Continuation of natalizumab versus interruption is associated with lower risk of relapses during pregnancy and postpartum in women with MS
ECTRIMS Online Library. Landi D. Sep 13, 2019; 279583; 338
Ms. Doriana Landi
Ms. Doriana Landi
Contributions
Abstract

Abstract: 338

Type: Scientific Session

Abstract Category: Scientific Session 17: Late Breaking News

D. Landi1, E. Portaccio2, F. Bovis3, P. Annovazzi4, V. Brescia Morra5, S. Bucello6, F. Caleri7, P. Cavalla8, D. Centonze1,9, C. Chisari10, E. Cocco11, G. Comi12, L. De Giglio13, V. Di Tommaso14, P. Gallo15, C. Gasperini16, A. Ghezzi4, F. Granella17, A. Grimaldi1, R. Lanzillo5, A. Laroni18,19, A. Lugaresi20,21, G. Marrosu11, V. Martinelli12, G. Mataluni1, M. Mirabella22, L. Moiola12, C.G. Nicoletti1, V. Nociti22, D. Paolicelli23, F. Patti10, P. Perini15, C. Pozzilli13, F. Rinaldi15, F. Sica9, M. Trojano23, A. Uccelli18,19, M. Zaffaroni4, M.P. Sormani3, M.P. Amato24,25, G.A. Marfia1, Multiple Sclerosis Study Group of the Italian Neurological Society

1Multiple Sclerosis Center and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, 2SOC Neurologia, AUSL Toscana Centro, San Giovanni di Dio Hospital, Florence, 3Department of Health Sciences (DISSAL), University of Genoa, Genoa, 4Multiple Sclerosis Center, ASST Valle Olona, Gallarate Hospital, Gallarate (VA), 5Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Naples, 6Multiple Sclerosis Center, Muscatello Augusta Asp 8 Hospital, Siracusa, 7Department of Neurology, F. Tappeiner Hospital, Merano (BZ), 8Department of Neurology, University of Turin, Turin, 9Unit of Neurology and Neurorehabilitation, IRCCS Istituto Neurologico Mediterraneo Neuromed, Pozzilli (IS), 10Department of Neuroscience G.F. Ingrassia, University of Catania, Catania, 11Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, 12Department of Neurology, Scientific Institute University Vita-Salute San Raffaele, Milan, 13Department of Neurology and Psychiatry, La Sapienza University, Rome, 14Department of Neuroscience and Imaging, University G. d'Annunzio of Chieti, Chieti, 15Department of Neurosciences, Multiple Sclerosis Center - Veneto Region (CeSMuV), University Hospital of Padova, Padova, 16Department of Neurosciences, San Camillo-Forlanini Hospital, Rome, 17Unit of Neuroscience, Department of Medicine and Surgery, University of Parma, Parma, 18Department of Neurology, University of Genoa, 19IRCCS Ospedale Policlinico San Martino, Genoa, 20UOSI Riabilitazione Sclerosi Multipla, IRCCS Istituto delle Scienze Neurologiche di Bologna, 21Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, 22Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, 23Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, 24Department of NEUROFARBA, University of Florence, Careggi University Hospital, 25IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy

Background and aims: Today wash-out of Natalizumab (NTZ) in women with multiple sclerosis (MS) planning a pregnancy is discouraged due to high risk of disease reactivation. NTZ suspension early after last menstrual period (LMP), while producing a 3-fold reduction of relapses during pregnancy, does not rule them out. NTZ continuation is a promising strategy to minimize the occurrence of relapses during pregnancy and postpartum, but there is a need of new evidence supporting the efficacy and the safety of this strategy.
Methods: WMS treated with NTZ and undergoing pregnancy followed in 19 Italian MS centers were analyzed. WMS were divided into 3 groups according to time of last infusion of NTZ with respect to LMP (Group 0=before LMP, Group 1=within the 1 trimester of pregnancy, Group 2=continuing treatment after 1 trimester). Annualized relapse rate (ARR) during pregnancy and 12 months postpartum was calculated for all groups. Outcomes of newborns were compared among groups.
Results: 92 completed pregnancies from 84 WMS (mean age 31.35±4.88, median EDSS 2.0) giving birth to 94 newborns (mean gestational age 38.42±3.12 weeks, birthweight 2878.08±579.95 mg, length 48.23±3.39 cm) were evaluated.
The median interval between last dose of NTZ and LMP was -70 (-465-5) days for Group 0 (n=31), +21 (1-94) for Group 1 (n=30), +189 (123-250) for Group 2 (n=31). Group 2 received a median of 5 (3-6) NTZ infusions during pregnancy with a median last prepartum-delivery dose interval of 81 (12-149) days. For women restarting NTZ in the postpartum, median interval between last prepartum-first postpartum dose was 411 (227-1042) days in group 0, 288 (206-525) in group 1, 103 (44-191) in group 2. ARR during pregnancy was 1.06 (95%CI: 0.69-1.54) in Group 0, 0.49 (95%CI:0.25-0.84) in Group 1, 0.09 (95%CI:0.01-0.27) in group 2. ARR postpartum was 0.39 (95%CI:0.21-0.65) in Group 0, 0.23 (95%CI:0.10-0.45), 0.10 (95%CI:0.04-0.30).
Newborns mean gestational age (p=0.523), birthweight (p=0.896) and length (p=0.331) were not different comparing groups. Anaemia was found in 5 Group 2 newborns (3/5 premature); malformations in 1 (minor) Group 0 newborn, 4 (4 minor, 1 major) Group 1, 3 (1 minor, 4 major) Group 2.
Conclusions: NTZ continuation during pregnancy and postpartum is associated with lower risk of relapses compared to wash-out and early interruption. No worrisome adverse events emerged in newborns. Occurrence of anaemia is consistent with previous findings and may be biased by prematurity.
Disclosure:

  • Amato MP served on scientific advisory boards for and has received speaker honoraria and research support from Biogen Idec, Merck Serono, Bayer Schering Pharma, and Sanofi-aventis and serves on the editorial board of BMC Neurology.
  • Annovazzi P served on Advisory Board for Biogen, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen, Teva, Novartis, Genzyme. He is involved as principal investigator in clinical trials for Genzyme.
  • Bovis F: nothing to disclose.
  • Brescia Morra V received personal compensation from Merck Serono, Novartis, Almirall, Genzyme, Bayer and TEVA for public speaking, editorial work and advisory boards.
  • Bucello S: nothing to disclose.
  • Caleri F: nothing to disclose.
  • Cavalla P: nothing to disclose.
  • Centonze D is an Advisory Board member of Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva and received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva. He is also the principal investigator in clinical trials for Bayer Schering, Biogen, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-Genzyme, Teva. His preclinical and clinical research was supported by grants from Bayer Schering, Biogen Idec, Celgene, Merck Serono, Novartis, Roche, Sanofi- Genzyme e Teva.
  • Chisari C: nothing to disclose.
  • Cocco E served on scientific advisory boards and received honoraria for speaking from Almirall Bayer, Biogen, Merck Serono, Novartis, Sanofi-Genzyme and Teva.
  • Comi G served as an advisor or consultant or speaking activities for Bayer HealthCare Pharmaceuticals, Merck Serono, Novartis Pharmaceuticals Corporation, Sanofi-Aventis, Schering-Plough Corporation, and Teva Pharmaceutical Industries Ltd.
  • De Giglio L received travel grants from Biogen, Novartis, and Teva.
  • Di Tommaso V: nothing to disclose.
  • Gallo P has been a consultant for Bayer Schering, Biogen Idec, Genzyme, Merck Serono and Novartis, received funding for travel and speaker honoraria from Merck-Serono, Biogen Idec, Sanofi-Aventis, Novartis Pharma and Bayer-Schering Pharma, Teva, received research support from Bayer, Biogen Idec/Elan, Merk Serono, Genzyme and Teva, and received research grant from the University of Padova, Veneto Region of Italy, the Italian Association for Multiple Sclerosis, the Italian Ministry of Public Health.
  • Gasperini C received compensation for consulting services and/or speaking activities from Teva, Merck, Genzyme, Biogen, Bayer, and Roche.
  • Ghezzi A received honoraria for speaking from Biogen-Idec, Merck-Serono, Novartis, Genzyme, Teva, and Allergan, and for consultancy from Merck-Serono, Teva, Novartis, and Biogen-Idec, and received support for participation in National and International Congresses from Schering, Biogen-Idec, Merck-Serono, Novartis, Genzyme, and Teva.
  • Granella F: nothing to disclose.
  • Grimaldi A: nothing to disclose.
  • Landi D received travel funding from Biogen, Merck Serono, Sanofi-Genzyme and Teva, honoraria for speaking from Sanofi-Genzyme and Teva, and consultation fees from Merck Serono and Teva. She is subinvestigator in clinical trials being conducted for Biogen, Merck Serono, Novartis, Roche and Teva.
  • Lanzillo received R personal compensation from Merck Serono, Novartis, Almirall, Genzyme,Bayer and TEVA for public speaking, editorial work and advisory boards.
  • Laroni A has received personal compensation from Novartis, Sanofi Genzyme, Biogen, Merck, Roche, and TEVA for public speaking and advisory boards.
  • Lugaresi A has served as a Bayer, Biogen, Merck, Novartis, Roche, Sanofi/ Genzyme and Teva Advisory Board Member. She received congress and travel/accommodation expense compensations and speaker honoraria from Bayer, Biogen, Merck, Novartis, Sanofi/Genzyme, Teva and Fondazione Italiana Sclerosi Multipla (FISM). Her institutions received research grants from Bayer, Biogen, Merck, Novartis, Sanofi/Genzyme, Teva and Fondazione Italiana Sclerosi Multipla (FISM).
  • Marfia GA is an Advisory Board member of Biogen Idec, Genzyme, Merck-Serono, Novartis, Teva and received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme, Teva. She is the principal investigator in clinical trials for Actelion, Biogen Idec, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-Genzyme, Teva.
  • Marrosu MG received speaker honoraria and honoraria for serving on advisory board activities from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Genzyme, Sanofi Aventis and Teva, and research grants from Merck Serono and Novartis.
  • Martinelli V served on scientific advisory board for Merck Serono and Genzyme and received honoraria for speaking, consultancy, or support for participation in National and International Congresses from Bayer Schering, Biogen-Dompè, Merck Serono, Novartis, Genzyme, and Teva Pharmaceutical.
  • Mataluni G received travel funding from Almirall, Biogen, Novartis and Sanofi-Genzyme; honoraria for speaking from Biogen. She is subinvestigator in clinical trials being conducted for Biogen, Merck Serono, Novartis, Roche and Teva.
  • Mirabella M: nothing to disclose.
  • Moiola L received honoraria for speaking or for advisory board from Sanofi-Genzyme, Biogen, Novartis and Teva.
  • Nicoletti CG received funding for traveling from Almirall, Biogen, Merck and Sanofi-Genzyme and is an Advisory Board member of Biogen Idec, Merck-Serono, Novartis, Almirall; she is subinvestigator in clinical trials being conducted for Biogen, Merck Serono, Novartis, Roche and Teva.
  • Nociti V: nothing to disclose.
  • Paolicelli D received honoraria for consultancy and/or speaking from Biogen Idec, Merck-Serono, Bayer-Schering, Sanofi-Genzyme, TEVA, Novartis, and Roche.
  • Patti F received honoraria for advisory board and speaking activities from Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi Genzyme and TEVA; he also received research grants from FISM and MIUR.
  • Perini P: nothing to disclose.
  • Portaccio E served on scientific advisory board for Biogen Idec and Merck Serono, received honoraria for speaking and funding for traveling from Biogen, Genzyme, Novartis, Merck, and Teva, and received research support from Merck Serono.
  • Pozzilli C received consulting and/or lecture fees and/or research funding and travel Grant from Almirall, Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
  • Rinaldi F served on advisory board for Biogen-Idec and received funding for travel and speaker honoraria from Merck Serono, Biogen Idec, Sanofi-Aventis, Teva and Bayer Schering Pharma.
  • Sica F: nothing to disclose.
  • Sormani MP: nothing to disclose.
  • Trojano M received honoraria for consultancy and/or speaking from Biogen Idec, Sanofi-Aventis, Merck-Serono, Novartis, Genzyme, TEVA and Bayer-Schering and research grants from Merck-Serono, Biogen Idec and Novartis.
  • Uccelli A received consultancy fees and support for travel expenses and participation to Congresses from Sanofi-Aventis, Biogen, Merck-Serono, Novartis, and Roche.
  • Zaffaroni M received honoraria for speaking or for serving in advisory boards and received funding for traveling from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Teva. He is involved as principal investigator in clinical trials promoted by Biogen, Genzyme, Novartis, Roche, Chugai.

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