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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.0000000000005068

1526-632X

Emilio Portaccio, Lucia Moiola, Vittorio Martinelli, Pietro Annovazzi, Angelo Ghezzi, Mauro Zaffaroni, 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, Claudio Solaro, Antonio Uccelli, Alice Laroni, Luisa Pastò, Marta Giannini, Maria Trojano, Giancarlo Comi, 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, Giancarlo Comi, 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,

Pregnancy and Medication Impact

Objective To assess the risk of disease reactivation during pregnancy after natalizumab suspension in women with multiple sclerosis (MS). 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 through a 2-factor repeated measures analysis. Predictors of disease activity were assessed through stepwise multivariable logistic regression models. Results A total of 92 pregnancies were tracked in 83 women receiving natalizumab. Among these pregnancies, 74 in 70 women resulted in live births, with a postpartum follow-up of at least 1 year, and were compared with 350 previously published pregnancies. Relapse rate during and after pregnancy was higher in women treated with natalizumab ( p < 0.001). In multivariable analysis, longer natalizumab washout period was the only predictor of relapse occurrence during pregnancy ( p = 0.001). Relapses in the postpartum year were related to relapses during pregnancy ( p = 0.019) and early reintroduction of disease-modifying drugs (DMD; p = 0.021). Disability progression occurred in 16.2% of patients and was reduced by early reintroduction of DMD ( p = 0.024). Conclusions Taken as a whole, our findings indicate that the combination of avoiding natalizumab washout and the early resumption of DMD after delivery could be the best option in the perspective of maternal risk. This approach must take into account possible fetal risks that need to be discussed with the mother and require further investigation. Classification of evidence This study provides Class IV evidence that in women with MS, the risk of relapses during pregnancy is higher in those who had been using natalizumab as compared to those who had been using interferon-β or no treatment.