Emerging injectable therapies for multiple sclerosis

The Lancet Neurology

Volumn 12, Issue 11, 2013, Pages 1115-1126

  Oh, Jiwon ^a   Calabresi, Peter A ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; BETA1A INTERFERON; BIIB 033; CYCLOPHOSPHAMIDE; DACLIZUMAB; GLATIRAMER; IMMUNOGLOBULIN; INTERFERON BETA SERINE; MITOXANTRONE; NATALIZUMAB; OCRELIZUMAB; OFATUMUMAB; PEGINTERFERON BETA1A; PLACEBO; RITUXIMAB; STEROID; UNCLASSIFIED DRUG;

ACUTE LEUKEMIA; ADD ON THERAPY; AUTOIMMUNE HEPATITIS; BLOOD BRAIN BARRIER; BRAIN HEMORRHAGE; BRAIN SIZE; CARDIOTOXICITY; CELL DIFFERENTIATION; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL PRACTICE; CONGESTIVE HEART FAILURE; DEATH; DISEASE ACTIVITY; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FLU LIKE SYNDROME; HEADACHE; HEART VENTRICLE FUNCTION; HUMAN; HUMORAL IMMUNITY; IDIOPATHIC THROMBOCYTOPENIC PURPURA; IMMUNOGENICITY; INFUSION RELATED REACTION; INJECTION SITE ERYTHEMA; LEUKOPENIA; LIPODYSTROPHY; LOW DRUG DOSE; MORNING DOSAGE; MULTICENTER STUDY (TOPIC); MULTIPLE SCLEROSIS; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; OLIGODENDROGLIA; OPPORTUNISTIC INFECTION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHENOTYPE; PLASMAPHERESIS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PSOAS ABSCESS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY TRACT INFECTION; RHEUMATOID ARTHRITIS; SEPTIC SHOCK; SHORT SURVEY; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; SKIN MANIFESTATION; SUBARACHNOID HEMORRHAGE; THROMBOTIC THROMBOCYTOPENIC PURPURA; URINARY TRACT INFECTION;

ANTIBODIES, MONOCLONAL, HUMANIZED; CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOLOGIC FACTORS; INJECTIONS; INTERFERON-BETA; MULTIPLE SCLEROSIS, RELAPSING-REMITTING;

EID: 84885371836     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(13)70192-3     Document Type: Short Survey

References (68)

1. Kieseier BC The mechanism of action of interferon-beta in relapsing multiple sclerosis. CNS Drugs 2011, 25:491-502.
2. Mehta LRG, Andrew D Multiple sclerosis. Continuum (Minneap Minn) 2007, 13:144-180.
3. Farina C, Weber MS, Meinl E, Wekerle H, Hohlfeld R Glatiramer acetate in multiple sclerosis: update on potential mechanisms of action. Lancet Neurol 2005, 4:567-575.
4. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996, 39:285-294. The Multiple Sclerosis Collaborative Research Group (MSCRG).
5. Simon JH, Jacobs LD, Campion M, et al. Magnetic resonance studies of intramuscular interferon beta-1a for relapsing multiple sclerosis. Ann Neurol 1998, 43:79-87. The Multiple Sclerosis Collaborative Research Group.
6. Ebers GC Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet 1998, 352:1498-1504. for the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
7. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis: I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993, 43:655-661. The IFNB Multiple Sclerosis Study Group.
8. Paty DW, Li DK Interferon beta-1b is effective in relapsing-remitting multiple sclerosis: II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993, 43:662-667. for the UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group.
9. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 1995, 45:1277-1285. The IFNB Multiple Sclerosis Study Group, the University of British Columbia MS/MRI Analysis Groupthe University of British Columbia MS/MRI Analysis Group.
10. Johnson KP, Brooks BR, Cohen JA, 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. Neurology 1995, 45:1268-1276. for the Copolymer 1 Multiple Sclerosis Study Group.
11. Comi G, Filippi M, Wolinsky JS European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol 2001, 49:290-297. for the European/Canadian Glatiramer Acetate Study Group.
12. Li DK, Paty DW Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis. Ann Neurol 1999, 46:197-206.
13. Lublin F, Cofield S, Cutter G, et al. The CombiRx trial: a multi-center, double-blind, randomized study comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in participants with relapsing-remitting multiple sclerosis-clinical outcomes. Neurology 2012, 78. for the CombiRx Investigators, PL02.003 (abstr).
14. Hynes RO Integrins: a family of cell surface receptors. Cell 1987, 48:549-554.
15. Polman CH, O'Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006, 354:899-910.
16. Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med 2012, 366:1870-1880.
17. Crespi MD, Ivanier SE, Genovese J, Baldi A Mitoxantrone affects topoisomerase activities in human breast cancer cells. Biochem Biophys Res Commun 1986, 136:521-528.
18. Hartung HP, Gonsette R, Konig N, et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002, 360:2018-2025.
19. Marriott JJ, Miyasaki JM, Gronseth G, O'Connor PW Evidence report: the efficacy and safety of mitoxantrone (novantrone) in the treatment of multiple sclerosis. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2010, 74:1463-1470.
20. Aktas O, Kieseier B, Hartung HP Neuroprotection, regeneration and immunomodulation: broadening the therapeutic repertoire in multiple sclerosis. Trends Neurosci 2010, 33:140-152.
21. Cox AL, Thompson SA, Jones JL, et al. Lymphocyte homeostasis following therapeutic lymphocyte depletion in multiple sclerosis. Eur J Immunol 2005, 35:3332-3342.
22. Jones JL, Phuah CL, Cox AL, et al. IL-21 drives secondary autoimmunity in patients with multiple sclerosis, following therapeutic lymphocyte depletion with alemtuzumab (Campath-1H). J Clin Invest 2009, 119:2052-2061.
23. Thompson SA, Jones JL, Cox AL, Compston DA, Coles AJ B-cell reconstitution and BAFF after alemtuzumab (Campath-1H) treatment of multiple sclerosis. J Clin Immunol 2010, 30:99-105.
24. Hill-Cawthorne GA, Button T, Tuohy O, et al. Long term lymphocyte reconstitution after alemtuzumab treatment of multiple sclerosis. J Neurol Neurosurg Psychiatry 2012, 83:298-304.
25. Coles AJ, Compston DA, Selmaj KW, et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med 2008, 359:1786-1801.
26. Cohen JA, Coles AJ, Arnold DL, 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, 380:1819-1828.
27. Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012, 380:1829-1839.
28. Fox EJ, Arnold DL, Cohen J, et al. Autoimmunity in patients treated with alemtuzumab for relapsing-remitting multiple sclerosis. 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Oct 10-13, 2012, Lyon, France (accessed Sept 5, 2013). http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=157477&XNSPRACHE_ID=2&XNKONGRESS_ID=171&XNMASKEN_ID=900.
29. Coles AJ, Fox E, Vladic A, et al. Alemtuzumab more effective than interferon beta-1a at 5-year follow-up of CAMMS223 clinical trial. Neurology 2012, 78:1069-1078.
30. Morgan RD, O'Callaghan JM, Knight SR, Morris PJ Alemtuzumab induction therapy in kidney transplantation: a systematic review and meta-analysis. Transplantation 2012, 93:1179-1188.
31. James DF, Kipps TJ Alemtuzumab in chronic lymphocytic leukemia. Future Oncol 2007, 3:29-42.
32. Jevsevar S, Kunstelj M, Porekar VG PEGylation of therapeutic proteins. Biotechnol J 2010, 5:113-128.
33. Kieseier BC, Calabresi PA PEGylation of interferon-beta-1a: a promising strategy in multiple sclerosis. CNS Drugs 2012, 26:205-214.
34. Hu X, Miller L, Richman S, et al. A novel PEGylated interferon beta-1a for multiple sclerosis: safety, pharmacology, and biology. J Clin Pharmacol 2012, 52:798-808.
35. Calabresi P, Kieseier B, Arnold D ADVANCE phase 3 study of pegylated interferon beta-1a for relapsing multiple sclerosis: patient baseline characteristics. Neurology 2012, 78. P01.133 (abstr).
36. Long-term safety and efficacy study of BIIB017 (ATTAIN), (accessed March 31, 2013). http://clinicaltrials.gov/ct2/show/NCT01332019?term=ATTAIN&rank=1.
37. Wynn D, Kaufman M, Montalban X, et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol 2010, 9:381-390.
38. Giovannoni G, Gold R, Selmaj K, et al. A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of daclizumab HYP monotherapy in relapsing-remitting multiple sclerosis: primary results of the SELECT trial. Mult Scler 2011, 10(suppl):S508. (abstr).
39. Giovannoni G, Gold R, Selmaj K, et al. Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis. 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Oct 10-13, 2012, Lyon, France (accessed Sept 5, 2013). http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=158412&XNSPRACHE_ID=2&XNKONGRESS_ID=171&XNMASKEN_ID=900.
40. Efficacy and safety of daclizumab high yield process versus interferon β 1a in patients with relapsing-remitting multiple sclerosis (DECIDE) (accessed Oct 24, 2012). http://clinicaltrials.gov/ct2/show/NCT01064401?term=daclizumab+and+DECIDE&rank=1.
41. Kappos L, Li D, Calabresi PA, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 2011, 378:1779-1787.
42. Kappos L, Li D, Calabresi PA Long-term safety and efficacy of ocrelizumab in patients with relapsing-remitting multiple sclerosis: week 144 results of a phase II, randomised, multicentre trial. 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Oct 10-13, 2012, Lyon, France (accessed Sept 5, 2013). http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=156258&XNSPRACHE_ID=2&XNKONGRESS_ID=171&XNMASKEN_ID=900.
43. A study of ocrelizumab in comparison with interferon beta-1a (Rebif) in patients with relapsing multiple sclerosis (accessed Oct 24, 2012). http://clinicaltrials.gov/ct2/show/NCT01247324?term=ocrelizumab+and+multiple+sclerosis&rank=1.
44. A study of ocrelizumab in comparison with interferon beta-1a (Rebif) in patients with relapsing multiple sclerosis (accessed Oct 24, 2012). http://clinicaltrials.gov/ct2/show/NCT01412333?term=ocrelizumab+and+multiple+sclerosis&rank=2.
45. Bielekova B, Catalfamo M, Reichert-Scrivner S, et al. Regulatory CD56(bright) natural killer cells mediate immunomodulatory effects of IL-2Ralpha-targeted therapy (daclizumab) in multiple sclerosis. Proc Natl Acad Sci USA 2006, 103:5941-5946.
46. Bielekova B, Howard T, Packer AN, et al. Effect of anti-CD25 antibody daclizumab in the inhibition of inflammation and stabilization of disease progression in multiple sclerosis. Arch Neurol 2009, 66:483-489.
47. Wuest SC, Edwan JH, Martin JF, et al. A role for interleukin-2 trans-presentation in dendritic cell-mediated T cell activation in humans, as revealed by daclizumab therapy. Nat Med 2011, 17:604-609.
48. Kausar F, Mustafa K, Sweis G, et al. Ocrelizumab: a step forward in the evolution of B-cell therapy. Expert Opin Biol Ther 2009, 9:889-895.
49. Genovese MC, Kaine JL, Lowenstein MB, et al. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum 2008, 58:2652-2661.
50. Hauser SL, Waubant E, Arnold DL, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med 2008, 358:676-688.
51. Emery P, Rigby W, Tak PP, et al. Serious infections with ocrelizumab in rheumatoid arthritis: pooled results from double-blind periods of the ocrelizumab phase II RA program. Arthritis Rheum 2010, 62(suppl):414. (abstr).
52. Kappos L, Leppert D, Tinbergen J Risk of infections and malignancies after treatment with anti-CD20 monoclonal antibodies: ocrelizumab and rituximab in rheumatoid arthritis and multiple sclerosis. 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Oct 10-13, 2012, Lyon, France (accessed Sept 5, 2013). http://registration.akm.ch/einsicht_iframe.php?XNABSTRACT_ID=156296&XNSPRACHE_ID=2&XNKONGRESS_ID=171&XNMASKEN_ID=900.
53. Cheson BD Ofatumumab, a novel anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. J Clin Oncol 2010, 28:3525-3530.
54. Li B, Shi S, Qian W, et al. Development of novel tetravalent anti-CD20 antibodies with potent antitumor activity. Cancer Res 2008, 68:2400-2408.
55. Natsume A, Niwa R, Satoh M Improving effector functions of antibodies for cancer treatment: enhancing ADCC and CDC. Drug Des Devel Ther 2009, 3:7-16.
56. Soelberg Sorensen P, Drulovic J, Havrdova E, Lisby S, Graff O, Shackelford S Magnetic resonance imaging (MRI) efficacy of ofatumumab in relapsing-remitting multiple sclerosis (RRMS)-24-week results of a phase II study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, 13-16 Oct, 2010, Gothenburg, Sweden (accessed Sept 5, 2013). http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=118695&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900.
57. Ofatumumab subcutaneous administration in subjects with relapsing-remitting multiple sclerosis (MIRROR) (accessed April 23, 2013). http://clinicaltrials.gov/ct2/show/NCT01457924?term=ofatumumab+and+multiple+sclerosis&rank=2.
58. Tran J, Palaparthy R, Zhao J Safety, tolerability and pharmacokinetics of the anti-LINGO-1 monoclonal antibody BIIB033 in healthy volunteers and subjects with multiple sclerosis. Neurology 2012, 78. P02.021 (abstr).
59. BIIB033 in acute optic neuritis (AON) (RENEW) (accessed March 30, 2013). http://clinicaltrials.gov/ct2/show/NCT01721161?term=BIIB033&rank=3.
60. Taylor PC, Quattrocchi E, Mallett S, Kurrasch R, Petersen J, Chang DJ Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. Ann Rheum Dis 2011, 70:2119-2125.
61. Mi S, Miller RH, Lee X, et al. LINGO-1 negatively regulates myelination by oligodendrocytes. Nat Neurosci 2005, 8:745-751.
62. Mi S, Lee X, Shao Z, et al. LINGO-1 is a component of the Nogo-66 receptor/p75 signaling complex. Nat Neurosci 2004, 7:221-228.
63. Zhao XH, Jin WL, Ju G An in vitro study on the involvement of LINGO-1 and Rho GTPases in Nogo-A regulated differentiation of oligodendrocyte precursor cells. Mol Cell Neurosci 2007, 36:260-269.
64. Yamashita T, Higuchi H, Tohyama M The p75 receptor transduces the signal from myelin-associated glycoprotein to Rho. J Cell Biol 2002, 157:565-570.
65. Lee X, Yang Z, Shao Z, et al. NGF regulates the expression of axonal LINGO-1 to inhibit oligodendrocyte differentiation and myelination. J Neurosci 2007, 27:220-225.
66. Mi S, Hu B, Hahm K, et al. LINGO-1 antagonist promotes spinal cord remyelination and axonal integrity in MOG-induced experimental autoimmune encephalomyelitis. Nat Med 2007, 13:1228-1233.
67. Mi S, Miller RH, Tang W, et al. Promotion of central nervous system remyelination by induced differentiation of oligodendrocyte precursor cells. Ann Neurol 2009, 65:304-315.
68. Cadavid D, Butzkueven H, Yaou L, Mi S Effect of LINGO-1 blockade on optic nerve axonal injury in MOG-EAE rodent models. Neurology 2013, 80. P05.186 (abstr).