1. Natalizumab treatment and pregnancy in multiple sclerosis: A reappraisal of maternal and infant outcomes after 6 years
- Author
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Emilio Portaccio, Luisa Pastò, Lorenzo Razzolini, Lucia Moiola, Vittorio Martinelli, Pietro Annovazzi, Angelo Ghezzi, Mauro Zaffaroni, Roberta Lanzillo, Vincenzo Brescia Morra, Francesca Rinaldi, Paolo Gallo, Claudio Gasperini, Damiano Paolicelli, Marta Simone, Carlo Pozzilli, Laura De Giglio, Paola Cavalla, Eleonora Cocco, Maria Giovanna Marrosu, Francesco Patti, Claudio Solaro, Giancarlo Comi, Massimo Filippi, Maria Trojano, Maria Pia Amato, Portaccio, Emilio, Pastò, Luisa, Razzolini, Lorenzo, Moiola, Lucia, Martinelli, Vittorio, Annovazzi, Pietro, Ghezzi, Angelo, Zaffaroni, Mauro, Lanzillo, Roberta, Brescia Morra, Vincenzo, Rinaldi, Francesca, Gallo, Paolo, Gasperini, Claudio, Paolicelli, Damiano, Simone, Marta, Pozzilli, Carlo, De Giglio, Laura, Cavalla, Paola, Cocco, Eleonora, Marrosu, Maria Giovanna, Patti, Francesco, Solaro, Claudio, Comi, Giancarlo, Filippi, Massimo, Trojano, Maria, and Amato, Maria Pia
- Subjects
Multiple Sclerosis ,Infant ,infant outcome ,Relapsing-Remitting ,Disability Evaluation ,Multiple Sclerosis, Relapsing-Remitting ,natalizumab ,Neurology ,Recurrence ,Humans ,Immunologic Factors ,Female ,Multiple sclerosi ,pregnancy ,Neurology (clinical) ,disability worsening ,infant outcomes ,Child - 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.
- Published
- 2022