• J. Neurol. Neurosurg. Psychiatr. · Sep 2022

    Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis.

    • Doriana Landi, Francesca Bovis, Alfonso Grimaldi, Pietro Osvaldo Annovazzi, Antonio Bertolotto, Alessia Bianchi, Giovanna Borriello, Vincenzo Brescia Morra, Sebastiano Bucello, Maria Chiara Buscarinu, Francesca Caleri, Marco Capobianco, Ruggero Capra, Maria Cellerino, Diego Centonze, Raffaella Cerqua, Clara Grazia Chisari, Marinella Clerico, Eleonora Cocco, Gaia Cola, Cinzia Cordioli, Erica Curti, Alessandro d'Ambrosio, Emanuele D'Amico, Giovanna De Luca, Massimiliano Di Filippo, Sonia Di Lemme, Roberta Fantozzi, Diana Ferraro, Elisabetta Ferraro, Antonio Gallo, Claudio Gasperini, Franco Granella, Matilde Inglese, Roberta Lanzillo, Lorena Lorefice, Giacomo Lus, Simona Malucchi, Monica Margoni, Giorgia Mataluni, Massimiliano Mirabella, Lucia Moiola, Carolina Gabri Nicoletti, Viviana Nociti, Francesco Patti, Federica Pinardi, Emilio Portaccio, Carlo Pozzilli, Paolo Ragonese, Sarah Rasia, Giuseppe Salemi, Elisabetta Signoriello, Francesca Vitetta, Rocco Totaro, Maria Pia Sormani, Maria Pia Amato, and Girolama Alessandra Marfia.
    • Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy doriana.landi@gmail.com.
    • J. Neurol. Neurosurg. Psychiatr. 2022 Sep 30.

    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.© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

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