메뉴 건너뛰기




Volumn 4, Issue 2, 2015, Pages 93-104

Delayed-Release Dimethyl Fumarate and Pregnancy: Preclinical Studies and Pregnancy Outcomes from Clinical Trials and Postmarketing Experience

Author keywords

Clinical trial; Delayed release dimethyl fumarate; Multiple sclerosis; Postmarketing; Preclinical; Pregnancy; Safety; Women

Indexed keywords

FUMARIC ACID DIMETHYL ESTER;

EID: 84977134291     PISSN: 21938253     EISSN: 21936536     Source Type: Journal    
DOI: 10.1007/s40120-015-0033-1     Document Type: Article
Times cited : (71)

References (33)
  • 1
    • 84884396661 scopus 로고    scopus 로고
    • Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis
    • PID: 23544716
    • Tullman MJ. Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis. Am J Manag Care. 2013;19:S15–20.
    • (2013) Am J Manag Care. , vol.19 , pp. S15-S20
    • Tullman, M.J.1
  • 2
    • 84896876753 scopus 로고    scopus 로고
    • A review of safety-related pregnancy data surrounding the oral disease-modifying drugs for multiple sclerosis
    • COI: 1:CAS:528:DC%2BC2cXivFeqsLw%3D, PID: 24343726
    • Lu E, Wang BW, Synnes A, Dahlgren L, Sadovnick AD, Tremlett H. A review of safety-related pregnancy data surrounding the oral disease-modifying drugs for multiple sclerosis. CNS Drugs. 2014;28:89–94.
    • (2014) CNS Drugs. , vol.28 , pp. 89-94
    • Lu, E.1    Wang, B.W.2    Synnes, A.3    Dahlgren, L.4    Sadovnick, A.D.5    Tremlett, H.6
  • 3
    • 84874601625 scopus 로고    scopus 로고
    • Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance
    • COI: 1:CAS:528:DC%2BC3sXjtlGrtbk%3D, PID: 23448215
    • Lu E, Wang BW, Guimond C, et al. Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance. Expert Rev Neurother. 2013;13(3):251–61.
    • (2013) Expert Rev Neurother , vol.13 , Issue.3 , pp. 251-261
    • Lu, E.1    Wang, B.W.2    Guimond, C.3
  • 4
    • 4444230646 scopus 로고    scopus 로고
    • Multiple sclerosis gender issues: clinical practices of women neurologists
    • COI: 1:STN:280:DC%2BD2crgt1ylug%3D%3D, PID: 15471377
    • Coyle PK, Christie S, Fodor P, et al. Multiple sclerosis gender issues: clinical practices of women neurologists. Mult Scler. 2004;10:582–8.
    • (2004) Mult Scler. , vol.10 , pp. 582-588
    • Coyle, P.K.1    Christie, S.2    Fodor, P.3
  • 5
    • 84895790850 scopus 로고    scopus 로고
    • The pill times 2: what every woman with multiple sclerosis should know
    • Langer-Gould AM. The pill times 2: what every woman with multiple sclerosis should know. Neurology. 2014;82:1–2.
    • (2014) Neurology. , vol.82 , pp. 1-2
    • Langer-Gould, A.M.1
  • 6
    • 84872295057 scopus 로고    scopus 로고
    • The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis
    • PID: 22633835
    • 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;115:154–9.
    • (2013) Clin Neurol Neurosurg , vol.115 , pp. 154-159
    • Fragoso, Y.D.1    Boggild, M.2    Macias-Islas, M.A.3
  • 7
    • 84977087600 scopus 로고    scopus 로고
    • Tecfidera (dimethyl fumarate) prescribing information
    • Accessed Oct 21, 2014
    • Tecfidera (dimethyl fumarate) prescribing information. Cambridge: Biogen Inc.; 2013. http://www.tecfidera.com/pdfs/full-prescribing-information.pdf. Accessed Oct 21, 2014.
    • (2013) Cambridge: Biogen Inc.
  • 8
    • 79952136166 scopus 로고    scopus 로고
    • Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway
    • PID: 21354971
    • Linker RA, Lee DH, Ryan S, et al. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. Brain. 2011;134:678–92.
    • (2011) Brain. , vol.134 , pp. 678-692
    • Linker, R.A.1    Lee, D.H.2    Ryan, S.3
  • 9
    • 84858648216 scopus 로고    scopus 로고
    • Fumarates promote cytoprotection of central nervous system cells against oxidative stress via the nuclear factor (erythroid-derived 2)-like 2 pathway
    • COI: 1:CAS:528:DC%2BC38XltVaguro%3D, PID: 22267202
    • Scannevin RH, Chollate S, Jung MY, et al. Fumarates promote cytoprotection of central nervous system cells against oxidative stress via the nuclear factor (erythroid-derived 2)-like 2 pathway. J Pharmacol Exp Ther. 2012;341:274–84.
    • (2012) J Pharmacol Exp Ther , vol.341 , pp. 274-284
    • Scannevin, R.H.1    Chollate, S.2    Jung, M.Y.3
  • 10
    • 84866423965 scopus 로고    scopus 로고
    • Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis
    • COI: 1:CAS:528:DC%2BC38XhsVKkur3F, PID: 22992073
    • Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012;367(12):1098–107.
    • (2012) N Engl J Med , vol.367 , Issue.12 , pp. 1098-1107
    • Gold, R.1    Kappos, L.2    Arnold, D.L.3
  • 11
    • 84866355653 scopus 로고    scopus 로고
    • Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis
    • COI: 1:CAS:528:DC%2BC38XhsVKkur3E, PID: 22992072
    • Fox RJ, Miller DH, Phillips T, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012;367(12):1087–97.
    • (2012) N Engl J Med , vol.367 , Issue.12 , pp. 1087-1097
    • Fox, R.J.1    Miller, D.H.2    Phillips, T.3
  • 12
    • 84977130329 scopus 로고    scopus 로고
    • Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
    • International Conference on Harmonisation [ICH] S5(R2) guideline: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility, current Step 4 version. 2005.
    • (2005) current Step 4 version
  • 13
    • 0033036901 scopus 로고    scopus 로고
    • Classification terms in developmental toxicology: need for harmonization. Report of the second workshop on the terminology in developmental toxicology
    • COI: 1:CAS:528:DyaK1MXhsFSmtrg%3D, PID: 10080303
    • Chahoud I, Buschmann J, Clark R, et al. Classification terms in developmental toxicology: need for harmonization. Report of the second workshop on the terminology in developmental toxicology. Reprod Toxicol. 1999;13(1):77–82.
    • (1999) Reprod Toxicol , vol.13 , Issue.1 , pp. 77-82
    • Chahoud, I.1    Buschmann, J.2    Clark, R.3
  • 14
    • 18844455301 scopus 로고    scopus 로고
    • Relationships between fetal body weight of Wistar rats at term and the extent of skeletal ossification
    • COI: 1:STN:280:DC%2BD2MzhtlSltQ%3D%3D, PID: 15962182
    • Chahoud I, Paumgartten FJR. Relationships between fetal body weight of Wistar rats at term and the extent of skeletal ossification. Braz J Med Biol Res. 2005;38:565–75.
    • (2005) Braz J Med Biol Res , vol.38 , pp. 565-575
    • Chahoud, I.1    Paumgartten, F.J.R.2
  • 15
    • 37849041285 scopus 로고    scopus 로고
    • Interpretation of skeletal variations for human risk assessment: delayed ossification and wavy ribs
    • COI: 1:CAS:528:DC%2BD1cXovVOntQ%3D%3D, PID: 18157903
    • Carney EW, Kimmel CA. Interpretation of skeletal variations for human risk assessment: delayed ossification and wavy ribs. Birth Defects Res B Dev Reprod Toxicol. 2007;80(6):473–96.
    • (2007) Birth Defects Res B Dev Reprod Toxicol. , vol.80 , Issue.6 , pp. 473-496
    • Carney, E.W.1    Kimmel, C.A.2
  • 16
    • 0019783829 scopus 로고
    • Dietary deprivation induces fetal loss and abortion in rabbits
    • COI: 1:STN:280:DyaL387nslSnsQ%3D%3D, PID: 7340015
    • Matsuzawa T, Nakata M, Goto I, Tsushima M. Dietary deprivation induces fetal loss and abortion in rabbits. Toxicology. 1981;22(3):255–9.
    • (1981) Toxicology , vol.22 , Issue.3 , pp. 255-259
    • Matsuzawa, T.1    Nakata, M.2    Goto, I.3    Tsushima, M.4
  • 17
    • 0025955454 scopus 로고
    • Selection of food allotment for New Zealand white rabbits in developmental toxicity studies
    • COI: 1:CAS:528:DyaK3MXmtlWjtLc%3D, PID: 1794660
    • Clark RL, Antonello JM, Wenger JD, Deverle-Brooks K, Duchai DM. Selection of food allotment for New Zealand white rabbits in developmental toxicity studies. Fundam Appl Toxicol. 1991;17(3):584–92.
    • (1991) Fundam Appl Toxicol , vol.17 , Issue.3 , pp. 584-592
    • Clark, R.L.1    Antonello, J.M.2    Wenger, J.D.3    Deverle-Brooks, K.4    Duchai, D.M.5
  • 18
    • 33745167387 scopus 로고    scopus 로고
    • Effects of stage and degree of restricted feeding on pregnancy outcome in rabbits
    • PID: 16772706
    • Matsuoka T, Mizoguchi Y, Serizawa K, Ishikura T, Mizuguchi H, Asano Y. Effects of stage and degree of restricted feeding on pregnancy outcome in rabbits. J Toxicol Sci. 2006;31(2):169–75.
    • (2006) J Toxicol Sci , vol.31 , Issue.2 , pp. 169-175
    • Matsuoka, T.1    Mizoguchi, Y.2    Serizawa, K.3    Ishikura, T.4    Mizuguchi, H.5    Asano, Y.6
  • 19
    • 27644593029 scopus 로고    scopus 로고
    • Effects of feed restriction during organogenesis on embryo-fetal development in rabbit
    • Cappon GD, Fleeman TL, Chapin RE, Hurtt ME. Effects of feed restriction during organogenesis on embryo-fetal development in rabbit. BDR(B). 2006;74:424–30.
    • (2006) BDR(B) , vol.74 , pp. 424-430
    • Cappon, G.D.1    Fleeman, T.L.2    Chapin, R.E.3    Hurtt, M.E.4
  • 20
    • 0029055281 scopus 로고
    • A review of drug-induced Leydig cell hyperplasia and neoplasia in the rat and some comparisons with man
    • COI: 1:CAS:528:DyaK2MXnsFKmtr0%3D, PID: 7576816
    • Prentice DE, Meikle AW. A review of drug-induced Leydig cell hyperplasia and neoplasia in the rat and some comparisons with man. Hum Exp Toxicol. 1995;14(7):562–72.
    • (1995) Hum Exp Toxicol , vol.14 , Issue.7 , pp. 562-572
    • Prentice, D.E.1    Meikle, A.W.2
  • 21
    • 0032903895 scopus 로고    scopus 로고
    • Rodent Leydig cell tumorigenesis: a review of the physiology, pathology, mechanisms, and relevance to humans
    • COI: 1:CAS:528:DyaK1MXitlOrs78%3D, PID: 10213111
    • Cook JC, Klinefelter GR, Hardisty JF, Sharpe RM, Foster PM. Rodent Leydig cell tumorigenesis: a review of the physiology, pathology, mechanisms, and relevance to humans. Crit Rev Toxicol. 1999;29(2):169–261.
    • (1999) Crit Rev Toxicol , vol.29 , Issue.2 , pp. 169-261
    • Cook, J.C.1    Klinefelter, G.R.2    Hardisty, J.F.3    Sharpe, R.M.4    Foster, P.M.5
  • 22
    • 0030999939 scopus 로고    scopus 로고
    • Leydig cell hyperplasia and adenoma formation: mechanisms and relevance to humans
    • COI: 1:CAS:528:DyaK2sXhsVGktbs%3D, PID: 9138629
    • Clegg ED, Cook JC, Chapin RE, Foster PM, Daston GP. Leydig cell hyperplasia and adenoma formation: mechanisms and relevance to humans. Reprod Toxicol. 1997;11(1):107–21.
    • (1997) Reprod Toxicol , vol.11 , Issue.1 , pp. 107-121
    • Clegg, E.D.1    Cook, J.C.2    Chapin, R.E.3    Foster, P.M.4    Daston, G.P.5
  • 23
    • 0036194998 scopus 로고    scopus 로고
    • Caudal regression syndrome in twin pregnancy with type II diabetes
    • PID: 11896527
    • Zaw W, Stone DG. Caudal regression syndrome in twin pregnancy with type II diabetes. J Perinatol. 2002;22(2):171–4.
    • (2002) J Perinatol , vol.22 , Issue.2 , pp. 171-174
    • Zaw, W.1    Stone, D.G.2
  • 24
    • 12944257119 scopus 로고    scopus 로고
    • In vitro pharmacokinetics of anti-psoriatic fumaric acid esters
    • PID: 15479475
    • Litjens NH, van Strijen E, van Gulpen C, et al. In vitro pharmacokinetics of anti-psoriatic fumaric acid esters. BMC Pharmacol. 2004;4:22. doi:10.1186/1471-2210-4-22.
    • (2004) BMC Pharmacol , vol.4 , pp. 22
    • Litjens, N.H.1    van Strijen, E.2    van Gulpen, C.3
  • 26
    • 84977087619 scopus 로고    scopus 로고
    • Gilenya (fingolimod) prescribing information.
    • Accessed Oct 21, 2014
    • Gilenya (fingolimod) prescribing information. East Hanover: Novartis International AG; 2014. http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf. Accessed Oct 21, 2014.
    • (2014) East Hanover: Novartis International AG
  • 27
    • 84977183669 scopus 로고    scopus 로고
    • Aubagio (teriflunomide) prescribing information.
    • Accessed Oct 21, 2014
    • Aubagio (teriflunomide) prescribing information. Cambridge: Genzyme Corporation, a Sanofi company; 2012. http://products.sanofi.us/aubagio/aubagio.pdf. Accessed Oct 21, 2014.
    • (2012) Cambridge: Genzyme Corporation, a Sanofi company
  • 28
    • 84895813139 scopus 로고    scopus 로고
    • Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis
    • PID: 24463630
    • Karlsson G, Francis G, Koren G, et al. Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis. Neurology. 2014;82:674–80.
    • (2014) Neurology. , vol.82 , pp. 674-680
    • Karlsson, G.1    Francis, G.2    Koren, G.3
  • 29
    • 69149096504 scopus 로고    scopus 로고
    • Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study
    • COI: 1:CAS:528:DC%2BD1MXht1agtr7L, PID: 19692433
    • Weber-Schoendorfer C, Schaefer C. Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study. Mult Scler. 2009;15:1037–42.
    • (2009) Mult Scler. , vol.15 , pp. 1037-1042
    • Weber-Schoendorfer, C.1    Schaefer, C.2
  • 30
    • 78650016412 scopus 로고    scopus 로고
    • Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis
    • COI: 1:CAS:528:DC%2BC3cXhsVans7jO, PID: 21079181
    • Amato MP, Portaccio E, Ghezzi A, et al. Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis. Neurology. 2010;75:1794–802.
    • (2010) Neurology. , vol.75 , pp. 1794-1802
    • Amato, M.P.1    Portaccio, E.2    Ghezzi, A.3
  • 31
    • 84887182441 scopus 로고    scopus 로고
    • Multiple sclerosis and pregnancy: therapeutic considerations
    • COI: 1:CAS:528:DC%2BC3sXntF2jsL8%3D, PID: 22926165
    • Houtchens MK, Kolb CM. Multiple sclerosis and pregnancy: therapeutic considerations. J Neurol. 2013;260:1202–14.
    • (2013) J Neurol , vol.260 , pp. 1202-1214
    • Houtchens, M.K.1    Kolb, C.M.2
  • 32
    • 44449168535 scopus 로고    scopus 로고
    • Pregnancy, delivery and birth outcome in different stages of maternal multiple sclerosis
    • PID: 18283397
    • Dahl J, Myhr KM, Daltveit AK, Gilhus NE. Pregnancy, delivery and birth outcome in different stages of maternal multiple sclerosis. J Neurol. 2008;255(6):623–7.
    • (2008) J Neurol , vol.255 , Issue.6 , pp. 623-627
    • Dahl, J.1    Myhr, K.M.2    Daltveit, A.K.3    Gilhus, N.E.4
  • 33
    • 84867560628 scopus 로고    scopus 로고
    • Disease-modifying drugs for multiple sclerosis in pregnancy: a systematic review
    • COI: 1:CAS:528:DC%2BC38XhtlCitLvN, PID: 22933738
    • Lu E, Wang BW, Guimond C, Synnes A, Sadovnick D, Tremlett H. Disease-modifying drugs for multiple sclerosis in pregnancy: a systematic review. Neurology. 2012;79(11):1130–5.
    • (2012) Neurology. , vol.79 , Issue.11 , pp. 1130-1135
    • Lu, E.1    Wang, B.W.2    Guimond, C.3    Synnes, A.4    Sadovnick, D.5    Tremlett, H.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.