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Bibliografia
1. Losy J, Bartosik-Psujek H, Członkowska A et al. Leczenie stwardnienia rozsianego. Zalecenia Polskiego Towarzystwa Neurologicznego. Pol Prz Neurol. 2016; 12(2): 80-95.
2. Programy Lekowe. Załącznik B.29. Leczenie chorych na stwardnienie rozsiane. 01.07.2023, Ministerstwo Zdrowia. Obwieszczenie Ministra Zdrowia z dnia 11 grudnia 2023 r. w sprawie wykazu refundowanych leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych na 1 stycznia 2024 r.
3. Kułakowska A, Mirowska-Guzel D, Kalinowska A et al. Leczenie modyfikujące przebieg stwardnienia rozsianego Rekomendacje Sekcji Stwardnienia Rozsianego i Neuroimmunologii Polskiego Towarzystwa Neurologicznego. Pol Prz Neurol. 2023; 19: 163-89. http://doi.org/10.5603/PPN.a2023.0018.
4. EMA, Tecdifera: EPAR – Product Information.
5. EMA. Summary of opinion. Tecfidera .
6. Tecfidera ChPL 10/2023.
7. Yadav SK, Soin D, Ito K, Dhib-Jalbut S. Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis. J Mol Med (Berl). 2019; 97(4): 463-72. http://doi.org/10.1007/s00109-019-01761-5.
8. Gold R, Kappos L, Arnold DL et al.; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012; 367(12): 1098-107. http://doi.org/10.1056/NEJMoa1114287. Erratum in: N Engl J Med. 2012; 367(24): 2362.
9. Fox RJ, Miller DH, Phillips JT et al.; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012; 367(12): 1087-97. http://doi.org/10.1056/NEJMoa1206328. Erratum in: N Engl J Med. 2012; 367(17): 1673.
10. Viglietta V, Miller D, Bar-Or A et al. Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials. Ann Clin Transl Neurol. 2015; 2(2): 103-18. http://doi.org/10.1002/acn3.148.
11. Gold R, Giovannoni G, Phillips JT et al. Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mult Scler. 2015; 21(1): 57-66. http://doi.org/10.1177/1352458514537013.
12. Gold R, Arnold DL, Bar-Or A et al. Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results. Mult Scler. 2022; 28(5): 801-16. http://doi.org/10.1177/13524585211037909.
13. Pandey K, Giles K, Balashov K et al. Real World Safety, Efficacy, and Patient-Related Outcomes of Delayed-release Dimethyl Fumarate in Patients with Relapsing Multiple Sclerosis: 5-Year Results From ESTEEM. Consortium of Multiple Sclerosis Centers 2021 Annual Meeting. 2021 Oct 25-28, Orlando, FL.
14. Pilo de la Fuente B, Sabín J, Galán V et al.; Dimethyl Fumarate Study Group. Three-Year Effectiveness of Dimethyl Fumarate in Multiple Sclerosis: A Prospective Multicenter Real-World Study. CNS Drugs. 2020; 34(12): 1275-86. http://doi.org/10.1007/s40263-020-00775-9.
15. Berger T, Brochet B, Brambilla L et al. Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC. Mult Scler J Exp Transl Clin. 2019; 5(4): 2055217319887191. http://doi.org/10.1177/2055217319887191. Erratum in: Mult Scler J Exp Transl Clin. 2020; 6(2): 2055217320921146.
16. Zanghì A, Avolio C, Amato MP et al.; Italian MS register. Real world comparison of teriflunomide and dimethyl fumarate in naïve relapsing multiple sclerosis patients: Evidence from the Italian MS register. Mult Scler Relat Disord. 2022; 58: 103489. http://doi.org/10.1016/j.msard.2022.103489.
17. Norborg H, Riise T, Myhr KM et al. Real-world discontinuation rate of teriflunomide and dimethyl fumarate in multiple sclerosis. Mult Scler J Exp Transl Clin. 2021; 7(2): 20552173211022027. http://doi.org/10.1177/20552173211022027.
18. Braune S, Grimm S, van Hövell P et al.; NTD Study Group. Comparative effectiveness of delayed-release dimethyl fumarate versus interferon, glatiramer acetate, teriflunomide, or fingolimod: results from the German NeuroTransData registry. J Neurol. 2018; 265(12): 2980-92. http://doi.org/10.1007/ s00415-018-9083-5.
19. Buron MD, Chalmer TA, Sellebjerg F et al. Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study. Neurology. 2019; 92(16): e1811-e1820. http://doi.org/10.1212/WNL.0000000000007314.
20. Lee A, Pike J, Edwards MR et al. Quantifying the Benefits of Dimethyl Fumarate Over β Interferon and Glatiramer Acetate Therapies on Work Productivity Outcomes in MS Patients. Neurol Ther. 2017; 6(1): 79-90. http://doi.org/10.1007/s40120-016-0061-5.
21. Lorscheider J, Benkert P, Lienert C et al. Comparative analysis of dimethyl fumarate and fingolimod in relapsing-remitting multiple sclerosis. J Neurol. 2021; 268(3): 941-9. http://doi.org/10.1007/s00415-020-10226-6.
22. Gold R, Arnold DL, Bar-Or A et al. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020; 13: 1756286420915005. http://doi.org/10.1177/1756286420915005. Erratum in: Ther Adv Neurol Disord. 2020; 13: 1756286420968357.
23. Havrdova E, Hutchinson M, Kurukulasuriya NC et al. Oral BG-12 (dimethyl fumarate) for relapsing–remitting multiple sclerosis: a review of DEFINE and CONFIRM. Expert Opin Pharmacother. 2013; 14(15): 2145-56. http://doi.org/10.1517/14656566.2013.826190.
24. Phillips JT, Selmaj K, Gold R et al. Clinical Significance of Gastrointestinal and Flushing Events in Patients with Multiple Sclerosis Treated with Delayed-Release Dimethyl Fumarate. Int J MS Care. 2015; 17(5): 236-43. http://doi.org/10.7224/1537-2073.2014-069.
25. Lyons J, Hughes R, McCarthy K et al. Progressive multifocal leukoencephalopathy outcomes in patients with multiple sclerosis treated with dimethyl fumarate. Mult Scler J Exp Transl Clin. 2022; 8(4): 20552173221132469. http://doi.org/10.1177/20552173221132469. Erratum in: Mult Scler J Exp Transl Clin. 2023; 9(1): 20552173231160312.
26. Fox RJ, Chan A, Gold R et al. Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: patient management considerations. Neurol Clin Pract. 2016; 6: 220-9.
27. Mehta D, Miller C, Arnold DL et al. Effect of dimethyl fumarate on lymphocytes in RRMS Implications for clinical practice. Neurology. 2019; 92(15): e1724-e1738.
28. Hellwig K, Rog D, McGuigan C et al. Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry. Neurol Neuroimmunol Neuroinflamm. 2021; 9(1): e1114. http://doi.org/10.1212/NXI.0000000000001114.
29. GILENA ChPL 09/2023.
30. AUBAGO ChPL 07/2023.
31. MAVECLAD ChPL 04/2022.
32. Andersen JB, Sellebjerg F, Magyari M. Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis. Eur J Neurol. 2023; 30(1): 162-71. http://doi.org/10.1111/ene.15559.
33. von Hehn C, Howard J, Liu S et al. Immune response to vaccines is maintained in patients treated with dimethyl fumarate. Neurol Neuroimmunol Neuroinflamm. 2017; 5(1): e409. http://doi.org/10.1212/NXI.0000000000000409.
34. Moser T, Seiberl M, Feige J et al. Tetravalent Influenza Vaccine Is Not Associated with Neuroaxonal Damage in Multiple Sclerosis Patients. Front Immunol. 2021; 12: 718895. http://doi.org/10.3389/fimmu.2021.718895.
2. Programy Lekowe. Załącznik B.29. Leczenie chorych na stwardnienie rozsiane. 01.07.2023, Ministerstwo Zdrowia. Obwieszczenie Ministra Zdrowia z dnia 11 grudnia 2023 r. w sprawie wykazu refundowanych leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych na 1 stycznia 2024 r.
3. Kułakowska A, Mirowska-Guzel D, Kalinowska A et al. Leczenie modyfikujące przebieg stwardnienia rozsianego Rekomendacje Sekcji Stwardnienia Rozsianego i Neuroimmunologii Polskiego Towarzystwa Neurologicznego. Pol Prz Neurol. 2023; 19: 163-89. http://doi.org/10.5603/PPN.a2023.0018.
4. EMA, Tecdifera: EPAR – Product Information.
5. EMA. Summary of opinion. Tecfidera .
6. Tecfidera ChPL 10/2023.
7. Yadav SK, Soin D, Ito K, Dhib-Jalbut S. Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis. J Mol Med (Berl). 2019; 97(4): 463-72. http://doi.org/10.1007/s00109-019-01761-5.
8. Gold R, Kappos L, Arnold DL et al.; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012; 367(12): 1098-107. http://doi.org/10.1056/NEJMoa1114287. Erratum in: N Engl J Med. 2012; 367(24): 2362.
9. Fox RJ, Miller DH, Phillips JT et al.; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012; 367(12): 1087-97. http://doi.org/10.1056/NEJMoa1206328. Erratum in: N Engl J Med. 2012; 367(17): 1673.
10. Viglietta V, Miller D, Bar-Or A et al. Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials. Ann Clin Transl Neurol. 2015; 2(2): 103-18. http://doi.org/10.1002/acn3.148.
11. Gold R, Giovannoni G, Phillips JT et al. Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mult Scler. 2015; 21(1): 57-66. http://doi.org/10.1177/1352458514537013.
12. Gold R, Arnold DL, Bar-Or A et al. Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results. Mult Scler. 2022; 28(5): 801-16. http://doi.org/10.1177/13524585211037909.
13. Pandey K, Giles K, Balashov K et al. Real World Safety, Efficacy, and Patient-Related Outcomes of Delayed-release Dimethyl Fumarate in Patients with Relapsing Multiple Sclerosis: 5-Year Results From ESTEEM. Consortium of Multiple Sclerosis Centers 2021 Annual Meeting. 2021 Oct 25-28, Orlando, FL.
14. Pilo de la Fuente B, Sabín J, Galán V et al.; Dimethyl Fumarate Study Group. Three-Year Effectiveness of Dimethyl Fumarate in Multiple Sclerosis: A Prospective Multicenter Real-World Study. CNS Drugs. 2020; 34(12): 1275-86. http://doi.org/10.1007/s40263-020-00775-9.
15. Berger T, Brochet B, Brambilla L et al. Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC. Mult Scler J Exp Transl Clin. 2019; 5(4): 2055217319887191. http://doi.org/10.1177/2055217319887191. Erratum in: Mult Scler J Exp Transl Clin. 2020; 6(2): 2055217320921146.
16. Zanghì A, Avolio C, Amato MP et al.; Italian MS register. Real world comparison of teriflunomide and dimethyl fumarate in naïve relapsing multiple sclerosis patients: Evidence from the Italian MS register. Mult Scler Relat Disord. 2022; 58: 103489. http://doi.org/10.1016/j.msard.2022.103489.
17. Norborg H, Riise T, Myhr KM et al. Real-world discontinuation rate of teriflunomide and dimethyl fumarate in multiple sclerosis. Mult Scler J Exp Transl Clin. 2021; 7(2): 20552173211022027. http://doi.org/10.1177/20552173211022027.
18. Braune S, Grimm S, van Hövell P et al.; NTD Study Group. Comparative effectiveness of delayed-release dimethyl fumarate versus interferon, glatiramer acetate, teriflunomide, or fingolimod: results from the German NeuroTransData registry. J Neurol. 2018; 265(12): 2980-92. http://doi.org/10.1007/ s00415-018-9083-5.
19. Buron MD, Chalmer TA, Sellebjerg F et al. Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study. Neurology. 2019; 92(16): e1811-e1820. http://doi.org/10.1212/WNL.0000000000007314.
20. Lee A, Pike J, Edwards MR et al. Quantifying the Benefits of Dimethyl Fumarate Over β Interferon and Glatiramer Acetate Therapies on Work Productivity Outcomes in MS Patients. Neurol Ther. 2017; 6(1): 79-90. http://doi.org/10.1007/s40120-016-0061-5.
21. Lorscheider J, Benkert P, Lienert C et al. Comparative analysis of dimethyl fumarate and fingolimod in relapsing-remitting multiple sclerosis. J Neurol. 2021; 268(3): 941-9. http://doi.org/10.1007/s00415-020-10226-6.
22. Gold R, Arnold DL, Bar-Or A et al. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020; 13: 1756286420915005. http://doi.org/10.1177/1756286420915005. Erratum in: Ther Adv Neurol Disord. 2020; 13: 1756286420968357.
23. Havrdova E, Hutchinson M, Kurukulasuriya NC et al. Oral BG-12 (dimethyl fumarate) for relapsing–remitting multiple sclerosis: a review of DEFINE and CONFIRM. Expert Opin Pharmacother. 2013; 14(15): 2145-56. http://doi.org/10.1517/14656566.2013.826190.
24. Phillips JT, Selmaj K, Gold R et al. Clinical Significance of Gastrointestinal and Flushing Events in Patients with Multiple Sclerosis Treated with Delayed-Release Dimethyl Fumarate. Int J MS Care. 2015; 17(5): 236-43. http://doi.org/10.7224/1537-2073.2014-069.
25. Lyons J, Hughes R, McCarthy K et al. Progressive multifocal leukoencephalopathy outcomes in patients with multiple sclerosis treated with dimethyl fumarate. Mult Scler J Exp Transl Clin. 2022; 8(4): 20552173221132469. http://doi.org/10.1177/20552173221132469. Erratum in: Mult Scler J Exp Transl Clin. 2023; 9(1): 20552173231160312.
26. Fox RJ, Chan A, Gold R et al. Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: patient management considerations. Neurol Clin Pract. 2016; 6: 220-9.
27. Mehta D, Miller C, Arnold DL et al. Effect of dimethyl fumarate on lymphocytes in RRMS Implications for clinical practice. Neurology. 2019; 92(15): e1724-e1738.
28. Hellwig K, Rog D, McGuigan C et al. Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry. Neurol Neuroimmunol Neuroinflamm. 2021; 9(1): e1114. http://doi.org/10.1212/NXI.0000000000001114.
29. GILENA ChPL 09/2023.
30. AUBAGO ChPL 07/2023.
31. MAVECLAD ChPL 04/2022.
32. Andersen JB, Sellebjerg F, Magyari M. Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis. Eur J Neurol. 2023; 30(1): 162-71. http://doi.org/10.1111/ene.15559.
33. von Hehn C, Howard J, Liu S et al. Immune response to vaccines is maintained in patients treated with dimethyl fumarate. Neurol Neuroimmunol Neuroinflamm. 2017; 5(1): e409. http://doi.org/10.1212/NXI.0000000000000409.
34. Moser T, Seiberl M, Feige J et al. Tetravalent Influenza Vaccine Is Not Associated with Neuroaxonal Damage in Multiple Sclerosis Patients. Front Immunol. 2021; 12: 718895. http://doi.org/10.3389/fimmu.2021.718895.