Maternal and fetal outcomes in an Italian multicentric cohort of women with multiple sclerosis exposed to dimethyl fumarate during pregnancy-Reference-Cited by-同舟云学术

Maternal and fetal outcomes in an Italian multicentric cohort of women with multiple sclerosis exposed to dimethyl fumarate during pregnancy

Published:2024-09-12 Issue: Volume: Page:
ISSN:1352-4585
Container-title:Multiple Sclerosis Journal
language:en
Short-container-title:Mult Scler

Author:

Landi Doriana¹,Bartolomeo Silvia¹^ORCID,Bovis Francesca²^ORCID,Amato Maria Pia³⁴^ORCID,Bonavita Simona⁵,Borriello Giovanna⁶⁷,Buccafusca Maria⁸,Bucello Sebastiano⁹^ORCID,Cavalla Paola¹⁰^ORCID,Cellerino Maria¹¹,Centonze Diego¹²¹³,Cocco Eleonora¹⁴^ORCID,Conte Antonella¹⁵,Cortese Antonio¹⁶,D’Amico Emanuele¹⁷,Di Filippo Massimiliano¹⁸,Docimo Renato⁵¹⁹,Fantozzi Roberta¹³,Ferraro Elisabetta¹⁶,Filippi Massimo²⁰^ORCID,Foschi Matteo²¹²²,Gallo Antonio²³,Granella Franco²⁴,Ianniello Antonio²⁵^ORCID,Lanzillo Roberta²⁶,Lorefice Lorena²⁷^ORCID,Lucchini Matteo²⁸²⁹^ORCID,Lus Giacomo³⁰³¹,Mataluni Giorgia¹,Mirabella Massimiliano²⁸²⁹^ORCID,Moiola Lucia²⁰^ORCID,Napoli Francesca¹,Nicoletti Carolina Gabri¹,Patti Francesco³²^ORCID,Ragonese Paolo³³,Realmuto Sabrina³⁴,Schirò Giuseppe³³,Signoriello Elisabetta³¹^ORCID,Sinisi Leonardo³⁵,Stromillo Maria Laura³⁶,Tomassini Valentina³⁷³⁸,Vecchio Domizia³⁹^ORCID,Sormani Maria Pia²⁴⁰^ORCID,Marfia Girolama Alessandra¹

Affiliation:

1. Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, Fondazione PTV Policlinico Tor Vergata, Tor Vergata University, Rome, Italy

2. Biostatistics Unit, Department of Health Sciences, University of Genoa, Genoa, Italy

3. Department NEUROFARBA, University of Florence, Florence, Italy

4. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy

5. Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy

6. MS Center, Neurology Unit, San Pietro Fatebenefratelli Hospital, Rome, Italy

7. Department of Public Health, University of Naples Federico II, Naples, Italy

8. Neurology and Neuromuscular Unit, Multiple Sclerosis Centre, “G. Martino” University Hospital, Messina, Italy

9. Multiple Sclerosis Centre, “E. Muscatello” Hospital—ASP8, Augusta, Italy

10. Department of Neuroscience, City of Health and Science University Hospital of Turin, Turin, Italy

11. Clinica Neurologica, Department of Neurology, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy

12. Italy Synaptic Immunopathology Lab, Department of Systems Medicine, Tor Vergata University, Rome, Italy

13. Unit of Neurology, IRCCS Neuromed, Pozzilli, Italy

14. Multiple Sclerosis Centre, Binaghi Hospital, ATS Sardegna, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy

15. IRCCS Neuromed, Pozzilli, Italy; Department of Human Neuroscience, Sapienza University, Rome, Italy

16. Multiple Sclerosis Centre, S. Filippo Neri Hospital, Rome, Italy

17. Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy

18. Section of Neurology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy

19. Multiple Sclerosis Center, “San Giuseppe Moscati” Hospital, ASL Caserta, Aversa, Italy

20. Neurology Unit, Multiple Sclerosis Center, IRCCS San Raffaele Institute, Vita-Salute San Raffaele University, Milan, Italy

21. Department of Neuroscience, Multiple Sclerosis Center, Neurology Unit, S. Maria delle Croci Hospital of Ravenna, AUSL Romagna, Ravenna, Italy

22. Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy

23. Multiple Sclerosis Center, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy

24. Department of Medicine and Surgery, University of Parma, Parma, Italy

25. Department of Human Neuroscience, Sapienza University, Rome, Italy

26. Multiple Sclerosis Clinical Care, Department of Neurosciences and Reproductive and Odontostomatological Sciences, University “Federico II,” Naples, Italy

27. Multiple Sclerosis Center, Department of Medical Sciences and Public Health, Binaghi Hospital, ASL Cagliari, Cagliari, Italy

28. Multiple Sclerosis Center, Fondazione Policlinico Universitario “Agostino Gemelli” IRCCS, Rome, Italy

29. Department of Neurosciences, Centro di Ricerca per la Sclerosi Multipla (CERSM), Università Cattolica del Sacro Cuore, Rome, Italy

30. Multiple Sclerosis Center, II Neurological Clinic, University of Campania “Luigi Vanvitelli,” Naples, Italy

31. Department of Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy

32. Department “G.F. Ingrassia,” MS Center, University of Catania, Catania, Italy

33. Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy

34. Multiple Sclerosis Centre, Neurology Unit and Stroke Unit, AOOR Villa Sofia-Cervello, Palermo, Italy

35. Neurology Unit and MS Center, San Paolo Hospital ASL Napoli 1 Centro, Naples, Italy

36. Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy

37. Institute of Advanced Biomedical Technologies (ITAB), Department of Neurosciences, Imaging and Clinical Sciences, University G. d’Annunzio of Chieti-Pescara, Chieti, Italy

38. MS Centre, Clinical Neurology, SS Annunziata University Hospital, Chieti, Italy

39. Multiple Sclerosis Centre, Neurology Unit, AOU Maggiore Della Carità, Department of Translational Medicine, University of Eastern Piedmont Avogadro, Novara, Italy

40. IRCCS Ospedale Policlinico San Martino, Genoa, Italy

Abstract

Background: Evidence on the impact of dimethyl fumarate (DMF) during pregnancy in women with multiple sclerosis (MS) is limited. Objectives: To investigate disease activity and pregnancy outcomes in a retrospective cohort of women exposed to DMF in early pregnancy. Methods: Women discontinuing DMF after pregnancy confirmation were identified from 29 Italian MS Centers. Disease activity 12 months before conception, during pregnancy, and 12 months postpartum were recorded, exploring reactivation predictors. Pregnancy and fetal outcomes were assessed. Results: The study analyzed 137 pregnancies (12 pregnancy losses, 125 live births) from 137 women (mean age 32.9 ± 4.7 years), discontinuing DMF within a median (interquartile range (IQR)) interval of 4.9 (3.7–5.7) weeks from conception. In live birth pregnancies, annualized relapse rate (ARR) significantly decreased during pregnancy (ARR = 0.07, 95% confidence interval (CI): 0.03–0.14, p = 0.021) compared to pre-conception (ARR = 0.21 (95% CI: 0.14–0.30)) and increased postpartum ((ARR = 0.22 (95% CI: 0.15–0.32), p = 0.006). Median time to first relapse (TTFR) was 3.16 (IQR: 1:87–5.42) months. Higher pre-conception relapse number (hazard ratio (HR) = 2.33, 95% CI: 1.08–5.02) and Expanded Disability Status Scale (EDSS; HR = 1.81, 95% CI: 1.17-2.74) were associated with shorter TTFR, while treatment resumption with longer TTFR (HR = 0.29, 95% CI: 0.11–0.74). Fetal outcomes were unaffected by DMF exposure. Conclusion: DMF discontinuation does not increase relapse risk during pregnancy. Early therapy restart prevents postpartum relapses. Early DMF exposure shows no adverse fetal outcomes.

Publisher

SAGE Publications

Link

https://journals.sagepub.com/doi/pdf/10.1177/13524585241274600

Reference32 articles.

1. Rate of Pregnancy-Related Relapse in Multiple Sclerosis

2. Pregnancy and multiple sclerosis (the PRIMS study): clinical predictors of post‐partum relapse

3. COPP-MS: COrticosteroids during the Post-Partum in relapsing Multiple Sclerosis patients

4. Predictors and dynamics of postpartum relapses in women with multiple sclerosis

5. Exposure to natalizumab throughout pregnancy: effectiveness and safety in an Italian cohort of women with multiple sclerosis