Bezpieczeństwo leków immunomodulacyjnych I linii stosowanych w stwardnieniu rozsianym w aspekcie ciąży Artykuł przeglądowy
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Opublikowane:
cze 30, 2017
Słowa kluczowe:
leki I linii, ciąża, bezpieczeństwo
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Abstrakt
Bezpieczeństwo terapii immunomodulacyjnej pacjentek ze stwardnieniem rozsianym będących w wieku reprodukcyjnym jest zagadnieniem bardzo istotnym, gdyż może ona wpływać na planowanie ciąży, koncepcję, przebieg ciąży i na sam płód. Liczne analizy potwierdzające brak negatywnego wpływu iniekcyjnych leków immunomodulacyjnych na ciążę i ich wysoki profil bezpieczeństwa pozwalają liberalniej spojrzeć na ten sposób leczenia w I linii w aspekcie ciąży. Wstępne dane dotyczące nowych leków doustnych są optymistyczne, ale wymagają jeszcze potwierdzenia.
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Bibliografia
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15. Salminen H.J., Leggett H., Boggild M.: Glatiramer acetate exposure in pregnancy: preliminary safety and birth outcomes. J. Neurol. 2010; 257: 2020-2023.
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19. Neudorfer O., Baruch P., Kolodny S. et al.: Pregnancy outcomes in patients with MS expose to branded glatiramer acetate. Prezentacja: AAN 2017; plakat 1.365.
20. Queiber-Wahrendorf A., Neumann D., Adamus E.: Early childhood development up to kindergarten age after glatiramer acetate exposure during early pregnancy in women with multiple sclerosis. Prezentacja: AAN 2017; plakat 1.348.
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24. Li J., Fox R., Phillips J. et al.: Delayed-release dimethyl fumarate and pregnancy: Preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience. Prezentacja: ECTRIMS 2015; plakat 608.
25. Everage N.J., Liu S., Newhook T.: Pregnancy outcomes with delayed-release dimethyl fumarate: preliminary registry results. Prezentacja: ECTRIMS 2016; plakat 714.
2. Boskovic R., Wide R., Wolpin J. et al.: The reproductive effects of beta interferon therapy in pregnancy: A longitudinal cohort. Neurology 2005; 65: 807-811.
3. Sandberg-Wollheim M., Frank D., Goodwin T.M. et al.: Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis. Neurology 2005; 65: 802-806.
4. Coyle P.K., Roberts S., Scheuerle A. et al.: The Betaseron (Interferon Beta-1b) Pregnancy Registry. Int. J. MS Care 2010; 12: 26-28.
5. Foulds P., Richman S., Glick G. et al.: Pregnancy outcomes from the Avonex® (interferon beta-1a) pregnancy exposure registry. Mult. Scler. 2010; 16: 894-896.
6. Lu E., Wang B.W., Guimond C. et al.: Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review. Neurology 2012; 79: 1130-1135.
7. Amato M.P., Portaccio E., Ghezzi A. et al.: Pregnancy and fetal outcomes after interferon-beta exposure in multiple sclerosis. Neurology 2010; 75: 1794-1802.
8. Hale T.W., Siddiqui A.A., Baker T.E.: Transfer of interferon b-1a into human breastmilk. Breastfeed Med. 2012: 7: 123-125.
9. Avonex. Summary of product characteristics [online].
10. Rebif. Summary of product characteristics [online].
11. Betaferon. Summary of product characteristics [online].
12. Copaxone (galtiramer acetate). Summary of product characteristic [online].
13. Coyle P., Johnson K., Pardo L.: Pregnancy outcomes in patients with multiple sclerosis treated with glatiramer acetate (Copaxone). Neurology 2003; 60: 60-62.
14. Fragoso Y.D., Finkelsztejn A., Kaimen-Maciel D.R. et al.: Long term use of glatiramer acetate by 11 pregnant women with multiple sclerosis; a retrospective, multicentre case series. CNC Drugs 2010; 24: 969-976.
15. Salminen H.J., Leggett H., Boggild M.: Glatiramer acetate exposure in pregnancy: preliminary safety and birth outcomes. J. Neurol. 2010; 257: 2020-2023.
16. Giannini M., Portaccio E., Ghezzi A. et al.: Pregnancy and fetal outcomes after glatiramer acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study. BMC Neurol. 2012; 12: 124-126.
17. Neudorfer O., Baruch P., Pery S.: Effect of exposure to branded glatiramer acetate during pregnancy on rates of pregnancy loss. Prezentacja: ECTRIMS 2016; plakat 1226.
18. Neudorfer O., Sandberg-Wolheim M., Coyle P.K.: The branded glatiramer acetate pregnancy database. Prezentacja: ECTRIMS 2015; plakat 1507.
19. Neudorfer O., Baruch P., Kolodny S. et al.: Pregnancy outcomes in patients with MS expose to branded glatiramer acetate. Prezentacja: AAN 2017; plakat 1.365.
20. Queiber-Wahrendorf A., Neumann D., Adamus E.: Early childhood development up to kindergarten age after glatiramer acetate exposure during early pregnancy in women with multiple sclerosis. Prezentacja: AAN 2017; plakat 1.348.
21. Hellwig K., Gold R.: Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J. Neurol. 2011; 258: 502-503.
22. Tekwidera (dimethyl fumarate). Summary of product characteristic [online].
23. Gold R.J., Phillips J.T., Havrdova E. et al.: Delayed-release demethyl fumarate and pregnancy: preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience. Neurol. Ther. 2015; 4: 93-104.
24. Li J., Fox R., Phillips J. et al.: Delayed-release dimethyl fumarate and pregnancy: Preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience. Prezentacja: ECTRIMS 2015; plakat 608.
25. Everage N.J., Liu S., Newhook T.: Pregnancy outcomes with delayed-release dimethyl fumarate: preliminary registry results. Prezentacja: ECTRIMS 2016; plakat 714.