The German Multiple Sclerosis and Pregnancy Registry: rationale, objective, design, and first results

1. Orton, SM, Herrera, BM, Yee, IM, et al Sex ratio of multiple sclerosis in Canada: a longitudinal study. Lancet Neurol 2006; 5: 932–936.
Google Scholar | Crossref | Medline | ISI2. EMA . Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-risk-assessment-medicinal-products-human-reproduction-lactation-data-labelling_en.pdf
Google Scholar3. EMA . Avonex® (interferon beta-1a) – EPAR summary of product characteristics, 2007 (As an example for all interferon- formulations with approval for treatment during lactation), http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000102/WC500029425.pdf
Google Scholar4. Romero, RS, Lunzmann, C, Bugge, JP. Pregnancy outcomes in patients exposed to interferon beta-1b. J Neurol Neurosurg Psychiatry 2015; 86: 587–589.
Google Scholar | Crossref | Medline | ISI5. Neudorfer, O, Sandberg-Wollheim, M, Coyle, PK, et al The Glatiramer acetate pregnancy database. ECTRIMS Online Libr 2015; 116357: P1507.
Google Scholar6. Friend, S, Richman, S, Bloomgren, G, et al Evaluation of pregnancy outcomes from the Tysabri(R) (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol 2016; 16: 150.
Google Scholar | Crossref | Medline | ISI7. Geissbühler, Y, Vile, J, Koren, G, et al Cumulative data on pregnancy outcomes after exposure to fingolimod and in comparison with the general population. In: 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), London, 15 September 2016.
Google Scholar8. Hellwig, K . We need to conduct clinical trials of disease-modifying therapy in pregnancy to optimize care of women with MS – no. Mult Scler 2019; 25: 189–190.
Google Scholar | SAGE Journals | ISI9. Vukusic, S, Hutchinson, M, Hours, M, et al Pregnancy and multiple sclerosis (the PRIMS study): clinical predictors of post-partum relapse. Brain 2004; 127: 1353–1360.
Google Scholar | Crossref | Medline | ISI10. Salemi, G, Callari, G, Gammino, M, et al The relapse rate of multiple sclerosis changes during pregnancy: a cohort study. Acta Neurol Scand 2004; 110: 23–26.
Google Scholar | Crossref | Medline11. Hughes, SE, Spelman, T, Gray, OM, et al Predictors and dynamics of postpartum relapses in women with multiple sclerosis. Mult Scler 2014; 20: 739–746.
Google Scholar | SAGE Journals | ISI12. Langer-Gould, A, Smith, JB, Albers, KB, et al Pregnancy-related relapses and breastfeeding in a contemporary multiple sclerosis cohort. Neurology 2020; 94: e1939–e1949.
Google Scholar | Crossref | Medline13. Rigau, V, Mania, A, Befort, P, et al Lethal multiple sclerosis relapse after natalizumab withdrawal. Neurology 2012; 79: 2214–2216.
Google Scholar | Crossref | Medline | ISI14. Hellwig, K, Gold, R. Immune reconstitution inflammatory syndrome after withdrawal of natalizumab? Neurology 2011; 76: 1362–1363; author reply 1363.
Google Scholar | Crossref | Medline15. Barry, B, Erwin, AA, Stevens, J, et al Fingolimod rebound: a review of the clinical experience and management considerations. Neurol Ther 2019; 8: 241–250.
Google Scholar | Crossref | Medline16. Hellwig, K, Haghikia, A, Gold, R. Pregnancy and natalizumab: results of an observational study in 35 accidental pregnancies during natalizumab treatment. Mult Scler 2011; 17: 958–963.
Google Scholar | SAGE Journals | ISI17. Sepúlveda, M, Montejo, C, Llufriu, S, et al Rebound of multiple sclerosis activity after fingolimod withdrawal due to planning pregnancy: analysis of predisposing factors. Mult Scler Relat Disord 2020; 38: 101483.
Google Scholar | Crossref | Medline18. Hellwig, K, Haghikia, A, Rockhoff, M, et al Multiple sclerosis and pregnancy: experience from a nationwide database in Germany. Ther Adv Neurol Disord 2012; 5: 247–253.
Google Scholar | SAGE Journals | ISI19. Paavilainen, T, Kurki, T, Parkkola, R, et al Magnetic resonance imaging of the brain used to detect early post-partum activation of multiple sclerosis. Eur J Neurol 2007; 14: 1216–1221.
Google Scholar | Crossref | Medline | ISI20. Fragoso, YD, Boggild, M, Macias-Islas, MA, et al The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Clin Neurol Neurosurg 2013; 115: 154–159.
Google Scholar21. Hellwig, K, Rockhoff, M, Herbstritt, S, et al Exclusive breastfeeding and the effect on postpartum multiple sclerosis relapses. JAMA Neurol 2015; 72: 1132–1138.
Google Scholar22. Langer-Gould, A, Hellwig, K. One can prevent post-partum MS relapses by exclusive breast feeding: yes. Mult Scler 2013; 19: 1567–1568.
Google Scholar | SAGE Journals | ISI23. Vukusic, S, Confavreux, C. One can prevent post-partum MS relapses by exclusive breast feeding: no. Mult Scler 2013; 19: 1565–1566.
Google Scholar | SAGE Journals | ISI24. Krysko, KM, Rutatangwa, A, Graves, J, et al Association between breastfeeding and postpartum multiple sclerosis relapses: a systematic review and meta-analysis. JAMA Neurol 2020; 77: 327–338.
Google Scholar | Crossref | Medline25. Krysko, KM, Graves, JS, Dobson, R, et al Sex effects across the lifespan in women with multiple sclerosis. Ther Adv Neurol Disord 2020; 13: 1756286420936166.
Google Scholar | SAGE Journals26. Hellwig, K, Gold, R. Breastfeeding and multiple sclerosis in a German cohort. Mult Scler 2008; 14: 718.
Google Scholar | SAGE Journals | ISI27. Hellwig, K, Brune, N, Haghikia, A, et al Reproductive counselling, treatment and course of pregnancy in 73 German MS patients. Acta Neurol Scand 2008; 118: 24–28.
Google Scholar | Crossref | Medline | ISI28. Hellwig, K, Agne, H, Gold, R. Interferon beta, birth weight and pregnancy in multiple sclerosis. J Neurol 2009; 256: 830–831.
Google Scholar | Crossref | Medline29. Hellwig, K, Beste, C, Schimrigk, S, et al Immunomodulation and postpartum relapses in patients with multiple sclerosis. Ther Adv Neurol Disord 2009; 2: 7–11.
Google Scholar | SAGE Journals30. Hellwig, K, Haghikia, A, Agne, H, et al Protective effect of breastfeeding in postpartum relapse rate of mothers with multiple sclerosis. Arch Neurol 2009; 66: 1580–1581; author reply 1581.
Google Scholar | Crossref | Medline31. Hellwig, K, Haghikia, A, Gold, R. Parenthood and immunomodulation in patients with multiple sclerosis. J Neurol 2010; 257: 580–583.
Google Scholar | Crossref | Medline | ISI32. Hellwig, K, Gold, R. Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J Neurol 2011; 258: 502–503.
Google Scholar | Crossref | Medline | ISI33. Hellwig, K, Schimrigk, S, Chan, A, et al A newborn with Pierre Robin sequence after preconceptional mitoxantrone exposure of a female with multiple sclerosis. J Neurol Sci 2011; 307: 164–165.
Google Scholar | Crossref | Medline | ISI34. Hellwig, K, Kleiter, I, Gold, R. Immune reconstitution inflammatory syndrome in natalizumab-associated PML. Neurology 2012; 78: 371; author reply 371.
Google Scholar | Crossref | Medline35. Kümpfel, T, Thiel, S, Meinl, I, et al Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: a cohort study from Germany. Neurol Neuroimmunol Neuroinflamm 2021; 8: e913.
Google Scholar | Crossref | Medline36. Lechner-Scott, J, Kappos, L, Hofman, M, et al Can the Expanded Disability Status Scale be assessed by telephone? Mult Scler 2003; 9: 154–159.
Google Scholar | SAGE Journals | ISI37. Nennstiel-Ratzel, U, Lüders, A, Arenz, S, et al Elternfragebögen zu Grenzsteinen der kindlichen Entwicklung im Alter von 1 bis 6 Jahren. Kinderärztl Prax 2013; 84: 106–114.
Google Scholar38. Thompson, AJ, Banwell, BL, Barkhof, F, et al Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol 2018; 17: 162–173.
Google Scholar | Crossref | Medline | ISI39. Wingerchuk, DM, Banwell, B, Bennett, JL, et al International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015; 85: 177–189.
Google Scholar | Crossref | Medline | ISI40. Vetter, K, Goeckenjan, M. [Prenatal care in Germany]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2013; 56: 1679–1685.
Google Scholar | Crossref | Medline41. Schling, S, Hillemanns, P, Gross, MM. [History of the German antenatal record (‘mutterpass’) and its need for updating]. Z Geburtshilfe Neonatol 2009; 213: 42–48.
Google Scholar | Crossref | Medline42. Uphoff, R, Nather, A. [Das neur Gelbe Kinderuntersuchungsheft]. Kinderkrankenschwester 2016; 35: 384–385.
Google Scholar | Medline43. Frankenburg, WK, Dodds, JB. The Denver developmental screening test. J Pediatr 1967; 71: 181–191.
Google Scholar | Crossref | Medline | ISI44. CDC . Metropolitan Atlanta Congenital Defects Program (MACDP), https://www.cdc.gov/ncbddd/birthdefects/macdp.html (2017, accessed June 2021).
Google Scholar45. EUROCAT . EUROCAT Guide 1.3 and reference documents Instructions for the Registration and Surveillance of Congenital Anomalies, https://eu-rd-platform.jrc.ec.europa.eu/sites/default/files/EUROCAT-Guide-1.3.pdf (2005, accessed 2020).
Google Scholar46. Hellwig, K, Correale, J. Artificial reproductive techniques in multiple sclerosis. Clin Immunol 2013; 149: 219–224.
Google Scholar | Crossref | Medline47. Thone, J, Kollar, S, Nousome, D, et al Serum anti-Mullerian hormone levels in reproductive-age women with relapsing-remitting multiple sclerosis. Mult Scler 2015; 21: 41–47.
Google Scholar | SAGE Journals | ISI48. Borisow, N, Kleiter, I, Gahlen, A, et al Influence of female sex and fertile age on neuromyelitis optica spectrum disorders. Mult Scler 2017; 23: 1092–1103.
Google Scholar | SAGE Journals | ISI49. Development EKSNIoCHaH . Pregnancy condition information, https://www.nichd.nih.gov/health/topics/pregnancy/conditioninfo (2017, accessed June 2021).
Google Scholar50. WHO . ICD-10: international statistical classification of diseases and related health problems, 10th revision, vol. 2. 2nd ed. Geneva: WHO, 2004.
Google Scholar51. Voigt, M . Analyse des neugeborenenkollektivs der Bundesrepublik deutschland. 12. mitteilung: Vorstellung engmaschiger perzentilwerte (-kurven). für die körpermaße neugeborener. Geburtsh Frauenheilk 2006; 66: 956–970.
Google Scholar | Crossref52. World Health Organization (WHO) NCoBDaDDftUSCfDCaPC, International Clearinghouse for Birth Defects Surveillance and Research (ICBDSR). Birth defects surveillance: a manual for programme managers, 2014, https://www.who.int/publications/i/item/9789241548724
Google Scholar53. Perrin, EC, Newacheck, P, Pless, IB, et al Issues involved in the definition and classification of chronic health conditions. Pediatrics 1993; 91: 787–793.
Google Scholar | Medline | ISI54. van der Lee, JH, Mokkink, LB, Grootenhuis, MA, et al Definitions and measurement of chronic health conditions in childhood: a systematic review. JAMA 2007; 297: 2741–2751.

Comments (0)

No login
gif