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



Yeh WZ1, 2 ; Van Der Walt A1, 2 ; Skibina OG2, 3, 4 ; Kalincik T5, 6 ; Alroughani R7 ; Kermode AG8, 9, 10 ; Fabispedrini MJ8, 9 ; Carroll WM8, 10 ; Lechnerscott J11, 12 ; Boz C13 ; Ozakbas S14 ; Buzzard K3, 4 ; Habek M15, 16 ; John NA17, 18 Show All Authors
Authors
  1. Yeh WZ1, 2
  2. Van Der Walt A1, 2
  3. Skibina OG2, 3, 4
  4. Kalincik T5, 6
  5. Alroughani R7
  6. Kermode AG8, 9, 10
  7. Fabispedrini MJ8, 9
  8. Carroll WM8, 10
  9. Lechnerscott J11, 12
  10. Boz C13
  11. Ozakbas S14
  12. Buzzard K3, 4
  13. Habek M15, 16
  14. John NA17, 18
  15. Prat A19
  16. Girard M19
  17. Duquette P19
  18. Baghbanian SM20
  19. Hodgkinson S21
  20. Van Pesch V22, 23
  21. Laureys G24
  22. Willekens B25, 26
  23. Prevost J27
  24. Foschi M28, 29
  25. De Gans K30
  26. Horakova D31
  27. Havrdova EK31
  28. Karabudak R32
  29. Patti F33, 34
  30. Mccombe PA35, 36
  31. Maimone D37
  32. Altintas A38
  33. Ampapa R39
  34. Spitaleri D40
  35. Gerlach OHH41, 42
  36. Sa MJ43, 44
  37. Hughes S45
  38. Gouider R46, 47
  39. Mrabet S46, 47
  40. Macdonell RA48
  41. Turkoglu R49
  42. Cartechini E50
  43. Alasmi A51
  44. Soysal A52
  45. Oh J53
  46. Murosle Rouzic E54
  47. Guye S54
  48. Pasquarelli N54
  49. Butzkueven H1, 2
  50. Jokubaitis VG1, 2
  51. Barnett M55
  52. Slee M56
  53. Van Hijfte L57
  54. Yamout B58
  55. Terzi M59
  56. Blanco Y60
  57. Grammond P61
  58. Izquierdo G62
  59. Besora S63
  60. Taylor B64
  61. Castillotrivino T65
  62. Sanchezmenoyo JL66
  63. Lugaresi A67
  64. Amato MP68
  65. Hardy T69
  66. Decoo D70
  67. Fragoso Y71
  68. Iuliano G72
  69. Gray O73
  70. Saladino ML74
  71. Grandmaison F75
  72. Sempere AP76
  73. Shaw C77
  74. Van Wijmeersch B78
  75. Csepany T79
  76. Solaro C80
  77. Alkhaboori J81
  78. Garber J82
  79. Dominguez JA83
  80. Piroska I84
  81. Mcguigan C85
  82. Cauchi M86
  83. Skromne E87
  84. Trevinofrenk I88
  85. Mason D89
  86. Sirbu CA90
  87. Etemadifar M91
  88. Nohara C92
  89. Cambron M93
  90. De Vecino MCA94
  91. Shalaby N95
  92. Field D96
  93. Agueramorales E97
  94. Khurana D98
  95. Matsumoto R99
  96. Shimizu F100
  97. Sinnige LGF101
  98. Cardenasrobledo S102
Show Affiliations
Authors Affiliations
  1. 1. Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Australia
  2. 2. Department of Neurology, Alfred Health, Melbourne, Australia
  3. 3. Department of Neurology, Box Hill Hospital, Box Hill, Australia
  4. 4. Department of Neurosciences, Eastern Health Clinical School, Monash University, Box Hill, Australia
  5. 5. Neuroimmunology Centre, Department of Neurology, Royal Melbourne Hospital, Australia
  6. 6. CORe, Department of Medicine, University of Melbourne, Australia
  7. 7. Amiri Hospital, Sharq, Kuwait
  8. 8. Perron Institute for Neurological and Translational Science, University of Western Australia, Nedlands, Australia
  9. 9. Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Perth, Australia
  10. 10. Sir Charles Gairdner Hospital, QEIIMC, Nedlands, Australia
  11. 11. University of Newcastle, Newcastle, Australia
  12. 12. Hunter New England Health, John Hunter Hospital, NSW, Australia
  13. 13. Karadeniz Technical University, Medical Faculty, Trabzon, Turkiye
  14. 14. Izmir University of Economics, Medical Point Hospital, Izmir, Turkiye
  15. 15. University Hospital Center Zagreb, School of Medicine, Croatia
  16. 16. University of Zagreb, School of Medicine, Croatia
  17. 17. Monash Health, School of Clinical Sciences, Monash University, Melbourne, Australia
  18. 18. Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, Australia
  19. 19. CHUM, Universite de Montreal, Canada
  20. 20. Neurology Department, Faculty of Medicine, Mazandaran University of Medical Sciences, Iran
  21. 21. University of New South Wales, Sydney, Australia
  22. 22. Cliniques Universitaires Saint-Luc, Brussels, Belgium
  23. 23. Universite Catholique de Louvain, Edegem, Belgium
  24. 24. Universitary Hospital Ghent, Edegem, Belgium
  25. 25. Department of Neurology, Antwerp University Hospital, Edegem, Belgium
  26. 26. Translational Neurosciences Research Group, Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium
  27. 27. CSSS Saint-Jerome, Saint-Jerome, Canada
  28. 28. Department of Neuroscience, Neurology Unit-MS Center, S. Maria Delle Croci Hospital, AUSL Romagna, Ravenna, Italy
  29. 29. Department of Biotechnological and Applied Clinical Sciences, University of l'Aquila, Italy
  30. 30. Groene Hart Ziekenhuis, Gouda, Netherlands
  31. 31. Charles University in Prague, General University Hospital, Prague, Czech Republic
  32. 32. Yeditepe University Kosuyolu Hospital, Neurological Sciences, Istanbul, Turkiye
  33. 33. Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, Catania, Italy
  34. 34. UOS Sclerosi Multipla, AOU Policlinico g Rodloico-San Marco, University of Catania, Italy
  35. 35. University of Queensland, Brisbane, Australia
  36. 36. Royal Brisbane and Women's Hospital, Australia
  37. 37. Centro Sclerosi Multipla, UOC Neurologia, Azienda Ospedaliera per l'Emergenza Cannizzaro, Catania, Italy
  38. 38. Koc University, Istanbul, Turkiye
  39. 39. Nemocnice Jihlava, Jihlava, Czech Republic
  40. 40. Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino, Avellino, Italy
  41. 41. Zuyderland Medical Center, Sittard-Geleen, Netherlands
  42. 42. School for Mental Health and Neuroscience, Maastricht University, Netherlands
  43. 43. Centro Hospitalar Universitario de Sao Joao, University Fernando Pessoa, Porto, Portugal
  44. 44. Faculty of Health Sciences, University Fernando Pessoa, Porto, Portugal
  45. 45. Royal Victoria Hospital, Belfast, United Kingdom
  46. 46. Department of Neurology, Research Laboratory LR18SP03, Clinical Investigation Center Neurosciences and Mental Health, Razi Hospital, Tunisia
  47. 47. Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia
  48. 48. Austin Health, Melbourne, Australia
  49. 49. Haydarpasa Numune Training and Research Hospital, Istanbul, Turkiye
  50. 50. Azienda Sanitaria Unica Regionale Marche - AV3, Macerata, Italy
  51. 51. Sultan Qaboos University, Al-Khodh, Oman
  52. 52. Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases, Istanbul, Turkiye
  53. 53. St. Michael's Hospital, Toronto, Canada
  54. 54. F. Hoffmann-La Roche Ltd, Basel, Switzerland
  55. 55. Brain and Mind Centre, Sydney, Australia
  56. 56. Flinders University, Adelaide, Australia
  57. 57. Ghent University Hospital, Ghent, Belgium
  58. 58. American University of Beirut Medical Center, Beirut, Lebanon
  59. 59. 19 Mayis University, Samsun, Turkiye
  60. 60. Hospital Clinic de Barcelona, Barcelona, Spain
  61. 61. CISSS Chaudiere-Appalache, Levis, Canada
  62. 62. Hospital Universitario Virgen Macarena, Sevilla, Spain
  63. 63. Hospital Universitari Mutua Terrassa, Barcelona, Spain
  64. 64. Royal Hobart Hospital, Hobart, Australia
  65. 65. Hospital Universitario Donostia, IIS Biodonostia, San Sebastian, Spain
  66. 66. Hospital de Galdakao-Usansolo, Galdakao, Spain
  67. 67. Universita di Bologna, Bologna, Italy
  68. 68. University of Florence, Florence, Italy
  69. 69. Concord Repatriation General Hospital, Sydney, Australia
  70. 70. AZ Alma Ziekenhuis, Damme, Sijsele, Belgium
  71. 71. Universidade Metropolitana de Santos, Santos, Brazil
  72. 72. Ospedali Riuniti di Salerno, Salerno, Italy
  73. 73. South Eastern HSC Trust, Belfast, United Kingdom
  74. 74. INEBA - Institute of Neuroscience Buenos Aires, Buenos Aires, Argentina
  75. 75. Neuro Rive-Sud, QC, Canada
  76. 76. Hospital General Universitario de Alicante, Alicante, Spain
  77. 77. Geelong Hospital, Geelong, Australia
  78. 78. Pelt and Hasselt University, Hasselt, Belgium
  79. 79. University of Debrecen, Debrecen, Hungary
  80. 80. ASL3 Genovese, Genova, Italy
  81. 81. Royal Hospital, Muscat, Oman
  82. 82. Westmead Hospital, Sydney, Australia
  83. 83. Hospital Universitario de la Ribera, Alzira, Spain
  84. 84. Veszprem Megyei Csolnoky Ferenc Korhaz Zrt., Veszprem, Hungary
  85. 85. St Vincent's University Hospital, Dublin, Ireland
  86. 86. Mater Dei Hospital, Balzan, Malta
  87. 87. Hospital Angeles de Las Lomas, Instituto Mexicano de Neurociencias, Estado de Mexico, Huixquilucan, Mexico
  88. 88. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico
  89. 89. Christchurch Hospital, Christchurch, New Zealand
  90. 90. Central Military Emergency University Hospital, Bucharest, Romania
  91. 91. Isfahan University of Medical Sciences, Isfahan, Iran
  92. 92. Tokyo Metropolitan Health and Medical Treatment Corporation Ebara Hospital, Tokyo, Japan
  93. 93. Az Sint-Jan Brugge, Bruges, Belgium
  94. 94. Hospital Moinhos de Vento, Porto Alegre, Brazil
  95. 95. Neuro Clinic, Cairo, Egypt
  96. 96. Lyell McEwin Hospital, Elizabeth Vale, Australia
  97. 97. University of Cordoba, Cordoba, Spain
  98. 98. PGIMER, Chandigarh, India
  99. 99. Kobe University, Graduate School of Medicine, Kobe, Japan
  100. 100. Yamaguchi University, Graduate School of Medicine, Ube, Japan
  101. 101. Medical Center Leeuwarden, Leeuwarden, Netherlands
  102. 102. Hospital Universitario Nacional de Colombia, Bogota, Colombia

Source: Neurology: Neuroimmunology and NeuroInflammation Published:2024


Abstract

Background and ObjectivesWomen 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.MethodsWe 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.ResultsA 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.DiscussionWomen 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 EvidenceThis 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. © 2024 American Academy of Neurology.
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