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BACKGROUND Biosimilars are biologic products similar in safety and efficacy to the originator product. Tumor necrosis factor-alpha inhibitors (anti-TNFs) are used in the treatment of inflammatory bowel diseases (IBD). There are limited studies evaluating the long-term outcomes of anti-TNF biosimilars in children with IBD. 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. METHODS This was a single-center retrospective review of patients with IBD, younger than 16 years old, and initiated on the IV anti-TNF originator or a biosimilar between April 2016 and February 2021 at Nationwide Children’s Hospital. To be eligible for the study and evaluate the primary outcome, patients must remain on the IV anti-TNF therapy for at least 12-months. We used propensity score methodology to identify 37 pairs of matched patients based on baseline characteristics (age of anti-TNF initiation, disease (CD vs UC/IC), behavior, location, perianal type, race). Demographic data, laboratory values, disease activity scores, and growth values (z-scores were recorded for weight, height, and BMI) were collected at baseline (prior to anti-TNF initiation) and 6-months and 12-months post initiation. Linear mixed models with random intercepts accounting for within patient correlation of measurements were fit to test differences in measures over time and between study groups. Hypothesis testing was conducted at an alpha of 0.05 to be used for all statistical analyses. RESULTS There were 113 patients on the originator and 39 patients on a biosimilar who met our eligibility criteria. Nineteen percent of patients on the originator and 16% of patients on a biosimilar were excluded from analysis due to discontinuing the IV anti-TNF agent prior to 12 months. Weight, height, and BMI z-scores increased over time (from baseline to 12-months) for both groups (p CONCLUSIONS There were similar improvements in growth and clinical outcomes in patients initiated on the IV anti-TNF originator compared to a biosimilar agent. This is the first study to evaluate whether anti-TNF biosimilars have similar growth outcomes in children with IBD.

BACKGROUND Studies in adults with inflammatory bowel disease (IBD) have demonstrated that a one-time switch from the originator to a biosimilar has not resulted in loss of response, increased side effects, or antibody development. Data describing non-medical switching is limited in adolescents and young adults. The objective of this study was to evaluate clinical outcomes of one-time switches from the originator to a biosimilar in adolescents and young adults with IBD. METHODS Patients with IBD that underwent a non-medical switch from infliximab originator to a biosimilar were retrospectively reviewed. Demographic data, physician global assessments (PGA), and laboratory values (albumin, hemoglobin, sedimentation rate (ESR), c-reactive protein (CRP), anti-TNF level, and anti-TNF antibody level) were recorded up to one year prior to the switch and up to one year after the switch. Rates of continuation on the biosimilar was reported at 6 and 12 months post-switch. Linear mixed effect models with random intercepts accounting for within patient correlation were used to compare continuous lab values before and after switching. RESULTS A total of 53 patients completed a switch from infliximab originator to a biosimilar. The mean age at the time of the switch was 18 (+/- 2.86) years old. Fifty-three percent of those undergoing a switch were female, 74% had Crohn’s disease, and 96% were switched to the biosimilar infliximab-dyyb. At the time of the switch, 52 (98%) patients had quiescent disease activity based on PGA and 1 (2%) patient had mild disease. At follow up after receiving at least 2 biosimilar infusions, 51 (96%) patients had quiescent disease and 2 (4%) patients had mild disease based on the PGA. At 6 months post switch, 48 (90%) patients were still on the biosimilar. Three (6%) patients switched back to the originator due to worsening symptoms, one (2%) patient developed worsening psoriasis, and one (2%) patient had ongoing issues with IV access. Of the 33 patients who had a full 12 months of follow-up data, 91% (30/33) remained on the biosimilar, one patient switched back to the originator due to worsening symptoms, and two switched to adalimumab due to the development of psoriasis and an underlying social situation, respectively. There was no statistically significant difference in albumin, hemoglobin, ESR, CRP, or anti-TNF levels when comparing pre- and post- switch values. The mean anti-TNF level prior to the switch was 17.3 ug/ml (95% CI: 13.7 -19.0) and 15.1 ug/ml (95% CI: 12.5 - 17.8) after the switch. No patients developed anti-drug antibodies or infusion reactions. CONCLUSION A one-time non-medical switch to an infliximab biosimilar in an adolescent and young adult cohort had no significant effect on clinical remission rates, laboratory markers of inflammation, serious adverse events, anti-TNF levels, or anti-drug antibodies.

INTRODUCTION Pediatric inflammatory bowel disease (IBD) is commonly treated with infliximab in a hospital setting or clinic where infusions are safely and effectively administered. In recent years, utilization of home infusions (HI) has increased due to reduced costs (insurance mandates) and patient factors (e.g., travel time savings, convenience). While 1 study of adult IBD patients found a higher likelihood for adverse outcomes among HI compared to those hospital-infused, the safety and efficacy of HI in children is understudied. We evaluated the adverse effects and outcomes of infliximab in children with IBD receiving HI compared to a matched cohort of children receiving infusions at a hospital-based infusion center. The frequency of clinic visits and lab monitoring, and durability of infliximab between cohorts were evaluated. METHODS Retrospectively, children who received HI of infliximab between September 2016-September 2018 were matched 1:1 based on age, race, ethnicity, sex, and disease type to a cohort receiving infliximab at a hospital-based infusion center. Patients completed induction at a hospital-based infusion center. A survival analysis (Kaplan-Meier curves and Cox Proportional Hazard (CPH) model) evaluated the hazard ratio for adverse outcomes in HI relative to hospital-infused children over 2 years. Adverse outcomes included stopping therapy for clinically relevant reasons, IBD-related hospitalizations, and emergency visits. Additional analyses included Chi-squared or Fisher exact tests and paired sample t-tests. RESULTS This study included 102 (51 pairs) children (63% male, 91% white, 92% Crohn’s disease). At baseline, there were no differences between cohorts by disease location, behavior, growth status, or disease severity. The portion of children with quiescent disease increased from 3% to 87% at year 1 and 93% at year 2 without cohort differences. At baseline, 94% of HI patients and 88% of controls were receiving 5 mg/kg q8weeks as standard maintenance therapy. After 1 year, 23% of all children remained on this dose, with a larger proportion of controls (33%) than children receiving HI ((14%), p=0.03). After 2 years, 19% of all children remained on this maintenance dose (no group differences. Over both years, the HI cohort had fewer labs drawn (p CONCLUSION When comparing outcomes of children receiving HI vs. controls, there were no differences in drug durability, adverse effects, or laboratory markers of disease activity, suggesting HI may be as effective and safe as hospital-based infusions, provided a standardized care approach is utilized.