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Clinical outcomes of lab values were not statistically different in changes from baseline to 12 months between children with inflammatory bowel disease initiated on the TNF originator or biosimilar.
Similar improvements in both clinical outcomes and growth were demonstrated in children with inflammatory bowel disease (IBD) initiated on an intravenous (IV) tumor necrosis factor inhibitor (TNF) originator compared with a biosimilar, according to data presented at Digestive Disease Week (DDW) 2023.1This was the first study to analyze the growth outcomes in this patient population.
“There are limited studies evaluating the long-term outcomes of anti-TNF biosimilars in children with IBD,” Stated Ross Maltz, MD, associate professor and pediatric gastroenterologist in the Department of Pediatrics at the Ohio State Wexner Medical Center, and colleagues. “Growth is an important clinical outcome, especially in childhood-onset IBD. However, no study to date has compared growth outcomes in patients initiated on the IV anti-TNF originator as compared to a biosimilar.”
The single-center retrospective study reviewed patients with IBD, aged younger than 16 years, that initiated the IV TNF originator or biosimilar between April 2016 and February 2021 at the Nationwide Children’s Hospital. Eligibility included only those who remained on the IV TNF treatment for 12 or more months. Propensity score methodology was utilized to identify 37 pairs of patients based on characteristics such as location, disease type, behavior, age at TNF initiation, and perianal type, were collected at baseline, and again at 6- and 12-months post TNF initiation. Linear mixed models were used to test differences in measures over time as well as between both study groups. Hypothesis testing was performed at an alpha of .05 for all statistical analyses.
Ultimately, 113 patients receiving the originator and 39 patients on the biosimilar met eligibility criteria. However, 19% of patients on the originator and 16% in the biosimilars cohort were excluded from the study due to discontinuing the IV TNF prior to the 12-month mark.
Weight, height, and BMI z-scores increased over 12 months in both groups (P <.05) with no significant differences in the rate of change for these measures during the follow-up period. Clinical outcomes of lab values, including albumin, C-reactive protein (CRP), and hemoglobin, were not statistically different in changes from baseline to 12 months between children with inflammatory bowel disease initiated on the originator or biosimilar. Additionally, no significant differences were observed regarding the pediatric Crohn’s disease activity index, pediatric ulcerative colitis (UC) activity index, or the physician global assessment among either patient group from baseline to 12 months.