Literature DB >> 33879599

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

Wei Zhen Yeh1,2, Putu Ayu Widyastuti1, Anneke Van der Walt1,2, Jim Stankovich1, Eva Havrdova3, Dana Horakova3, Karolina Vodehnalova3, Serkan Ozakbas4, Sara Eichau5, Pierre Duquette6, Tomas Kalincik7,8, Francesco Patti9,10, Cavit Boz11, Murat Terzi12, Bassem I Yamout13, Jeannette Lechner-Scott14, Patrizia Sola15, Olga G Skibina2, Michael Barnett16, Marco Onofrj17, Maria José Sá18, Pamela Ann McCombe19, Pierre Grammond20, Radek Ampapa21, Francois Grand'Maison22, Roberto Bergamaschi23, Daniele L A Spitaleri24, Vincent Van Pesch25, Elisabetta Cartechini26, Suzanne Hodgkinson27, Aysun Soysal28, Albert Saiz29,30, Melissa Gresle1,2, Tomas Uher3, Davide Maimone31, Recai Turkoglu32, Raymond Mm Hupperts33, Maria Pia Amato34,35, Franco Granella36, Celia Oreja-Guevara37,38, Ayse Altintas39, Richard A Macdonell40, Tamara Castillo-Trivino41, Helmut Butzkueven1,2,42, Raed Alroughani43, Vilija G Jokubaitis44,2.   

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 31 Dec 2010 from 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 1998 pregnancies from 1619 women with MS. Preconception annualized relapse rate (ARR) was 0.29 (95% CI 0.27-0.32), fell to 0.19 (0.14-0.24) in 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 (OR 0.76 per month [0.60-0.95], p=0.017). DMT re-initiation with natalizumab protected against postpartum relapse (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). 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 re-initiation after delivery is an effective option to minimize relapse risks. Strategies of DMT use have to be balanced against potential fetal/neonatal complications.
© 2021 American Academy of Neurology.

Entities:  

Year:  2021        PMID: 33879599      PMCID: PMC8253565          DOI: 10.1212/WNL.0000000000012084

Source DB:  PubMed          Journal:  Neurology        ISSN: 0028-3878            Impact factor:   9.910


  37 in total

1.  The apparently milder course of multiple sclerosis: changes in the diagnostic criteria, therapy and natural history.

Authors:  Per Soelberg Sorensen; Finn Sellebjerg; Hans-Peter Hartung; Xavier Montalban; Giancarlo Comi; Mar Tintoré
Journal:  Brain       Date:  2020-09-01       Impact factor: 13.501

2.  Relapse occurrence in women with multiple sclerosis during pregnancy in the new treatment era.

Authors:  Raed Alroughani; Maryam S Alowayesh; Samar F Ahmed; Raed Behbehani; Jasem Al-Hashel
Journal:  Neurology       Date:  2018-02-02       Impact factor: 9.910

Review 3.  Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.

Authors:  Alan J Thompson; Brenda L Banwell; Frederik Barkhof; William M Carroll; Timothy Coetzee; Giancarlo Comi; Jorge Correale; Franz Fazekas; Massimo Filippi; Mark S Freedman; Kazuo Fujihara; Steven L Galetta; Hans Peter Hartung; Ludwig Kappos; Fred D Lublin; Ruth Ann Marrie; Aaron E Miller; David H Miller; Xavier Montalban; Ellen M Mowry; Per Soelberg Sorensen; Mar Tintoré; Anthony L Traboulsee; Maria Trojano; Bernard M J Uitdehaag; Sandra Vukusic; Emmanuelle Waubant; Brian G Weinshenker; Stephen C Reingold; Jeffrey A Cohen
Journal:  Lancet Neurol       Date:  2017-12-21       Impact factor: 44.182

4.  Defining reliable disability outcomes in multiple sclerosis.

Authors:  Tomas Kalincik; Gary Cutter; Tim Spelman; Vilija Jokubaitis; Eva Havrdova; Dana Horakova; Maria Trojano; Guillermo Izquierdo; Marc Girard; Pierre Duquette; Alexandre Prat; Alessandra Lugaresi; Francois Grand'Maison; Pierre Grammond; Raymond Hupperts; Celia Oreja-Guevara; Cavit Boz; Eugenio Pucci; Roberto Bergamaschi; Jeannette Lechner-Scott; Raed Alroughani; Vincent Van Pesch; Gerardo Iuliano; Ricardo Fernandez-Bolaños; Cristina Ramo; Murat Terzi; Mark Slee; Daniele Spitaleri; Freek Verheul; Edgardo Cristiano; José Luis Sánchez-Menoyo; Marcela Fiol; Orla Gray; Jose Antonio Cabrera-Gomez; Michael Barnett; Helmut Butzkueven
Journal:  Brain       Date:  2015-09-10       Impact factor: 13.501

5.  Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis.

Authors:  Goeril Karlsson; Gordon Francis; Gideon Koren; Peter Heining; Xiaoli Zhang; Jeffrey A Cohen; Ludwig Kappos; William Collins
Journal:  Neurology       Date:  2014-01-24       Impact factor: 9.910

6.  Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study.

Authors:  Susan Friend; Sandra Richman; Gary Bloomgren; Lynda M Cristiano; Madé Wenten
Journal:  BMC Neurol       Date:  2016-08-24       Impact factor: 2.474

7.  Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice.

Authors:  Devangi Mehta; Catherine Miller; Douglas L Arnold; Eris Bame; Amit Bar-Or; Ralf Gold; Jerome Hanna; Ludwig Kappos; Shifang Liu; André Matta; J Theodore Phillips; Derrick Robertson; Christian A von Hehn; Jordana Campbell; Karen Spach; Lili Yang; Robert J Fox
Journal:  Neurology       Date:  2019-03-27       Impact factor: 11.800

8.  Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder.

Authors:  Andrea Ines Ciplea; Annette Langer-Gould; Annick de Vries; Tiny Schaap; Sandra Thiel; Marius Ringelstein; Ralf Gold; Kerstin Hellwig
Journal:  Neurol Neuroimmunol Neuroinflamm       Date:  2020-04-23

9.  Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: A cohort study from Germany.

Authors:  Tania Kümpfel; Sandra Thiel; Ingrid Meinl; Andrea I Ciplea; Antonios Bayas; Frank Hoffmann; Ulrich Hofstadt-van Oy; Muna Hoshi; Jakob Kluge; Marius Ringelstein; Orhan Aktas; Muriel Stoppe; Annette Walter; Martin S Weber; Ilya Ayzenberg; Kerstin Hellwig
Journal:  Neurol Neuroimmunol Neuroinflamm       Date:  2020-12-17

10.  Delayed-Release Dimethyl Fumarate and Pregnancy: Preclinical Studies and Pregnancy Outcomes from Clinical Trials and Postmarketing Experience.

Authors:  Ralf Gold; J Theodore Phillips; Eva Havrdova; Amit Bar-Or; Ludwig Kappos; Norman Kim; Tim Thullen; Patricia Valencia; Lauren Oliva; Mark Novas; Jie Li; Marianne T Sweetser; Nuwan Kurukulasuriya; Vissia Viglietta; Robert J Fox
Journal:  Neurol Ther       Date:  2015-10-12
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  4 in total

Review 1.  Updated Perspectives on the Challenges of Managing Multiple Sclerosis During Pregnancy.

Authors:  Ramón Villaverde-González
Journal:  Degener Neurol Neuromuscul Dis       Date:  2022-01-05

2.  Multiple Sclerosis Disease Activity and Disability Following Discontinuation of Natalizumab for Pregnancy.

Authors:  Kerstin Hellwig; Marianne Tokic; Sandra Thiel; Nina Esters; Charlotte Spicher; Nina Timmesfeld; Andrea I Ciplea; Ralf Gold; Annette Langer-Gould
Journal:  JAMA Netw Open       Date:  2022-01-04

3.  Drug and Neurofilament Levels in Serum and Breastmilk of Women With Multiple Sclerosis Exposed to Natalizumab During Pregnancy and Lactation.

Authors:  Undine Proschmann; Rocco Haase; Hernan Inojosa; Katja Akgün; Tjalf Ziemssen
Journal:  Front Immunol       Date:  2021-08-26       Impact factor: 7.561

4.  Estimating Risk of Multiple Sclerosis Disease Reactivation in Pregnancy and Postpartum: The VIPRiMS Score.

Authors:  Gabriel Bsteh; Harald Hegen; Katharina Riedl; Patrick Altmann; Franziska Di Pauli; Rainer Ehling; Gudrun Zulehner; Paulus Rommer; Fritz Leutmezer; Florian Deisenhammer; Thomas Berger
Journal:  Front Neurol       Date:  2022-01-17       Impact factor: 4.003

  4 in total

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