Emilio Portaccio1, Luisa Pastò2, Lorenzo Razzolini3, Lucia Moiola4, Vittorio Martinelli4, Pietro Annovazzi5, Angelo Ghezzi5, Mauro Zaffaroni6, Roberta Lanzillo7, Vincenzo Brescia Morra7, Francesca Rinaldi8, Paolo Gallo8, Claudio Gasperini9, Damiano Paolicelli10, Marta Simone11, Carlo Pozzilli12, Laura De Giglio12, Paola Cavalla13, Eleonora Cocco14, Maria Giovanna Marrosu15, Francesco Patti16, Claudio Solaro17, Giancarlo Comi6, Massimo Filippi18, Maria Trojano10, Maria Pia Amato1. 1. Division Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy/IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy. 2. Division Neurological Rehabilitation, Careggi University Hospital, Florence, Italy. 3. Division Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy. 4. Neurology Unit and MS Center, IRCCS San Raffaele Scientific Institute, Milan, Italy. 5. Dipartimento di Scienze della Salute, Università del Piemonte Orientale, Novara, Italy. 6. Multiple Sclerosis Center, ASST Valle Olona, Gallarate Hospital (VA), Gallarate, Italy. 7. Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Naples, Italy. 8. Department of Neurosciences, Multiple Sclerosis Centre-Veneto Region (CeSMuV), University Hospital of Padova, Padova, Italy. 9. Department of Neurology, San Camillo Forlanini Hospital, Rome, Italy. 10. Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy. 11. Child and Adolescence Neuropsychiatry Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs, University Aldo Moro Bari, Bari, Italy. 12. Department of Neurology and Psychiatry, "La Sapienza" University, Rome, Italy. 13. Neurology Unit 1 and MS Center, City of Health and Science University Hospital, Torino, Italy. 14. Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy. 15. Dipartimento di Scienze Mediche e Chirurgiche, e Tecnologie Avanzate, GF Ingrassia Università di Catania, Catania, Italy. 16. Dipartimento di Scienze Mediche e Chirurgiche, e Tecnologie Avanzate, GF Ingrassia Università di Catania, Catania, Italy/Centro Sclerosi Multipla, Università di Catania, Catania, Italy. 17. Department of Rehabilitation, "Mons. Luigi Novarese" Hospital, Moncrivello, Italy. 18. Neurology Unit and MS Center, IRCCS San Raffaele Scientific Institute, Milan, Italy/Vita-Salute San Raffaele University, Milan, Italy/Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy/Neurorehabilitation Unit and Neurophysiology Service, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Abstract
OBJECTIVES: To assess the impact of timing of natalizumab cessation/redosing on long-term maternal and infant outcomes in 72 out of the original 74 pregnancies of the Italian Pregnancy Dataset in multiple sclerosis (MS). METHODS: Maternal outcomes in patients who received natalizumab until conception and restarted the drug within 1 month after delivery ("treatment approach," (TA)) and patients who stopped natalizumab before conception and/or restarted the drug later than 1 month after delivery ("conservative approach," (CA)) were compared through multivariable Cox regression analyses. Pediatric outcomes were assessed through a semi-structured questionnaire. RESULTS: After a mean follow-up of 6.1 years, CA (hazard ratio (HR) = 4.1, 95% CI 1.6-10.6, p = 0.003) was the only predictor of relapse occurrence. Worsening on the Expanded Disability Status Scale (EDSS) was associated with higher annualized relapse-rate during the follow-up (HR = 3.3, 95% CI 1.4-7.9 p = 0.007). We found no major development abnormalities in children. DISCUSSION: Our data confirm that TA reduces the risk of disease activity; we did not observe an increase in major development abnormalities in the child.
OBJECTIVES: To assess the impact of timing of natalizumab cessation/redosing on long-term maternal and infant outcomes in 72 out of the original 74 pregnancies of the Italian Pregnancy Dataset in multiple sclerosis (MS). METHODS: Maternal outcomes in patients who received natalizumab until conception and restarted the drug within 1 month after delivery ("treatment approach," (TA)) and patients who stopped natalizumab before conception and/or restarted the drug later than 1 month after delivery ("conservative approach," (CA)) were compared through multivariable Cox regression analyses. Pediatric outcomes were assessed through a semi-structured questionnaire. RESULTS: After a mean follow-up of 6.1 years, CA (hazard ratio (HR) = 4.1, 95% CI 1.6-10.6, p = 0.003) was the only predictor of relapse occurrence. Worsening on the Expanded Disability Status Scale (EDSS) was associated with higher annualized relapse-rate during the follow-up (HR = 3.3, 95% CI 1.4-7.9 p = 0.007). We found no major development abnormalities in children. DISCUSSION: Our data confirm that TA reduces the risk of disease activity; we did not observe an increase in major development abnormalities in the child.