The Transition From First-Line to Second-Line Therapy in Multiple Sclerosis

Current Treatment Options in Neurology

Volumn 17, Issue 6, 2015, Pages

  Dörr, Jan ^a   Paul, Friedemann ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Disease activity; Disease modifying drug; Escalation; Multiple sclerosis; Treatment; Treatment failure; Window of opportunity

Indexed keywords

ALEMTUZUMAB; AZATHIOPRINE; BETA INTERFERON; DACLIZUMAB; FINGOLIMOD; FUMARIC ACID DIMETHYL ESTER; GLATIRAMER; MITOXANTRONE; NATALIZUMAB; OCRELIZUMAB; TERIFLUNOMIDE;

DECISION MAKING; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; EVIDENCE BASED PRACTICE; HUMAN; MEDICATION COMPLIANCE; MULTIPLE SCLEROSIS; REVIEW; RISK BENEFIT ANALYSIS; TREATMENT RESPONSE;

EID: 84928684543     PISSN: 10928480     EISSN: 15343138     Source Type: Journal    
DOI: 10.1007/s11940-015-0354-5     Document Type: Review

References (56)

1. Ransohoff RM, Hafler DA, Lucchinetti CF. Multiple sclerosis—a quiet revolution. Nat Rev Neurol. 2015;11:134–42. Comprehensive review on the achievements of drug therapy in MS over the last two decades.
2. Sinnecker T, Mittelstaedt P, Dörr J, Pfueller CF, Harms L, Niendorf T, et al. Multiple sclerosis lesions and irreversible brain tissue damage: a comparative ultrahigh-field strength magnetic resonance imaging study. Arch Neurol. 2012;69:739–45.
3. Oberwahrenbrock T, Ringelstein M, Jentschke S, Deuschle K, Klumbies K, Bellmann-Strobl J, et al. Retinal ganglion cell and inner plexiform layer thinning in clinically isolated syndrome. Mult Scler J. 2013;19:1887–95.
4. Filippi M, van den Heuvel MP, Fornito A, He Y, Hulshoff Pol HE, Agosta F, et al. Assessment of system dysfunction in the brain through MRI-based connectomics. Lancet Neurol. 2013;12:1189–99.
5. Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sørensen PS, Thompson AJ, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83:278–86. Important revision of the classification of MS disease courses.
6. Kurtzke JF. On the evaluation of disability in multiple sclerosis. Neurology. 1961;11:686–94.
7. Confavreux C, Vukusic S, Moreau T, Adeleine P. Relapses and progression of disability in multiple sclerosis. N Engl J Med. 2000;343:1430–8.
8. Leray E, Yaouanq J, Le Page E, Coustans M, Laplaud D, Oger J, et al. Evidence for a two-stage disability progression in multiple sclerosis. Brain J Neurol. 2010;133:1900–13. Milestone publication for the perception of MS as a two-stage disease.
9. Coyle PK. Current evaluation of alemtuzumab in multiple sclerosis. Expert Opin Biol Ther. 2014;14:127–35.
10. Paul F, Dörr J, Wurfel J, Vogel HP, Zipp F. Early mitoxantrone-induced cardiotoxicity in secondary progressive multiple sclerosis. J Neurol Neurosurg Psychiatry. 2007;78:198–200.
11. Dörr J, Bitsch A, Schmailzl KJ, Chan A, von Ahsen N, Hummel M, et al. Severe cardiac failure in a patient with multiple sclerosis following low-dose mitoxantrone treatment. Neurology. 2009;73:991–3.
12. Stroet A, Hemmelmann C, Starck M, Zettl U, Dörr J, Paul F, et al. Incidence of therapy-related acute leukaemia in mitoxantrone-treated multiple sclerosis patients in Germany. Ther Adv Neurol Disord. 2012;5:75–9.
13. Cocco E, Marrosu MG. The current role of mitoxantrone in the treatment of multiple sclerosis. Expert Rev Neurother. 2014;14:607–16.
14. Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362:402–15.
15. Kappos L, Radue E-W, O’Connor P, Polman C, Hohlfeld R, Calabresi P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362:387–401.
16. Calabresi PA, Radue E-W, Goodin D, Jeffery D, Rammohan KW, Reder AT, 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;13:545–56.
17. Havrdova E, Galetta S, Hutchinson M, Stefoski D, Bates D, Polman CH, 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;8:254–60.
18. Wingerchuk DM, Carter JL. Multiple sclerosis: current and emerging disease-modifying therapies and treatment strategies. Mayo Clin Proc. 2014;89:225–40.
19. Heesen C, Köpke S, Solari A, Geiger F, Kasper J. Patient autonomy in multiple sclerosis—possible goals and assessment strategies. J Neurol Sci. 2013;331:2–9.
20. Mäurer M, Dachsel R, Domke S, Ries S, Reifschneider G, Friedrich A, et al. Health care situation of patients with relapsing-remitting multiple sclerosis receiving immunomodulatory therapy: a retrospective survey of more than 9000 German patients with MS. Eur J Neurol Off J Eur Fed Neurol Soc. 2011;18:1036–45.
21. Cocco E, Sardu C, Spinicci G, Musu L, Massa R, Frau J, et al. Influence of treatments in multiple sclerosis disability: A cohort study. Mult. Scler. Houndmills Basingstoke Engl. 2014.
22. Scalfari A, Neuhaus A, Daumer M, Muraro PA, Ebers GC. Onset of secondary progressive phase and long-term evolution of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2014;85:67–75.
23. Tremlett H, Yousefi M, Devonshire V, Rieckmann P, Zhao Y. UBC Neurologists. Impact of multiple sclerosis relapses on progression diminishes with time. Neurology. 2009;73:1616–23.
24. Bermel RA, You X, Foulds P, Hyde R, Simon JH, Fisher E, et al. Predictors of long-term outcome in multiple sclerosis patients treated with interferon β. Ann Neurol. 2013;73:95–103. Important report on the long-term impact of MRI activity in IFN beta treated MS patients.
25. Prosperini L, Mancinelli CR, De Giglio L, De Angelis F, Barletta V, Pozzilli C. Interferon beta failure predicted by EMA criteria or isolated MRI activity in multiple sclerosis. Mult Scler Houndmills Basingstoke Engl. 2014;20:566–76.
26. Río J, Tintoré M, Sastre-Garriga J, Nos C, Castilló J, Tur C, et al. Change in the clinical activity of multiple sclerosis after treatment switch for suboptimal response. Eur J Neurol Off J Eur Fed Neurol Soc. 2012;19:899–904.
27. Sormani MP, Rio J, Tintorè M, Signori A, Li D, Cornelisse P, et al. Scoring treatment response in patients with relapsing multiple sclerosis. Mult Scler Houndmills Basingstoke Engl. 2013;19:605–12.
28. Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, et al. Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients. Mult Scler Houndmills Basingstoke Engl. 2014;20:1602–8.
29. Havrdova E, Galetta S, Stefoski D, Comi G. Freedom from disease activity in multiple sclerosis. Neurology. 2010;74 Suppl 3:S3–7. Introduction of the NEDA concept.
30. Weinges-Evers N, Brandt AU, Bock M, Pfueller CF, Dörr J, Bellmann-Strobl J, et al. Correlation of self-assessed fatigue and alertness in multiple sclerosis. Mult Scler Houndmills Basingstoke Engl. 2010;16:1134–40.
31. Stangel M, Penner IK, Kallmann BA, Lukas C, Kieseier BC. Towards the implementation of “no evidence of disease activity” in multiple sclerosis treatment: the multiple sclerosis decision model. Ther Adv Neurol Disord. 2015;8:3–13.
32. Rotstein DL, Healy BC, Malik MT, Chitnis T, Weiner HL. Evaluation of no evidence of disease activity in a 7-year longitudinal multiple sclerosis cohort. JAMA Neurol. 2015;72:152–8.
33. Coyle PK. Switching therapies in multiple sclerosis. CNS Drugs. 2013;27:239–47.
34. Gajofatto A, Bacchetti P, Grimes B, High A, Waubant E. Switching first-line disease-modifying therapy after failure: impact on the course of relapsing-remitting multiple sclerosis. Mult Scler Houndmills Basingstoke Engl. 2009;15:50–8.
35. Carrá A, Onaha P, Luetic G, Burgos M, Crespo E, Deri N, et al. Therapeutic outcome 3 years after switching of immunomodulatory therapies in patients with relapsing-remitting multiple sclerosis in Argentina. Eur J Neurol Off J Eur Fed Neurol Soc. 2008;15:386–93.
36. Capobianco M, Rizzo A, Malucchi S, Sperli F, Di Sapio A, Oggero A, et al. Glatiramer acetate is a treatment option in neutralising antibodies to interferon-beta-positive patients. Neurol Sci Off J Ital Neurol Soc Ital Soc Clin Neurophysiol. 2008;29 Suppl 2:S227–9.
37. Caon C, Din M, Ching W, Tselis A, Lisak R, Khan O. Clinical course after change of immunomodulating therapy in relapsing-remitting multiple sclerosis. Eur J Neurol Off J Eur Fed Neurol Soc. 2006;13:471–4.
38. Prosperini L, Borriello G, De Giglio L, Leonardi L, Barletta V, Pozzilli C. Management of breakthrough disease in patients with multiple sclerosis: when an increasing of Interferon beta dose should be effective? BMC Neurol. 2011;11:26.
39. Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012;367:1087–97.
40. Vermersch P, Czlonkowska A, Grimaldi LME, Confavreux C, Comi G, Kappos L, et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler Houndmills Basingstoke Engl. 2014;20:705–16.
41. Castillo-Trivino T, Mowry EM, Gajofatto A, Chabas D, Crabtree-Hartman E, Cree BA, et al. Switching multiple sclerosis patients with breakthrough disease to second-line therapy. PLoS One. 2011;6, e16664.
42. Belachew S, Phan-Ba R, Bartholomé E, Delvaux V, Hansen I, Calay P, et al. Natalizumab induces a rapid improvement of disability status and ambulation after failure of previous therapy in relapsing-remitting multiple sclerosis. Eur J Neurol Off J Eur Fed Neurol Soc. 2011;18:240–5.
43. Putzki N, Kollia K, Woods S, Igwe E, Diener HC, Limmroth V. Natalizumab is effective as second line therapy in the treatment of relapsing remitting multiple sclerosis. Eur J Neurol Off J Eur Fed Neurol Soc. 2009;16:424–6.
44. Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, et al. Relapse rates in patients with multiple sclerosis switching from interferon to fingolimod or glatiramer acetate: a US claims database study. PLoS One. 2014;9, e88472.
45. He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, et al. Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis. JAMA Neurol. 2015;1–10. Important paper arguing for escalation of treatment insead of intra class switching.
46. Prosperini L, Giannì C, Leonardi L, De Giglio L, Borriello G, Galgani S, et al. Escalation to natalizumab or switching among immunomodulators in relapsing multiple sclerosis. Mult Scler Houndmills Basingstoke Engl. 2012;18:64–71.
47. CAMMS223 Trial Investigators, Coles AJ, Compston DAS, Selmaj KW, Lake SL, Moran S, et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008;359:1786–801.
48. Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012;380:1819–28.
49. Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380:1829–39.
50. Kalincik T, Horakova D, Spelman T, Jokubaitis V, Trojano M, Lugaresi A, et al. Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Ann Neurol. 2015;77:425–35.
51. Bergvall N, Lahoz R, Reynolds T, Korn JR. Healthcare resource use and relapses with fingolimod versus natalizumab for treating multiple sclerosis: a retrospective US claims database analysis. Curr Med Res Opin. 2014;30:1461–71.
52. Williamson EM, Berger JR. Infection risk in patients on multiple sclerosis therapeutics. CNS Drugs. 2015.
53. Kappos L, Li D, Calabresi PA, O’Connor P, Bar-Or A, Barkhof F, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011;378:1779–87.
54. Pfender N, Martin R, Pt A. Daclizumab (anti-CD25) in multiple sclerosis. Exp Neurol. 2014;262:44–51.
55. Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, et al. Randomized study combining interferon and glatiramer acetate in multiple sclerosis. Ann Neurol. 2013;73:327–40. Crucial study evaluating the combination of IFN beta and GA treatment.
56. Narula S, Hopkins SE, Banwell B. Treatment of pediatric multiple sclerosis. Curr Treat Options Neurol. 2015;17:336.