Abstract

Background: Infliximab infusion therapy administered in the home setting can be a convenient, safe, and effective treatment option for patients being treated for inflammatory conditions. Infusion related adverse events (AEs) can occur with infliximab infusion regardless of setting but may be less common after therapy initiation. Product labeling reports 9% of infusion related reactions occur during the maintenance period in those that did not have a reaction during the induction period. We sought to assess the rate of real-world infusion related adverse events in patients receiving maintenance infusions in the home setting. Methods: An observational retrospective study using data collected during infliximab infusion visits, administered by Accredo (an Evernorth company) field nurses, was conducted. Assessment data related to the visit, including patient weight, infused drug information, occurrence of an AE, type and timing of AE, and action taken, was recorded on an electronic mobile device. The collected data would later be transferred to the organization’s internal information warehouse. The prevalence of AEs in the study population, breakdown of AE type, and percentage of patients that were transferred to an emergency room were evaluated. Results: A total of 863 patients accounted for 8,388 infliximab infusions in calendar years 2020 and 2021. On site adverse events, during or after infusion, occurred in 39 unique patients (4.5%) with a total of 49 (0.58%) adverse events over the study time period. Among the 49 recorded AEs, the most common types were fatigue (22.4%), dermatologic (20.4%), and cardio/pulmonary (16.3%). Among the 863 patients being treated with infliximab, 11 (1.3%) experienced fatigue, 10 (1.2%) had a skin related AE and 8 (0.9%) experienced a cardio/pulmonary related AE. During the study period 3 patients (0.35%) sought emergency room care after infusion. Conclusion(s): Studies on biologic infusions administered in the home setting have reported higher rates of adverse events requiring escalation of care. However, in our experience, over 95% of patients that received an infliximab infusion in the home setting during the study period tolerated the infusion without incident. Infusion related adverse events occurred infrequently and were mild to moderate in severity. Adverse events were associated with only 0.58% of infusions and only 3 patients (0.35%) required escalation to emergency room care. Our results demonstrate that home infusion services are a safe option for patients to obtain their medication in a familiar and convenient setting.

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