To determine the feasibility and efficacy of a safety program designed for monitoring infusion DMTs prescribed for MS.

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. Non-adherence to safety monitoring can lead to DMT-related complications.

A safety nurse navigator regularly reviewed safety data via chart review for patients receiving infusion DMTs from November 2020 to December 2022, and contacted these patients to review and address barriers to safety monitoring. Patients were screened for any barriers to safe infusion as the primary outcome, including out-of-date safety labs for the specific DMT, out-of-date imaging, and/or outdated follow-up with their neurologist. Multivariate logistic regression analysis was performed to assess for predictors of incomplete safety monitoring and of successful safety intervention.

We reviewed 343 patients on infusible DMTs over the study time period: 75 natalizumab, 31 rituximab, and 237 ocrelizumab. Our cohort’s mean age was 43 years (±11), 71% female, 81% relapsing-remitting MS, and median EDSS was 2. Of the 343 patients, 286 (83%) were found to have a barrier to safe infusion, with 64% requiring safety labs, 47% prescriber follow-up, and 26% a surveillance MRI. The safety nurse had a successful intervention in 82% of interactions. Use of B-cell depletion was associated with outdated lab monitoring (p<0.001), while use of natalizumab was associated with outdated appointments (p=0.002) and imaging (p=0.001). White race was associated with a lower rate of incomplete safety monitoring, and a higher rate of successful intervention.

This pilot safety initiative identified practice gaps 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.