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Pregnancy decision-making in women with multiple sclerosis treated with natalizumab

2018; Lippincott Williams & Wilkins; Volume: 90; Issue: 10 Linguagem: Inglês

10.1212/wnl.0000000000005067

1526-632X

Emilio Portaccio, Pietro Annovazzi, Angelo Ghezzi, Mauro Zaffaroni, Lucia Moiola, Vittorio Martinelli, Roberta Lanzillo, Vincenzo Brescia Morra, Francesca Rinaldi, Paolo Gallo, Carla Tortorella, Damiano Paolicelli, Carlo Pozzilli, Laura De Giglio, Paola Cavalla, Eleonora Cocco, Maria Giovanna Marrosu, Francesco Patti, Claudio Solaro, Paolo Bellantonio, Antonio Uccelli, Alice Laroni, Luisa Pastò, Marta Giannini, Maria Trojano, Gıancarlo Comı, Maria Pia Amato, Maria Pia Amato, Emilio Portaccio, Bahia Hakiki, Luisa Pastò, Marta Giannini, Lorenzo Razzolini, Isabella Righini, G. Siracusa, Angelo Ghezzi, Pietro Annovazzi, Mauro Zaffaroni, V. Martinelli, Marta Radaelli, Lucia Moiola, Gıancarlo Comı, Alessandra Protti, Emanuela Susani, R. Marazzi, Paolo Confalonieri, Valentina Torri Clerici, Paola Cavalla, Carlotta Chiavazza, Roberto Bergamaschi, Gianluigi Mancardi, Antonio Uccelli, Elisabetta Capello, Alice Laroni, Claudio Solaro, MR Tola, Luisa Caniatti, Franco Granella, Pasquale Annunziata, Katrin Plewnia, Leonello Guidi, ML Bartolozzi, Maria Rosa Mazzoni, Carlo Pozzilli, Laura De Giglio, Rocco Totaro, A Carolei, Maria Rita Rossi, Alessandra Lugaresi, Giovanna De Luca, V. Di Tommaso, Carla Tortorella, Damiano Paolicelli, Martina D’Onghia, Maria Trojano, Maria Giovanna Marrosu, Eleonora Cocco, Maurizio Melis, Francesco Patti, Cláudio Leone, Salvatore Lo Fermo, P. Bellantonio, Roberta Fantozzi, Claudio Gasperini, Alfonso Iudice, Antonio Bosco, Arianna Sartori, Roberta Lanzillo, Vincenzo Brescia Morra,

Polyomavirus and related diseases

Objective To assess fetal risk after pregnancy exposure to natalizumab in women with multiple sclerosis (MS), with a specific focus on spontaneous abortion (SA) and congenital anomalies (CA). Methods Data of all pregnancies occurring between 2009 and 2015 in patients with MS treated with natalizumab and referring to 19 participating sites were collected and compared with those of pregnancies in untreated patients and patients treated with injectable immunomodulatory agents. Rates of SA and CA were also compared with those reported in the Italian population. Multivariable logistic and linear regression models were performed. Results A total of 92 pregnancies were tracked in 83 women. In the multivariable analysis, natalizumab exposure was associated with SA (odds ratio [OR] 3.9, 95% confidence interval [CI] 1.9–8.5, p < 0.001). However, the rate of SA (17.4%) was within the estimates for the general population, as well as the rate of major CA (3.7%). Moreover, exposure to natalizumab and interferon-β (IFN-β) was associated with lower length and weight of the babies ( p < 0.001). Conclusion Our results showed that natalizumab exposure to up 12 weeks of gestation is associated with an increased risk of SA, although within the limits expected in the general population, whereas the risk of CA needs further investigation. Taking into account the high risk of disease reactivation after natalizumab suspension, pregnancy could be planned continuing natalizumab while strictly monitoring conception. Classification of evidence This study provides Class III evidence that in women with MS, natalizumab exposure increases the risk of spontaneous abortion as compared to IFN-β-exposed or untreated patients (OR 3.9, 95% CI 1.9–8.5).