ABSTRACT
Natalizumab is a well-established disease-modifying therapy used in active multiple sclerosis (MS). The most serious adverse event is progressive multifocal leukoencephalopathy. For safety reasons, hospital implementation is mandatory. The SARS-CoV-2 pandemic has deeply affected hospital practices leading French authorities to temporarily authorize to administer the treatment at home. The safety of natalizumab home administration should be assessed to allow ongoing home infusion. The aim of the study is to describe the procedure and assess the safety in a home infusion natalizumab model. Patients presenting relapsing-remitting MS treated by natalizumab for over two years, non-exposed to John Cunningham Virus (JCV) and living in the Lille area (France) were included from July 2020 to February 2021 to receive natalizumab infusion at home every four weeks for 12 months. Teleconsultation occurrence, infusion occurrence, infusion cancelling, JCV risk management, annual MRI completion were analyzed. The number of teleconsultations allowing infusion was 365 (37 patients included in the analysis), all home infusions were preceded by a teleconsultation. Nine patients did not complete the one-year home infusion follow-up. Two teleconsultations canceled infusions. Two teleconsultations led to a hospital visit to assess a potential relapse. No severe adverse event was reported. All 28 patients who have completed the follow-up benefited from biannual hospital examination and JCV serologies and annual MRI. Our results suggested that the established home natalizumab procedure was safe using the university hospital home-care department. However, the procedure should be evaluated using home-based services outside the university hospital.
ABSTRACT
Introduction: Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. However global vaccination hesitancy remains and potential effect of COVID19 vaccination on disease activity needs to be assessed. Objective(s): We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects. Method(s): This multicentric observational study is based on the RISC cohort. Data regarding COVID19 infection and vaccination has been collected between January 2020 and December 2021. We compared the occurrence of clinical conversion to MS and EDA in patients according to their vaccination status. The same analysis was conducted by comparing patients according to their history of COVID19 infection. Result(s): 217 subjects with known vaccination status were included (Mean age: 44yrs, F/M sex ratio 2.7). 80% of subjects had a complete vaccination and 20% were incompletely or not vaccinated. Both groups did not differ regarding the main demographical data and known risk factors of conversion to MS. No difference was found concerning clinical conversion to MS in the vaccinated versus unvaccinated group (2.4% versus 2.5%, p = 0.9747). We did not observe any statistical difference regarding the rate of EDA in both groups. 20% of subjects had a history of COVID-19 infection. The rate of clinical conversion to MS in the infected compared to the noninfected group did not show any difference The global conversion rate to MS in the whole RISC cohort in 2021 was 2.64%, which is comparable with the observed rates during the four previous years (5.75%, 2.55%, 4.79%, and 4.85% per year respectively). Conclusion(s): Our study suggests that COVID19 vaccination does not increase the risk of clinical conversion to MS in RIS subjects and supports that immunization can be safely proposed for these patients.
ABSTRACT
Introduction: Natalizumab (NTZ) is a well-established disease modifying therapy used in active multiple sclerosis (MS). The most serious adverse event (AE) is progressive multifocal leukoencephalopathy. For safety reasons, hospital implementation is mandatory. Risk management strategy consists in monitoring exposition index to the JC virus (JCV) and regular MRI evaluation depending on the JCV exposition. The SARS-CoV-2 pandemic has deeply affected hospital practices leading French authorities to temporarily authorize to administer the treatment at home. The safety of NTZ home administration should be assessed. Objective(s): To describe the procedure and assess the safety in a home infusion NTZ model. Method(s): Patients presenting remitting-MS treated by NTZ for over two years, non-exposed to JCV and living in the area covered by the home care department were included from July 2020 to February 2021 to receive NTZ infusion at home every four weeks for 12 months. We did not include patients with inconsistent adherence to proper clinical and MRI monitoring or who had significant cognitive impairment. Each infusion was necessarily preceded by a teleconsultation (TC) with a neurologist to allow or cancel infusion the day before the scheduled date. A home care physician then received the information and notified the nursing team intervening at home. JCV serologies and clinical examination were organized and performed every 6 months for each patient at the hospital. Patients could ask for a visit in hospital at any time if neurological status was suspected to have changed. TC occurrence, JCV risk management, annual MRI completion were analyzed. Result(s): From 198 NTZ-treated patients in Lille MS center,35 were eligible and included in the analysis. Seven of them did not complete the one-year home infusion follow-up. Preliminary results show that 369 TC allowing infusion were performed, 100% (369/369) of the home infusion were preceded by a TC. Two TC canceled the scheduled infusion, two TC led to a hospital visit to assess a potential relapse. No AE related to the home infusion process was reported. All 28 patients who have completed the follow-up benefited from hospital examination and JCV serologies two times and one annual MRI. Conclusion(s): Preliminary results suggest that the established home NTZ procedure was safe. However, multicenter, prospective and comparative cohorts with large numbers are needed to confirm the safety of a home infusion NTZ model.