The Safety of Natalizumab Administration in the Home During the COVID-19 Pandemic for Patients with Multiple Sclerosis
Authors:   Option Care Health, Musa Rohae , Giannakos Maria , Kluge Suzanne 
Published: February 2025

Background: Multiple sclerosis (MS) is a progressive autoimmune inflammatory disorder causing demyelination and degeneration of the central nervous system. Natalizumab is a highly effective monoclonal antibody for the treatment of relapsing-remitting multiple sclerosis (RRMS).1 It is usually delivered as 300 mg 1-hour intravenous infusion every 4 weeks.1 Natalizumab is generally well tolerated, however, there are infusion-related reactions associated with the drug, and a risk of progressive multifocal leukoencephalopathy (PML.) Patients were previously required to receive the infusions in an authorized infusion center under a restricted distribution program.1 Due to the COVID-19 pandemic, there was concern for additional exposure of immunocompromised patients during health care facility visits. The manufacturer had obtained Food and Drug Administration (FDA) approval that temporarily permitted the infusion of natalizumab in the home under the TOUCH® Risk Evaluation and Mitigation Strategy (REMS) program.

Purpose: The study assessed the safety of natalizumab administration by comparing outcomes after receiving natalizumab infusions at home vs. infusion suites.

Methods: The study was a retrospective, non-inferiority multi-center chart review of patients receiving natalizumab in the home and outpatient infusion center. The primary outcome included safety (adverse events and infections), as assessed by pharmacist documentation. Non-inferiority was declared if the proportion of adverse events and infections for home infusion was no worse than the proportion for infusions performed in infusion suites, within statistical variability, by a margin of -3.0 percentage points. The study included MS patients over 18 years old prescribed natalizumab who have been treated for 6 consecutive uninterrupted natalizumab infusions prior to starting home infusion natalizumab. Exclusion criteria included natalizumab naive patients and patients receiving an MS concurrent therapy.

Results: Between May 4, 2020, and August 21, 2021, 7,699 natalizumab patients were screened based on referral information. Ninety-eight RRMS patients were randomly selected (natalizumab home infusion n=49 vs. natalizumab outpatient infusion n=49). Overall, there were no demographic differences between the 2 groups, other than female sex. Adverse events were reported in 6.1% (n=3) of the patients treated in an infusion suite and 8.2% (n=4) of patients treated in the home setting. There were no episodes of anaphylaxis, infections, unexpected toxicities, and no additional safety concerns identified.

Conclusion: The incidence of infusion-related events and adverse events was similar in both natalizumab groups. This retrospective study demonstrated a low incidence of adverse events in patients receiving natalizumab at home. These findings demonstrated that delivering natalizumab to patients who have received 6 consecutive uninterrupted infusions prior to starting home infusion natalizumab, is as safe as those who receive it in outpatient clinic. The convenience of the home setting should be considered in future care for immunocompromised patients. The results may be utilized in future studies to evaluate the safety of natalizumab infusions in the home setting. Furthermore, the framework of this study supports future studies to evaluate the safety of other monoclonal antibodies in the home setting.