Stanowisko polskich ekspertów w sprawie praktycznych aspektów leczenia kladrybiną w tabletkach Stanowisko ekspertów
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Opublikowane:
gru 31, 2023
Słowa kluczowe:
stwardnienie rozsiane, kladrybina w tabletkach, rekomendacje
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Abstrakt
Kladrybina w tabletkach jest dostępna w Polsce do leczenia rzutowo-remisyjnej postaci stwardnienia rozsianego, zarówno u pacjentów wcześniej nieleczonych, jak i po wcześniejszym leczeniu oraz w szybko rozwijającej się, ciężkiej postaci choroby. W niniejszym opracowaniu grono polskich ekspertów na podstawie własnych doświadczeń klinicznych oraz danych literaturowych sformułowało praktyczne zalecenia dla lekarzy neurologów dotyczące stosowania kladrybiny w tabletkach. Poruszono kwestie profilu pacjenta, u którego należy zastosować lek, czynników predykcyjnych skuteczności leczenia, zmiany leczenia z innych terapii modyfikujących przebieg choroby na kladrybinę i z kladrybiny, profilu bezpieczeństwa leku, diagnostyki przed rozpoczęciem terapii, monitorowania leczenia, skuteczności szczepień w okresie leczenia, interakcji kladrybiny z innymi preparatami oraz planowania ciąży.
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Dział
Artykuły
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Bibliografia
1. Program lekowy B.29 Leczenie chorych na stwardnienie rozsiane (access: 27.11.2023).
2. Kułakowska A, Mirowska-Guzel D, Kalinowska A et al. Leczenie modyfikujące przebieg stwardnienia rozsianego. Rekomendacje Sekcji Stwardnienia Rozsianego i Neuroimmunologii Polskiego Towarzystwa Neurologicznego. Pol Przegl Neurol. 2023; 19(3): 163-89.
3. Charakterystyka produktu leczniczego Mavenclad (access: 27.11.2023).
4. Annovazzi P, Prosperini L, Capuano R et al. Relapse-free and NEDA status with Cladribine in a real life population: a multicentre study. ECTRIMS, 13–15 Oct. Poster Present P842. 2021.
5. Petracca M, Ruggieri S, Barbuti E et al. Predictors of Cladribine Effectiveness and Safety in Multiple Sclerosis: A Real-World, Multicenter, 2-Year Follow-Up Study. Neurol Ther. 2022; 11(3): 1193-208.
6. Meca-Lallana V, García Domínguez JM, López Ruiz R et al. Expert-Agreed Practical Recommendations on the Use of Cladribine. Neurol Ther. 2022; 11(4): 1475-88.
7. Montalban X. Update to the ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. ECTRIMS, 13–15 Oct. Oral Present O184. 2021.
8. Sørensen PS, Centonze D, Giovannoni G et al. Expert opinion on the use of cladribine tablets in clinical practice. Ther Adv Neurol Disord. 2020; 13: 175628642093501.
9. Barry B, Erwin AA, Stevens J et al. Fingolimod Rebound: A Review of the Clinical Experience and Management Considerations. Neurol Ther. 2019; 8(2): 241-50.
10. Clerico M, Artusi C, Liberto A et al. Natalizumab in Multiple Sclerosis: Long-Term Management. Int J Mol Sci. 2017; 18(5): 940.
11. Möhn N, Skripuletz T, Sühs KW et al. Therapy with cladribine is efficient and safe in patients previously treated with natalizumab. Ther Adv Neurol Disord. 2019; 12: 175628641988759.
12. Giovannoni G, Marta M, Davis A et al. Switching patients at high risk of PML from natalizumab to another disease-modifying therapy. Pract Neurol. 2016; 16(5): 389-93.
13. Adamec I, Jovanović I, Krbot Skorić M et al. Double immune reconstitution therapy: Cladribine after alemtuzumab in the treatment of multiple sclerosis. Eur J Neurol. 2022; 29(3): 901-4.
14. Stępień A, Pogoda-Wesołowska A, Tokarz-Kupczyk E et al. Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: a real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic. Neurol Neurochir Pol. 2023; 57(4): 371-8.
15. Celius EG. Normal antibody response after COVID-19 during treatment with cladribine. Mult Scler Relat Disord. 2020; 46: 102476.
16. Dersch R, Wehrum T, Fähndrich S et al. COVID-19 pneumonia in a multiple sclerosis patient with severe lymphopenia due to recent cladribine treatment. Mult Scler. 2020; 26(10): 1264-6.
17. Oreja-Guevara C, Meca-Lallana V, Brieva L et al. COVID-10 in cladribine treated patients with multiple sclerosis. ECTRIMS-ACTRIMS. 11-13 Sept. Poster Present LB1165. 2020.
18. Jack D, Nolting A, Galazka A. Favorable outcomes after COVID-19 infection in multiple sclerosis patients treated with cladribine tablets. Mult Scler Relat Disord. 2020; 46: 102469.
19. Pawłowska M, Flisiak R, Gil L et al. Profilaktyka reaktywacji zakażeń HBV – rekomendacje grupy roboczej profilaktyki reaktywacji HBV. Acta Haematol Pol. 2019; 50(4): 192-8.
20. Brownlee WJ, Wolf C, Hartung HP et al. Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations. Mult Scler. 2022; 28(14): 2177-89.
21. Terranova N, Hicking C, Dangond F et al. Effects of Postponing Treatment in the Second Year of Cladribine Administration: Clinical Trial Simulation Analysis of Absolute Lymphocyte Counts and Relapse Rate in Patients with Relapsing-Remitting Multiple Sclerosis. Clin Pharmacokinet. 2019; 58(3): 325-33.
22. Otero-Romero S, Lebrun-Frénay C, Reyes S et al. ECTRIMS/EAN consensus on vaccination in people with multiple sclerosis: Improving immunization strategies in the era of highly active immunotherapeutic drugs. Mult Scler. 2023; 29(8): 904-25.
23. Coyle PK, Gocke A, Vignos M et al. Vaccine Considerations for Multiple Sclerosis in the COVID-19 Era. Adv Ther. 2021; 38(7): 3550-88.
24. Otero-Romero S, Rodríguez-García J, Vilella A et al. Recomendaciones para la vacunación en pacientes con esclerosis múltiple candidatos a terapias inmunosupresoras: documento de consenso español. Neurología. 2021; 36(1): 50-60.
25. Gold R, Fätkenheuer G, Hartung HP et al. Vaccination in multiple sclerosis patients treated with highly effective disease-modifying drugs: an overview with consideration of cladribine tablets. Ther Adv Neurol Disord. 2021; 14: 175628642110195.
26. Schmierer K, Wiendl H, Oreja-Guevara C et al. Varicella zoster virus and influenza vaccine antibody titres in patients from MAGNIFY-MS who were treated with cladribine tablets for highly active relapsing multiple sclerosis. Mult Scler J. 2022; 28(13): 2151-3.
27. Grothe C, Steffen F, Bittner S. Humoral immune response and lymphocyte levels after complete vaccination against COVID-19 in a cohort of multiple sclerosis patients treated with cladribine tablets. J Cent Nerv Syst Dis. 2021; 13:117957352110601.
28. Baker D, Herrod SS, Alvarez-Gonzalez C et al. Both cladribine and alemtuzumab may effect MS via B-cell depletion. Neurol Neuroimmunol Neuroinflamm. 2017; 4(4): e360.
29. AlJumah M, Alkhawajah MM, Qureshi S et al. Cladribine Tablets and Relapsing–Remitting Multiple Sclerosis: A Pragmatic, Narrative Review of What Physicians Need to Know. Neurol Ther. 2020; 9(1): 11-23.
30. Sorensen PS, Dangond F, Hicking Ch et al. Long-Term Lymphocyte Counts in Patients with RRMS Treated with Cladribine Tablets 3.5 Mg/Kg: Total Lymphocytes, B-, and T-Cell Subsets. ACTRIMS. 1-3 Feb. Poster Present P084. 2018.
31. Wiendl H, Schmierer K, Hodgkinson S et al. Specific Patterns of Immune Cell Dynamics May Explain the Early Onset and Prolonged Efficacy of Cladribine Tablets. Neurol Neuroimmunol Neuroinflamm. 2023; 10(1).
32. 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(5): 416-26.
33. Cook S, Leist T, Comi G et al. Safety of cladribine tablets in the treatment of patients with multiple sclerosis: An integrated analysis. Mult Scler Relat Disord. 2019; 29: 157-67.
34. Dolk H, Loane M, Garne E. The Prevalence of Congenital Anomalies in Europe. Adv Exp Med Biol. 2010; 686: 349-64.
35. EUROCAT Datenbank (access: 25.10.2021).
36. Ziemssen T, Posevitz-Fejar A, Wagner T et al. Treatment emergent adverse events experienced early and transiently in the treatment course with cladribine tablets: data from the CLEVER real-world study. 26-28 Oct. ECTRIMS. Poster Present P772. 2022.
37. Galazka A, Nolting A, Cook S et al. An analysis of malignancy risk in the clinical development programme of cladribine tablets in patients with relapsing multiple sclerosis. 16-19 June. EAN. ePoster Present EPO1083. 2018.
38. Clavelou P, Castelnovo G, Pourcher V et al. Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis. Neurol Ther. 2023; 12(5): 1457-76.
39. Hermann R, Karlsson MO, Novakovic AM et al. The Clinical Pharmacology of Cladribine Tablets for the Treatment of Relapsing Multiple Sclerosis. Clin Pharmacokinet. 2019; 58(3): 283-97.
40. Dost-Kovalsky K, Thiel S, Ciplea A et al. Cladribine and pregnancy in women with multiple sclerosis – a case series from Germany. 26-28 Oct. ECTRIMS. Poster Present P287. 2022.
41. MS und Kinderwunsch. Register DMSKW (access: 30.11.2023).
42. Hellwig K, Tilson H, Seebeck J et al. Pregnancy and Infant Outcomes from an Ongoing Worldwide Surveillance Program of Cladribine Tablets: 5-year Pharmacovigilance Results from MAPLE-MS. 23-25 Feb. ACTRIMS. Poster Present P482. 2023.
43. Datta P, Hale TW, Thiel S et al. Low transfer of cladribine into human milk. Mult Scler. 2023; 29(10): 1346-7.
2. Kułakowska A, Mirowska-Guzel D, Kalinowska A et al. Leczenie modyfikujące przebieg stwardnienia rozsianego. Rekomendacje Sekcji Stwardnienia Rozsianego i Neuroimmunologii Polskiego Towarzystwa Neurologicznego. Pol Przegl Neurol. 2023; 19(3): 163-89.
3. Charakterystyka produktu leczniczego Mavenclad (access: 27.11.2023).
4. Annovazzi P, Prosperini L, Capuano R et al. Relapse-free and NEDA status with Cladribine in a real life population: a multicentre study. ECTRIMS, 13–15 Oct. Poster Present P842. 2021.
5. Petracca M, Ruggieri S, Barbuti E et al. Predictors of Cladribine Effectiveness and Safety in Multiple Sclerosis: A Real-World, Multicenter, 2-Year Follow-Up Study. Neurol Ther. 2022; 11(3): 1193-208.
6. Meca-Lallana V, García Domínguez JM, López Ruiz R et al. Expert-Agreed Practical Recommendations on the Use of Cladribine. Neurol Ther. 2022; 11(4): 1475-88.
7. Montalban X. Update to the ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. ECTRIMS, 13–15 Oct. Oral Present O184. 2021.
8. Sørensen PS, Centonze D, Giovannoni G et al. Expert opinion on the use of cladribine tablets in clinical practice. Ther Adv Neurol Disord. 2020; 13: 175628642093501.
9. Barry B, Erwin AA, Stevens J et al. Fingolimod Rebound: A Review of the Clinical Experience and Management Considerations. Neurol Ther. 2019; 8(2): 241-50.
10. Clerico M, Artusi C, Liberto A et al. Natalizumab in Multiple Sclerosis: Long-Term Management. Int J Mol Sci. 2017; 18(5): 940.
11. Möhn N, Skripuletz T, Sühs KW et al. Therapy with cladribine is efficient and safe in patients previously treated with natalizumab. Ther Adv Neurol Disord. 2019; 12: 175628641988759.
12. Giovannoni G, Marta M, Davis A et al. Switching patients at high risk of PML from natalizumab to another disease-modifying therapy. Pract Neurol. 2016; 16(5): 389-93.
13. Adamec I, Jovanović I, Krbot Skorić M et al. Double immune reconstitution therapy: Cladribine after alemtuzumab in the treatment of multiple sclerosis. Eur J Neurol. 2022; 29(3): 901-4.
14. Stępień A, Pogoda-Wesołowska A, Tokarz-Kupczyk E et al. Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: a real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic. Neurol Neurochir Pol. 2023; 57(4): 371-8.
15. Celius EG. Normal antibody response after COVID-19 during treatment with cladribine. Mult Scler Relat Disord. 2020; 46: 102476.
16. Dersch R, Wehrum T, Fähndrich S et al. COVID-19 pneumonia in a multiple sclerosis patient with severe lymphopenia due to recent cladribine treatment. Mult Scler. 2020; 26(10): 1264-6.
17. Oreja-Guevara C, Meca-Lallana V, Brieva L et al. COVID-10 in cladribine treated patients with multiple sclerosis. ECTRIMS-ACTRIMS. 11-13 Sept. Poster Present LB1165. 2020.
18. Jack D, Nolting A, Galazka A. Favorable outcomes after COVID-19 infection in multiple sclerosis patients treated with cladribine tablets. Mult Scler Relat Disord. 2020; 46: 102469.
19. Pawłowska M, Flisiak R, Gil L et al. Profilaktyka reaktywacji zakażeń HBV – rekomendacje grupy roboczej profilaktyki reaktywacji HBV. Acta Haematol Pol. 2019; 50(4): 192-8.
20. Brownlee WJ, Wolf C, Hartung HP et al. Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations. Mult Scler. 2022; 28(14): 2177-89.
21. Terranova N, Hicking C, Dangond F et al. Effects of Postponing Treatment in the Second Year of Cladribine Administration: Clinical Trial Simulation Analysis of Absolute Lymphocyte Counts and Relapse Rate in Patients with Relapsing-Remitting Multiple Sclerosis. Clin Pharmacokinet. 2019; 58(3): 325-33.
22. Otero-Romero S, Lebrun-Frénay C, Reyes S et al. ECTRIMS/EAN consensus on vaccination in people with multiple sclerosis: Improving immunization strategies in the era of highly active immunotherapeutic drugs. Mult Scler. 2023; 29(8): 904-25.
23. Coyle PK, Gocke A, Vignos M et al. Vaccine Considerations for Multiple Sclerosis in the COVID-19 Era. Adv Ther. 2021; 38(7): 3550-88.
24. Otero-Romero S, Rodríguez-García J, Vilella A et al. Recomendaciones para la vacunación en pacientes con esclerosis múltiple candidatos a terapias inmunosupresoras: documento de consenso español. Neurología. 2021; 36(1): 50-60.
25. Gold R, Fätkenheuer G, Hartung HP et al. Vaccination in multiple sclerosis patients treated with highly effective disease-modifying drugs: an overview with consideration of cladribine tablets. Ther Adv Neurol Disord. 2021; 14: 175628642110195.
26. Schmierer K, Wiendl H, Oreja-Guevara C et al. Varicella zoster virus and influenza vaccine antibody titres in patients from MAGNIFY-MS who were treated with cladribine tablets for highly active relapsing multiple sclerosis. Mult Scler J. 2022; 28(13): 2151-3.
27. Grothe C, Steffen F, Bittner S. Humoral immune response and lymphocyte levels after complete vaccination against COVID-19 in a cohort of multiple sclerosis patients treated with cladribine tablets. J Cent Nerv Syst Dis. 2021; 13:117957352110601.
28. Baker D, Herrod SS, Alvarez-Gonzalez C et al. Both cladribine and alemtuzumab may effect MS via B-cell depletion. Neurol Neuroimmunol Neuroinflamm. 2017; 4(4): e360.
29. AlJumah M, Alkhawajah MM, Qureshi S et al. Cladribine Tablets and Relapsing–Remitting Multiple Sclerosis: A Pragmatic, Narrative Review of What Physicians Need to Know. Neurol Ther. 2020; 9(1): 11-23.
30. Sorensen PS, Dangond F, Hicking Ch et al. Long-Term Lymphocyte Counts in Patients with RRMS Treated with Cladribine Tablets 3.5 Mg/Kg: Total Lymphocytes, B-, and T-Cell Subsets. ACTRIMS. 1-3 Feb. Poster Present P084. 2018.
31. Wiendl H, Schmierer K, Hodgkinson S et al. Specific Patterns of Immune Cell Dynamics May Explain the Early Onset and Prolonged Efficacy of Cladribine Tablets. Neurol Neuroimmunol Neuroinflamm. 2023; 10(1).
32. 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(5): 416-26.
33. Cook S, Leist T, Comi G et al. Safety of cladribine tablets in the treatment of patients with multiple sclerosis: An integrated analysis. Mult Scler Relat Disord. 2019; 29: 157-67.
34. Dolk H, Loane M, Garne E. The Prevalence of Congenital Anomalies in Europe. Adv Exp Med Biol. 2010; 686: 349-64.
35. EUROCAT Datenbank (access: 25.10.2021).
36. Ziemssen T, Posevitz-Fejar A, Wagner T et al. Treatment emergent adverse events experienced early and transiently in the treatment course with cladribine tablets: data from the CLEVER real-world study. 26-28 Oct. ECTRIMS. Poster Present P772. 2022.
37. Galazka A, Nolting A, Cook S et al. An analysis of malignancy risk in the clinical development programme of cladribine tablets in patients with relapsing multiple sclerosis. 16-19 June. EAN. ePoster Present EPO1083. 2018.
38. Clavelou P, Castelnovo G, Pourcher V et al. Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis. Neurol Ther. 2023; 12(5): 1457-76.
39. Hermann R, Karlsson MO, Novakovic AM et al. The Clinical Pharmacology of Cladribine Tablets for the Treatment of Relapsing Multiple Sclerosis. Clin Pharmacokinet. 2019; 58(3): 283-97.
40. Dost-Kovalsky K, Thiel S, Ciplea A et al. Cladribine and pregnancy in women with multiple sclerosis – a case series from Germany. 26-28 Oct. ECTRIMS. Poster Present P287. 2022.
41. MS und Kinderwunsch. Register DMSKW (access: 30.11.2023).
42. Hellwig K, Tilson H, Seebeck J et al. Pregnancy and Infant Outcomes from an Ongoing Worldwide Surveillance Program of Cladribine Tablets: 5-year Pharmacovigilance Results from MAPLE-MS. 23-25 Feb. ACTRIMS. Poster Present P482. 2023.
43. Datta P, Hale TW, Thiel S et al. Low transfer of cladribine into human milk. Mult Scler. 2023; 29(10): 1346-7.