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Anti-CD20 therapies in pregnancy and breast feeding: a review and ABN guidelines
  1. Ruth Dobson1,2,
  2. David Rog3,
  3. Caroline Ovadia4,
  4. Katy Murray5,6,
  5. Stella Hughes7,
  6. Helen L Ford8,9,
  7. Owen R Pearson10,
  8. Sarah White11,
  9. Nicola Bonham6,
  10. Joela Mathews2,
  11. Catherine Nelson-Piercy12,13,
  12. Peter Brex14
  1. 1Preventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University, London, UK
  2. 2Department of Neurology, The Royal London Hospital, London, UK
  3. 3Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, UK
  4. 4Department of Women and Children’s Health, King's College London, London, UK
  5. 5Anne Rowling Regenerative Neurology Clinic, The University of Edinburgh, Edinburgh, UK
  6. 6Department of Neurology, Forth Valley Royal Hospital, Larbert, UK
  7. 7Department of Neurology, Belfast Health and Social Care Trust, Belfast, UK
  8. 8Department of Neurology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  9. 9Department of Neurosciences, University of Leeds Faculty of Medicine and Health, Leeds, UK
  10. 10Department of Neurology, Morriston Hospital, Swansea, UK
  11. 11Department of Neurology, St George's Hospitals NHS Trust, London, UK
  12. 12Department of Obstetrics, Guy's and St Thomas' Hospitals NHS Trust, London, UK
  13. 13Department of Obstetrics, King's College Hospital NHS Foundation Trust, London, UK
  14. 14Department of Neurology, King's College Hospital NHS Foundation Trust, London, UK
  1. Correspondence to Dr Ruth Dobson, Wolfson Institute of Population Health, Queen Mary University of London, London E1 4NS, UK; ruth.dobson{at}qmul.ac.uk

Abstract

Neurologists increasingly use anti-CD20 therapies, including for women of childbearing age, despite these medications being unlicensed for use in pregnancy. Current evidence suggests that women can safely conceive while taking anti-CD20 therapy. Women should not be denied treatment during pregnancy when it is clinically indicated, although they should be counselled regarding live vaccinations for their infant. Women receiving regular ocrelizumab for multiple sclerosis should preferably wait 3 months before trying to conceive. There are few data around ofatumumab in pregnancy, and while there is probably a class effect across all anti-CD20 therapies, ofatumumab may need to be continued during pregnancy to maintain efficacy. We recommend that anti-CD20 therapies can be safely given while breast feeding. It is important to make time to discuss treatments with women of childbearing age to help them choose their most suitable treatment. Outcomes should be monitored in pregnancy registries.

  • MULTIPLE SCLEROSIS

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

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Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

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Footnotes

  • Twitter @CarolineOvadia, @helenlouiseford

  • Contributors RD, DR, KM, SH, ORP, HLF, NB, SW and PB conceived the idea of these guidelines. They were initially drafted by RD, who performed the initial literature search. PB and KM provided additional literature searches. All authors reviewed the guidelines and commented on the consensus recommendations. RD, DR, KM, SH, HLF, ORP and PB are neurologists with a special interest in MS and pregnancy SW and NB are MS Specialist Nurses with an interest in MS and pregnancy JM is a neuro-pharmacist CO is an obstetrician with a special interest in medical disorders in pregnancy CN-P is an obstetric physician.

  • Funding This work received no specific funding. The UK MS Pregnancy Register is supported by funding from the Horne Family Charitable Trust.

  • Competing interests RD, DR, KM, SH, ORP, HLF, NB-M, SW and PB are on the steering committee for the UK MS Pregnancy Register, which seeks to improve our understanding of the safety of DMT in pregnancy. RD has received honoraria for sitting on advisory boards from Roche and Novartis. She sits on the steering committee for the MINORE and SOPRANINO studies, which are examining the safety of ocrelizumab in pregnancy and breastfeeding. She receives grant support from the UK MS Society, BMA foundation, NIHR, MRC, NMSS, Horne Family Charitable Trust, Biogen, Celgene, and Merck. She has received honoraria for advisory boards and/or educational activities from Biogen, Teva, Sanofi, Merck, Janssen, Novartis, and Roche. DR has received honoraria for sitting on advisory boards and/or speaker fees from from Biogen, Celgene, Hikma, Janssen, MedDay, Merck Serono, Novartis, Roche, Sanofi, Teva Neuroscience. He is the UK Coordinating Investigator for Tecfidera, Aubagio and Lemtrada pregnancy registries. He has received research support, paid to his institution, from Actelion, Biogen, Janssen, Merck Serono, Mitsubishi, Novartis, Sanofi, Teva Neuroscience, TG Therapeutics. CO consults for Mirum Pharmaceuticals. KM reports honoraria for advisory boards/educational activities from Biogen, Roche, Merck, Teva, Novartis, Sanofi. ORP has received honoraria for advisory boards and/or educational activities from Biogen, Teva, Sanofi, Merck, Janssen, Novartis, and Roche. SH has received unrestricted educational grants or speaking honoraria from Biogen, Merck Serono, Novartis, Roche and Sanofi Genzyme. NB-M has nothing to declareSW reports honoraria for advisory boards and/or educational activities from Biogen, Sanofi, Merck, Janssen, Novartis, Roche and Celgene. CN-P reports speakers fees from UCB, Sanofi, Jansen, and Alexion. PB has received honoraria for advisory boards and/or educational activities from Merck, Biogen, Roche, MS Academy, Janssen, Sanofi-Genzyme, Teva and MedDay Pharmacuticals.

  • Provenance and peer review Commissioned; externally peer reviewed by James Stevens, Bristol, UK and Emma Tallantyre, Cardiff, UK.

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