX. The project will also enable ICN to review cases in which COMBINE findings are not implemented, so we can better understand the contextual factors that impact clinical decision making.

ImproveCareNow’s existing Learning Health Network infrastructure, including improvement and implementation science expertise, strong engagement from patients, families, clinicians, and researchers, and its registry and analytic capabilities, will accelerate the implementation of COMBINE’s findings across pediatric GI practice in an equitable and reliable manner. The scale of ICN as a Learning Health Network, consisting of 100+ care centers across the U.S., England, Belgium & Qatar, with more than 1700 healthcare professionals and serving more than 31,000 Inflammatory Bowel Disease (IBD) patients, makes it uniquely equipped to spread key learnings from this novel pediatric clinical trial into practice – effectively shortening the time it takes for research to impact clinical care and patient outcomes.

During the next three years, ICN and key stakeholders from the ICN community will work together to accomplish these project goals:

1. Increase awareness and motivation to change care across the ICN community based on the COMBINE results.
2. Increase adoption and implementation of the findings into clinical practice.
3. Increase the effectiveness of TNFi therapy in achieving remission.
4. Maintain the adoption and implementation of these changes over time.

“At Helmsley, we are committed to ensuring that optimized treatment is provided to all patients with Crohn’s disease,” said Terry Felton, Program Officer in the Crohn’s Disease Program at Helmsley. “This project will ensure that research findings from the COMBINE trails are disseminated and implemented systematically, and hopefully improve outcomes for children with Crohn’s disease.”

ImproveCareNow will continue to share updates on the progress of our work as this grant continues. Stay connected with our updates by:

• Subscribing to CIRCLE eNewsletter to receive regular ICN updates & opportunities, IBD stories & perspectives, plus co-produced IBD resources.
• Subscribing to Research Updates to receive periodic research-specific updates & opportunities from ICN.

References

• ¹ ImproveCareNow Researchers Announce Findings from Landmark Clinical Trial for Pediatric Crohn’s Disease
• ICN Research Explained: The COMBINE Trial
• Learn more about ImproveCareNow’s Current Research

About ImproveCareNow

ImproveCareNow is a Learning Health Network dedicated to transforming care, health and costs for all children and youth with Crohn’s disease and ulcerative colitis (Inflammatory Bowel Disease or IBD) by building a sustainable collaborative chronic care network. We are enabling patients, families, clinicians and researchers to work together in a learning health care system to accelerate innovation, discovery and the application of new knowledge. We invite everyone interested in getting kids with IBD better right now to join us and support our work.

About The Leona M. and Harry B. Helmsley Charitable Trust

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning its active grantmaking in 2008, Helmsley has committed $4.5 billion for a wide range of charitable purposes. Helmsley's Crohn's Disease Program supports impactful ideas and mobilizes a global community committed to improving the lives of Crohn's disease patients while pursuing a cure. For more information on Helmsley and its programs, visit helmsleytrust.org.