Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks

MS Study Group of the Italian Neurological Society

Research output: Contribution to journalArticle

Abstract

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).

Original languageEnglish
Pages (from-to)e823-e831
JournalNeurology
Volume90
Issue number10
DOIs
Publication statusPublished - Mar 6 2018

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Multiple Sclerosis
Decision Making
Spontaneous Abortion
Pregnancy
Interferons
Linear Models
Odds Ratio
Confidence Intervals
Population
Natalizumab
Suspensions
Logistic Models
Weights and Measures
Injections

Cite this

Pregnancy decision-making in women with multiple sclerosis treated with natalizumab : I: Fetal risks. / MS Study Group of the Italian Neurological Society.

In: Neurology, Vol. 90, No. 10, 06.03.2018, p. e823-e831.

Research output: Contribution to journalArticle

MS Study Group of the Italian Neurological Society. / Pregnancy decision-making in women with multiple sclerosis treated with natalizumab : I: Fetal risks. In: Neurology. 2018 ; Vol. 90, No. 10. pp. e823-e831.
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title = "Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks",
abstract = "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).",
author = "{MS Study Group of the Italian Neurological Society} and Emilio Portaccio and Pietro Annovazzi and Angelo Ghezzi and Mauro Zaffaroni and Lucia Moiola and Vittorio Martinelli and Roberta Lanzillo and {Brescia Morra}, Vincenzo and Francesca Rinaldi and Paolo Gallo and Carla Tortorella and Damiano Paolicelli and Carlo Pozzilli and {De Giglio}, Laura and Paola Cavalla and Eleonora Cocco and Marrosu, {Maria Giovanna} and Francesco Patti and Claudio Solaro and Paolo Bellantonio and Antonio Uccelli and Alice Laroni and Luisa Past{\`o} and Marta Giannini and Maria Trojano and Giancarlo Comi and Amato, {Maria Pia}",
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T1 - Pregnancy decision-making in women with multiple sclerosis treated with natalizumab

T2 - I: Fetal risks

AU - MS Study Group of the Italian Neurological Society

AU - Portaccio, Emilio

AU - Annovazzi, Pietro

AU - Ghezzi, Angelo

AU - Zaffaroni, Mauro

AU - Moiola, Lucia

AU - Martinelli, Vittorio

AU - Lanzillo, Roberta

AU - Brescia Morra, Vincenzo

AU - Rinaldi, Francesca

AU - Gallo, Paolo

AU - Tortorella, Carla

AU - Paolicelli, Damiano

AU - Pozzilli, Carlo

AU - De Giglio, Laura

AU - Cavalla, Paola

AU - Cocco, Eleonora

AU - Marrosu, Maria Giovanna

AU - Patti, Francesco

AU - Solaro, Claudio

AU - Bellantonio, Paolo

AU - Uccelli, Antonio

AU - Laroni, Alice

AU - Pastò, Luisa

AU - Giannini, Marta

AU - Trojano, Maria

AU - Comi, Giancarlo

AU - Amato, Maria Pia

N1 - © 2018 American Academy of Neurology.

PY - 2018/3/6

Y1 - 2018/3/6

N2 - 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).

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).

U2 - 10.1212/WNL.0000000000005067

DO - 10.1212/WNL.0000000000005067

M3 - Article

C2 - 29438046

VL - 90

SP - e823-e831

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 10

ER -