Novel agents for relapsing forms of multiple sclerosis

Annual Review of Medicine

Volumn 67, Issue , 2016, Pages 309-321

  Farber, Rebecca Straus ^a   Harel, Asaff ^a   Lublin, Fred ^a  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Alemtuzumab; Daclizumab; Dimethyl fumarate; Fingolimod; Multiple sclerosis; Natalizumab; Ocrelizumab; Ofatumumab; Teriflunomide

Indexed keywords

ALEMTUZUMAB; DACLIZUMAB; FINGOLIMOD; FUMARIC ACID DIMETHYL ESTER; NATALIZUMAB; OCRELIZUMAB; OFATUMUMAB; TERIFLUNOMIDE; CD20 ANTIGEN; CROTONIC ACID DERIVATIVE; IMMUNOGLOBULIN G; IMMUNOLOGIC FACTOR; IMMUNOLOGICAL ADJUVANT; IMMUNOSUPPRESSIVE AGENT; MONOCLONAL ANTIBODY; TOLUIDINE DERIVATIVE;

ABDOMINAL PAIN; ALLERGIC REACTION; ARTICLE; AUTOIMMUNE HEMOLYTIC ANEMIA; AUTOIMMUNE THYROIDITIS; BASAL CELL CARCINOMA; BRADYCARDIA; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG INDICATION; DRUG MECHANISM; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; ECZEMA; ERYTHEMA; FETUS MALFORMATION; FIRST DEGREE ATRIOVENTRICULAR BLOCK; GASTROINTESTINAL SYMPTOM; GLOMERULONEPHRITIS; HEART VENTRICLE ARRHYTHMIA; HERPES VIRUS INFECTION; HERPES ZOSTER; HOT FLUSH; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; IDIOPATHIC THROMBOCYTOPENIC PURPURA; INFECTION; INFUSION RELATED REACTION; LYMPHOCYTOPENIA; MACULAR EDEMA; MELANOMA; MULTIPLE SCLEROSIS; NAUSEA; NEUTROPENIA; PANCYTOPENIA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PITYRIASIS RUBRA PILARIS; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SECOND DEGREE ATRIOVENTRICULAR BLOCK; SIDE EFFECT; SKIN CANCER; THYROID CANCER; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URTICARIA; VOMITING; DRUG EFFECTS; RECURRENT DISEASE;

ADJUVANTS, IMMUNOLOGIC; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD20; CROTONATES; DIMETHYL FUMARATE; FINGOLIMOD HYDROCHLORIDE; HUMANS; IMMUNOGLOBULIN G; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; MULTIPLE SCLEROSIS; NATALIZUMAB; RECURRENCE; TOLUIDINES;

EID: 84954556196     PISSN: 00664219     EISSN: 1545326X     Source Type: Book Series    
DOI: 10.1146/annurev-med-052814-023415     Document Type: Article

References (53)

1. Polman CH, O'Connor PW, Havrdova E, et al. (2006). A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. 354: 899-910
2. Rudick RA, Stuart WH, Calabresi PA, et al. (2006). Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N. Engl. J. Med. 354: 911-23
3. Kleinschmidt-DeMasters BK, Tyler KL. (2005). Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N. Engl. J. Med. 353: 369-74
4. Van Assche G, Van Ranst M, Sciot R, et al. (2005). Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N. Engl. J. Med. 353: 362-68
5. Fox RJ, Rudick RA. (2012). Risk stratification and patient counseling for natalizumab in multiple sclerosis. Neurology 78: 436-37
6. Bloomgren G, Richman S, Hotermans C, et al. (2012). Risk of natalizumab-Associated progressive multifocal leukoencephalopathy. N. Engl. J. Med. 366: 1870-80
7. Sorensen PS, Bertolotto A, Edan G, et al. (2012). Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult. Scler. 18: 143-52
8. Gorelik L, Lerner M, Bixler S, et al. (2010). Anti-JC virus antibodies: implications for PML risk stratification. Ann. Neurol. 68: 295-303
9. Tubridy N, Behan PO, Capildeo R, et al. (1999). The effect of anti-Alpha4 integrin antibody on brain lesion activity in MS. The UK Antegren Study Group. Neurology 53: 466-72
10. Gueguen A, Roux P, Deschamps R, et al. (2014). Abnormal inflammatory activity returns after natalizumab cessation in multiple sclerosis. J. Neurol. Neurosurg. Psychiatry 85: 1038-40
11. O'Connor PW, Goodman A, Kappos L, et al. (2011). Disease activity return during natalizumab treatment interruption in patients with multiple sclerosis. Neurology 76: 1858-65
12. Sorensen PS, Koch-Henriksen N, Petersen T, et al. (2014). Recurrence or rebound of clinical relapses after discontinuation of natalizumab therapy in highly active MS patients. Neurology 261: 1170-77
13. O'Connor P, Goodman A, Kappos L, et al. (2014). Long-Term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology 83: 78-86
14. Novartis. (2010). GilenyaTM (fingolimod) highlights of prescribing information. http://www.accessdata. fda.gov/drugsatfda-docs/label/2012/022527s008lbl.pdf
15. Brinkmann V, Davis MD, Heise CE, et al. (2002). The immune modulator FTY720 targets sphingosine 1-phosphate receptors. J. Biol. Chem. 277: 21453-57
16. Groves A, Kihara Y, Chun J. (2013). Fingolimod: Direct CNS effects of sphingosine 1-phosphate (S1P) receptor modulation and implications in multiple sclerosis therapy. J. Neurol. Sci. 328: 9-18
17. Kappos L, Radue EW, O'Connor P, et al. (2010). A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N. Engl. J. Med. 362: 387-401
18. Kappos L, O'Connor P, Radue EW, et al. (2015). Long-Term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial. Neurology 84: 1582-91
19. Cohen JA, Barkhof F, Comi G, et al. (2010). Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N. Engl. J. Med. 362: 402-15
20. Aguiar C, Batista S, Pacheco R. (2014). Cardiovascular effects of fingolimod: relevance, detection and approach. Rev. Port. Cardiol. 34: 279-85
21. Espinosa PS, Berger JR. (2011). Delayed fingolimod-Associated asystole. Mult. Scler. 17: 1387-89
22. Lindsey JW, Haden-Pinneri K, Memon NB, Buja LM. (2012). Sudden unexpected death on fingolimod. Mult. Scler. 18: 1507-8
23. Kappos L, Antel J, Comi G, et al. (2006). Oral fingolimod (FTY720) for relapsing multiple sclerosis. N. Engl. J. Med. 355: 1124-40
24. Calabresi PA, Radue EW, Goodin D, et al. (2014). 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. 13: 545-56
25. Novartis (2015). Gilenya safety update. http://www.novartis.com/newsroom/product-related-infocenter/gilenya-safety-update.shtml
26. Warnke C, Meyer zu Horste G, Hartung HP, et al. (2009). Review of teriflunomide and its potential in the treatment of multiple sclerosis. Neuropsychiatr. Dis. Treat. 5: 333-40
27. Gold R, Wolinsky JS. (2010). Pathophysiology of multiple sclerosis and the place of teriflunomide. Acta. Neurol. Scand. 124: 75-84
28. O'Connor P, Wolinsky JS, Confavreux C, et al. (2011). Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N. Engl. J. Med. 365: 1293-303
29. Confavreux C, O'Connor P, Comi G, et al. (2014). Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 13: 247-56
30. Miller AE, Wolinsky JS, Kappos L, et al. (2014). Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 13: 977-86
31. Vermersch P, Czlonkowska A, Grimaldi LM, et al. (2014). Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult. Scler. 20: 705-16
32. Genzyme. (2012). AubagioR-(teriflunomide) highlights of prescribing information. Cambridge, MA. http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/202992s000lbl.pdf
33. Papadopoulou A, Kappos L, Sprenger T. (2015). Safety of teriflunomide for the management of relapsingremitting multiple sclerosis. Expert Opin. Drug Saf. 14: 749-59
34. Gold R, Kappos L, Arnold DL, et al. (2012). Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N. Engl. J. Med. 367: 1098-107
35. Fox RJ, Miller DH, Phillips JT, et al. (2012). Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N. Engl. J. Med. 367: 1087-97
36. Rosenkranz T, Novas M, Terborg C. 2015.PMLin a patient with lymphocytopenia treated with dimethyl fumarate. N. Engl. J. Med. 372: 1476-78
37. Nieuwkamp DJ, Murk JL, van Oosten BW, et al. (2015). PML in a patient without severe lymphocytopenia receiving dimethyl fumarate. N. Engl. J. Med. 372: 1474-76
38. Genzyme. (2014). LemtradaTM (alemtuzumab) highlights of prescribing information. Cambridge, MA. http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/103948s5139lbl.pdf
39. Coles AJ, Twyman CL, Arnold DL, et al. (2012). Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 380: 1829-39
40. Cohen JA, Coles AJ, Arnold DL, et al. (2012). Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 380: 1819-28
41. Pace AA, Zajicek JP. (2009). Melanoma following treatment with alemtuzumab for multiple sclerosis. Eur. J. Neurol. 16: e70-e71
42. Bielekova B, Catalfamo M, Reichert-Scrivner S, et al. (2006). Regulatory CD56(bright) natural killer cells mediate immunomodulatory effects of IL-2Ralpha-Targeted therapy (daclizumab) in multiple sclerosis. PNAS 103: 5941-46
43. Wynn D, Kaufman M, Montalban X, et al. (2010). Daclizumab in active relapsing multiple sclerosis (CHOICE Study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 9: 381-90
44. Gold R, Giovannoni G, Selmaj K, et al. (2013). Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet 381: 2167-75
45. Pfender N, Martin R. (2014). Daclizumab (anti-CD25) in multiple sclerosis. Exp. Neurol. 262(Pt. A): 44-51
46. Giovannoni G, Gold R, Selmaj K, et al. (2014). Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): amulticentre, randomised, double-blind extension trial. Lancet Neurol. 13: 472-81
47. Kappos LSK, Arnold DL, Havrdova E, et al. (2014). Primary results of DECIDE: a randomized, double-blind, double-dummy, active controlled trial of daxlizumab HYP versus interferon beta-1a in RRMS patients. Presented at Joint Meet. Am. Comm. Treatment and Research in Multiple Sclerosis and Eur. Comm. Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS), Boston, Sep
48. Hauser SL, Waubant E, Arnold DL, et al. (2008). B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N. Engl. J. Med. 358: 676-88
49. Hawker K, O'Connor P, Freedman MS, et al. (2009). Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann. Neurol. 66: 460-71
50. Clifford DB, Ances B, Costello C, et al. (2011). Rituximab-Associated progressive multifocal leukoencephalopathy in rheumatoid arthritis. Arch. Neurol. 68: 1156-64
51. Tuccori M, Focosi D, Blandizzi C, et al. (2010). Inclusion of rituximab in treatment protocols for non-Hodgkin's lymphomas and risk for progressive multifocal leukoencephalopathy. Oncologist 15: 1214-19
52. Kappos L, Li D, Calabresi PA, et al. (2011). Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 378: 1779-87
53. Sorensen PS, Lisby S, Grove R, et al. (2014). Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. Neurology 82: 573-81