Safety Evaluation of an Expedited Omalizumab Home Self-Administration Pathway

Abstract

Introduction The Northern Ireland Regional Immunology Service (NIRIS) has developed an expedited omalizumab home self-administration pathway to reduce face-to-face clinic attendance during the coronavirus disease 2019 (COVID-19) pandemic. This audit evaluates the safety of this pathway with a particular focus on anaphylaxis. Objectives This study aimed to retrospectively audit the records of 39 patients undertaking expedited home self-administration at NIRIS for complications, particularly emergency department attendance for anaphylaxis. The target was for 100% of patients to complete a six-month course without experiencing anaphylaxis related to omalizumab administration. Materials and methods A total of 39 records of patients who underwent expedited omalizumab self-administration were audited by a single reviewer. They were prospectively collected between March 2020 and August 2021. Clinical data were collected from the Northern Ireland Electronic Care Record (NIECR). Results Hundred percent of patients were in the process of completing or had completed a six-dose course without anaphylaxis. During the course of omalizumab, 7.6% of patients attended the emergency department. Zero percent of patients have experienced anaphylaxis triggered by omalizumab. The target of 100% patients completing the expedited pathway without omalizumab-related anaphylaxis was met. Conclusion Home self-administration of omalizumab is preferred by patients and clinicians for reducing expense, travel, and unnecessary clinical contact during the COVID-19 pandemic. An expedited omalizumab home self-administration training pathway appears to be safe in a population of Northern Irish patients with chronic spontaneous urticaria (CSU). More research is needed to determine whether the expedited pathway should become the standard of care post-pandemic.