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 e823
OP e831
DO 10.1212/WNL.0000000000005067
VO 90
IS 10
A1 Portaccio, Emilio
A1 Annovazzi, Pietro
A1 Ghezzi, Angelo
A1 Zaffaroni, Mauro
A1 Moiola, Lucia
A1 Martinelli, Vittorio
A1 Lanzillo, Roberta
A1 Brescia Morra, Vincenzo
A1 Rinaldi, Francesca
A1 Gallo, Paolo
A1 Tortorella, Carla
A1 Paolicelli, Damiano
A1 Pozzilli, Carlo
A1 De Giglio, Laura
A1 Cavalla, Paola
A1 Cocco, Eleonora
A1 Marrosu, Maria Giovanna
A1 Patti, Francesco
A1 Solaro, Claudio
A1 Bellantonio, Paolo
A1 Uccelli, Antonio
A1 Laroni, Alice
A1 Pastò, Luisa
A1 Giannini, Marta
A1 Trojano, Maria
A1 Comi, Giancarlo
A1 Amato, Maria Pia
A1 ,
YR 2018
UL http://n.neurology.org/content/90/10/e823.abstract
AB 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).CI=confidence interval; CP=control pregnancies; DMD=disease-modifying drug; EDSS=Expanded Disability Status Scale; EUROCAT=European Surveillance of Congenital Anomalies; IFN-β=interferon-β; IFNBEP=interferon-β-exposed pregnancies; MS=multiple sclerosis; NatEP=natalizumab-exposed pregnancies; OR=odds ratio; SA=spontaneous abortion