. 2024 Nov;11(6):e200328.

doi: 10.1212/NXI.0000000000200328. Epub 2024 Oct 23.

Disease Activity in Pregnant and Postpartum Women With Multiple Sclerosis Receiving Ocrelizumab or Other Disease-Modifying Therapies

Wei Z Yeh¹, Anneke Van Der Walt¹, Olga G Skibina¹, Tomas Kalincik¹, Raed Alroughani¹, Allan G Kermode¹, Marzena J Fabis-Pedrini¹, William M Carroll¹, Jeannette Lechner-Scott¹, Cavit Boz¹, Serkan Ozakbas¹, Katherine Buzzard¹, Mario Habek¹, Nevin A John¹, Alexandre Prat¹, Marc Girard¹, Pierre Duquette¹, Seyed Mohammad Baghbanian¹, Suzanne Hodgkinson¹, Vincent Van Pesch¹, Guy Laureys¹, Barbara Willekens¹, Julie Prevost¹, Matteo Foschi¹, Koen De Gans¹, Dana Horakova¹, Eva Kubala Havrdova¹, Rana Karabudak¹, Francesco Patti¹, Pamela A Mccombe¹, Davide Maimone¹, Ayse Altintas¹, Radek Ampapa¹, Daniele Spitaleri¹, Oliver H H Gerlach¹, Maria Jose Sa¹, Stella Hughes¹, Riadh Gouider¹, Saloua Mrabet¹, Richard A Macdonell¹, Recai Turkoglu¹, Elisabetta Cartechini¹, Abdullah Al-Asmi¹, Aysun Soysal¹, Jiwon Oh¹, Erwan Muros-Le Rouzic¹, Sabrina Guye¹, Noemi Pasquarelli¹, Helmut Butzkueven¹, Vilija G Jokubaitis¹; MSBase Study Group¹

Collaborators, Affiliations

Collaborators

MSBase Study Group:
Michael Barnett, Mark Slee, Liesbeth Van Hijfte, Bassem Yamount, Murat Terzi, Yoland Blanco, Pierre Grammond, Guillermo Izquierdo, Sarah Besora, Bruce Taylor, Tamara Castillo-Triviño, Jose Luis Sanchez-Menoyo, Alessandra Lugaresi, Maria Pia Amato, Todd Hardy, Yara Fragoso, Gerardo Iuliano, Orla Gray, Maria Laura Saladino, Francois Grand'Maison, Angel Perez Sempere, Cameron Shaw, Bart Van Wijmeersch, Tunde Csepany, Jabir Alkhaboori, Justin Garber, Jose Andres Dominguez, Imre Piroska, Chris McGuigan, Marija Cauchi, Eli Skromne, Irene Treviño-Frenk, Deborah Mason, Carmen-Adella Sirbu, Masoud Etemadifar, Chiyoko Nohara, Melissa Cambron, Maria Cecilia Aragon de Vecino, Nevin Shalaby, Deborah Field, Eduardo Aguera-Morales, Dheeraj Khurana, Riki Matsumoto, Fumitaka Shimizu, L G F Sinnige, Simón Cárdenas-Robledo

Affiliation

¹ From the Department of Neuroscience (W.Z.Y., A.V.D.W., H.B., V.G.J.), School of Translational Medicine, Monash University; Department of Neurology (W.Z.Y., A.V.D.W., O.G.S., H.B., V.G.J.), Alfred Health, Melbourne; Department of Neurology (O.G.S., K.B.), Box Hill Hospital; Department of Neurosciences (O.G.S., K.B.), Eastern Health Clinical School, Monash University, Box Hill; Neuroimmunology Centre (T.K.), Department of Neurology, Royal Melbourne Hospital; CORe (T.K.), Department of Medicine, University of Melbourne, Australia; Amiri Hospital (R.A.), Sharq, Kuwait; Perron Institute for Neurological and Translational Science (A.G.K., M.J.F.-P., W.M.C.), University of Western Australia, Nedlands; Centre for Molecular Medicine and Innovative Therapeutics (A.G.K., M.J.F.-P.), Murdoch University, Perth; Sir Charles Gairdner Hospital (A.G.K., W.M.C.), QEIIMC, Nedlands; University of Newcastle (J.L.-S.), Newcastle; Hunter New England Health (J.L.-S.), John Hunter Hospital, New South Wales, Australia; Karadeniz Technical University (C.B.), Medical Faculty, Trabzon; Izmir University of Economics (S.O.), Medical Point Hospital, Izmir, Turkey; University Hospital Center Zagreb (M.H.); University of Zagreb (M.H.), School of Medicine, Croatia; Monash Health (N.A.J.); Department of Medicine (N.A.J.), School of Clinical Sciences, Monash University, Melbourne, Australia; CHUM and Universite de Montreal (A.P., M.G., P.D.), Canada; Neurology Department (S.M.B.), Faculty of Medicine, Mazandaran University of Medical Sciences, Iran; University of New South Wales (Suzanne Hodgkinson), Sydney, Australia; Cliniques Universitaires Saint-Luc (V.V.P.), Brussels; Université Catholique de Louvain (V.V.P.); Universitary Hospital Ghent (G.L.); Department of Neurology (B.W.), Antwerp University Hospital, Edegem; Translational Neurosciences Research Group (B.W.), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium; CSSS Saint-Jérôme (J.P.), Saint-Jerome, Canada; Department of Neuroscience (M.F.), Neurology Unit-MS Center, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy; Department of Biotechnological and Applied Clinical Sciences (M.F.), University of L'Aquila, Italy; Groene Hart Ziekenhuis (K.D.G.), Gouda, Netherlands; Charles University in Prague and General University Hospital (D.H., E.K.H.), Prague, Czech Republic; Yeditepe University Kosuyolu Hospital (R.K.), Neurological Sciences, Istanbul, Turkey; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Catania; UOS Sclerosi Multipla (F.P.), AOU Policlinico "G Rodloico-San Marco", University of Catania, Italy; University of Queensland (P.A.M.), Brisbane; Royal Brisbane and Women's Hospital (P.A.M.), Australia; Centro Sclerosi Multipla (D.M.), UOC Neurologia, Azienda Ospedaliera per l'Emergenza Cannizzaro, Catania, Italy; Koc University (A.A.), Istanbul, Turkey; Nemocnice Jihlava (Radek Ampapa), Jihlava, Czech Republic; Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino (D.S.), Avellino, Italy; Zuyderland Medical Center (O.H.H.G.), Sittard-Geleen; School for Mental Health and Neuroscience (O.H.H.G.), Maastricht University, The Netherlands; Centro Hospitalar Universitario de Sao Joao (M.J.S.); Faculty of Health Sciences (M.J.S.), University Fernando Pessoa, Porto, Portugal; Royal Victoria Hospital (Stella Hughes), Belfast, United Kingdom; Department of Neurology (R.G., S.M.), Research laboratory LR18SP03, Clinical investigation Center Neurosciences and Mental Health, Razi Hospital; Faculty of Medicine of Tunis (R.G., S.M.), University of Tunis El Manar, Tunis, Tunisia; Austin Health (R.A.M.), Melbourne, Australia; Haydarpasa Numune Training and Research Hospital (R.T.), Istanbul, Turkey; Azienda Sanitaria Unica Regionale Marche - AV3 (E.C.), Macerata, Italy; Sultan Qaboos University (A.A.-A.), Al-Khodh, Oman; Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases (A.S.), Istanbul, Turkey; St. Michael's Hospital (J.O.), Toronto, Canada; and F. Hoffmann-La Roche Ltd (E.M.-L.R., S.G., N.P.), Basel, Switzerland.

PMID: 39442037
PMCID: PMC11502106
DOI: 10.1212/NXI.0000000000200328

Disease Activity in Pregnant and Postpartum Women With Multiple Sclerosis Receiving Ocrelizumab or Other Disease-Modifying Therapies

Wei Z Yeh et al. Neurol Neuroimmunol Neuroinflamm. 2024 Nov.

. 2024 Nov;11(6):e200328.

doi: 10.1212/NXI.0000000000200328. Epub 2024 Oct 23.

Authors

Collaborators

MSBase Study Group:
Michael Barnett, Mark Slee, Liesbeth Van Hijfte, Bassem Yamount, Murat Terzi, Yoland Blanco, Pierre Grammond, Guillermo Izquierdo, Sarah Besora, Bruce Taylor, Tamara Castillo-Triviño, Jose Luis Sanchez-Menoyo, Alessandra Lugaresi, Maria Pia Amato, Todd Hardy, Yara Fragoso, Gerardo Iuliano, Orla Gray, Maria Laura Saladino, Francois Grand'Maison, Angel Perez Sempere, Cameron Shaw, Bart Van Wijmeersch, Tunde Csepany, Jabir Alkhaboori, Justin Garber, Jose Andres Dominguez, Imre Piroska, Chris McGuigan, Marija Cauchi, Eli Skromne, Irene Treviño-Frenk, Deborah Mason, Carmen-Adella Sirbu, Masoud Etemadifar, Chiyoko Nohara, Melissa Cambron, Maria Cecilia Aragon de Vecino, Nevin Shalaby, Deborah Field, Eduardo Aguera-Morales, Dheeraj Khurana, Riki Matsumoto, Fumitaka Shimizu, L G F Sinnige, Simón Cárdenas-Robledo

Affiliation

¹ From the Department of Neuroscience (W.Z.Y., A.V.D.W., H.B., V.G.J.), School of Translational Medicine, Monash University; Department of Neurology (W.Z.Y., A.V.D.W., O.G.S., H.B., V.G.J.), Alfred Health, Melbourne; Department of Neurology (O.G.S., K.B.), Box Hill Hospital; Department of Neurosciences (O.G.S., K.B.), Eastern Health Clinical School, Monash University, Box Hill; Neuroimmunology Centre (T.K.), Department of Neurology, Royal Melbourne Hospital; CORe (T.K.), Department of Medicine, University of Melbourne, Australia; Amiri Hospital (R.A.), Sharq, Kuwait; Perron Institute for Neurological and Translational Science (A.G.K., M.J.F.-P., W.M.C.), University of Western Australia, Nedlands; Centre for Molecular Medicine and Innovative Therapeutics (A.G.K., M.J.F.-P.), Murdoch University, Perth; Sir Charles Gairdner Hospital (A.G.K., W.M.C.), QEIIMC, Nedlands; University of Newcastle (J.L.-S.), Newcastle; Hunter New England Health (J.L.-S.), John Hunter Hospital, New South Wales, Australia; Karadeniz Technical University (C.B.), Medical Faculty, Trabzon; Izmir University of Economics (S.O.), Medical Point Hospital, Izmir, Turkey; University Hospital Center Zagreb (M.H.); University of Zagreb (M.H.), School of Medicine, Croatia; Monash Health (N.A.J.); Department of Medicine (N.A.J.), School of Clinical Sciences, Monash University, Melbourne, Australia; CHUM and Universite de Montreal (A.P., M.G., P.D.), Canada; Neurology Department (S.M.B.), Faculty of Medicine, Mazandaran University of Medical Sciences, Iran; University of New South Wales (Suzanne Hodgkinson), Sydney, Australia; Cliniques Universitaires Saint-Luc (V.V.P.), Brussels; Université Catholique de Louvain (V.V.P.); Universitary Hospital Ghent (G.L.); Department of Neurology (B.W.), Antwerp University Hospital, Edegem; Translational Neurosciences Research Group (B.W.), Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium; CSSS Saint-Jérôme (J.P.), Saint-Jerome, Canada; Department of Neuroscience (M.F.), Neurology Unit-MS Center, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy; Department of Biotechnological and Applied Clinical Sciences (M.F.), University of L'Aquila, Italy; Groene Hart Ziekenhuis (K.D.G.), Gouda, Netherlands; Charles University in Prague and General University Hospital (D.H., E.K.H.), Prague, Czech Republic; Yeditepe University Kosuyolu Hospital (R.K.), Neurological Sciences, Istanbul, Turkey; Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Catania; UOS Sclerosi Multipla (F.P.), AOU Policlinico "G Rodloico-San Marco", University of Catania, Italy; University of Queensland (P.A.M.), Brisbane; Royal Brisbane and Women's Hospital (P.A.M.), Australia; Centro Sclerosi Multipla (D.M.), UOC Neurologia, Azienda Ospedaliera per l'Emergenza Cannizzaro, Catania, Italy; Koc University (A.A.), Istanbul, Turkey; Nemocnice Jihlava (Radek Ampapa), Jihlava, Czech Republic; Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino (D.S.), Avellino, Italy; Zuyderland Medical Center (O.H.H.G.), Sittard-Geleen; School for Mental Health and Neuroscience (O.H.H.G.), Maastricht University, The Netherlands; Centro Hospitalar Universitario de Sao Joao (M.J.S.); Faculty of Health Sciences (M.J.S.), University Fernando Pessoa, Porto, Portugal; Royal Victoria Hospital (Stella Hughes), Belfast, United Kingdom; Department of Neurology (R.G., S.M.), Research laboratory LR18SP03, Clinical investigation Center Neurosciences and Mental Health, Razi Hospital; Faculty of Medicine of Tunis (R.G., S.M.), University of Tunis El Manar, Tunis, Tunisia; Austin Health (R.A.M.), Melbourne, Australia; Haydarpasa Numune Training and Research Hospital (R.T.), Istanbul, Turkey; Azienda Sanitaria Unica Regionale Marche - AV3 (E.C.), Macerata, Italy; Sultan Qaboos University (A.A.-A.), Al-Khodh, Oman; Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases (A.S.), Istanbul, Turkey; St. Michael's Hospital (J.O.), Toronto, Canada; and F. Hoffmann-La Roche Ltd (E.M.-L.R., S.G., N.P.), Basel, Switzerland.

PMID: 39442037
PMCID: PMC11502106
DOI: 10.1212/NXI.0000000000200328

Abstract

Background and objectives: Women with multiple sclerosis (MS) are at risk of disease reactivation in the early postpartum period. Ocrelizumab (OCR) is an anti-CD20 therapy highly effective at reducing MS disease activity. Data remain limited regarding use of disease-modifying therapies (DMTs), including OCR, and disease activity during peripregnancy periods.

Methods: We performed a retrospective cohort study using data from the MSBase Registry including pregnancies conceived after December 31, 2010, from women aged 18 years and older, with relapsing-remitting MS or clinically isolated syndrome. Women were classified by preconception exposure to DMTs, including OCR, rituximab (RTX), natalizumab (NAT), stratified into active (NAT-A; continued ≥28 weeks of gestation, restarted ≤1 month postpartum) or conservative (NAT-C; continued ≤4 weeks of gestation, restarted >1 month postpartum) strategies, dimethyl fumarate (DMF) or low-efficacy DMTs (interferon-beta, glatiramer acetate). Annualized relapse rates (ARRs) were calculated for 12-month prepregnancy, pregnancy, and 6-month postpartum periods.

Results: A total of 2,009 live births from 1,744 women were analyzed, including 73 live births from 69 women treated with preconception OCR. For OCR, no within-pregnancy relapse was observed and 3 women (4.1%) experienced 1 relapse in the postpartum period (ARR 0.09 [95% CI 0.02-0.27]). For NAT-A, 3 (3.7%) of 82 women relapsed during pregnancy (0.05 [0.01-0.15]) and 4 (4.9%) relapsed during postpartum (0.10 [0.03-0.26]). However, for NAT-C, 13 (15.9%) of 82 women relapsed within pregnancy (0.32 [0.20-0.51]) and 25 (30.5%) relapsed during postpartum (0.74 [0.50-1.06]). In the low-efficacy DMT group, 101 (7.6%) of 1,329 women experienced within-pregnancy relapse (0.12 [0.10-0.14]), followed by an increase in postpartum relapse activity with 234 women (17.6%) relapsing (0.43 [0.38-0.48]). This was similarly seen in the DMF group with 13 (7.9%) of 164 women experiencing within-pregnancy relapse (0.12 [0.06-0.20]) and 25 (15.2%) of 164 relapsing postpartum (0.39 [0.26-0.57]). Our RTX cohort had 0 of 24 women experiencing within-pregnancy relapse and 3 (12.5%) of 24 experiencing postpartum relapse.

Discussion: Women treated with OCR or NAT-A were observed to have low relapse rates during pregnancy and postpartum. NAT-C was associated with increased risk of relapses. There was no within-pregnancy relapse in our RTX cohort, although we caution overinterpretation due to our sample size. An effective DMT strategy with a favorable safety profile for the mother and infant should be discussed and implemented well in advance of planning a family.

Classification of evidence: This study provides Class III evidence that for women with relapsing-remitting MS or clinically isolated syndrome who become pregnant, ocrelizumab, rituximab, and natalizumab (continued ≥28 weeks of gestation and restarted ≤1 month postpartum) were associated with reduced risk of relapses, compared with other therapeutic strategies.

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Conflict of interest statement

W.Z. Yeh has received speaker honoraria from Merck and Novartis. A. Van Der Walt served on advisory boards & receives unrestricted research grants from Novartis, Biogen, Merck & Roche, received speaker's honoraria & travel support from Novartis, Roche & Merck, and receives grant support from the National Health & Medical Research Council of Australia & MS Research Australia. O. Skibina received honoraria & consulting fees from Bayer Schering, Novartis, Merck, Biogen & Genzyme. T. Kalincik has served on scientific advisory boards for MS International Federation & World Health Organisation, BMS, Roche, Janssen, Sanofi Genzyme, Novartis, Merck & Biogen, steering committee for Brain Atrophy Initiative by Sanofi Genzyme, received conference travel support &/or speaker honoraria from WebMD Global, Eisai, Novartis, Biogen, Roche, Sanofi-Genzyme, Teva, BioCSL & Merck, and received research or educational event support from Biogen, Novartis, Genzyme, Roche, Celgene and Merck. R. Alroughani has received honoraria as a speaker and for serving on scientific advisory boards from Bayer, Biogen, GSK, Merck, Novartis, Roche and Sanofi-Genzyme. A. Kermode has in recent times received speaker honoraria and Scientific Advisory Board fees from Bayer, BioCSL, Biogen-Idec, Clene Nanomedicine, Lgpharma, Merck, Novartis, Roche, Sanofi-Aventis, Sanofi-Genzyme, Teva, NeuroScientific Biopharmaceuticals, Innate Immunotherapeutics, Mitsubishi Tanabe Pharma and Esai. His work currently receives grant funding from the Trish MS Foundation, MS Research Australia, MS Western Australia, the MS Base Foundation, the National Health and Medical Research Council of Australia, the NMSS USA, and the Eyewall Foundation. He is currently an investigator in pharmaceutical trials sponsored by Biogen-Idec, Novartis, Merck and Clene Nanomedicine. M.J. Fabis-Pedrini received travel compensation from Merck. W. Carroll received travel assistance and honoraria for participation in industry sponsored meetings from, and provided advice to, Bayer Schering Pharma, Biogen-Idec, Novartis, Roche, Genzyme, Sanofi-Aventis, CSL, Teva, Merck and Cellgene. J. Lechner-Scott has received travel compensation from Novartis, Biogen, Roche and Merck. Her institution receives the honoraria for talks and advisory board commitment as well as research grants from Biogen, Merck, Roche, TEVA and Novartis. C. Boz received conference travel support from Biogen, Novartis, Bayer-Schering, Merck and Teva and has participated in clinical trials by Sanofi Aventis, Roche and Novartis. S. Ozakbas reports no disclosures. K. Buzzard received speaker honoraria and/or education support from Biogen, Teva, Novartis, Genzyme-Sanofi, Roche, Merck and Alexion and has been a member of advisory boards for Merck and Biogen. M. Habek participated as a clinical investigator and/or received consultation and/or speaker fees from Biogen, Sanofi Genzyme, Merck, Novartis, Pliva/Teva, Roche, Actelion, Alexion Pharmaceuticals, and TG Pharmaceuticals. N. John is a local principal investigator on commercial studies funded by Novartis, Biogen, Amicus and Sanofi. He has received speaker honoraria from Merck. He has received congress travel and registration reimbursement from Novartis. A. Prat reports no disclosures. M. Girard received consulting fees from Teva Canada Innovation, Biogen, Novartis and Genzyme Sanofi and lecture payments from Teva Canada Innovation, Novartis and EMD. He has also received a research grant from Canadian Institutes of Health Research. P. Duquette served on editorial boards and has been supported to attend meetings by EMD, Biogen, Novartis, Genzyme, and TEVA Neuroscience. He holds grants from the CIHR and the MS Society of Canada and has received funding for investigator-initiated trials from Biogen, Novartis, and Genzyme. S.M. Baghbanian reports no disclosures. S. Hodgkinson received honoraria and consulting fees from Novartis, Bayer Schering and Sanofi, and travel grants from Novartis, Biogen Idec and Bayer Schering. V. Van Pesch has received travel grants from Merck Healthcare KGaA (Darmstadt, Germany), Biogen, Sanofi, Bristol Meyer Squibb, Almirall and Roche. His institution has received research grants and consultancy fees from Roche, Biogen, Sanofi, Merck Healthcare KGaA (Darmstadt, Germany), Bristol Meyer Squibb, Janssen, Almirall, Alexion and Novartis Pharma. G. Laureys has received travel and/or consultancy compensation from Sanofi-Genzyme, Roche, Teva, Merck, Novartis, Celgene, and Biogen. B. Willekens has received honoraria for acting as a member of Scientific Advisory Boards for Alexion, Almirall, Biogen, Celgene/BMS, Merck Serono, Novartis, Roche, Sanofi-Genzyme and speaker honoraria and travel support from Biogen, Merck Serono, Novartis, Roche, and Sanofi-Genzyme and research and/or patient support grants from Roche, Biogen, MerckSerono, and Sanofi-Genzyme. Honoraria and grants were paid to UZA/UZA Foundation. She receives grant support from Research Foundation Flanders, Belgian Charcot Foundation, Queen Elisabeth Medical Foundation, National MS Society USA and Start2Cure Foundation. J. Prevost accepted travel compensation from Novartis, Biogen, Genzyme, and Teva, and speaking honoraria from Biogen, Novartis, Genzyme and Teva. M. Foschi served as scientific consultant for Roche and Novartis and received compensation for travel or speaker honoraria from Biogen, Merck, Roche, Novartis, and Sanofi-Genzyme. K. de Gans served on scientific advisory boards for Roche, Janssen, Sanofi-Genzyme, Novartis and Merck, received conference fee and travel support from Novartis, Biogen, Sanofi-Genzyme, Teva, Abbvie and Merck and received educational event support from Novartis. D. Horakova was supported by the Charles University: Cooperatio Program in Neuroscience, by the project National Institute for Neurologic Research (Programme EXCELES, ID Project No. LX22NPO5107) - Funded by the European Union – Next Generation EU, and by General University Hospital in Prague project MH CZ-DRO-VFN64165. She also received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck, Bayer, Sanofi Genzyme, Roche, and Teva, as well as support for research activities from Biogen Idec. E.K. Havrdova received honoraria/research support from Biogen, Merck Serono, Novars, Roche, and Teva; has been a member of advisory boards for Actelion, Biogen, Celgene, Merck Serono, Novars, and Sanofi Genzyme; received honoraria/research support from Biogen, Merck Serono, Novars, Roche, and Teva; has been member of advisory boards for Actelion, Biogen, Celgene, Merck Serono, Novars, and Sanofi Genzyme; and has been supported by the Czech Ministry of Education – project Cooperatio LF1, research area Neuroscience, and the project National Institute for Neurologic Research (Programme EXCELES, ID project No LX22NPO5107) – funded by the European Union-Next Generation EU. R. Karabudak received speaker honoraria/research support and travel grants from Sanofi, Biogen-Gen, Merck Serono, Novartis, Roche, Sanovel, Aİ Farma and Teva; she has been member of advisory boards for Roche, Sanofi, Sanovel, Aİ Farma, Alexion, Biogen-Gen, Merck Serono, Farmanova. F. Patti received personal compensation for serving on advisory board by Almirall, Alexion, Biogen, Bristol, Berck, Novartis and Roche. The authors further received research grant by Biogen, Merck and Roche and by FISM, Reload Association (Onlus), Italian Health Minister, University of Catania. P. McCombe received speaker fees and travel grants from Novartis, Biogen, T’évalua, Sanofi. D. Maimone received speaker honoraria for Advisory Board and travel grants from Almirall, Biogen, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva. A. Altintas received speaker honoraria from Novartis and Alexion. R. Ampapa received conference travel support from Novartis, Teva, Biogen, Bayer and Merck and has participated in a clinical trials by Biogen, Novartis, Teva and Actelion. D. Spitaleri received honoraria as a consultant on scientific advisory boards by Bayer-Schering, Novartis and Sanofi-Aventis and compensation for travel from Novartis, Biogen, Sanofi Aventis, Teva and Merck. O.H.H. Gerlach reports no disclosures. M.J. Sa received consulting fees, speaker honoraria, and/or travel expenses for scientific meetings from Alexion, Bayer Healthcare, Biogen, Bristol Myers Squibb, Celgene, Janssen, Merck-Serono, Novartis, Roche, Sanofi and Teva. S. Hughes has received unrestricted educational grants or speaking honoraria from Biogen, Merck Serono, Novartis, Roche and Sanofi Genzyme. R. Gouider reports no disclosures. S. Mrabet has received a MENACTRIMS clinical fellowship grant (2020). R. Macdonell received compensation for traveling, conference fees and consulting fees from Merck, Teva, Sanofi Genzyme, Biogen Idec, Novartis, Roche, BMS, and Celgene. R. Turkoglu reports no disclosures. E. Cartechini reports no disclosures. A. Al-Asmi has received personal compensation for serving as a Scientific Advisory or speaker/moderator for Novartis, Biogen, Roche, Sanofi-Genzyme, and Merck. A. Soysal reports no disclosures. J. Oh has received research funding from MS Canada, National MS Society, Brain Canada, Biogen, and Roche and personal compensation for consulting or speaking from Biogen, BMS, EMD Serono (an affiliate of Merck KGaA), Eli-Lilly, Horizon Therapeutics, Novartis, Roche, and Sanofi-Genzyme. E. Muros-Le Rouzic is an employee and shareholder of F. Hoffmann-La Roche Ltd. S. Guye was an employee of F. Hoffmann-La Roche Ltd. during the development of this study and an employee of UCB Farchim SA during the development of the manuscript. She is a shareholder of F. Hoffmann-La Roche Ltd. N. Pasquarelli is an employee and shareholder of F. Hoffmann-La Roche Ltd. H. Butzkueven received institutional (Monash University) funding from Biogen, F. Hoffmann-La Roche Ltd, Merck, Alexion, CSL & Novartis; carried out contracted research for Novartis, Merck, F. Hoffmann-La Roche Ltd & Biogen; taken part in speakers' bureaus for Biogen, Genzyme, UCB, Novartis, F. Hoffmann-La Roche Ltd & Merck; and received personal compensation from Oxford Health Policy Forum for the Brain Health Steering Committee. V. Jokubaitis received speaker's honoraria from Novartis outside of the submitted work. Her research institute receives research funding from the National Health and Medical Research Council of Australia (NHMRC) and Roche outside of the submitted work. Go to Neurology.org/NN for full disclosures.

Figures

**Figure 1. Flowchart of Pregnancy and Patient Inclusion/Exclusion**

**Figure 2. Annualized Relapse Rates (ARRs) Before Pregnancy, During Pregnancy, and in the Postpartum Period for Term/Preterm Pregnancies by Preconception Disease-Modifying Therapy Group**
(A) ARR was plotted for each 3-month interval. (B) ARR was summarized for the 1-year prepregnancy, pregnancy, and 6-month postpartum periods, respectively. Natalizumab (NAT) groups represent either an active (NAT-A) or conservative (NAT-C) strategy of use during and after pregnancy. Low-efficacy group refers to interferon-beta or glatiramer acetate preconception use. Error bars represent 95% confidence intervals. Table represents number of women with time included for each 3-month interval. DMF = dimethyl fumarate; NAT = natalizumab; OCR = ocrelizumab.

**Figure 3. Characteristics of 3 Women Who Used Ocrelizumab (OCR) Before Conception and Experienced Postpartum Relapse**
OCR use during pregnancy was based on the last administered dose. ARR = annualized relapse rate; EDSS = Expanded Disability Status Scale.

**Figure 4. Annualized Relapse Rates (ARR) Before Pregnancy, During Pregnancy, and in the Postpartum Period for Abortions, Miscarriages, and Stillbirths by Preconception Disease-Modifying Therapy Group**
Low-efficacy group refers to interferon-beta or glatiramer acetate preconception use. Error bars represent 95% confidence intervals. DMF = dimethyl fumarate; NAT = natalizumab; OCR = ocrelizumab.

See this image and copyright information in PMC

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Disease Activity in Pregnant and Postpartum Women With Multiple Sclerosis Receiving Ocrelizumab or Other Disease-Modifying Therapies

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Disease Activity in Pregnant and Postpartum Women With Multiple Sclerosis Receiving Ocrelizumab or Other Disease-Modifying Therapies

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