Establishment of the first at-home natalizumab infusion service for the treatment of relapsing remitting multiple sclerosis (rmms)

Abstract

ObjectivesRRMS is an immune-mediated, demyelinating condition often treated with the monoclonal antibody natalizumab. The administration of this intravenous infusion 4 weekly and the potential for adverse events poses a great inconvenience to patients requiring them to attend hospital day-units to receive treatment. We aimed to establish a safe, patient centric home infusion service for patients being treated with natalizumab as monotherapy for RRMS. Establishment of the home infusion service addressed regulatory requirements, risk minimisation strategies for known toxicities, occupational health and safety concerns and medication management, including storage and transport.MethodsAn accredited, hospital substitute service (chemo@home) developed a protocol for the administration of natalizumab at home. The protocol was approved by the health services Expert Reference Group (Neurology) and Medication Advisory Group. Medical governance is retained by the neurologist. All health professionals (medical, nursing and pharmacy) complete the relevant sections of the Tysabri Australian prescribing program (TAPP). JC virus seronegative patients are monitored 6 monthly for seroconversion. Resources for the management of adverse reactions (including resuscitation equipment/medications) are available. All pre-infusion regulatory and clinical requirements are fulfilled. Natalizumab infusions are prepared, using a closed system, and administered in the patient’s home by registered nurses. Patient questionnaires on the experience were collected.Results Between February 2014 and January 2017, 34 patients received 494 doses of natalizumab at home. A median of 11 (range 1–37). infusions were given. There were no episodes of anaphylaxis, hypersensitivity, unexpected toxicities and no additional safety concerns identified. Patient satisfaction was high. The at-home service made treatment significantly easier and less stressful than in hospital.ConclusionsTo our knowledge this is the first establishment of an accredited, hospital-substitute service (chemo@home) in Australia which gives RRMS patients access to natalizumab treatment at home. It was achieved without compromising safety and with a high level of patient satisfaction.

Developing a Model of Care for Home Infusions of Natalizumab for People With Multiple Sclerosis

“…Hazards in the home environment include bloodborne pathogen exposures, demanding patient mobilization and transfer tasks, threat of violence and other personal safety issues, and the presence of pets. 39 The importance of a safe environment for both home care nurses and patients 28 , 37 was addressed in POCaH orientation, including strategies for improving safety in home care and use of an environment checklist. The checklist included items relating to parking, patient's health status, presence of family members, cleanliness and suitability of the environment, and other issues, such as the presence of pets.…”

“… 32 A search for relevant evidence (“preclinical or theoretical phase”) was first conducted in March 2016 and updated in June 2018. PubMed, Scopus, Cochrane Library, Joanna Briggs Institute, and Cumulative Index to Nursing and Allied Health Literature databases were searched using search terms and medical subject headings including “home infusion”; “home care”; “natalizumab”; “monoclonal antibody”; “adverse events”; “IV infusion”; “multiple sclerosis”; and “home care services.” The search identified 35 published studies relevant to the aims of this study, including studies in 5 main topics: safety and adverse effects of natalizumab, 2 , 4 – 13 home care, 19 – 22 , 33 – 36 home infusions, 18 , 24 – 28 , 37 – 41 infusion guidelines and standards, 15 , 42 and medication management. 43 In addition to relevant published studies, product information, 3 training guides, 44 Australian health care standards, 45 and organizational protocols 16 were included, and US infusion therapy standards 46 were reviewed for applicability in the Australian setting.…”

“… 27 Similarly, the first at-home natalizumab infusion service in which 34 patients received nearly 500 doses in total at home was recently described in a conference abstract. 28 No specific details were published about the protocol for home infusions or how it was developed and approved.…”

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

“…Indeed, no AEs were reported in any of the 207 infusions conducted in either the clinic or home settings, replicating earlier findings for a similar number of patients over a longer time frame and a total of 494 infusions. 22 Although 1%–2% of natalizumab infusions involve an AE, 6 patients in this study had on average 5 years’ experience with natalizumab and were excluded if they had fewer than six prior infusions when AEs are more likely. 4 Additionally, those more likely to experience an AE (based on past experience) may have been less likely to consent.…”

“… 16 , 17 , 18 A systematic review of home infusion therapy concluded that home infusions were safe and clinically effective, resulted in significantly lower costs and were overwhelmingly preferred by patients because of increased physical and mental wellbeing and decreased disruption of family and personal responsibilities. 19 Although uptake of home infusions of monoclonal antibodies has lagged other forms of treatment such as antibiotic therapy, 19 home infusions of infliximab have been demonstrated to be safe and cost‐effective for children and adults with Crohn’s disease 20 , 21 and, more recently, natalizumab has been delivered by infusion at home for people with MS. 22 …”