Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial

Abstract

Objective The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing‐remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out‐patients’ clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs. Methods In this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared. Results No adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with “convenience” of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients” out‐of‐pocket costs. Interpretation There were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes.

Safety and patient experience with at‐home infusion of ocrelizumab for multiple sclerosis

“…In a pilot crossover clinical study, patients with MS were randomized to receive usual care or home infusions of natalizumab, and were then switched to receive the alternate treatment. 27 No AEs were recorded in the crossover pilot study of natalizumab treatment, and no differences were found between adherence or infection rates between settings. Significantly greater satisfaction with convenience was found with home infusions, and costs were reduced compared with infusions received in clinical settings.…”

“…It is important to note that available studies in other DMTs and antibiotic treatment administration have shown comparable safety and efficacy with at‐home treatments compared with standard clinical settings. In a pilot crossover clinical study, patients with MS were randomized to receive usual care or home infusions of natalizumab, and were then switched to receive the alternate treatment 27 . No AEs were recorded in the crossover pilot study of natalizumab treatment, and no differences were found between adherence or infection rates between settings.…”

Customer-centric product presentations for monoclonal antibodies

“…To optimize satisfaction and quality of life with intravenous mAb treatments and to improve healthcare institutional resource utilization in MS, efforts are made to support home-based and outpatient infusion management (Vijayan et al 2017 ; Schultz et al 2021 ; Barrera et al 2022 ; Räuber et al 2022 ). It was found that people are generally open to receiving the intravenous treatment at home and that supporting health services need to ensure safety and be efficient, responsive, and flexible.…”

Switching from natalizumab administration at the day hospital to administration at home. A 1 year prospective study of patient experience and quality of life in 30 consecutive patients with multiple sclerosis (TYSAD-35)

“…91 748 of July 31, 1991, and depends on dedicated medical and paramedical teams in a given area. Beyond the context of the pandemic and the need to ensure the continued treatment of these patients (risk of rebound when natalizumab is stopped) ( O'Connor et al., 2011 ), the decision of the HAS was based on a few previous experiences, particularly in Australia, reporting encouraging results for safety, efficacy, and patient satisfaction ( Vijayan et al., 2017 ; Schultz et al., 2019 ; Juaton et al., 2020 ; Schultz et al., 2021 ). Indeed, it is essential to take the patients’ viewpoint into account (in addition to the clinical criteria of efficacy and safety) when implementing of new modes of organization for their care ( Committee on Quality of Health Care in America ; Carman et al., 2013 ).…”