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

被引:79
作者
Portaccio, Emilio [1 ]
Annovazzi, Pietro [2 ]
Ghezzi, Angelo [2 ]
Zaffaroni, Mauro [2 ]
Moiola, Lucia [3 ]
Martinelli, Vittorio [3 ]
Lanzillo, Roberta [4 ]
Morra, Vincenzo Brescia [4 ]
Rinaldi, Francesca [5 ]
Gallo, Paolo [5 ]
Tortorella, Carla [6 ]
Paolicelli, Damiano [6 ]
Pozzilli, Carlo [7 ]
De Giglio, Laura [7 ]
Cavalla, Paola [8 ]
Cocco, Eleonora [9 ]
Marrosu, Maria Giovanna [9 ]
Patti, Francesco [10 ]
Solaro, Claudio [11 ]
Bellantonio, Paolo [12 ]
Uccelli, Antonio [13 ]
Laroni, Alice [13 ]
Pasto, Luisa [14 ]
Giannini, Marta [14 ]
Trojano, Maria [6 ]
Comi, Giancarlo [3 ]
Amato, Maria Pia [14 ]
机构
[1] IRCCS Don Gnocchi Fdn, Florence, Italy
[2] Gallarate Hosp VA, ASST Valle Olona, Multiple Sclerosis Study Ctr, Gallarate, Italy
[3] Sci Inst Univ Vita Salute San Raffaele, Milan, Italy
[4] Federico II Univ Naples, Dept Neurosci Reprod & Odontostomatol Sci, Naples, Italy
[5] Univ Hosp Padova, Multiple Sclerosis Ctr Veneto Reg CeSMuV, Dept Neurosci, Padua, Italy
[6] Univ Bari, Dept Neurol, Bari, Italy
[7] Univ Roma La Sapienza, Dept Neurol & Psychiat, Rome, Italy
[8] Univ Torino, Dept Neurol, Turin, Italy
[9] Univ Cagliari, Dept Med Sci & Publ Hlth, Cagliari, Italy
[10] Univ Catania, Dept Neurol, Catania, Italy
[11] ASL3 Genovese, Dept Neurol, Genoa, Italy
[12] IRCCS Neuromed, Multiple Sclerosis Ctr, Pozzilli, Italy
[13] Univ Genoa, Dept Neurol, Genoa, Italy
[14] Univ Florence, Dept NEUROFARBA, Florence, Italy
关键词
POSTPARTUM RELAPSES; DIAGNOSTIC-CRITERIA; DISCONTINUATION; INTEGRINS; EXPOSURE; OUTCOMES; PATIENT;
D O I
10.1212/WNL.0000000000005067
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
ObjectiveTo 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).MethodsData 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.ResultsA 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- (IFN-) was associated with lower length and weight of the babies (p < 0.001).ConclusionOur 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 evidenceThis study provides Class III evidence that in women with MS, natalizumab exposure increases the risk of spontaneous abortion as compared to IFN--exposed or untreated patients (OR 3.9, 95% CI 1.9-8.5).
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收藏
页码:E823 / E831
页数:9
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