Why was this study done?

Pediatric patients with inflammatory bowel disease (IBD), including Crohn’s Disease and ulcerative colitis, who take biologic medications (like infliximab and adalimumab) have decreased hospitalizations, surgery rates, and improved quality of life. However, biologic medicines are expensive. Biosimilars are similar biological therapies that are just as safe and effective as the original biologic medication, although they are often less expensive. There are currently two medications (infliximab/Remicade and adalimumab/Humira) used to treat IBD that have biosimilars available. Despite the cost savings, the utilization of biosimilars in the treatment of IBD has been low. The exact reasons why the utilization of biosimilars is low is not well known or well-studied.

The objective of this study was to evaluate pediatric gastroenterologists’ perspectives of biosimilars and to evaluate factors that impact pediatric gastroenterologists’ comfort level with prescribing biosimilars.

Why was this study done?

Pediatric patients with IBD have a higher rate of psychosocial needs than young people without IBD, including anxiety, low mood, fatigue, and body image complexities. Multidisciplinary care, including psychosocial providers (psychologists, social workers), is considered the standard of care in pediatric IBD. However, there is limited research exploring how medical providers (e.g., physicians) think about and engage with psychosocial providers in pediatric IBD.

Why was this study done?

Depression is the number one health problem in adolescents, and by age 18, 20% of adolescents will experience a major depressive episode. For kids and teens with inflammatory bowel disease, the risk for depression is high. One in three adolescents struggle with some form of depression. Depression is linked to (associated with) difficulty adhering to medication, worsened disease activity, and higher healthcare costs. Yet, little is known about depression screening practices in pediatric IBD care. An improved understanding of current screening practices is an important step toward promoting mental health in pediatrics.

ImproveCareNow (ICN) is a Learning Health Network that enables patients, families, clinicians and researchers to work together to accelerate innovation, discovery and the application of new knowledge.

ICN’s Outcomes registry is a key enabler of new research and innovation for our community. To date, more than 27,000 patients have given their consent for their data to be used for research in support of ICN’s mission to improve outcomes for children and adolescents with IBD.

ImproveCareNow (ICN) is excited to share the findings from a years-long clinical trial COMBINE (Clinical Outcomes of Methotrexate Binary treatment with INfliximab or adalimumab in practice). The aim of this trial was to study if treatment with a single anti-TNF medication (infliximab and adalimumab) or dual therapy that includes methotrexate is more effective in children with moderate to severe Crohn’s disease.   

ImproveCareNow has been integral to this clinical trial from the beginning, including leading a research prioritization project in which the aim of this study was a top priority for members of the ICN community, to voting for the name of the study at the 2015 Community Conference. ICN care centers recruited for participation in this trial were vital to its success.  

Below is an excerpt from an article highlighting the key takeaways of this important trial from Principal Investigator Mike Kappelman, MD, MPH’s care center, University of North Carolina at Chapel Hill.  

--

Pediatric patients with IBD can have challenges with fatigue (feeling tired a lot of the time) and difficulties with sleep. While fatigue and sleep are known to be important factors in supporting optimal psychosocial and medical outcomes in pediatric IBD, it is unknown how these topics are talked about in IBD care with patients.

A new research project aims to learn more about Sleep & Fatigue in Pediatric IBD.