FDA-Approved Preventative Therapies for MS: First-line Agents

Neurologic Clinics

Volumn 29, Issue 2, 2011, Pages 401-409

  Kita, Mariko ^a,b  

^a Virginia Mason Multiple Sclerosis Center   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

Author keywords

Clinically isolated syndrome; First line agents; Preventative therapy; Relapsing remitting multiple sclerosis

Indexed keywords

BETA1A INTERFERON; GLATIRAMER; INTERFERON BETA SERINE; MITOXANTRONE; NATALIZUMAB; PLACEBO;

CHEST TIGHTNESS; DISABILITY; DRUG APPROVAL; DRUG EFFICACY; FLU LIKE SYNDROME; FLUSHING; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERTRANSAMINASEMIA; INJECTION SITE BURNING; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; LEUKOPENIA; LIPOATROPHY; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; RELAPSE; REVIEW; SIDE EFFECT;

DRUG APPROVAL; HUMANS; IMMUNOLOGIC FACTORS; INTERFERONS; MULTIPLE SCLEROSIS; PEPTIDES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79952839577     PISSN: 07338619     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ncl.2011.01.007     Document Type: Review

References (40)

1. 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. The IFNB Multiple Sclerosis Study Group. Neurology 1993, 43:655-661.
2. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group. Neurology 1995, 45(7):1277-1285.
3. Jacobs L.D., Cookfair D.L., Rudick R.A., et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol 1996, 39(3):285-294.
4. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet 1998, 352(9139):1498-1504.
5. Johnson K.P., Brooks B.R., Cohen J.A., 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. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995, 45(7):1268-1276.
6. Betaseron [package insert] 2007, Berlex, Montville (MJ).
7. Avonex [package insert] 2006, BiogenIdec Inc, Cambridge (MA).
8. 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 2001, 56(12):1628-1636.
9. Rebif [package insert] 2005, Serono Inc, Rocklan (MA).
10. Sorensen P.S., Ross C., Clemmesen K.M., et al. Clinical importance of neutralising antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis. Lancet 2003, 362(9391):1184-1191.
11. Malucchi S., Sala A., Gilli F., et al. A Neutralizing antibodies reduce the efficacy of Beta IFN during treatment of multiple sclerosis. Neurology 2004, 62(11):2031-2037.
12. Kappos L., Clanet M., Sandberg-Wollheim M., et al. Neutralizing antibodies and efficacy of interferon beta-1a: a 4-year controlled study. Neurology 2005, 65(1):40-47.
13. Francis G.S., Rice G.P., Alsop J.C. Interferon beta-1a in MS: results following development of neutralizing antibodies in PRISMS. Neurology 2005, 65(1):48-55.
14. Bertolotto A., Gilli F., Sala A., et al. Persistent neutralizing antibodies abolish the interferon beta bioavailability in MS patients. Neurology 2003, 60(4):634-639.
15. Khan O.A., Dhib-Jalbut S.S. Neutralizing antibodies to interferon beta-1a and interferon beta-1b in MS patients are cross-reactive. Neurology 1998, 51:1698-1702.
16. Sorensen P.S., Deisenhammer F., Duda P., et al. Guidelines on use of anti-IFN-beta antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-beta antibodies in multiple sclerosis. Eur J Neurol 2005, 12(11):817-827.
17. Sorensen P.S., Koch-Henriksen N., Ross C., et al. Appearance and disappearance of neutralizing antibodies during interferon-beta therapy. Neurology 2005, 65(1):33-39.
18. Goodin D.S., Frohman E.M., Hurwitz B., et al. Neutralizing antibodies to interferon beta: assessment of their clinical and radiographic impact: an evidence report: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2007, 68(13):977-984.
19. Comi G., Filippi M., Wolinsky J.S. 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. European/Canadian Glatiramer Acetate Study Group. Ann Neurol 2001, 49(3):290-297.
20. Copaxone [package insert] 2007, Teva Neuroscience Inc, Kansas City (MO).
21. Durelli L., Verdun E., Barbero P., et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002, 359(9316):1453-1460.
22. Available at:, Accessed January 24, 2011. http://www.clinicaltrial.gov/.
23. O'Connor P., Filippi M., Arnason B., 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 2009, 8(10):889-897.
24. Panitch H., Goodin D.S., Francis G., et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial. Neurology 2002, 59(10):1496-1506.
25. Mikol D.D., Barkhof F., Chang P., et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the Rebif vs Glatiramer Acetate in Relapsing MS Disease [REGARD]study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol 2008, 7(10):903-914.
26. Beck R.W., Trobe J.D., Moke P.S., et al. High- and low-risk profiles for the development of multiple sclerosis within 10 years after optic neuritis: experience of the optic neuritis treatment trial. Arch Ophthalmol 2003, 121(7):944-949.
27. Brex P.A., Ciccarelli O., O'Riordan J.I., et al. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med 2002, 346(3):158-164.
28. Miller D., Barkhof F., Montalban X., et al. Clinically isolated syndromes suggestive of multiple sclerosis, part I: natural history, pathogenesis, diagnosis, and prognosis. Lancet Neurol 2005, 4(5):281-288.
29. Montalban X., Tintore M., Swanton J., et al. MRI criteria for MS in patients with clinically isolated syndromes. Neurology 2010, 74(5):427-434.
30. Jacobs L.D., Beck R.W., Simon J.H., et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med 2000, 343(13):898-904.
31. Comi G., Filippi M., Barkhof F., et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 2001, 357(9268):1576-1582.
32. Kappos L., Polman C.H., Freedman M.S., et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 2006, 67(7):1242-1249.
33. Comi G., Martinelli V., Rodegher M., 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 2009, 374(9700):1503-1511.
34. Available at:, Accessed January 24, 2011. http://www.clinicaltrial.gov/.
35. Clerico M., Faggiano F., Palace J., et al. Recombinant interferon beta or glatiramer acetate for delaying conversion of the first demyelinating event to multiple sclerosis. Cochrane Database Syst Rev 2008, 2. CD005278.
36. Kinkel R.P., Kollman C., O'Connor P., et al. IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology 2006, 66(5):678-684.
37. Kappos L., Freedman M.S., Polman C.H., et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 2007, 370(9585):389-397.
38. Kappos L., Freedman M.S., Polman, et al. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol 2009, 8(11):987-997.
39. Available at:, Accessed January 24, 2011. http://www.clinicaltrial.gov/.
40. Polman C.H., Reingold S.C., Edan G., et al. Diagnostic criteria for multiple sclerosis; 2005 revisions to the " McDonald Criteria." Ann Neurol 2005, 58(6):840-846.