Pregnancy outcomes following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis.
Bernd C. Kieseier,Myriam Benamor +1 more
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TLDR
Available data do not indicate any teratogenic signals in patients treated with teriflunomide.Abstract:
Introduction
Teriflunomide, indicated for the treatment of relapsing–remitting multiple sclerosis, is contraindicated in pregnancy based on signs of developmental toxicity in the offspring of rats and rabbits; developmental toxicity has also been observed in preclinical studies of other disease-modifying therapies. Despite the requirement to use reliable contraception in clinical trials evaluating the safety and efficacy of teriflunomide, a number of pregnancies have been reported. This work reports pregnancy outcomes in teriflunomide clinical trials.read more
Citations
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Journal ArticleDOI
ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis:
Xavier Montalban,Ralf Gold,Alan J. Thompson,Susana Otero-Romero,Maria Pia Amato,Dhia Chandraratna,Michel Clanet,Giancarlo Comi,Tobias Derfuss,Franz Fazekas,Hans-Peter Hartung,Eva Havrdova,Bernhard Hemmer,Ludwig Kappos,Roland S. Liblau,Catherine Lubetzki,Elena Marcus,David Miller,Tomas Olsson,Stephen Pilling,Krzysztof Selmaj,Aksel Siva,Per Soelberg Sørensen,Maria Pia Sormani,Christoph Thalheim,Heinz Wiendl,Frauke Zipp +26 more
TL;DR: An evidence-based clinical practice guideline for the pharmacological treatment of people with MS, which takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication.
Journal ArticleDOI
2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases
Lisa R. Sammaritano,Bonnie L. Bermas,E. Chakravarty,Christina D. Chambers,Megan E.B. Clowse,Michael D. Lockshin,Wendy Marder,Gordon Guyatt,D. Ware Branch,Jill P. Buyon,Lisa Christopher-Stine,Rachelle Crow‐Hercher,John J. Cush,Maurice L. Druzin,Arthur Kavanaugh,Carl A. Laskin,Lauren A. Plante,Jane E. Salmon,Julia F. Simard,Emily C. Somers,Virginia D. Steen,Sara K. Tedeschi,Evelyne Vinet,C. Whitney White,Jinoos Yazdany,Medha Barbhaiya,Brittany Bettendorf,Amanda M Eudy,Arundathi Jayatilleke,Amit Aakash Shah,Nancy Sullivan,Laura Tarter,Mehret Birru Talabi,Marat Turgunbaev,Amy S. Turner,Kristen E. D'Anci +35 more
TL;DR: To develop an evidence‐based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancy assessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD).
Journal ArticleDOI
ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis.
Xavier Montalban,Ralf Gold,Alan J. Thompson,Susana Otero-Romero,Maria Pia Amato,Dhia Chandraratna,Michel Clanet,Giancarlo Comi,Tobias Derfuss,Franz Fazekas,Hans-Peter Hartung,Eva Havrdova,Bernhard Hemmer,Ludwig Kappos,Roland S. Liblau,Catherine Lubetzki,Elena Marcus,David Miller,Tomas Olsson,Stephen Pilling,Krzysztof Selmaj,Aksel Siva,Per Soelberg Sørensen,Maria Pia Sormani,Christoph Thalheim,Heinz Wiendl,Frauke Zipp +26 more
TL;DR: The objective was to develop an evidence‐based clinical practice guideline for the pharmacological treatment of people with MS.
Journal ArticleDOI
Immunological Aspects of Approved MS Therapeutics.
Paulus S. Rommer,Ron Milo,May H. Han,Sammita Satyanarayan,Johann Sellner,Larissa Hauer,Zsolt Illes,Clemens Warnke,Sarah Laurent,Martin S. Weber,Yinan Zhang,Olaf Stüve +11 more
TL;DR: The objective of this review is to present the modes of action of these drugs and their effects on the immunopathogenesis of MS and each agent's clinical development and potential side effects are discussed.
Journal ArticleDOI
2019 American College of Rheumatology Reproductive Health in Rheumatic and Musculoskeletal Diseases Guideline
Lisa R. Sammaritano,Bonnie L. Bermas,E. Chakravarty,Christina D. Chambers,Megan E.B. Clowse,Michael D. Lockshin,Wendy Marder,Gordon H. Guyatt,D. Ware Branch,Jill P. Buyon,Lisa Christopher-Stine,Rachelle Crow‐Hercher,John J. Cush,Maurice L. Druzin,Arthur Kavanaugh,Carl A. Laskin,Lauren A. Plante,Jane E. Salmon,Julia F. Simard,Emily C. Somers,Virginia D. Steen,Sara K. Tedeschi,Evelyne Vinet,C. Whitney White,Jinoos Yazdany,Medha Barbhaiya,Brittany Bettendorf,Amanda M Eudy,Arundathi Jayatilleke,Amit Aakash Shah,Nancy Sullivan,Laura Tarter,Mehret Birru Talabi,Marat Turgunbaev,Amy S. Turner,Kristen E. D'Anci +35 more
TL;DR: This ACR guideline intends that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences and comorbidities.
References
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Journal ArticleDOI
Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis
Paul O'Connor,Jerry S. Wolinsky,Christian Confavreux,Giancarlo Comi,Ludwig Kappos,Tomas Olsson,Hadj Benzerdjeb,Philippe Truffinet,Lin Wang,Aaron E. Miller,Mark S. Freedman +10 more
TL;DR: Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo.
Journal ArticleDOI
Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.
Christian Confavreux,Paul O'Connor,Giancarlo Comi,Mark S. Freedman,Aaron E. Miller,Tomas Olsson,Jerry S. Wolinsky,Teresa Bagulho,Jean Luc Delhay,Deborah Dukovic,Philippe Truffinet,Ludwig Kappos +11 more
TL;DR: Teriflunomide 14 mg was associated with a lower relapse rate and less disability accumulation compared with placebo, with a similar safety and tolerability profile to that reported in previous studies.
Journal ArticleDOI
Risk factors in miscarriage: a review.
TL;DR: In this revision, the only two etiologic factors recognized by all authors are uterine malformations and parental balanced chromosomal rearrangements are discussed.
Journal ArticleDOI
Birth outcomes in women who have taken leflunomide during pregnancy
Christina D. Chambers,Diana Johnson,Luther K. Robinson,Stephen R. Braddock,Ronghui Xu,Janina Lopez-Jimenez,Nicole Mirrasoul,Elizabeth Salas,Yunjun J. Luo,Shelia Jin,Kenneth L. Jones +10 more
TL;DR: The data do not support the notion that there is a substantial increased risk of adverse pregnancy outcomes due to leflunomide exposure among women who undergo cholestyramine elimination procedure early in pregnancy, and can provide some reassurance to women who inadvertently become pregnant while taking leflinomide and undergo the washout procedure.
Journal ArticleDOI
Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis
Goeril Karlsson,Gordon Francis,Gideon Koren,Peter Heining,Xiaoli Zhang,Jeffrey A. Cohen,Ludwig Kappos,William Collins +7 more
TL;DR: Given the known risks of teratogenicity in animals and the present data, women of childbearing potential should use effective contraception during fingolimod therapy and for 2 months after discontinuation.