Zasady terapii postaci rzutowej stwardnienia rozsianego Artykuł przeglądowy
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Opublikowane:
mar 31, 2018
Słowa kluczowe:
stwardnienie rozsiane, leczenie, immunomodulacja, immunosupresja, zalecenia
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Abstrakt
Obecnie dostępnych jest ponad 10 leków o udokumentowanej skuteczności w terapii postaci rzutowej stwardnienia rozsianego. Różnią się one między sobą skutecznością kliniczną i profilem bezpieczeństwa. Aktualnie stosuje się 2 modele farmakoterapii stwardnienia rozsianego: indukcję lub eskalację. Wybór powinien być maksymalnie zindywidualizowany i uwzględniać takie parametry jak: aktywność choroby, czas jej trwania, dotychczasowe leczenie, choroby współistniejące i preferencje pacjenta. Optymalna terapia jest wynikiem zbalansowania skuteczności i dokładnego monitorowania bezpieczeństwa leczenia.
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Numer
Dział
Artykuły
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Bibliografia
1. Confavreux C., Vukusic S.: Natural history of multiple sclerosis: a unifying concept. Brain 2006; 129(Pt 3): 606-616.
2. Degenhardt A., Ramagopalan S.V., Scalfari A. et al.: Clinical prognostic factors in multiple sclerosis: a natural history review. Nat. Rev. Neurol. 2009; 5(12): 672-682.
3. Lublin F.D., Reingold S.C., Cohen J.A. et al.: Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology 2014; 83(3): 278-286.
4. Thompson A.J., Banwell B.L., Barkhof F. et al.: Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018; 17(2): 162-173.
5. Edan G., Leray E.: A new treatment era in multiple sclerosis: clinical applications of new concepts. J. Neurol. Sci. 2011; 306: 170-172.
6. Giovannoni G., Turner B., Gnanapavan S. et al.: Is it time to target no evident disease activity (NEDA) in multiple sclerosis? Mult. Scler. Relat. Disord. 2015; 4: 329-333.
7. Freedman M.S., Comi G., De Stefano N. et al.: Moving toward earlier treatment of multiple sclerosis: findings from a decade of clinical trials and implications for clinical practice. Mult. Scler. Relat. Disord. 2014; 3: 147-155.
8. Jokubaitis V.G., Spelman T., Kalincik T. et al.: Predictors of long-term disability accrual in relapse-onset multiple sclerosis. Ann. Neurol. 2016; 80(1): 89-100.
9. Calabresi P.A., Kieseier B.C., Arnold D.L. et al.: Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double- blind study. Lancet Neurol. 2014; 13: 657-665.
10. Gold R., Kappos L., Arnold D.L. et al.: Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N. Engl. J. Med. 2012; 367: 1098-1107.
11. Vermersch P., Czlonkowska A., Grimaldi L.M. et al.: Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult. Scler. 2014; 20: 705-716.
12. Calabresi P.A., Radue E.W., Goodin D. et al.: Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double- blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014; 13: 545-556.
13. Cohen J.A., Coles A.J., Arnold D.L. et al.: Alemtuzumab versus interferon beta 1a as firstline treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012; 380(9856): 1819-1828.
14. Confavreux C., O’Connor P., Comi G. et al.: Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo- controlled, phase 3 trial. Lancet Neurol. 2014; 13: 247-256.
15. Fox R.J., Miller D.H., Phillips J.T. et al.: Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N. Engl. J. Med. 2012; 367: 1087-1097.
16. Giovannoni G., Comi G., Cook S. et al.: A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N. Engl. J. Med. 2010; 362: 416-426.
17. Hauser S.L., Bar-Or A., Comi G. et al.: Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N. Engl. J. Med. 2017; 376(3): 221-234.
18. Jacobs L.D., Cookfair D.L., Rudick R.A. et al.: Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. 1996; 39: 285-294.
19. Polman C.H., O’Connor P.W., Havrdova E. et al.: A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. 2006; 354(9): 899-910.
20. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo- controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-1504.
21. Comi G.: Induction vs. escalating therapy in multiple sclerosis: practical implications. Neurol. Sci. 2008; 29(supl. 2): S253-S255.
22. Coles A.J., Cox A., Le P.E. et al.: The window of therapeutic opportunity in multiple sclerosis evidence from monoclonal antibody therapy. J. Neurol. 2006; 253: 98-108.
23. Cook S.D., Dhib-Jalbut S., Dowling P. et al.: Use of magnetic resonance imaging as well as clinical disease activity in the clinical classification of multiple sclerosis and assessment of its course: A report from an international CMSC consensus conference, March 5–7, 2010. Int. J. MS Care 2012; 14(3): 105-114.
24. Simon J.H., Li D., Traboulsee A. et al.: Standardized MR imaging protocol for multiple sclerosis: consortium of MS Centers consensus guidelines. AJNR Am. J. Neuroradiol. 2006; 27(2): 455-461.
25. Kister I., Spelman T., Alroughani R. et al.: Discontinuing disease-modifying therapy in MS after a prolonged relapse-free period: a propensity score-matched study. J. Neurol. Neurosurg. Psychiatry 2016; 87(10): 1133-1137.
26. Rio J., Tintore M., Sastre-Garriga J. et al.: Change in the clinical activity of multiple sclerosis after treatment switch for suboptimal response. Eur. J. Neurol. 2012; 19: 899-904.
27. Edan G., Comi G., Le P.E. et al.: Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial. J. Neurol. Neurosurg. Psychiatry 2011; 82: 1344-1350.
28. Montalban X., Gold R., Thompson A.J. et al.: ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult. Scler. J. 2018; 24: 96-120.
29. Lu E., Wang B.W., Guimond C. et al.: Diseasemodifying drugs for multiple sclerosis in pregnancy: a systematic review. Neurology 2012; 79(11): 1130-1135.
30. Stuve O., Centonze D.: Treatment decisions for patients with active multiple sclerosis. JAMA Neurol. 2015; 72: 387-389.
31. Vollmer T., Stewart T., Baxter N.: Mitoxantrone and cytotoxic drugs’ mechanisms of action. Neurology 2010; 74(Supl. 1): S41-S46.
32. De Flon P., Gunnarsson M., Laurell K. et al.: Reduced inflammation in relapsing-remitting multiple sclerosis after therapy switch to rituximab. Neurology 2016; 87: 141-147.
33. Sorensen P.S., Lisby S., Grove R. et al.: Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase II study. Neurology 2014; 82: 573-581.
34. Scolding N.J., Pasquini M., Reingold S.C. et al.: Cell-based therapeutic strategies for multiple sclerosis. Brain 2017; 140: 2776-2796.
35. Atkins H.L., Freedman M.S.: Five Questions Answered: A Review of Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Multiple Sclerosis. Neurotherapeutics 2017; 14: 888-893.
36. Clanet M.C., Wolinsky J.S., Ashton R.J. et al.: Risk evaluation and monitoring in multiple sclerosis therapeutics. Multipl. Scler. 2014; 20: 1306-1311.
37. Rush C.A., MacLean H.J., Freedmen M.S.: Agrressive multiple sclerosis: proposed definition and treatment algorithm. Nat. Rev. Neurol. 2015; 11: 29-39.
38. Sorensen P.S., Bertolotto A., Edan G. et al.: Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult. Scler. 2012; 18: 143-152.
2. Degenhardt A., Ramagopalan S.V., Scalfari A. et al.: Clinical prognostic factors in multiple sclerosis: a natural history review. Nat. Rev. Neurol. 2009; 5(12): 672-682.
3. Lublin F.D., Reingold S.C., Cohen J.A. et al.: Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology 2014; 83(3): 278-286.
4. Thompson A.J., Banwell B.L., Barkhof F. et al.: Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018; 17(2): 162-173.
5. Edan G., Leray E.: A new treatment era in multiple sclerosis: clinical applications of new concepts. J. Neurol. Sci. 2011; 306: 170-172.
6. Giovannoni G., Turner B., Gnanapavan S. et al.: Is it time to target no evident disease activity (NEDA) in multiple sclerosis? Mult. Scler. Relat. Disord. 2015; 4: 329-333.
7. Freedman M.S., Comi G., De Stefano N. et al.: Moving toward earlier treatment of multiple sclerosis: findings from a decade of clinical trials and implications for clinical practice. Mult. Scler. Relat. Disord. 2014; 3: 147-155.
8. Jokubaitis V.G., Spelman T., Kalincik T. et al.: Predictors of long-term disability accrual in relapse-onset multiple sclerosis. Ann. Neurol. 2016; 80(1): 89-100.
9. Calabresi P.A., Kieseier B.C., Arnold D.L. et al.: Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double- blind study. Lancet Neurol. 2014; 13: 657-665.
10. Gold R., Kappos L., Arnold D.L. et al.: Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N. Engl. J. Med. 2012; 367: 1098-1107.
11. Vermersch P., Czlonkowska A., Grimaldi L.M. et al.: Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult. Scler. 2014; 20: 705-716.
12. Calabresi P.A., Radue E.W., Goodin D. et al.: Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double- blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014; 13: 545-556.
13. Cohen J.A., Coles A.J., Arnold D.L. et al.: Alemtuzumab versus interferon beta 1a as firstline treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012; 380(9856): 1819-1828.
14. Confavreux C., O’Connor P., Comi G. et al.: Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo- controlled, phase 3 trial. Lancet Neurol. 2014; 13: 247-256.
15. Fox R.J., Miller D.H., Phillips J.T. et al.: Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N. Engl. J. Med. 2012; 367: 1087-1097.
16. Giovannoni G., Comi G., Cook S. et al.: A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N. Engl. J. Med. 2010; 362: 416-426.
17. Hauser S.L., Bar-Or A., Comi G. et al.: Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N. Engl. J. Med. 2017; 376(3): 221-234.
18. Jacobs L.D., Cookfair D.L., Rudick R.A. et al.: Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. 1996; 39: 285-294.
19. Polman C.H., O’Connor P.W., Havrdova E. et al.: A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. 2006; 354(9): 899-910.
20. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo- controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-1504.
21. Comi G.: Induction vs. escalating therapy in multiple sclerosis: practical implications. Neurol. Sci. 2008; 29(supl. 2): S253-S255.
22. Coles A.J., Cox A., Le P.E. et al.: The window of therapeutic opportunity in multiple sclerosis evidence from monoclonal antibody therapy. J. Neurol. 2006; 253: 98-108.
23. Cook S.D., Dhib-Jalbut S., Dowling P. et al.: Use of magnetic resonance imaging as well as clinical disease activity in the clinical classification of multiple sclerosis and assessment of its course: A report from an international CMSC consensus conference, March 5–7, 2010. Int. J. MS Care 2012; 14(3): 105-114.
24. Simon J.H., Li D., Traboulsee A. et al.: Standardized MR imaging protocol for multiple sclerosis: consortium of MS Centers consensus guidelines. AJNR Am. J. Neuroradiol. 2006; 27(2): 455-461.
25. Kister I., Spelman T., Alroughani R. et al.: Discontinuing disease-modifying therapy in MS after a prolonged relapse-free period: a propensity score-matched study. J. Neurol. Neurosurg. Psychiatry 2016; 87(10): 1133-1137.
26. Rio J., Tintore M., Sastre-Garriga J. et al.: Change in the clinical activity of multiple sclerosis after treatment switch for suboptimal response. Eur. J. Neurol. 2012; 19: 899-904.
27. Edan G., Comi G., Le P.E. et al.: Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial. J. Neurol. Neurosurg. Psychiatry 2011; 82: 1344-1350.
28. Montalban X., Gold R., Thompson A.J. et al.: ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult. Scler. J. 2018; 24: 96-120.
29. Lu E., Wang B.W., Guimond C. et al.: Diseasemodifying drugs for multiple sclerosis in pregnancy: a systematic review. Neurology 2012; 79(11): 1130-1135.
30. Stuve O., Centonze D.: Treatment decisions for patients with active multiple sclerosis. JAMA Neurol. 2015; 72: 387-389.
31. Vollmer T., Stewart T., Baxter N.: Mitoxantrone and cytotoxic drugs’ mechanisms of action. Neurology 2010; 74(Supl. 1): S41-S46.
32. De Flon P., Gunnarsson M., Laurell K. et al.: Reduced inflammation in relapsing-remitting multiple sclerosis after therapy switch to rituximab. Neurology 2016; 87: 141-147.
33. Sorensen P.S., Lisby S., Grove R. et al.: Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase II study. Neurology 2014; 82: 573-581.
34. Scolding N.J., Pasquini M., Reingold S.C. et al.: Cell-based therapeutic strategies for multiple sclerosis. Brain 2017; 140: 2776-2796.
35. Atkins H.L., Freedman M.S.: Five Questions Answered: A Review of Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Multiple Sclerosis. Neurotherapeutics 2017; 14: 888-893.
36. Clanet M.C., Wolinsky J.S., Ashton R.J. et al.: Risk evaluation and monitoring in multiple sclerosis therapeutics. Multipl. Scler. 2014; 20: 1306-1311.
37. Rush C.A., MacLean H.J., Freedmen M.S.: Agrressive multiple sclerosis: proposed definition and treatment algorithm. Nat. Rev. Neurol. 2015; 11: 29-39.
38. Sorensen P.S., Bertolotto A., Edan G. et al.: Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult. Scler. 2012; 18: 143-152.