Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis
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Published:2022-09-30
Issue:
Volume:
Page:jnnp-2022-329657
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ISSN:0022-3050
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Container-title:Journal of Neurology, Neurosurgery & Psychiatry
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language:en
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Short-container-title:J Neurol Neurosurg Psychiatry
Author:
Landi Doriana, Bovis FrancescaORCID, Grimaldi Alfonso, Annovazzi Pietro Osvaldo, Bertolotto Antonio, Bianchi AlessiaORCID, Borriello Giovanna, Brescia Morra Vincenzo, Bucello Sebastiano, Buscarinu Maria Chiara, Caleri Francesca, Capobianco MarcoORCID, Capra Ruggero, Cellerino Maria, Centonze DiegoORCID, Cerqua Raffaella, Chisari Clara Grazia, Clerico Marinella, Cocco EleonoraORCID, Cola Gaia, Cordioli Cinzia, Curti Erica, d'Ambrosio Alessandro, D'Amico Emanuele, De Luca Giovanna, Di Filippo MassimilianoORCID, Di Lemme Sonia, Fantozzi Roberta, Ferraro DianaORCID, Ferraro Elisabetta, Gallo Antonio, Gasperini ClaudioORCID, Granella Franco, Inglese Matilde, Lanzillo RobertaORCID, Lorefice Lorena, Lus Giacomo, Malucchi Simona, Margoni MonicaORCID, Mataluni Giorgia, Mirabella Massimiliano, Moiola Lucia, Nicoletti Carolina Gabri, Nociti VivianaORCID, Patti Francesco, Pinardi Federica, Portaccio EmilioORCID, Pozzilli Carlo, Ragonese PaoloORCID, Rasia Sarah, Salemi Giuseppe, Signoriello Elisabetta, Vitetta Francesca, Totaro Rocco, Sormani Maria PiaORCID, Amato Maria Pia, Marfia Girolama Alessandra
Abstract
ObjectiveAssessing the risk of clinical and radiological reactivation during pregnancy and post partum in women with multiple sclerosis (MS) treated with natalizumab (NTZ) throughout pregnancy (LONG_EXP) compared with women interrupting treatment before (NO_EXP) and within >−30 days and ≤90 days from conception (SHORT_EXP), and describing newborns’ outcomes.MethodsMaternal clinical and radiological outcomes and obstetric and fetal outcomes were retrospectively collected and compared among groups (NO_EXP, SHORT_EXP, LONG_EXP). Predictors of clinical and radiological reactivation were investigated through univariable and multivariable analysis.Results170 eligible pregnancies from 163 women referring to 29 Italian MS centres were included. Annualised relapse rate (ARR) was significantly lower in LONG_EXP (n=66, 0.02 (0.001–0.09)) compared with NO_EXP (n=31, 0.43 (0.21–0.75), p=0.002) and SHORT_EXP (n=73, 0.46 (0.30–0.66), p=0.0004) during pregnancy, and in LONG_EXP (0.12 (0.05–0.24)) compared with SHORT_EXP (0.30 (0.17–0.50), p=0.008) during post partum. Gadolinium-enhancing (Gd+) lesions were less frequent in LONG_EXP (n=6/50, 2.00%) compared with NO_EXP (n=9/21, 42.86%) and SHORT_EXP after delivery (n=17/49, 34.69%, p=0.010).Delaying NTZ resumption after delivery significantly increased the risk of relapses (OR=1.29 (95% CI 1.07 to 1.57), p=0.009) and Gd+ lesions (OR=1.49 (95% CI 1.17 to 1.89, p=0.001). Newborns’ weight, length, head circumference and gestational age did not differ among groups after adjusting for confounders. Anaemia was tracked in 4/69 LONG_EXP newborns. Congenital anomaly rate was within the expected range for the untreated MS population.ConclusionsOur findings indicate that in women with MS treated with NTZ before conception, continuation of NTZ throughout pregnancy and its early resumption after delivery mitigate the risk of clinical and radiological reactivation. This approach has no major impact on newborns’ outcomes.
Funder
Biogen Italia S.r.l. Italian Ministry of Health
Subject
Psychiatry and Mental health,Neurology (clinical),Surgery
Cited by
15 articles.
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