Pregnancy Registries and Longitudinal Data Collection
All patients with multiple sclerosis (MS) should be offered and have access to medications that have been well studied, and these patients should receive counseling with regard to the risks and benefits of using these medications. Women with MS who are pregnant or planning a pregnancy, however, are usually at a disadvantage because of the limited data available on the safety of medications indicated for MS. Collection of post-marketing data on the effects of disease-modifying therapies (DMTs) during pregnancy can be achieved through the use of pregnancy exposure and/or disease registries that collect information on MS treatments. However, there is a need for a specific pregnancy registry for MS that would encompass a large multicenter prospective observational study, designed to collect longitudinal data on medication exposure and outcomes in exposed and unexposed MS pregnancies and provide relevant information and counseling to women with MS who are pregnant or of childbearing age.
KeywordsMultiple Sclerosis Multiple Sclerosis Patient Pregnancy Outcome Spontaneous Abortion Adverse Pregnancy Outcome
- 6.National Multiple Sclerosis Society (NMSS). Disease management consensus statement. 2007. www.nmss.org. Accessed 24 Apr 2011.
- 7.Naya M, Fujita T, Takahashi H, Hara T, Takahira H. Toxicology study of GKT-beta-teratogenicity study in rats administered intravenously. Kiso to Rinsho. 1988;22(1):137–45.Google Scholar
- 8.Novartis International AG. Gilenya (fingolimod) [online]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf. Accessed 27 Aug 2015.
- 9.Sanofi Aventis US. Aubagio (teriflunomide) [online]. Available at: www.accessdata.fda.gov/drugsatdfda_docs/label/2012/202992s000lbl.pdf. Accessed 27 Aug 2015.
- 14.Metropolitan Atlanta Congenital Defects Program. http://www.cdc.gov/ncbddd/birthdefects/MACDP.html.Google Scholar
- 15.National Center for Health Statistics. http://www.cdc.gov/nchs/.Google Scholar
- 17.Richman S, Wallace K, Liu S, Sperling B. Final results from the AVONEX® (Intramuscular Interferon Beta-1a) pregnancy exposure registry. Neurology. 2012;78 (meeting abstracts 1). p. P06–191.Google Scholar
- 19.Cristiano L, Bozic C, Kooijmans M. Preliminary evaluation of pregnancy outcomes from Tysabri (nat) pregnancy registry. In: Fifth joint triennial congress of the European and the Americas Committees for Treatment and Research in multiple sclerosis. 2011. p. P1005.Google Scholar
- 20.Coyle PK, et al. Pregnancy outcomes in patients with multiple sclerosis treated with glatiramer acetate (Copaxone). J Neurol Neurosurg Psychiatry. 2003;74:443 [poster].Google Scholar
- 21.Karlsson G, et al. Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis. Neurology. 2014;82(8):674–80.Google Scholar
- 22.Kieseier B, Benamor M, Benzerdjeb H, Stuve O. Pregnancy outcomes from teriflunomide clinical development programme: retrospective analysis of the teriflunomide clinical trial database. Mult Scler. 2012;18 Suppl 4:P737.Google Scholar
- 23.Gold R, et al. Delayed-release dimethyl fumarate and pregnancy: preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience. Neurol Ther. 2015;4(2):93–104.Google Scholar
- 24.McCombe P, et al. Pregnancy outcomes in the alemtuzumab MS clinical development program. ECTRIMS Online Library. 2014 64543 (Poster).Google Scholar
- 29.Ebrahimi N, et al. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler. 2015;21(2):198–205.Google Scholar
- 31.Weber-Schoendorfer C, Schaefer C. Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study. Mult Scler. 2009;15(9):1037–42.Google Scholar
- 36.Agency for Health Research and Quality. Registries for evaluating patient’s outcomes: a user’s guide. 2014 [cited 2014]. Available from: http://www.effectivehealthcare.ahrq.gov/ehc/products/420/1337/RegistriesforEvaluatingPatientOutcomes3rdEd_DraftReport_20121128.pdf.
- 39.Coscia LA, et al. Report from the National Transplantation Pregnancy Registry (NTPR): outcomes of pregnancy after transplantation. Clin Transpl. 2010:65–85. PMID 21698831.Google Scholar