Natalizumab treatment and pregnancy in multiple sclerosis: A reappraisal of maternal and infant outcomes after 6 years. (November 2022)

• Record Type: Journal Article
• Authors: 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; Amato, Maria Pia
• Is Part Of: Multiple sclerosis. Volume 28:Number 13(2022)
• Page Start: 2137
• Page End: 2141
• Publication Date: 2022-11
• Subjects: Multiple sclerosis -- pregnancy -- natalizumab -- infant outcomes -- disability worsening; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/13524585221079598
• Languages: English
• ISSNs: 1352-4585

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.