Posted by ImproveCareNow™ on March 11, 2026
ImproveCareNow (ICN) is excited to share that findings from a years-long observational study, Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study are now published in the March 2026 issue of the Journal of Pediatric Gastroenterology and Nutrition. The study aimed to assess the effectiveness and safety of ustekinumab in real-world clinical settings for children with Crohn’s disease, and showed that the effectiveness and safety of ustekinumab treatment were similar in pediatric patients and young adult patients. You can read more about these findings here.
The value of this analysis of off-label use of ustekinumab in pediatric inflammatory bowel disease (IBD) is that it demonstrates across a large representation of pediatric IBD physicians and centers how the medication is prescribed. These patients are not enrolled in a clinical trial with strict inclusion/exclusion criteria and strict dosing regimens, but rather represent patients with a large variety of disease severity, ages, and co-morbidities who are dosed and dose-adjusted in order to best control their IBD. We have learned how the medication is really being used- that is the power of real-world data.
- Steve Steiner, MD - Principal Co-Investigator, Indiana University – Riley Children’s Hospital
This is the first time that real-world data, collected as part of routine care of patients, has been utilized for effectiveness assessment of therapy between pediatric and adult patient populations and for regulatory approval in pediatric IBD. This is a paradigm shift and reduces the time and cost it takes to set up clinical trials assessing safety and efficacy of novel treatments in children with IBD.
– Shehzad Saeed, MD - Clinical Director, ImproveCareNow
The REALITI study, sponsored by Johnson & Johnson, includes principal co-investigators Steve Steiner, MD, Indiana University – Riley Children’s Hospital; Shehzad Saeed, MD, ImproveCareNow & Dayton Children’s Hospital; and Jeremy Adler, MD, University of Michigan – C.S. Mott Children’s Hospital, in collaboration with ICN site co-investigators.
Working with ImproveCareNow on the REALITI study demonstrated the exceptional quality and rigor of ICN’s real-world data. The completeness and clinical relevance of these data gave regulators confidence and played a critical role in enabling an earlier European Medicines Agency (EMA) approval, ultimately helping us move effective therapies to children faster.
- Richard Strauss, MD - Global Medical Head, Immunology, Johnson & Johnson Innovative Medicine
ImproveCareNow uses its Outcomes registry to safely house clinical data for enrolled patients with IBD who receive care at participating ICN centers. These data are fundamental in enabling innovative observational research studies, like the REALITI study, that can lead to faster learning and advance evidence-based approaches to improving outcomes.
Learn more about other Current Research approved by the ImproveCareNow Research Committee and read the latest Research Explained LOOP blog posts.
--
Johnson & Johnson has provided funding to ImproveCareNow to perform this study; however, it is important to note that this is an observational study with a retrospective chart review and not an interventional study.
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.