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June 15, 2021; 96 (24) Article

Natalizumab, Fingolimod, and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis

View ORCID ProfileWei Zhen Yeh, Putu Ayu Widyastuti, View ORCID ProfileAnneke Van der Walt, Jim Stankovich, Eva Havrdova, Dana Horakova, View ORCID ProfileKarolina Vodehnalova, Serkan Ozakbas, Sara Eichau, Pierre Duquette, View ORCID ProfileTomas Kalincik, Francesco Patti, Cavit Boz, Murat Terzi, Bassem I. Yamout, Jeannette Lechner-Scott, View ORCID ProfilePatrizia Sola, Olga G. Skibina, View ORCID ProfileMichael Barnett, Marco Onofrj, Maria José Sá, Pamela Ann McCombe, Pierre Grammond, Radek Ampapa, View ORCID ProfileFrancois Grand'Maison, Roberto Bergamaschi, Daniele L.A. Spitaleri, View ORCID ProfileVincent Van Pesch, Elisabetta Cartechini, Suzanne Hodgkinson, Aysun Soysal, Albert Saiz, Melissa Gresle, View ORCID ProfileTomas Uher, Davide Maimone, View ORCID ProfileRecai Turkoglu, Raymond M.M. Hupperts, Maria Pia Amato, Franco Granella, Celia Oreja-Guevara, Ayse Altintas, Richard A. Macdonell, Tamara Castillo-Trivino, Helmut Butzkueven, Raed Alroughani, View ORCID ProfileVilija G. Jokubaitis, on behalf of the MSBase Study Group
First published April 20, 2021, DOI: https://doi.org/10.1212/WNL.0000000000012084
Wei Zhen Yeh
From the Department of Neuroscience (W.Z.Y., P.A.W., A.V.d.W., J.S., M.G., H.B., V.G.J.), Central Clinical School, Monash University; Department of Neurology (W.Z.Y., A.V.d.W., O.G.S., M.G., H.B., V.G.J.), Alfred Health, Melbourne, Victoria, Australia; Department of Neurology and Center of Clinical Neuroscience (E.H., D.H., K.V., T.U.), First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic; Dokuz Eylul University (S.O.), Izmir, Turkey; Hospital Universitario Virgen Macarena (S.E.), Sevilla, Spain; CHUM–Hopital Notre Dame (P.D.), Montreal, Canada; CORe (T.K.), Department of Medicine, University of Melbourne; Melbourne MS Centre (T.K.), Royal Melbourne Hospital, Australia; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia (F.P.), and AOU Policlinico-San Marco (F.P.), University of Catania, Sicily; KTU Medical Faculty Farabi Hospital (C.B.), Trabzon, Turkey; Medical Faculty (M.T.), Mayis University, Samsun, Turkey; Faculty of Medicine (B.I.Y.), Nehme and Therese Multiple Sclerosis Center, American University of Beirut, Lebanon; John Hunter Hospital (J.L.-S.), Newcastle, Australia; Neurology Unit (P.S.), Azienda Ospedaliero-Universitaria of Modena, Italy; Brain and Mind Centre (M.B.), University of Sydney, Camperdown, Australia; Univ G.d’Annunzio Chieti-Pescara (M.O.), Chieti, Italy; Department of Neurology (M.J.S.), São João Universitary Hospital Center, Porto, Portugal; St. Andrews Place (P.A.M.), Spring Hill, Australia; Royal Brisbane and Women's Hospital (P.A.M.), Herston, Australia; Centre de réadaptation déficience physique Chaudière-Appalache (P.G.), Levis, Canada; Nemocnice Jihlava (R.A.), Czech Republic; Neuro Rive-Sud (F. Grand’Maison), Greenfield Park, Canada; IRCCS Mondino Foundation (R.B.), Pavia; AORN San Giuseppe Moscati Avellino (D.L.A.S.), Italy; Cliniques Universitaires Saint-Luc (V.V.P.), Université Catholique de Louvain, Belgium; Ospedale Generale Provinciale Macerata (E.C.), Italy; Liverpool Hospital (S.H.), Australia; Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases (A. Soysal), Istanbul, Turkey; Service of Neurology (A. Saiz), Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS); Institut de Neurociències (A. Saiz), Universitat de Barcelona, Spain; Centro Sclerosi Multipla (D.M.), UOC Neurologia, ARNAS Garibaldi, Catania, Italy; Haydarpasa Numune Training and Research Hospital (R.T.), Istanbul, Turkey; Maaslandziekenhuis (R.M.M.H.), Sittard, the Netherlands; Department NEUROFARBA (M.P.A.), University of Florence; IRCCS Fondazione Don Carlo Gnocchi (M.P.A.), Florence; University of Parma (F. Granella), Italy; Department of Neurology (C.O.-G.), Hospital Clínico San Carlos; Departamento de Medicina (C.O.-G.), Facultad de Medicina, Universidad Complutense de Madrid (UCM); IdISSC (C.O.-G.), Madrid, Spain; Department of Neurology (A.A.), Koc University School of Medicine, Istanbul, Turkey; Department of Neurology (R.A.M.), Austin Health, Heidelberg, Australia; Department of Neurology (T.C.-T.), Hospital Universitario Donostia, San Sebastian, Spain; Box Hill Hospital (H.B.), Australia; and Amiri Hospital (R.A.), Kuwait City, Kuwait.
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Putu Ayu Widyastuti
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Anneke Van der Walt
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Jim Stankovich
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Eva Havrdova
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Serkan Ozakbas
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Sara Eichau
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Pierre Duquette
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Tomas Kalincik
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Francesco Patti
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Cavit Boz
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Murat Terzi
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Bassem I. Yamout
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Olga G. Skibina
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Michael Barnett
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Marco Onofrj
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Maria José Sá
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Francois Grand'Maison
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Roberto Bergamaschi
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Daniele L.A. Spitaleri
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Vincent Van Pesch
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Raymond M.M. Hupperts
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Franco Granella
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Vilija G. Jokubaitis
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Natalizumab, Fingolimod, and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis
Wei Zhen Yeh, Putu Ayu Widyastuti, Anneke Van der Walt, Jim Stankovich, Eva Havrdova, Dana Horakova, Karolina Vodehnalova, Serkan Ozakbas, Sara Eichau, Pierre Duquette, Tomas Kalincik, Francesco Patti, Cavit Boz, Murat Terzi, Bassem I. Yamout, Jeannette Lechner-Scott, Patrizia Sola, Olga G. Skibina, Michael Barnett, Marco Onofrj, Maria José Sá, Pamela Ann McCombe, Pierre Grammond, Radek Ampapa, Francois Grand'Maison, Roberto Bergamaschi, Daniele L.A. Spitaleri, Vincent Van Pesch, Elisabetta Cartechini, Suzanne Hodgkinson, Aysun Soysal, Albert Saiz, Melissa Gresle, Tomas Uher, Davide Maimone, Recai Turkoglu, Raymond M.M. Hupperts, Maria Pia Amato, Franco Granella, Celia Oreja-Guevara, Ayse Altintas, Richard A. Macdonell, Tamara Castillo-Trivino, Helmut Butzkueven, Raed Alroughani, Vilija G. Jokubaitis, on behalf of the MSBase Study Group
Neurology Jun 2021, 96 (24) e2989-e3002; DOI: 10.1212/WNL.0000000000012084

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Abstract

Objective To investigate pregnancy-related disease activity in a contemporary multiple sclerosis (MS) cohort.

Methods Using data from the MSBase Registry, we included pregnancies conceived after December 31, 2010, in women with relapsing-remitting MS or clinically isolated syndrome. Predictors of intrapartum relapse and postpartum relapse and disability progression were determined by clustered logistic regression or Cox regression analyses.

Results We included 1,998 pregnancies from 1,619 women with MS. Preconception annualized relapse rate (ARR) was 0.29 (95% confidence interval 0.27–0.32), fell to 0.19 (0.14–0.24) in the third trimester, and increased to 0.59 (0.51–0.67) in early postpartum. Among women who used fingolimod or natalizumab, ARR before pregnancy was 0.37 (0.28–0.49) and 0.29 (0.22–0.37), respectively, and increased during pregnancy. Intrapartum ARR decreased with preconception dimethyl fumarate use. ARR spiked after delivery across all DMT groups. Natalizumab continuation into pregnancy reduced the odds of relapse during pregnancy (odds ratio 0.76 per month [0.60–0.95], p = 0.017). DMT reinitiation with natalizumab protected against postpartum relapse (hazard ratio [HR] 0.11 [0.04–0.32], p < 0.0001). Breastfeeding women were less likely to relapse (HR 0.61 [0.41–0.91], p = 0.016). We found that 5.6% of pregnancies were followed by confirmed disability progression, predicted by higher relapse activity in pregnancy and postpartum.

Conclusion Intrapartum and postpartum relapse probabilities increased among women with MS after natalizumab or fingolimod cessation. In women considered to be at high relapse risk, use of natalizumab before pregnancy and continued up to 34 weeks gestation with early reinitiation after delivery is an effective option to minimize relapse risks. Strategies of disease-modifying therapy use have to be balanced against potential fetal/neonatal complications.

Glossary

ARR=
annualized relapse rate;
CI=
confidence interval;
CIS=
clinically isolated syndrome;
DMT=
disease-modifying therapy;
EDSS=
Expanded Disability Status Scale;
HR=
hazard ratio;
IQR=
interquartile range;
MS=
multiple sclerosis;
OR=
odds ratio;
RRMS=
relapsing-remitting MS

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • MSBase Study Group coinvestigators are listed at links.lww.com/WNL/B381.

  • Received October 28, 2020.
  • Accepted in final form March 17, 2021.
  • © 2021 American Academy of Neurology
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