Long-term follow-up of clinical trials in multiple sclerosis therapies. Part II – second- and third-line treatments Review article
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Published:
Jun 30, 2016
Keywords:
long-term follow-up study, fingolimod, natalizumab, alemtuzumab
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Abstract
In this part of the paper results of the long-term follow-up studies and prospective registers for fingolimod, natalizumab and alemtuzumab were being discussed. Some key-issues regarding not only efficacy, but also safety in long-term perspective are summarized.
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References
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10. Montalban X., Comi G., Antel J. et al.: Long-term results from phase 2 extension study of fingolimod at high and approved dose in relapsing multiple sclerosis. J. Neurol. 2015; 262: 2627-2634.
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12. Cohen J.A., Khatri B., Brakhof F. et al.: Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J. Neurol. Neurosurg. Psychiatry 2016; 87: 468-475.
13. Cohen J., Kappos L., Selmaj K. et al.: Long-term safety and effectiveness of fingolimod: 7 year data from the LONGTERMS study. Poster P591 przedstawiony na zjeździe ECTRIMS; 7–10.10.2015, Barcelona, Hiszpania.
14. Cree B.A., Kappos L., Freedman M.S. et al.: Long-term effects of fingolimod on NEDA by year of treatment. Poster P627 przedstawiony na zjeździe ECTRIMS, 7–10.10.2015, Barcelona, Hiszpania.
15. O’Connor P., Kremenchutzky M.: Use of natalizumab in patients with multiple sclerosis: 2015 Update. Can. J. Neurol. Sci. 2015; 42: 372-380.
16. McGuigan C., Craner M., Guadagno J. et al.: Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group. J. Neurol. Neurosurg. Psychiatry 2016; 87: 117-125.
17. Butzkueven H., Kappos L., Pellegrini F. et al.: Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J. Neurol. Neurosurg. Psychiatry 2014; 85: 1190-1197.
18. Dong-Si T., Richman S., Wattjes M.P. et al.: Outcome and survival of asymptomatic PML in natalizumab-treated MS patients. Ann. Clin. Transl. Neurol. 2014; 1: 755-764.
19. Derwenskus J., Lublin F.D.: Future treatment approaches to multiple sclerosis. Handb. Clin. Neurol. 2014; 122: 563-577.
20. Coles A., Deans J., Compston A.: Campath-1H treatment of multiple sclerosis: lessons from the bedside for the bench. Clin. Neurol. Neurosurg. 2004; 106: 270-274.
21. Tuohy O., Costelloe L., Hill-Cawthorne G. et al.: Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J. Neurol. Neurosurg. Psychiatry 2015; 86: 208-215.
22. Coles A., Fox E., Vladic A. et al.: Alemtuzumab more effective than interferon beta-1a at 5-year follow-up of the CAMMS223 clinical trial. Neurology 2012; 78: 1069-1078.
23. Compston A., Arnold D., Giovannoni G. et al.: Durable effect of alemtuzumab on clinical outcomes in treatment naïve relapsing-remitting multiple sclerosis patients: Four-year follow up of CARE-MS I. Poster S4.007 przedstawiony na zjeździe AAN, 18–25.04.2015, Waszyngton, USA.
24. Havrdova E., Giovannoni G., Arnold D. et al.: Durable effect of alemtuzumab on clinical outcomes in patients with relapsing-remitting multiple sclerosis who relapsed on Prior Therapy: 4-year follow-up of CARE-MS II. Poster P7.276 przedstawiony na zjeździe AAN, 18–25.04.2015, Waszyngton, USA.
2. Havrdova E., Galetta S., Hutchinson M. et al.: Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study. Lancet Neurol. 2009; 8: 254-260.
3. Ziemssen T., Derfuss T., de Stefano N. et al.: Optimizing treatment success in multiple sclerosis. J. Neurol. 2015 [doi: 10.1007/s00415-015-7986-y].
4. Cohen J.A., Chun J.: Mechanism of fingolimod’s efficacy and adverse effects in multiple sclerosis. Ann. Neurol. 2011; 69: 759-777.
5. Kappos L., Radue E.W., O’Connor P. et al.: A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N. Engl. J. Med. 2010; 362: 387-401.
6. Cohen J.A., Barkhof F., Comi G. et al.: Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N. Engl. J. Med. 2010; 362: 402-415.
7. 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: 899-910.
8. Cohen J.A., Coles A.J., Arnold D.L. et al.: Alemtuzumab vesrsus interferon β-1a as first-line treatment for patients with relapsing remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012; 380: 1819-1828.
9. Coles A.J., Twyman C.L., Arnold D.L. et al.: Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012; 380: 1829-1839.
10. Montalban X., Comi G., Antel J. et al.: Long-term results from phase 2 extension study of fingolimod at high and approved dose in relapsing multiple sclerosis. J. Neurol. 2015; 262: 2627-2634.
11. Kappos L., O’Connor P., Radue E.W. et al.: Long-term effects of fingolimod in multiple sclerosis. The randomized FREEDOMS extension trial. Neurology 2015; 84: 1582-1591.
12. Cohen J.A., Khatri B., Brakhof F. et al.: Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J. Neurol. Neurosurg. Psychiatry 2016; 87: 468-475.
13. Cohen J., Kappos L., Selmaj K. et al.: Long-term safety and effectiveness of fingolimod: 7 year data from the LONGTERMS study. Poster P591 przedstawiony na zjeździe ECTRIMS; 7–10.10.2015, Barcelona, Hiszpania.
14. Cree B.A., Kappos L., Freedman M.S. et al.: Long-term effects of fingolimod on NEDA by year of treatment. Poster P627 przedstawiony na zjeździe ECTRIMS, 7–10.10.2015, Barcelona, Hiszpania.
15. O’Connor P., Kremenchutzky M.: Use of natalizumab in patients with multiple sclerosis: 2015 Update. Can. J. Neurol. Sci. 2015; 42: 372-380.
16. McGuigan C., Craner M., Guadagno J. et al.: Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group. J. Neurol. Neurosurg. Psychiatry 2016; 87: 117-125.
17. Butzkueven H., Kappos L., Pellegrini F. et al.: Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J. Neurol. Neurosurg. Psychiatry 2014; 85: 1190-1197.
18. Dong-Si T., Richman S., Wattjes M.P. et al.: Outcome and survival of asymptomatic PML in natalizumab-treated MS patients. Ann. Clin. Transl. Neurol. 2014; 1: 755-764.
19. Derwenskus J., Lublin F.D.: Future treatment approaches to multiple sclerosis. Handb. Clin. Neurol. 2014; 122: 563-577.
20. Coles A., Deans J., Compston A.: Campath-1H treatment of multiple sclerosis: lessons from the bedside for the bench. Clin. Neurol. Neurosurg. 2004; 106: 270-274.
21. Tuohy O., Costelloe L., Hill-Cawthorne G. et al.: Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J. Neurol. Neurosurg. Psychiatry 2015; 86: 208-215.
22. Coles A., Fox E., Vladic A. et al.: Alemtuzumab more effective than interferon beta-1a at 5-year follow-up of the CAMMS223 clinical trial. Neurology 2012; 78: 1069-1078.
23. Compston A., Arnold D., Giovannoni G. et al.: Durable effect of alemtuzumab on clinical outcomes in treatment naïve relapsing-remitting multiple sclerosis patients: Four-year follow up of CARE-MS I. Poster S4.007 przedstawiony na zjeździe AAN, 18–25.04.2015, Waszyngton, USA.
24. Havrdova E., Giovannoni G., Arnold D. et al.: Durable effect of alemtuzumab on clinical outcomes in patients with relapsing-remitting multiple sclerosis who relapsed on Prior Therapy: 4-year follow-up of CARE-MS II. Poster P7.276 przedstawiony na zjeździe AAN, 18–25.04.2015, Waszyngton, USA.