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      Eculizumab during Pregnancy in a Patient with Treatment-Refractory Myasthenia Gravis: A Case Report

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          Abstract

          The recombinant humanized monoclonal antibody eculizumab has been shown to be effective and well tolerated in patients with anti-acetylcholine receptor antibody-positive, treatment-refractory generalized myasthenia gravis (gMG). Myasthenia gravis (MG) often affects women of child-bearing potential. However, management can be challenging during pregnancy, and current treatment options are limited due to potential teratogenicity. Data are currently lacking on the use of eculizumab in pregnant women with gMG. This case report describes a successful pregnancy in a young woman with treatment-refractory gMG treated with eculizumab before, during, and after pregnancy. Eculizumab appeared to have a favorable benefit-risk profile in this setting, with no treatment-related adverse effects noted in either the patient or the neonate. The patient remains neurologically stable on eculizumab, which she has now been receiving for 5 years. This first report of the use of eculizumab during pregnancy in a patient with treatment-refractory gMG suggests a potential role for eculizumab in this setting, although further clinical experience is necessary to support its use during pregnancy in women with MG.

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          Most cited references16

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          International consensus guidance for management of myasthenia gravis

          Objective: To develop formal consensus-based guidance for the management of myasthenia gravis (MG). Methods: In October 2013, the Myasthenia Gravis Foundation of America appointed a Task Force to develop treatment guidance for MG, and a panel of 15 international experts was convened. The RAND/UCLA appropriateness methodology was used to develop consensus guidance statements. Definitions were developed for goals of treatment, minimal manifestations, remission, ocular MG, impending crisis, crisis, and refractory MG. An in-person panel meeting then determined 7 treatment topics to be addressed. Initial guidance statements were developed from literature summaries. Three rounds of anonymous e-mail votes were used to attain consensus on guidance statements modified on the basis of panel input. Results: Guidance statements were developed for symptomatic and immunosuppressive treatments, IV immunoglobulin and plasma exchange, management of impending and manifest myasthenic crisis, thymectomy, juvenile MG, MG associated with antibodies to muscle-specific tyrosine kinase, and MG in pregnancy. Conclusion: This is an international formal consensus of MG experts intended to be a guide for clinicians caring for patients with MG worldwide.
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            Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

            Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial.
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              Eculizumab in Pregnant Patients with Paroxysmal Nocturnal Hemoglobinuria

              Eculizumab, a humanized monoclonal antibody against complement protein C5 that inhibits terminal complement activation, has been shown to prevent complications of paroxysmal nocturnal hemoglobinuria (PNH) and improve quality of life and overall survival, but data on the use of eculizumab in women during pregnancy are scarce.
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                Author and article information

                Journal
                Case Rep Neurol
                Case Rep Neurol
                CRN
                Case Reports in Neurology
                S. Karger AG (Allschwilerstrasse 10, P.O. Box · Postfach · Case postale, CH–4009, Basel, Switzerland · Schweiz · Suisse, Phone: +41 61 306 11 11, Fax: +41 61 306 12 34, karger@karger.com )
                1662-680X
                Jan-Apr 2021
                1 February 2021
                1 February 2021
                : 13
                : 1
                : 65-72
                Affiliations
                Department of Neurology, University of South Florida, Tampa, Florida, USA
                Author notes
                *Tuan Vu, Department of Neurology, University of South Florida, 13220 USF Laurel Dr., Tampa, FL 33612 (USA), tvu6@ 123456usf.edu
                Article
                crn-0013-0065
                10.1159/000511957
                7923701
                f2a6b9df-e1ca-4df1-9070-755cb629a6d3
                Copyright © 2021 by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial-4.0 International License (CC BY-NC) (http://www.karger.com/Services/OpenAccessLicense). Usage and distribution for commercial purposes requires written permission.

                History
                : 10 August 2020
                : 22 September 2020
                : 2021
                Page count
                Tables: 1, References: 15, Pages: 8
                Categories
                Single Case − General Neurology

                Neurology
                generalized myasthenia gravis,pregnancy,eculizumab
                Neurology
                generalized myasthenia gravis, pregnancy, eculizumab

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