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Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis.
Landi, Doriana; Bovis, Francesca; Grimaldi, Alfonso; Annovazzi, Pietro Osvaldo; Bertolotto, Antonio; Bianchi, Alessia; Borriello, Giovanna; Brescia Morra, Vincenzo; Bucello, Sebastiano; Buscarinu, Maria Chiara; Caleri, Francesca; Capobianco, Marco; Capra, Ruggero; Cellerino, Maria; Centonze, Diego; Cerqua, Raffaella; Chisari, Clara Grazia; Clerico, Marinella; Cocco, Eleonora; Cola, Gaia; Cordioli, Cinzia; Curti, Erica; d'Ambrosio, Alessandro; D'Amico, Emanuele; De Luca, Giovanna; Di Filippo, Massimiliano; Di Lemme, Sonia; Fantozzi, Roberta; Ferraro, Diana; Ferraro, Elisabetta; Gallo, Antonio; Gasperini, Claudio; Granella, Franco; Inglese, Matilde; Lanzillo, Roberta; Lorefice, Lorena; Lus, Giacomo; Malucchi, Simona; Margoni, Monica; Mataluni, Giorgia; Mirabella, Massimiliano; Moiola, Lucia; Nicoletti, Carolina Gabri; Nociti, Viviana; Patti, Francesco; Pinardi, Federica; Portaccio, Emilio; Pozzilli, Carlo; Ragonese, Paolo; Rasia, Sarah.
Afiliação
  • Landi D; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy doriana.landi@gmail.com.
  • Bovis F; Department of Health Sciences, Section of Biostatistics, University of Genova, Genoa, Italy.
  • Grimaldi A; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.
  • Annovazzi PO; Multiple Sclerosis Center, Neurology II Unit, ASST Valle Olona, Gallarate Hospital, Gallarate, Italy.
  • Bertolotto A; Multiple Sclerosis Center (CRESM), Department of Neurology, 'San Luigi Gonzaga' University Hospital, Orbassano, Italy.
  • Bianchi A; Unit of Neurology, Department of Biomedicine, Neurosciences and Advanced Diagnostics, Palermo University, Palermo, Italy.
  • Borriello G; Multiple Sclerosis Center, 'S. Andrea' Hospital, Sapienza University of Rome, Rome, Italy.
  • Brescia Morra V; Department of Neurosciences Reproductive Sciences and Odontostomatology, Multiple Sclerosis Center, Federico II University, Naples, Italy.
  • Bucello S; Multiple Sclerosis Center, "E. Muscatello" Hospital - ASP8, Augusta (SR), Italy.
  • Buscarinu MC; Department of Neuroscience, Mental Health and Sensory Organs, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
  • Caleri F; Multiple Sclerosis Center, Department of Neurology, 'F. Tappeiner' Hospital, Merano (BZ), Italy.
  • Capobianco M; Multiple Sclerosis Center (CRESM), Department of Neurology, 'San Luigi Gonzaga' University Hospital, Orbassano, Italy.
  • Capra R; Multiple Sclerosis Center, Spedali Civili of Brescia, Montichiari (BS), Italy.
  • Cellerino M; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genova, Italy.
  • Centonze D; Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
  • Cerqua R; Unit of Neurology, IRCCS Neuromed, Pozzilli (IS), Italy.
  • Chisari CG; Neurological Clinic, Department of Experimental and Clinical Medicine, Ospedali Riuniti, Ancona, Italy.
  • Clerico M; Department of Medical and Surgical Sciences and Advanced Technologies 'G.F. Ingrassia', Section of Neurosciences, University of Catania, Catania, Italy.
  • Cocco E; Clinical and Biological Sciences Department, Neurology Unit, University of Torino, 'San Luigi Gonzaga' Hospital, Orbassano, Italy.
  • Cola G; Multiple Sclerosis Center, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.
  • Cordioli C; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.
  • Curti E; Multiple Sclerosis Center, Spedali Civili of Brescia, Montichiari (BS), Italy.
  • d'Ambrosio A; Unit of Neurology, Department of General and Specialized Medicine, Parma University Hospital, Parma, Italy.
  • D'Amico E; I Division of Neurology, Department of Advanced Medical and Surgical Sciences (DAMSS), University of Campania "Luigi Vanvitelli", Napoli, Italy.
  • De Luca G; Department of Medical and Surgical Sciences and Advanced Technologies 'G.F. Ingrassia', Section of Neurosciences, University of Catania, Catania, Italy.
  • Di Filippo M; Multiple Sclerosis Center, 'SS Annunziata' Hospital, 'Gabriele d'Annunzio' University Chieti-Pesacara, Chieti, Italy.
  • Di Lemme S; Section of Neurology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
  • Fantozzi R; Unit of Neurology, IRCCS Neuromed, Pozzilli (IS), Italy.
  • Ferraro D; Unit of Neurology, IRCCS Neuromed, Pozzilli (IS), Italy.
  • Ferraro E; Department of Biomedical Metabolic and Neurosciences, University of Modena and Reggio Emilia, Modena, Italy.
  • Gallo A; Neurology Unit, Presidio Ospedaliero 'San Filippo Neri', Roma, Italy.
  • Gasperini C; I Division of Neurology, Department of Advanced Medical and Surgical Sciences (DAMSS), University of Campania "Luigi Vanvitelli", Napoli, Italy.
  • Granella F; Department of Neurosciences, 'San Camillo Forlanini' Hospital, Rome, Italy.
  • Inglese M; Unit of Neurology, Department of General and Specialized Medicine, Parma University Hospital, Parma, Italy.
  • Lanzillo R; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genova, Italy.
  • Lorefice L; Department of Neurology, Policlinico 'San Martino Hospital'-Sistema Sanitario Regione, Genoa, Italy.
  • Lus G; Department of Neurosciences Reproductive Sciences and Odontostomatology, Multiple Sclerosis Center, Federico II University, Naples, Italy.
  • Malucchi S; Multiple Sclerosis Centre, Binaghi Hospital, ATS Sardegna-Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
  • Margoni M; Department of Advanced Medical and Surgical Sciences, II Division of Neurology, Multiple Sclerosis Center, University of Campania 'L. Vanvitelli', Naples, Italy.
  • Mataluni G; Multiple Sclerosis Center (CRESM), Department of Neurology, 'San Luigi Gonzaga' University Hospital, Orbassano, Italy.
  • Mirabella M; Multiple Sclerosis Center of the Veneto Region, Department of Neurosciences, University of Padua, Padua, Italy.
  • Moiola L; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.
  • Nicoletti CG; Department of Neurosciences, Centro di Ricerca Sclerosi Multipla (CERSM), Università Cattolica del Sacro Cuore, Rome, Italy, 'A.Gemelli' University Hospital, Rome, Italy.
  • Nociti V; Multiple Sclerosis Center, Neurology Department, San Raffaele Hospital IRCCS, Milan, Italy.
  • Patti F; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Roma, Italy.
  • Pinardi F; Department of Neurosciences, Centro di Ricerca Sclerosi Multipla (CERSM), Università Cattolica del Sacro Cuore, Rome, Italy, 'A.Gemelli' University Hospital, Rome, Italy.
  • Portaccio E; Department of Medical and Surgical Sciences and Advanced Technologies 'G.F. Ingrassia', Section of Neurosciences, University of Catania, Catania, Italy.
  • Pozzilli C; UOSI Multiple Sclerosis Rehabilitation, IRCCS Istituto delle scienze neurologiche, Bologna, Italy.
  • Ragonese P; Division Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy.
  • Rasia S; Multiple Sclerosis Center, Department of Human Neurosciences, 'S.Andrea' Hospital, Sapienza University of Rome, Rome, Italy.
J Neurol Neurosurg Psychiatry ; 2022 Sep 30.
Article em En | MEDLINE | ID: mdl-36180219
OBJECTIVE: Assessing 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. METHODS: Maternal 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. RESULTS: 170 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. CONCLUSIONS: Our 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: J Neurol Neurosurg Psychiatry Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Itália
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: J Neurol Neurosurg Psychiatry Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Itália