RESUMEN
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.
Asunto(s)
COVID-19 , Virus JC , Leucoencefalopatía Multifocal Progresiva , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Natalizumab/efectos adversos , Factores Inmunológicos/efectos adversos , SARS-CoV-2 , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/epidemiología , Gestión de RiesgosRESUMEN
OBJECTIVE: Compare the maternal and neonatal outcomes in pregnancies complicated by preterm prelabour rupture of membranes (PPROM), which were managed either at home (HAD) or hospital (HC). MATERIALS AND METHODS: Retrospective study in two level III maternities during 2 years. Inclusion criteria in HAD were: singleton pregnancy, PPROM between 24 and 35 weeks of gestation, absence of chorioamnionitis, clinical stability at D7 of the rupture, cervical dilatation <3 cm, patient residing in the geographic area. RESULTS: Thirty-two patients were included in the HAD group and 24 in the HC group. Our populations were similar in the 2 groups. The duration of latency was longer in the HAD group than in the HC group (27.5 d [20-37] versus 16.5 d [12.5 to 29.5]; P=0.026). Patients in the HAD group received fewer antibiotics with a similar rate of chorioamnionitis. No difference in terms of obstetrical and neonatal outcomes was observed. Number of days in neonatal resuscitation was lower in the HAD group than in the HC group (12.5 d [10-22] versus 43 d [20-52]; P=0.003). CONCLUSION: HAD seems to be an alternative to continuous hospitalization for patients followed for PPROM between 24 and 35 weeks. A randomized study with a larger number of patients, including other data such as maternal satisfaction and cost analysis, would be interesting to confirm those preliminary results.