EQUIVALENT ADVERSE OUTCOMES FOR HOME AND HOSPITAL-BASED INFUSIONS OF INFLIXIMAB IN CHILDREN AND ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE. (22nd January 2022) - Gupta, Shivani
Abstract: 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<0.001) as expected per site protocols, but there were no differences in lab results for calprotectin, CRP, ESR, albumin, and hemoglobin or the number of clinic visits at each time point. The risk for adverse outcomes was similar in both groups (CPH odds ratio=0.89 [0.32, 2.46]). 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.