Leczenie immunomodulacyjne (DMT) a ciąża Artykuł przeglądowy
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Opublikowane:
wrz 30, 2020
Słowa kluczowe:
leki immunomodulacyjne, ciąża, bezpieczeństwo
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Abstrakt
Wiedza na temat bezpieczeństwa terapii immunomodulacyjnej w stwardnieniu rozsianym i jej wpływu na przebieg ciąży jest niezmiernie istotna. Leki pierwszego i drugiego rzutu mają różny profil bezpieczeństwa i wraz z dostępnością do nowych danych nasze spojrzenie na konkretne terapie stale ulega zmianie. Znajomość tego zagadnienia pozwala właściwie zaplanować terapię pacjentek w wieku reprodukcyjnym, które planują ciążę, jak również uniknąć potencjalnych następstw w przypadku nieplanowanej ciąży.
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Numer
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Artykuły
Copyright © by Medical Education. All rights reserved.
Bibliografia
1. Van der Kop M, Pearce M, Dahlgren L et al. Neonatal and delivery outcomes in women with multiple sclerosis. Ann Neurol. 2011; 70: 41-50.
2. Houtchens M, Edwards N, Schneider G et al. Pregnancy rates and outcomes in women with and without MS in the United States. Neurology. 2018; 91(17): e1559-69.
3. Confavreux Ch, Hutchinson H, Hours M et al. Rate of pregnancy-related relapse in multiple sclerosis. N Engl J Med. 1998; 339(5): 285-91.
4. Langer-Gould A. Prezentacja: ANN Annual Meeting, 2019. Platform Session S6.007.
5. Fragoso Y, Adoni T, Vasconcelos C. Practical evidence-based recommendations for patients with multiple sclerosis who want to have children. Neurol Ther. 2018; 7(2): 207-32.
6. Hughes S, Spelman T, Gray O et al. Predictors and dynamics of postpartum relapses in women with multiple sclerosis. Mult Scler. 2014; 20(6): 739-46.
7. Rebif®. ChPL, Avonex®. ChPL. Betaferon®, ChPL, Plegridy®. ChPL.
8. Ferrero S, Pretta S, Ragni N. Multiple sclerosis: Management issues during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2004; 115: 3-9.
9. Boskovic R, Wide R, Wolpin J et al. The reproductive effects of beta interferon therapy in pregnancy: A longitudinal cohort. Neurology. 2005; 65: 807-11.
10. Sandberg-Wollheim M, Frank D, Goodwin TM et al. Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis. Neurology. 2005; 65: 802-6.
11. Coyle PK, Roberts S, Scheuerle A et al. The Betaseron (Interferon Beta-1b) Pregnancy Registry. Int J MS Care. 2010; 12: 26-8.
12. Foulds P, Richman S, Glick G et al. Pregnancy outcomes from the Avonex® (interferon beta-1a) pregnancy exposure registry. Mult Scler. 2010; 16: 894-6.
13. Hellwig K, Geissbuehler Y, Sabidó M et al. Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry. J Neurol. 2020; 267: 1715-23.
14. Burkill S, Vattulainen P, Geissbuehler Y et al. The association between exposure to interferon-beta during pregnancy and birth measurement in offspring of women with multiple sclerosis. PLoS One. 2019; 14(12): e0227120.
15. Hellwig K. The fetal/child perspective – risks related drug exposure of the child, breastfeeding and when to reassume medication. ECTRIMS. 2019 Online Library.
16. Hale TW, Siddiqui AA, Baker TE. Transfer of interferon b-1a into human breastmilk. Breastfeed Med. 2012; 7: 123-5.
17. Cilpea A, Langer-Gould A, Stahl A et al. Safety of potential breast milk exposure to INF-β or glatiramer acetate. One-year infant outcomes. Neurology. 2020; 7(4): e757.
18. Montalban X, Gold R, Thompson A et al. ECTRIMS/EAN guadline on the pharmacological treatment of people with multiple sclerosis. Eur J Neurol. 2018; 25: 215-37.
19. Dobson R, Dassan P, Roberts M et al. UK consensus on pregnancy in multiple sclerosis: Association of British Neurologists’ guidelines. Pract Neurol. 2019; 19: 106-14.
20. Ministerstwo Zdrowia. Obwieszczenie Ministra Zdrowia z dnia 24 sierpnia 2020 r. w sprawie wykazu refundowanych leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych na 1 września 2020 r.
21. Copaxone®. ChPL
22. Coyle P, Johnson K, Pardo L. Pregnancy outcomes in patients with multiple sclerosis treated with glatiramer acetate (Copaxone). Neurology. 2003; 60: 60-2.
23. Fragoso YD, Finkelsztejn A, Kaimen-Maciel DR et al. Long term use of glatiramer acetate by 11 pregnant women with multiple sclerosis; a retrospective, multicentre case series. CNC Drugs. 2010; 24: 969-76.
24. Salminen HJ, Leggett H, Boggild M. Glatiramer acetate exposure in pregnancy: preliminary safety and birth outcomes. J Neurol. 2010; 257: 2020-3.
25. 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: 124-6.
26. Neudorfer O, Baruch P, Kolodny S et al. Pregnancy Outcomes in patients with MS expose to branded glatiramer acetate. Prezentacja: AAN. 2017; P1365.
27. Hellwig K, Neudorfer O, Melamed-Gal S et al. Pregnancy outcomes in patients with multiple sclerosis and exposure branded glatiramer acetate during all three trimesters. Prezentacja: ECTRIMS. 2017; P765.
28. 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; P1348.
29. Hellwig K, Gold R. Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J Neurol. 2011; 258: 502-3.
30. Tecfidera®. ChPL .
31. Gold RJ, Phillips JT, Havrdova E et al. Delayed-release dimethyl fumarate and pregnancy: preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience. Neurol Ther. 2015; 4: 93-104.
32. Li J, Fox R, Phillips J et al. Delayed-release dimethyl fumarate and pregnancy: Preclinical studies and pregnancy outcomes from clinical trials and post-marketing experience. Prezentacja: ECTRIMS. 2015; P608.
33. Hellwig K, Rog D, McGuigan Ch et al. Interim analysis of pregnancy outcomes following exposure to dimethyl fumarate in a prospective international registry. ECTRIMS-ACTRIMS. 2020; P0345.
34. Aubagio®. ChPL.
35. Kieseier B, Benamor M. Pregnancy outcome following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis. Neurol Ther. 2014; 3: 133-8.
36. Vukusic S, Coyle P, Jurgensen S et al. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: Clinical study data and 5-years of post-marketing experience. Mult Scler. 2020; 26(7): 829-36.
37. Aubagio®. ChPL.
38. Gilenya®. ChPL .
39. Collins W, Francis G, Koren G et al. Lack of interaction between fingolimod (FTY720) and oral contraceptives, and pregnancy experience in clinical program of fingolimod in MS. AAN. 2011; P7184.
40. Geissbuhler Y, Butzkueven H, Harnandez-Diaz S et al. Multinational Gilenya Pregnancy Exposure Registry: preliminary results. Prezentacja: AAN. 2013; P403.
41. Geissbuhler Y, Koren G, Wang H et al. Pregnancy outcomes after exposure to fingolimod and in the general population. Prezentacja: ECTRIMS. 2015; P61.
42. Lopez-Leon S. Effect of fingolimod on pregnancy outcomes in patients with multiple sclerosis. Prezentacja: ECTRIMS. 2019; P411.
43. EMA. Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy .
44. Prach LM, Moore A, Rezzallah B et al. Cumulative update on pregnancy outcomes afer fingolimod treatment in patients with multiple sclerosis. ECTRIMS-ACTRIMS. 2020; P1118.
45. Mavenclad®. ChPL .
46. Giovannoni G, Galazka A, Schick R et al. Pregnancy outcomes during the clinical development program of cladribine in multiple sclerosis: An integrated analysis of safety. Drug Saf. 2020; 43(7): 635-43.
47. Tysabri®. ChPL .
48. Ebrahimi N, Herbstritt S, Gold R et al. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler. 2015; 21(2): 198-205.
49. Portaccio E, Annovazzi P, Ghezzi A et al. Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks. Neurology. 2018; 90(10): e823-e831.
50. Peng A, Qiu X, Zhang L et al. Natalizumab exposure during pregnancy in multiple sclerosis: a systematic review. J Neurol Science. 2019; 396: 202-5.
51. Haghikia A, Langer-Gould A, Rellensmann G et al. Natalizumab use during the third trimester of pregnancy. JAMA Neurol. 2014; 71(7): 891-5.
52. Friend S, Richman S, Bloomgren G et al. Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. 2016; 16(1): 150. https://doi.org/10.1186/s12883-016-0674-4.
53. Kümpfel T, Thiel S, Meinl I et al. Long-term exposure to natalizumab during pregnancy - a prospective case series from the German Multiple Sclerosis and Pregnancy Registry. Prezentacja: ECTRIMS. 2017.
54. Portaccio E, Moiola L, Martinelli V et al. Pregnancy decison-making in women withmultiple sclerosis treated with natalizumab: II maternal risks. Neurology. 2018; 90: 832-9.
55. Baker T, Cooper S, Kessler L et al. Transfer of natalizumab into breast milk in a mother with multiple sclerosis. J Hum Lact. 2015; 31(2): 233-6.
56. Ocrevus®. ChPL .
57. Bove R, Oreja-Guevera C, Hellwig K et al. Pregnancy outcomes in patients treated with ocrelizumab. ACTRIMS-ECTRIMS. 2020; P1132.
58. Chakravarty E, Murray E, Kelman A et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011; 117: 1499-506.
59. Lemtrada®. ChPL .
60. Rog D. Pregnancy outcomes in patients with RRMS Treated With Alemtuzumab From the Clinical Development Program. Prezentacja: ECTRIMS. 2017; P749.
61. McCarthy C, Brown J, Tuohy O et al. Long-term safety of alemtuzumab in relapsing-remitting multiple sclerosis: pregnancy and infection data from a cohort of patients on open label studies in Cambridge, UK. Long-term safety of alemtuzumab in relapsing-remitting multiple sclerosis: pregnancy and infection data from a cohort of patients on open label studies in Cambridge. Prezentacja: ECTRIMS. 2015.
62. Gerbershagen KS, Thiel S, Limmroth V et al. Disease activity during pregnancy and pregnancy outcomes in patients with multiple sclerosis (MS) treated with alemtuzumab – A case series from the German MS and pregnancy registry. Prezentacja: ECTRIMS. 2016; P862.
63. Daniels G, Vladic A, Brinar V et al. Alemtuzumab-related thyroid dysfunction in a phase 2 trial of patients with relapsing-remitting multiple sclerosis. J Clin Endocrinol Metab. 2014; 99: 80-9.
64. Rog D. Pregnancy outcomes in patients with RRMS treated with alemtuzumab from the clinical development program. Prezentacja: ECTRIMS. 2017; P749.
65. Celius E, Ciplea A, Drulović J et al. Alemtuzumab and pregnancy – case series from the German MS and Pregnancy Registry, Norway and Serbia. Prezentacja: ECTRIMS. 2018; P915.
2. Houtchens M, Edwards N, Schneider G et al. Pregnancy rates and outcomes in women with and without MS in the United States. Neurology. 2018; 91(17): e1559-69.
3. Confavreux Ch, Hutchinson H, Hours M et al. Rate of pregnancy-related relapse in multiple sclerosis. N Engl J Med. 1998; 339(5): 285-91.
4. Langer-Gould A. Prezentacja: ANN Annual Meeting, 2019. Platform Session S6.007.
5. Fragoso Y, Adoni T, Vasconcelos C. Practical evidence-based recommendations for patients with multiple sclerosis who want to have children. Neurol Ther. 2018; 7(2): 207-32.
6. Hughes S, Spelman T, Gray O et al. Predictors and dynamics of postpartum relapses in women with multiple sclerosis. Mult Scler. 2014; 20(6): 739-46.
7. Rebif®. ChPL, Avonex®. ChPL. Betaferon®, ChPL, Plegridy®. ChPL.
8. Ferrero S, Pretta S, Ragni N. Multiple sclerosis: Management issues during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2004; 115: 3-9.
9. Boskovic R, Wide R, Wolpin J et al. The reproductive effects of beta interferon therapy in pregnancy: A longitudinal cohort. Neurology. 2005; 65: 807-11.
10. Sandberg-Wollheim M, Frank D, Goodwin TM et al. Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis. Neurology. 2005; 65: 802-6.
11. Coyle PK, Roberts S, Scheuerle A et al. The Betaseron (Interferon Beta-1b) Pregnancy Registry. Int J MS Care. 2010; 12: 26-8.
12. Foulds P, Richman S, Glick G et al. Pregnancy outcomes from the Avonex® (interferon beta-1a) pregnancy exposure registry. Mult Scler. 2010; 16: 894-6.
13. Hellwig K, Geissbuehler Y, Sabidó M et al. Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry. J Neurol. 2020; 267: 1715-23.
14. Burkill S, Vattulainen P, Geissbuehler Y et al. The association between exposure to interferon-beta during pregnancy and birth measurement in offspring of women with multiple sclerosis. PLoS One. 2019; 14(12): e0227120.
15. Hellwig K. The fetal/child perspective – risks related drug exposure of the child, breastfeeding and when to reassume medication. ECTRIMS. 2019 Online Library.
16. Hale TW, Siddiqui AA, Baker TE. Transfer of interferon b-1a into human breastmilk. Breastfeed Med. 2012; 7: 123-5.
17. Cilpea A, Langer-Gould A, Stahl A et al. Safety of potential breast milk exposure to INF-β or glatiramer acetate. One-year infant outcomes. Neurology. 2020; 7(4): e757.
18. Montalban X, Gold R, Thompson A et al. ECTRIMS/EAN guadline on the pharmacological treatment of people with multiple sclerosis. Eur J Neurol. 2018; 25: 215-37.
19. Dobson R, Dassan P, Roberts M et al. UK consensus on pregnancy in multiple sclerosis: Association of British Neurologists’ guidelines. Pract Neurol. 2019; 19: 106-14.
20. Ministerstwo Zdrowia. Obwieszczenie Ministra Zdrowia z dnia 24 sierpnia 2020 r. w sprawie wykazu refundowanych leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych na 1 września 2020 r.
21. Copaxone®. ChPL
22. Coyle P, Johnson K, Pardo L. Pregnancy outcomes in patients with multiple sclerosis treated with glatiramer acetate (Copaxone). Neurology. 2003; 60: 60-2.
23. Fragoso YD, Finkelsztejn A, Kaimen-Maciel DR et al. Long term use of glatiramer acetate by 11 pregnant women with multiple sclerosis; a retrospective, multicentre case series. CNC Drugs. 2010; 24: 969-76.
24. Salminen HJ, Leggett H, Boggild M. Glatiramer acetate exposure in pregnancy: preliminary safety and birth outcomes. J Neurol. 2010; 257: 2020-3.
25. 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: 124-6.
26. Neudorfer O, Baruch P, Kolodny S et al. Pregnancy Outcomes in patients with MS expose to branded glatiramer acetate. Prezentacja: AAN. 2017; P1365.
27. Hellwig K, Neudorfer O, Melamed-Gal S et al. Pregnancy outcomes in patients with multiple sclerosis and exposure branded glatiramer acetate during all three trimesters. Prezentacja: ECTRIMS. 2017; P765.
28. 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; P1348.
29. Hellwig K, Gold R. Glatiramer acetate and interferon-beta throughout gestation and postpartum in women with multiple sclerosis. J Neurol. 2011; 258: 502-3.
30. Tecfidera®. ChPL .
31. Gold RJ, Phillips JT, Havrdova E et al. Delayed-release dimethyl fumarate and pregnancy: preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience. Neurol Ther. 2015; 4: 93-104.
32. Li J, Fox R, Phillips J et al. Delayed-release dimethyl fumarate and pregnancy: Preclinical studies and pregnancy outcomes from clinical trials and post-marketing experience. Prezentacja: ECTRIMS. 2015; P608.
33. Hellwig K, Rog D, McGuigan Ch et al. Interim analysis of pregnancy outcomes following exposure to dimethyl fumarate in a prospective international registry. ECTRIMS-ACTRIMS. 2020; P0345.
34. Aubagio®. ChPL.
35. Kieseier B, Benamor M. Pregnancy outcome following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis. Neurol Ther. 2014; 3: 133-8.
36. Vukusic S, Coyle P, Jurgensen S et al. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: Clinical study data and 5-years of post-marketing experience. Mult Scler. 2020; 26(7): 829-36.
37. Aubagio®. ChPL.
38. Gilenya®. ChPL .
39. Collins W, Francis G, Koren G et al. Lack of interaction between fingolimod (FTY720) and oral contraceptives, and pregnancy experience in clinical program of fingolimod in MS. AAN. 2011; P7184.
40. Geissbuhler Y, Butzkueven H, Harnandez-Diaz S et al. Multinational Gilenya Pregnancy Exposure Registry: preliminary results. Prezentacja: AAN. 2013; P403.
41. Geissbuhler Y, Koren G, Wang H et al. Pregnancy outcomes after exposure to fingolimod and in the general population. Prezentacja: ECTRIMS. 2015; P61.
42. Lopez-Leon S. Effect of fingolimod on pregnancy outcomes in patients with multiple sclerosis. Prezentacja: ECTRIMS. 2019; P411.
43. EMA. Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy .
44. Prach LM, Moore A, Rezzallah B et al. Cumulative update on pregnancy outcomes afer fingolimod treatment in patients with multiple sclerosis. ECTRIMS-ACTRIMS. 2020; P1118.
45. Mavenclad®. ChPL .
46. Giovannoni G, Galazka A, Schick R et al. Pregnancy outcomes during the clinical development program of cladribine in multiple sclerosis: An integrated analysis of safety. Drug Saf. 2020; 43(7): 635-43.
47. Tysabri®. ChPL .
48. Ebrahimi N, Herbstritt S, Gold R et al. Pregnancy and fetal outcomes following natalizumab exposure in pregnancy. A prospective, controlled observational study. Mult Scler. 2015; 21(2): 198-205.
49. Portaccio E, Annovazzi P, Ghezzi A et al. Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks. Neurology. 2018; 90(10): e823-e831.
50. Peng A, Qiu X, Zhang L et al. Natalizumab exposure during pregnancy in multiple sclerosis: a systematic review. J Neurol Science. 2019; 396: 202-5.
51. Haghikia A, Langer-Gould A, Rellensmann G et al. Natalizumab use during the third trimester of pregnancy. JAMA Neurol. 2014; 71(7): 891-5.
52. Friend S, Richman S, Bloomgren G et al. Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. 2016; 16(1): 150. https://doi.org/10.1186/s12883-016-0674-4.
53. Kümpfel T, Thiel S, Meinl I et al. Long-term exposure to natalizumab during pregnancy - a prospective case series from the German Multiple Sclerosis and Pregnancy Registry. Prezentacja: ECTRIMS. 2017.
54. Portaccio E, Moiola L, Martinelli V et al. Pregnancy decison-making in women withmultiple sclerosis treated with natalizumab: II maternal risks. Neurology. 2018; 90: 832-9.
55. Baker T, Cooper S, Kessler L et al. Transfer of natalizumab into breast milk in a mother with multiple sclerosis. J Hum Lact. 2015; 31(2): 233-6.
56. Ocrevus®. ChPL .
57. Bove R, Oreja-Guevera C, Hellwig K et al. Pregnancy outcomes in patients treated with ocrelizumab. ACTRIMS-ECTRIMS. 2020; P1132.
58. Chakravarty E, Murray E, Kelman A et al. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011; 117: 1499-506.
59. Lemtrada®. ChPL .
60. Rog D. Pregnancy outcomes in patients with RRMS Treated With Alemtuzumab From the Clinical Development Program. Prezentacja: ECTRIMS. 2017; P749.
61. McCarthy C, Brown J, Tuohy O et al. Long-term safety of alemtuzumab in relapsing-remitting multiple sclerosis: pregnancy and infection data from a cohort of patients on open label studies in Cambridge, UK. Long-term safety of alemtuzumab in relapsing-remitting multiple sclerosis: pregnancy and infection data from a cohort of patients on open label studies in Cambridge. Prezentacja: ECTRIMS. 2015.
62. Gerbershagen KS, Thiel S, Limmroth V et al. Disease activity during pregnancy and pregnancy outcomes in patients with multiple sclerosis (MS) treated with alemtuzumab – A case series from the German MS and pregnancy registry. Prezentacja: ECTRIMS. 2016; P862.
63. Daniels G, Vladic A, Brinar V et al. Alemtuzumab-related thyroid dysfunction in a phase 2 trial of patients with relapsing-remitting multiple sclerosis. J Clin Endocrinol Metab. 2014; 99: 80-9.
64. Rog D. Pregnancy outcomes in patients with RRMS treated with alemtuzumab from the clinical development program. Prezentacja: ECTRIMS. 2017; P749.
65. Celius E, Ciplea A, Drulović J et al. Alemtuzumab and pregnancy – case series from the German MS and Pregnancy Registry, Norway and Serbia. Prezentacja: ECTRIMS. 2018; P915.