RT Journal Article
SR Electronic
T1 Pregnancy decision-making in women with multiple sclerosis treated with natalizumab
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP e832
OP e839
DO 10.1212/WNL.0000000000005068
VO 90
IS 10
A1 Emilio Portaccio
A1 Lucia Moiola
A1 Vittorio Martinelli
A1 Pietro Annovazzi
A1 Angelo Ghezzi
A1 Mauro Zaffaroni
A1 Roberta Lanzillo
A1 Vincenzo Brescia Morra
A1 Francesca Rinaldi
A1 Paolo Gallo
A1 Carla Tortorella
A1 Damiano Paolicelli
A1 Carlo Pozzilli
A1 Laura De Giglio
A1 Paola Cavalla
A1 Eleonora Cocco
A1 Maria Giovanna Marrosu
A1 Claudio Solaro
A1 Antonio Uccelli
A1 Alice Laroni
A1 Luisa Pastò
A1 Marta Giannini
A1 Maria Trojano
A1 Giancarlo Comi
A1 Maria Pia Amato
A1 For the MS Study Group of the Italian Neurological Society
YR 2018
UL http://n.neurology.org/content/90/10/e832.abstract
AB 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.CI=confidence interval; CP=control pregnancies; DMD=disease-modifying drugs; EDSS=Expanded Disability Status Scale; IFN-β=interferon-β; MS=multiple sclerosis; noWOP=no washout pregnancies; NP=natalizumab pregnancies; ONP=other natalizumab pregnancy; OR=odds ratio; WOP=washout pregnancies