Risk stratification and mitigation in multiple sclerosis

Multiple Sclerosis and Related Disorders

Volumn 3, Issue 5, 2014, Pages 639-649

  Ontaneda, Daniel ^a,b   Cohn, Samuel ^b   Fox, Robert J ^a,b  

^a NEUROLOGICAL INSTITUTE   (United States)

^b CASE WESTERN RESERVE UNIVERSITY   (United States)

Author keywords

Benefits; Mitigation; Multiple sclerosis; Risk; Stratification

Indexed keywords

ALEMTUZUMAB; BETA1A INTERFERON; FINGOLIMOD; FUMADERM; FUMARIC ACID DIMETHYL ESTER; GLATIRAMER; INTERFERON BETA SERINE; NATALIZUMAB; PLACEBO; PSORINOVO; TERIFLUNOMIDE; UNCLASSIFIED DRUG; IMMUNOLOGIC FACTOR; IMMUNOSUPPRESSIVE AGENT;

ALOPECIA; ARTHRALGIA; ATRIOVENTRICULAR BLOCK; AUTOIMMUNE DISEASE; BACKACHE; BRADYCARDIA; CHILL; DEPRESSION; DIARRHEA; DIZZINESS; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ENZYME BLOOD LEVEL; EYE DISEASE; FATIGUE; FEVER; GASTROINTESTINAL DISEASE; GOODPASTURE SYNDROME; HEADACHE; HEART ARRHYTHMIA; HEART PALPITATION; HEMOLYTIC ANEMIA; HERPES SIMPLEX; HERPES VIRUS INFECTION; HOT FLUSH; HUMAN; IDIOPATHIC THROMBOCYTOPENIC PURPURA; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INSULIN DEPENDENT DIABETES MELLITUS; INTESTINE TUBERCULOSIS; LEUKOENCEPHALOPATHY; LEUKOPENIA; LIMB PAIN; LIPOATROPHY; LYMPHOCYTOPENIA; MEDICAL DECISION MAKING; MULTIPLE SCLEROSIS; MYALGIA; NAUSEA; PARESTHESIA; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL (TOPIC); PRURITUS; RESPIRATORY TRACT INFECTION; RETINA MACULA EDEMA; REVIEW; RISK ASSESSMENT; SIDE EFFECT; SKIN ALLERGY; SUDDEN CARDIAC DEATH; TACHYCARDIA; THORAX PAIN; THYROID PAPILLARY CARCINOMA; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URTICARIA; COMPLICATION; EVIDENCE BASED MEDICINE; PROCEDURES; TREATMENT OUTCOME;

EVIDENCE-BASED MEDICINE; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; MULTIPLE SCLEROSIS; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 84906324104     PISSN: 22110348     EISSN: 22110356     Source Type: Journal    
DOI: 10.1016/j.msard.2014.05.003     Document Type: Review

References (88)

1. F. Bagnato, N. Jeffries, N.D. Richert, R.D. Stone, J.M. Ohayon, and H.F. McFarland et al. Evolution of T1 black holes in patients with multiple sclerosis imaged monthly for 4 years Brain 126 Pt 8 2003 1782 1789
2. R.R. Bartlett, and R. Schleyerbach Immunopharmacological profile of a novel isoxazol derivative, HWA 486, with potential antirheumatic activity - I. disease modifying action on adjuvant arthritis of the rat Int J Immunopharmacol 7 1 1985 7 18
3. R.R. Bartlett, H. Anagnostopulos, T. Zielinski, T. Mattar, and R. Schleyerbach Effects of leflunomide on immune responses and models of inflammation Semin Immunopathol 14 4 1993 381 394
4. Biogen Idec. Tysabri (natalizumab) injection: full prescribing information; March 2011.
5. Biogen Idec. Medical information web site. https://medinfo.biogenidec. com/; updated 2013. [accessed 07.12.13].
6. G. Bloomgren, S. Richman, and C. Hotermans et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy N Engl J Med 366 20 2012 1870 1880
7. M.B. Bornstein, A. Miller, and S. Slagle et al. A pilot trial of cop 1 in exacerbating-remitting multiple sclerosis N Engl J Med 317 7 1987 408 414
8. C. Bozic, S. Richman, and T. Plavina et al. Anti-john cunnigham virus antibody prevalence in multiple sclerosis patients: baseline results of STRATIFY-1 Ann Neurol 70 5 2011 742 750
9. CAMMS223 Trial Investigators, A.J. Coles, and D.A. Compston et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis N Engl J Med 359 17 2008 1786 1801
10. R.L. Carruthers, T. Chitnis, and B.C. Healy Modeling probability of additional cases of natalizumab-associated JCV sero-negative progressive multifocal leukoencephalopathy Mult Scler 2013
11. J. Chun, and H.P. Hartung Mechanism of action of oral fingolimod (FTY720) in multiple sclerosis Clin Neuropharmacol 33 2 2010 91 101
12. D.B. Clifford, A. De Luca, D.M. Simpson, G. Arendt, G. Giovannoni, and A. Nath Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases Lancet Neurol 9 4 2010 438 446
13. ClinicalTrials.gov. A study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis (TENERE).
14. Cohen J. Long-term safety of fingolimod in relapsing multiple sclerosis: update to integrated analyses of phase 2 and 3 studies and extension phases. In: Proceedings of the 28th congress of the European committee for treatment and research in multiple sclerosis; October 12, 2012.
15. J.A. Cohen, F. Barkhof, and G. Comi et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis N Engl J Med 362 5 2010 402 415
16. J.A. Cohen, A.J. Coles, and D.L. Arnold 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 380 9856 2012 1819 1828
17. A.J. Coles, E. Fox, and A. Vladic et al. Alemtuzumab more effective than interferon beta-1a at 5-year follow-up of CAMMS223 clinical trial Neurology 78 14 2012 1069 1078
18. A.J. Coles, C.L. Twyman, and D.L. Arnold et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial Lancet 380 9856 2012 1829 1839
19. W. Collins, J. Cohen, and P. O'Connor Long-term safety of oral fingolimod (FTY720) in relapsing multiple sclerosis: integrated analyses of phase 2 and 3 studies (P843) Mult Scler 16 Suppl. 10 2010 S295
20. G. Comi, V. Martinelli, and M. Rodegher et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial Lancet 374 9700 2009 1503 1511
21. C. Confavreux, D.K. Li, and M.S. Freedman et al. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years Mult Scler 18 9 2012 1278 1289
22. M. Cossburn, A.A. Pace, and J. Jones et al. Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort Neurology 77 6 2011 573 579
23. A.L. Cox, S.A. Thompson, and J.L. Jones et al. Lymphocyte homeostasis following therapeutic lymphocyte depletion in multiple sclerosis Eur J Immunol 35 11 2005 3332 3342
24. S. Dhib-Jalbut Mechanisms of action of interferons and glatiramer acetate in multiple sclerosis Neurology 58 8 Suppl. 4 2002 S3 S9
25. R. de Jong, A.C. Bezemer, and T.P. Zomerdijk et al. Selective stimulation of T helper 2 cytokine responses by the anti-psoriasis agent monomethylfumarate Eur J Immunol 26 9 1996 2067 2074
26. U. Ermis, J. Weis, and J.B. Schulz PML in a patient treated with fumaric acid N Engl J Med 368 17 2013 1657 1658
27. FDA. Gilenya (fingolimod): drug safety communication - safety review of a reported death after the first dose.
28. FDA. Fingolimod drug label; 2010.
29. FDA. FDA drug safety communication: new risk factor for progressive multifocal leukoencephalopathy (PML) associated with tysabri (natalizumab); 2012a.
30. FDA. FDA drug safety communication: revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug gilenya (fingolimod); 2012b.
31. FDA. Tecfidera FDA approved labeling; 2013a.
32. FDA. Peripheral and central nervous system drugs advisory committee meeting: Alemtuzumab (BLA 103948\5139) background package; November 13, 2013b.
33. FDA. FDA drug safety communication: FDA investigating rare brain infection in patient taking gilenya (fingolimod); 2013c. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm366529.htm.
34. L.K. Fisniku, P.A. Brex, D.R. Altmann, K.A. Miszkiel, C.E. Benton, and R. Lanyon et al. Disability and T2 MRI lesions: a 20-year follow-up of patients with relapse onset of multiple sclerosis Brain 131 Pt 3 2008 808 817
35. C. Ford, A.D. Goodman, and K. Johnson et al. Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate Mult Scler 16 3 2010 342 350
36. R.J. Fox, D.H. Miller, and J.T. Phillips et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis N Engl J Med 367 12 2012 1087 1097
37. G.S. Francis, Y. Grumser, and E. Alteri et al. Hepatic reactions during treatment of multiple sclerosis with interferon-beta-1a: incidence and clinical significance Drug Saf 26 11 2003 815 827
38. M.H. Gilleece, and T.M. Dexter Effect of campath-1H antibody on human hematopoietic progenitors in vitro Blood 82 3 1993 807 812
39. R. Gold, P. Rieckmann, P. Chang, J. Abdalla PRISMS Study Group The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study Eur J Neurol 12 8 2005 649 656
40. R. Gold, L. Kappos, and D.L. Arnold et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis N Engl J Med 367 12 2012 1098 1107
41. L. Gorelik, M. Lerner, and S. Bixler et al. Anti-JC virus antibodies: Implications for PML risk stratification Ann Neurol 68 3 2010 295 303
42. S. Greene, K. Watanabe, J. Braatz-Trulson, and L. Lou Inhibition of dihydroorotate dehydrogenase by the immunosuppressive agent leflunomide Biochem Pharmacol 50 6 1995 861 867
43. J.J. Hoefnagel, H.B. Thio, R. Willemze, and J.N. Bouwes Bavinck Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis Br J Dermatol 149 2 2003 363 369
44. S. Inusah, M.P. Sormani, S.S. Cofield, I.B. Aban, S.K. Musani, and V. Srinivasasainagendra et al. Assessing changes in relapse rates in multiple sclerosis Mult.Scler 16 12 2010 1414 1421
45. L.D. Jacobs, R.W. Beck, J.H. Simon, and CHAMPS Study Group et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis N Engl J Med 343 13 2000 898 904
46. K.P. Johnson, B.R. Brooks, and J.A. Cohen et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. 1995 Neurology 57 12 Suppl. 5 2001 S16 S24
47. J.L. Jones, C.L. Phuah, and A.L. Cox et al. IL-21 drives secondary autoimmunity in patients with multiple sclerosis, following therapeutic lymphocyte depletion with alemtuzumab (campath-1H) J Clin Investig 119 7 2009 2052 2061
48. L. Kappos, E.W. Radue, and P. O'Connor et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis N Engl J Med 362 5 2010 387 401
49. O. Khan, P. Rieckmann, A. Boyko, K. Selmaj, R. Zivadinov GALA Study Group Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis Ann Neurol 73 6 2013 705 713
50. B.O. Khatri, S. Man, and G. Giovannoni et al. Effect of plasma exchange in accelerating natalizumab clearance and restoring leukocyte function Neurology 72 5 2009 402 409
51. B.K. Kleinschmidt-DeMasters, and K.L. Tyler Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis N Engl J Med 353 4 2005 369 374
52. T. Korn, T. Magnus, K. Toyka, and S. Jung Modulation of effector cell functions in experimental autoimmune encephalomyelitis by leflunomide - mechanisms independent of pyrimidine depletion J Leukoc Biol 76 5 2004 950 960
53. A. Langer-Gould, S.W. Atlas, A.J. Green, A.W. Bollen, and D. Pelletier Progressive multifocal leukoencephalopathy in a patient treated with natalizumab N Engl J Med 353 4 2005 375 381
54. D.K. Li, and D.W. Paty Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis. prevention of relapses and disability by interferon-beta1a subcutaneously in multiple sclerosis Ann Neurol 46 2 1999 197 206
55. J.W. Lindsey, K. Haden-Pinneri, N.B. Memon, and L.M. Buja Sudden unexpected death on fingolimod Mult Scler 18 10 2012 1507 1508
56. R.A. Linker, D.H. Lee, and S. Ryan et al. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway Brain 134 Pt 3 2011 678 692
57. F.D. Lublin, M. Baier, and G. Cutter Effect of relapses on development of residual deficit in multiple sclerosis Neurology 61 11 2003 1528 1532
58. F.D. Lublin, S.S. Cofield, and G.R. Cutter et al. Randomized study combining interferon and glatiramer acetate in multiple sclerosis Ann Neurol 73 3 2013 327 340
59. A. Miller, L. Kappos, G. Comi, and C. Confavreux et al. Teriflunomide efficacy and safety in patients with relapsing multiple sclerosis: results from TOWER, a second, pivotal, phase 3 placebo-controlled study Neurology 80 2013
60. D.H. Miller, D. Soon, and K.T. Fernando et al. MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS Neurology 68 17 2007 1390 1401
61. D.C. Mohr, W. Likosky, P. Dwyer, J. Van Der Wende, A.C. Boudewyn, and D.E. Goodkin Course of depression during the initiation of interferon beta-1a treatment for multiple sclerosis Arch Neurol 56 10 1999 1263 1265
62. Novartis. Novartis statement: Gilenya (fingolimod) safety information update; 2012.
63. Novartis. Gilenya world watch. http://gilenya-world-watch.com/English. html; updated 2013 [accessed 07.12.13].
64. P. O'Connor, M. Filippi, and B. Arnason et al. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study Lancet Neurol 8 10 2009 889 897
65. P. O'Connor, J.S. Wolinsky, and C. Confavreux et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis N Engl J Med 365 14 2011 1293 1303
66. J. Oh, and P.W. O'Connor An update of teriflunomide for treatment of multiple sclerosis J Ther Clin Risk Manag 9 2013 177 190
67. S.B. Patten, and L.M. Metz Interferon beta-1a and depression in relapsing-remitting multiple sclerosis: an analysis of depression data from the PRISMS clinical trial Mult Scler 7 4 2001 243 248
68. D.W. Paty, D.K. Li, and UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial Neurology 43 4 1993 662 667
69. T. Plavina, M. Subramanyam, and G. Bloomgren et al. JCV antibody index stratifies PML risk in natalizumab-treated MS patients Consort Mult Scler Centers DX51 2013
70. C.H. Polman, P.W. O'Connor, and E. Havrdova et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis N Engl J Med 354 9 2006 899 910
71. PRISMS Study Group and the University of British Columbia MS/MRI Analysis Group PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS Neurology 56 12 2001 1628 1636
72. 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 352 9139 1998 1498 1504
73. E.W. Radue, P. O'Connor, and C.H. Polman et al. Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis Arch Neurol 69 10 2012 1259 1269
74. N.S. Roskell, E.A. Zimovetz, C.E. Rycroft, B.J. Eckert, and D.A. Tyas Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod Curr Med Res Opin 28 5 2012 767 780
75. R.A. Rudick, W.H. Stuart, and P.A. Calabresi et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis N Engl J Med 354 9 2006 911 923
76. M.A. Sahraian, E.W. Radue, S. Haller, and L. Kappos Black holes in multiple sclerosis: definition, evolution, and clinical correlations Acta Neurol Scand 122 1 2010 1 8
77. Sheikh S., Nestorov I., Russell H., et al. Safety, tolerability, and pharmacokinetics of BG-12 administered with and without aspirin: key findings from a randomized, double-blind, placebo-controlled trial in healthy volunteers (P04.136). Neurology. 2012;78(Meeting Abstracts 1):P04.136.
78. M.P. Sormani, D.K. Li, P. Bruzzi, B. Stubinski, P. Cornelisse, and S. Rocak et al. Combined MRI lesions and relapses as a surrogate for disability in multiple sclerosis Neurology 77 18 2011 1684 1690
79. J.P. Stellmann, A. Neuhaus, L. Herich, S. Schippling, M. Roeckel, and M. Daumer et al. Placebo cohorts in phase-3 MS treatment trials - predictors for on-trial disease activity 1990-2010 based on a meta-analysis and individual case data PLoS One 7 11 2012 e50347
80. M.T. Sweetser, K.T. Dawson, and C. Bozic Manufacturers response to case reports of PML N Engl J Med 368 17 2013 1659 1661
81. D. Teitelbaum, A. Meshorer, T. Hirshfeld, R. Arnon, and M. Sela Suppression of experimental allergic encephalomyelitis by a synthetic polypeptide Eur J Immunol 1 4 1971 242 248
82. H.L. Tremlett, E.M. Yoshida, and J. Oger Liver injury associated with the beta-interferons for MS: a comparison between the three products Neurology 62 4 2004 628 631
83. The IFNB Multiple Sclerosis Study Group Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43 4 1993 655 661
84. B.W. van Oosten, J. Killestein, F. Barkhof, C.H. Polman, and M.P. Wattjes PML in a patient treated with dimethyl fumarate from a compounding pharmacy N Engl J Med 368 17 2013 1658 1659
85. G. Van Assche, M. Van Ranst, and R. Sciot et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohns disease N Engl J Med 353 4 2005 362 368
86. M.T. Wallin, J.A. Wilken, A.P. Turner, R.M. Williams, and R. Kane Depression and multiple sclerosis: review of a lethal combination J Rehab Res Dev 43 1 2006 45 62
87. T.A. Yednock, C. Cannon, L.C. Fritz, F. Sanchez-Madrid, L. Steinman, and N. Karin Prevention of experimental autoimmune encephalomyelitis by antibodies against alpha 4 beta 1 integrin Nature 356 6364 1992 63 66
88. R Zivadinov, J Sepcic, D Nasuelli, R De Masi, LM Bragadin, and MA Tommasi et al. A longitudinal study of brain atrophy and cognitive disturbances in the early phase of relapsing-remitting multiple sclerosis J Neurol Neurosurg Psychiatry 70 6 2001 773 780