Posted by ImproveCareNow™ on June 04, 2026
Johnson & Johnson recently announced the Federal Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for pediatric Crohn’s disease. This approval offers patients over the age of two with moderately to severely active Crohn’s disease more treatment options and better access to effective therapies. Ustekinumab is the first non-TNF biologic to treat both adult and pediatric patients with Crohn’s disease two years and older.
After more than a decade since the last major therapeutic approval in 2014, the regulatory approval of ustekinumab for pediatric Crohn’s disease marks more than scientific progress—it represents renewed hope, expanded choice, and a long-overdue commitment to children living with chronic inflammatory bowel diseases. By expanding our arsenal, we are taking a major step forward in improving outcomes and quality of life for children facing this challenging condition.
– Shehzad Saeed, MD, FAAP, AGAF, Clinical Director, ImproveCareNow
ImproveCareNow worked closely with Johnson & Johnson, who sponsored the REALITI study, and recently published findings in the Journal of Pediatric Gastroenterology and Nutrition, on the effectiveness and safety of real-world data of the off-label use of ustekinumab. This study was part of the totality of evidence that contributed to the approval of ustekinumab in children two years and older. Ustekinumab was first approved for pediatric indication by the European Commission (EC) in 2025, in which the real-world data from the REALITI study supported the approval of use in children weighing 40 kg or more.
The data [from the REALITI Study] was a meaningful part of the overall evidence package and played a role in supporting the extrapolation of efficacy and safety findings from young adult populations to the pediatric group. A modification in the pediatric developmental plan for the European Union allowed us to secure approval for this group approximately one year earlier than originally planned.
- Sheri Volger, Sr Director, Pediatric Development Team, Johnson & Johnson
The use of real-world data from the REALITI study to help secure approval for ustekinumab in pediatric patients represents an important step in the evolution of how medications will be approved in the future. I’m grateful to all of the patients, families, providers and researchers of ImproveCareNow who helped make this such a successful study.
- Steve Steiner, MD, Principal Co-Investigator REALITI Study, Indiana University – Riley Children’s Hospital
ImproveCareNow’s registry is an important tool in leading a real-world observational study like the REALITI Study. With standardized data captured at routine visits, the ICN registry holds more than 30,000 patients’ data that are essential to continuously learn about pediatric IBD, spur innovation, and discover new ways to optimize care and health for all children and youth with IBD. New enhancements to the registry make it easier for care centers to capture medications and labs to increase efficiency of data entry of their patient population. The registry also is uniquely capable of quickly and efficiently developing and carrying out novel clinical trials (including those using real-world data), observational studies, and comparative effectiveness research, as well as engaging patients, clinicians, and researchers in collaboration to help us all learn more about pediatric IBD quickly, cost effectively and together.
ImproveCareNow is grateful to the more than 30,000 patients, and their families, who have entrusted us with their health data so that they and other young people with IBD can benefit as we improve care together.
Related Links
Johnson & Johnson Announces FDA Approval of STELARA® for Pediatric Crohn’s Disease
👉 Learn more about other Current Research approved by the ImproveCareNow Research Committee and read the latest Research Explained LOOP blog posts.
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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.