The Impact of a Safety Program Initiative for Monitoring Infusion Disease Modifying Therapies for Multiple Sclerosis

Background: Infusion-based high-efficacy disease modifying therapies (DMTs) represent a major advance in the treatment of multiple sclerosis (MS). However, safe administration of these medications requires close monitoring of laboratory studies, imaging, and clinical examinations, all of which have been impacted due to the COVID-19 pandemic. Non-adherence to recommended safety monitoring can lead to inappropriate administration of these medications which may result in DMT-related complications.

Objectives: To determine the feasibility and overall impact of a safety program designed for monitoring infusion medications prescribed for MS.

Methods: A safety nurse navigator within the Johns Hopkins MS Center regularly reviewed safety data for patients receiving infusion DMTs from November 2020 to May 2021 via chart review. Data assessed included surveillance MRIs, laboratory results, and appointments with the prescribing neurologist for their infusion therapy. Patients were screened for any barriers to safe infusion as the primary outcome, including out-of-date safety labs for the specific medication, out-of-date imaging for PML monitoring, and/or lack of appropriate follow-up with their neurologist.

Results: A total of 160 patients on infusible DMTs were reviewed; 37 natalizumab, 123 B-cell depletion. Cohort’s mean age was 43 years (±11), 71% were female, 81% relapsing-remitting MS, and mean EDSS was 2.8. Of the 160, 54 (34%) patients were identified to have a barrier to safe infusion, with 46% requiring prescriber follow-up, 40% requiring safety labs, and 14% requiring MRI. Our nurse navigator contacted these patients utilizing a hybrid model (MyChart, phone, telehealth visits) to review patient barriers and provide patient education on safety monitoring.

Conclusions: This pilot safety program initiative was able to identify gaps in practice settings for managing infusion-based high-efficacy MS DMTs. Our safety nurse navigator played an instrumental role in identifying patients who were non-adherent to safety monitoring and intervened in order to avoid drug-related complications. This is of particular interest in the setting of the ongoing COVID-19 pandemic as some patients may have reduced contact with their neurology team. Future directions will include assessing the patient experience of this safety initiative, as well as expanding to evaluate our entire cohort of patients on infusible therapies.