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The Effectiveness of Natalizumab Vs Fingolimod–A Comparison of International Registry Studies Publisher Pubmed



Andersen JB1, 95 ; Sharmin S2, 93 ; Lefort M4, 86 ; Kochhenriksen N6 ; Sellebjerg F7 ; Sorensen PS8, 13, 96 ; Hilt Christensen CC9 ; Rasmussen PV10 ; Jensen MB11 ; Frederiksen JL12 ; Bramow S7 ; Mathiesen HK8, 13, 96 ; Schreiber KI7 ; Horakova D14, 15 Show All Authors
Authors
  1. Andersen JB1, 95
  2. Sharmin S2, 93
  3. Lefort M4, 86
  4. Kochhenriksen N6
  5. Sellebjerg F7
  6. Sorensen PS8, 13, 96
  7. Hilt Christensen CC9
  8. Rasmussen PV10
  9. Jensen MB11
  10. Frederiksen JL12
  11. Bramow S7
  12. Mathiesen HK8, 13, 96
  13. Schreiber KI7
  14. Horakova D14, 15
  15. Havrdova EK14, 15
  16. Alroughani R16
  17. Izquierdo G17, 18
  18. Eichau S17, 18
  19. Ozakbas S19
  20. Patti F20
  21. Onofrj M21
  22. Lugaresi A22
  23. Terzi M23
  24. Grammond P24
  25. Grand Maison F25
  26. Yamout B26
  27. Prat A27, 28, 29
  28. Girard M27, 28, 29
  29. Duquette P27, 28, 29
  30. Boz C30
  31. Trojano M31
  32. Mccombe P32
  33. Slee M33
  34. Lechnerscott J34
  35. Turkoglu R36
  36. Sola P37, 38
  37. Ferraro D37, 38
  38. Granella F39
  39. Shaygannejad V41
  40. Prevost J42
  41. Skibina O43
  42. Solaro C44
  43. Karabudak R46
  44. Wijmeersch BV47
  45. Csepany T48
  46. Spitaleri D49
  47. Vucic S50
  48. Casey R51
  49. Debouverie M54
  50. Edan G55
  51. Ciron J56
  52. Ruet A57
  53. Seze JD58
  54. Maillart E59
  55. Zephir H60
  56. Labauge P61
  57. Defer G62
  58. Lebrun C63
  59. Moreau T64
  60. Berger E65
  61. Clavelou P66
  62. Pelletier J67
  63. Stankoff B68
  64. Gout O69
  65. Thouvenot E70
  66. Heinzlef O71
  67. Alkhedr A72
  68. Bourre B73
  69. Casez O74
  70. Cabre P75
  71. Montcuquet A76
  72. Wahab A77
  73. Camdessanche JP78
  74. Marousset A79
  75. Patry I80
  76. Hankiewicz K81
  77. Pottier C82
  78. Maubeuge N83
  79. Labeyrie C84
  80. Nifle C85
  81. Leray E4, 86
  82. Laplaud DA88
  83. Butzkueven H90
  84. Kalincik T2, 93
  85. Vukusic S1, 95
  86. Magyari M1, 7, 95

Source: Multiple Sclerosis and Related Disorders Published:2021


Abstract

Background: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. Methods: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. Results: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. Conclusion: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed. © 2021 Elsevier B.V.
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