Multiple sclerosis disease-modifying therapies: Adverse effect surveillance and management

Expert Review of Neurotherapeutics

Volumn 6, Issue 3, 2006, Pages 333-346

  Wingerchuk, Dean M ^a  

^a MAYO CLINIC   (United States)

Author keywords

interferon; Adverse effects; Glatiramer acetate; Long term therapy; Mitoxantrone; Multiple sclerosis; Natalizumab

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA TOCOPHEROL; ANESTHETIC AGENT; ANTICONVULSIVE AGENT; ANTIEMETIC AGENT; ANTIINFECTIVE AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BETA1A INTERFERON; CORTICOSTEROID; DEXAMETHASONE; GLATIRAMER; GRANULOCYTE COLONY STIMULATING FACTOR; HORMONE; HYDROCORTISONE; IBUPROFEN; IMMUNOSUPPRESSIVE AGENT; INTERFERON BETA SERINE; MINOXIDIL; MITOXANTRONE; NAPROXEN; NATALIZUMAB; NONSTEROID ANTIINFLAMMATORY AGENT; ONDANSETRON; PARACETAMOL; PENTOXIFYLLINE; PREDNISONE; PROCHLORPERAZINE; TRICYCLIC ANTIDEPRESSANT AGENT; TRIPTAN DERIVATIVE; UNINDEXED DRUG;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ABNORMALLY LOW SUBSTRATE CONCENTRATION IN BLOOD; ABSCESS; AMENORRHEA; ANAPHYLAXIS; ANEMIA; ANTIBODY PRODUCTION; ANXIETY DISORDER; BREAKTHROUGH BLEEDING; CARDIOTOXICITY; CENTRAL NERVOUS SYSTEM INFECTION; CHEST TIGHTNESS; CHILL; CHROMOSOME ABERRATION; CLINICAL TRIAL; DEPRESSION; DISEASE EXACERBATION; DOWN SYNDROME; DRUG EFFICACY; DRUG MARKETING; DRUG MEGADOSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; DUCHENNE ERB PARALYSIS; DYSPNEA; ERYTHEMA; EYE DISEASE; FATIGUE; FETUS DEATH; FEVER; FLU LIKE SYNDROME; FLUSHING; HEADACHE; HEART PALPITATION; HEPATITIS; HORMONAL THERAPY; HUMAN; HYDROCEPHALUS; HYPERSENSITIVITY REACTION; HYPOTENSION; IMMUNOPATHOLOGY; INDUCED ABORTION; INFECTION; INFLUENZA; INJECTION SITE PAIN; INJECTION SITE REACTION; LEUKOPENIA; LIPOATROPHY; LIVER FAILURE; LIVER TOXICITY; LOW BIRTH WEIGHT; LYMPHADENOPATHY; LYMPHOCYTOPENIA; LYMPHOCYTOSIS; MALAISE; MEDICAL PRACTICE; MENSTRUATION DISORDER; MENTAL PATIENT; MICROTHROMBUS; MIGRAINE; MONOCYTOSIS; MOOD DISORDER; MULTIPLE SCLEROSIS; MYALGIA; NAUSEA; NEUTROPENIA; NONHUMAN; OPPORTUNISTIC INFECTION; PATIENT CARE; PATIENT COMPLIANCE; PNEUMONIA; PREGNANCY COMPLICATION; PREMATURITY; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PRURITUS; RASH; REVIEW; SCLERA DISEASE; SIDE EFFECT; SKILL; SKIN DEFECT; SKIN INDURATION; SKIN MANIFESTATION; SKIN NECROSIS; SKIN PAIN; SPASTICITY; SPONTANEOUS ABORTION; SPOTTING; STILLBIRTH; SUICIDE ATTEMPT; SUPERINFECTION; TERATOGENICITY; THORAX PAIN; THROMBOCYTOPENIA; TITRIMETRY; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URTICARIA; VASCULITIS; WOUND HEALING IMPAIRMENT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DISEASE MANAGEMENT; HUMANS; MULTIPLE SCLEROSIS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 33645887535     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/14737175.6.3.333     Document Type: Review

References (87)

1. Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N. Engl. J. Med. 343(13), 938-952 (2000).
2. Poser CM, Paty DW, Scheinberg L et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann. Neurol. 13(3), 227-231 (1983).
3. O'Riordan JI, Thompson AJ, Kingsley DP et al. The prognostic value of brain MRI in clinically isolated syndromes of the CNS. A 10-year follow-up. Brain 121(Pt 3), 495-503 (1998).
4. Brex PA, Ciccarelli O, O'Riordan JI, Sailer M, Thompson AJ, Miller DH. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N. Engl. J. Med. 346(3), 158-164 (2002).
5. McDonald WI, Compston A, Edan G et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis. Ann. Neurol. 50(1), 121-127 (2001).
6. Kantarci OH, Weinshenker BG. Natural history of multiple sclerosis. Neurol. Clin. 23(1), 17-38 (2005).
7. Weinshenker BG, Bass B, Rice GP et al. The natural history of multiple sclerosis: a geographically based study. I. Clinical course and disability. Brain 112, 133-146 (1989).
8. Pittock SJ, McClelland RL, Mayr WT et al. Clinical implications of benign multiple sclerosis: a 20-year population-based follow-up study. Ann. Neurol. 56(2), 303-306 (2004).
9. Sospedra M, Martin R. Immunology of multiple sclerosis. Ann. Rev. Immunol. 23, 683-747 (2005).
10. Lucchinetti C, Bruck W, Parisi J, Scheithauer B, Rodriguez M, Lassmann H. Heterogeneity of multiple sclerosis lesions: implications for the pathogenesis of demyelination. Ann. Neurol. 47(6), 707-717 (2000).
11. Keegan M, Konig F, McClelland R et al. Relation between humoral pathological changes in multiple sclerosis and response to therapeutic plasma exchange. Lancet 366(9485), 579-582 (2005). •• Demonstrates that multiple sclerosis pathological subtype can predict the response to therapeutic plasmapheresis. Only patients whose lesions have evidence of antibody deposition or complement activation are likely to benefit.
12. Van Assche G, Van Ranst M, Sciot R et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N. Engl. J. Med. 353(4), 362-368 (2005).
13. Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon β-1a for multiple sclerosis. N. Engl. J. Med. 353(4), 369-374 (2005).
14. Langer-Gould A, Atlas SW, Green AJ, Bollen AW, Pelletier D. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N. Engl. J. Med. 353(4), 375-381 (2005).
15. Berger JR, Koralnik IJ. Progressive multifocal leukoencephalopathy and natalizumab-unforeseen consequences. N. Engl. J. Med. 353(4), 414-416 (2005). •• Three case reports and an accompanying editorial describe natalizumab-associated cases of progressive multifocal leukoencephalopathy and interesting speculation about underlying pathogenic mechanisms.
16. Yong VW. Differential mechanisms of action of interferon-β and glatiramer acetate in MS. Neurology 59(6), 802-808 (2002).
17. Betaseron®, package insert. Berlex Laboratories, NJ, USA (2003).
18. Avonex®, package insert. Biogen, Inc., MA, USA (2003).
19. Rebif®, package insert. Serono, Inc., MA, USA (2003).
20. The IFN-B Multiple Sclerosis Study Group. Interferon β-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43(4), 655-661 (1993).
21. Paty DW, Li DK. Interferon β-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFN-B Multiple Sclerosis Study Group. Neurology 43(4), 662-667 (1993).
22. The IFN-B Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group. Interferon β-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 45(7), 1277-1285 (1995).
23. Johnson KP, Brooks BR, Cohen JA et al. Co-polymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a Phase III multicenter, double-blind placebo-controlled trial. The co-polymer 1 Multiple Sclerosis Study Group. Neurology 45(7), 1268-1276 (1995).
24. Jacobs LD, Cookfair DL, Rudick RA et al. Intramuscular interferon β-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. 39(3), 285-294 (1996).
25. PRISMS (Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet 352(9139), 1498-1504 (1998).
26. European Study Group on interferon β-1b in secondary progressive MS. Placebo-controlled multicentre randomised trial of interferon β-1b in treatment of secondary progressive multiple sclerosis. Lancet 352(9139), 1491-1497 (1998).
27. Panitch H, Miller A, Paty D, Weinshenker B. Interferon β-1b in secondary progressive MS: results from a 3-year controlled study. Neurology 63(10), 1788-1795 (2004).
28. Kappos L, Weinshenker B, Pozzilli C et al. Interferon β-1b in secondary progressive MS: a combined analysis of the two trials. Neurology 63(10), 1779-1787 (2004).
29. Cohen JA, Cutter GR, Fischer JS et al. Benefit of interferon β-1a on MSFC progression in secondary progressive MS. Neurology 59(5), 679-687 (2002).
30. Frohman EM, Brannon K, Alexander S et al. Disease modifying agent related skin reactions in multiple sclerosis: prevention, assessment, and management. Mult. Scler. 10(3), 302-307 (2004).
31. Rice GP, Ebers GC, Lublin FD, Knobler RL. Ibuprofen treatment versus gradual introduction of interferon β-1b in patients with MS. Neurology 52(9), 1893-1895 (1999).
32. Bayas A, Rieckmann P. Managing the adverse effects of interferon-β therapy in multiple sclerosis. Drug Saf. 22(2), 149-159 (2000).
33. Frohman E, Phillips T, Kokel K et al. Disease-modifying therapy in multiple sclerosis: strategies for optimizing management. Neurologist 8(4), 227-236 (2002).
34. Walther EU, Hohlfeld R. Multiple sclerosis: side effects of interferon β therapy and their management. Neurology 53(8), 1622-1627 (1999).
35. Khan OA, Hebel JR. Incidence of exacerbations in the first 90 days of treatment with recombinant human interferon β-1b in patients with relapsing-remitting multiple sclerosis. Ann. Neurol. 44(1), 138-139 (1998).
36. Reess J, Haas J, Gabriel K, Fuhlrott A, Fiola M. Both paracetamol and ibuprofen are equally effective in managing flu-like symptoms in relapsing-remitting multiple sclerosis patients during interferon β-1a (AVONEX) therapy. Mult. Scler. 8(1), 15-18 (2002).
37. Rio J, Nos C, Marzo ME, Tintore M, Montalban X. Low-dose steroids reduce flu-like symptoms at the initiation of IFN-β-1b in relapsing-remitting MS. Neurology 50(6), 1910-1912 (1998).
38. Weber F, Polak T, Gunther A et al. Synergistic immunomodulatory effects of interferon-β1b and the phosphodiesterase inhibitor pentoxifylline in patients with relapsing-remitting multiple sclerosis. Ann. Neurol. 44(1), 27-34 (1998).
39. Pollmann W, Erasmus LP, Feneberg W, Then Bergh F, Straube A. Interferon β but not glatiramer acetate therapy aggravates headaches in MS. Neurology 59(4), 636-639 (2002).
40. D'Amico D, La Mantia L, Rigamonti A et al. Prevalence of primary headaches in people with multiple sclerosis. Cephalalgia 24(11), 980-984 (2004).
41. Panitch H, Goodin DS, Francis G et al. Randomized, comparative study of interferon β-1a treatment regimens in MS: the EVIDENCE Trial. Neurology 59(10), 1496-1506 (2002).
42. Durelli L, Verdun E, Barbero P et al. Every-other-day interferon β-1b versus once-weekly interferon β-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 359(9316), 1453-1460 (2002).
43. Tremlett HL, Yoshida EM, Oger J. Liver injury associated with the β-interferons for MS: a comparison between the three products. Neurology 62 (4), 628-631 (2004).
44. Tremlett HL, Oger J. Elevated aminotransferases during treatment with interferon-β for multiple sclerosis: actions and outcomes. Mult. Scler. 10(3), 298-301 (2004). • This pair of reports provides comparative data regarding the frequency and outcome of liver function test abnormalities with different interferon preparations.
45. Yoshida EM, Rasmussen SL, Steinbrecher UP et al. Fulminant liver failure during interferon β treatment of multiple sclerosis. Neurology 56(10), 1416 (2001).
46. Patten SB, Fridhandler S, Beck CA, Metz LM. Depressive symptoms in a treated multiple sclerosis cohort. Mult. Scler. 9(6), 616-620 (2003).
47. Zephir H, De Seze J, Stojkovic T et al. Multiple sclerosis and depression: influence of interferon β therapy. Mult. Scler. 9(3), 284-288 (2003).
48. Galeazzi GM, Ferrari S, Giaroli G et al. Psychiatric disorders and depression in multiple sclerosis out-patients: impact of disability and interferon β therapy. Neurol. Sci. 26(4), 255-262 (2005).
49. Patten SB, Francis G, Metz LM, Lopez Bresnahan M, Chang P, Curtin F. The relationship between depression and interferon β-1a therapy in patients with multiple sclerosis. Mult. Scler. 11(2), 175-181 (2005).
50. Siegert RJ, Abernethy DA. Depression in multiple sclerosis: a review. J. Neurol. Neurosurg. Psychiatry 76(4), 469-475 (2005).
51. Mohr DC, Goodkin DE, Likosky W, Gatto N, Baumann KA, Rudick RA. Treatment of depression improves adherence to interferon β-1b therapy for multiple sclerosis. Arch. Neurol. 54(5), 531-533 (1997).
52. Schiffer RB, Wineman NM. Antidepressant pharmacotherapy of depression associated with multiple sclerosis. Am. J. Psychiatry 147(11), 1493-1497 (1990).
53. Sandberg-Wollheim M, Frank D, Goodwin TM et al. Pregnancy outcomes during treatment with interferon β-1a in patients with multiple sclerosis. Neurology 65(6), 802-806(2005).
54. Boskovic R, Wide R, Wolpin J, Bauer DJ, Koren G. The reproductive effects of β interferon therapy in pregnancy: a longitudinal cohort. Neurology 65(6), 807-811 (2005). •• These recent reports provide important new information about pregnancy outcomes when mothers are exposed to interferon around the time of conception.
55. Langer-Gould A, Moses HH, Murray TJ. Strategies for managing the side effects of treatments for multiple sclerosis. Neurology 63(11 Suppl. 5), S35-S41 (2004).
56. Ross EK, Shapiro J. Management of hair loss. Dermatol. Clin. 23(2), 227-243 (2005).
57. Bertolotto A. Neutralizing antibodies to interferon β: implications for the management of multiple sclerosis. Curr. Opin. Neurol. 17(3), 241-246 (2004).
58. Sorensen PS, Koch-Henriksen N, Ross C, Clemmesen KM, Bendtzen K. Appearance and disappearance of neutralizing antibodies during interferon-β therapy. Neurology 65(1), 33-39 (2005).
59. Kappos L, Clanet M, Sandberg-Wollheim M et al. Neutralizing antibodies and efficacy of interferon β-1a: a 4-year controlled study. Neurology 65(1), 40-47 (2005).
60. Francis GS, Rice GP, Alsop JC. Interferon β-1a in MS: results following development of neutralizing antibodies in PRISMS. Neurology 65(1), 48-55 (2005).
61. Rudick RA, Lee JC, Simon J, Ransohoff RM, Fisher E. Defining interferon β response status in multiple sclerosis patients. Ann. Neurol. 56(4), 548-555 (2004).
62. Freedman MS, Patry DG, Grand'Maison F, Myles ML, Paty DW, Selchen DH. Treatment optimization in multiple sclerosis. Can. J. Neurol. Sci. 31(2), 157-168 (2004).
63. Cohen BA, Khan O, Jeffery DR et al. Identifying and treating patients with suboptimal responses. Neurology 63(12 Suppl. 6), S33-S40 (2004).
64. 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. European/Canadian Glatiramer Acetate Study Group. Ann. Neurol. 49(3), 290-297 (2001).
65. Filippi M, Rovaris M, Rocca MA, Sormani MP, Wolinsky JS, Comi G. Glatiramer acetate reduces the proportion of new MS lesions evolving into 'black holes'. Neurology 57(4), 731-733 (2001).
66. Neuhaus O, Farina C, Wekerle H, Hohlfeld R. Mechanisms of action of glatiramer acetate in multiple sclerosis. Neurology 56(6), 702-708 (2001).
67. Johnson KP, Brooks BR, Ford CC et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Co-polymer 1 Multiple Sclerosis Study Group. Mult. Scler. 6(4), 255-266 (2000).
68. Edgar CM, Brunet DG, Fenton P, McBride EV, Green P. Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Can. J. Neurol. Sci. 31(1), 58-63 (2004).
69. Copaxone®, package insert. Teva Pharmaceutical Industries, Inc., MO, USA (2002).
70. Windhagen A, Maniak S, Marckmann S, Lindert RB, Heidenreich F, Blasczyk R. Lymphadenopathy in patients with multiple sclerosis undergoing treatment with glatiramer acetate. J. Neurol. Neurosurg. Psychiatry 70(3), 415-416 (2001).
71. Salama HH, Hong J, Zang YC, El-Mongui A, Zhang J. Blocking effects of serum reactive antibodies induced by glatiramer acetate treatment in multiple sclerosis. Brain 126(Pt 12), 2638-2647 (2003).
72. Teitelbaum D, Brenner T, Abramsky O, Aharoni R, Sela M, Arnon R. Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy. Mult. Scler. 9(6), 592-599 (2003).
73. Goodin DS, Arnason BG, Coyle PK, Frohman EM, Paty DW. The use of mitoxantrone (Novantrone) for the treatment of multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 61(10), 1332-1338 (2003).
74. Cohen BA, Mikol DD. Mitoxantrone treatment of multiple sclerosis: safety considerations. Neurology 63(12 Suppl. 6), S28-S32 (2004).
75. Openshaw H, Stuve O, Antel JP et al. Multiple sclerosis flares associated with recombinant granulocyte colony-stimulating factor. Neurology 54(11), 2147-2150 (2000).
76. Novantrone (package insert). Serono, Inc., MA, USA (2005).
77. Ghalie RG, Edan G, Laurent M et al. Cardiac adverse effects associated with mitoxantrone (Novantrone) therapy in patients with MS. Neurology 59(6), 909-913 (2002).
78. Avasarala JR, Cross AH, Clifford DB, Singer BA, Siegel BA, Abbey EE. Rapid onset mitoxantrone-induced cardiotoxicity in secondary progressive multiple sclerosis. Mult. Scler. 9(1), 59-62 (2003). • Describes large-scale and routine practice experience with symptomatic and asymptomatic cardiotoxicity due to mitoxantrone.
79. Edan G, Brochet B, Clanet M et al. Safety profile of mitoxantrone in a cohort of 802 multiple sclerosis patients: a 4 year mean follow-up study. Neurology 62(Suppl. 5), A493 (2004).
80. Linassier C, Barin C, Calais G et al. Early secondary acute myelogenous leukemia in breast cancer patients after treatment with mitoxantrone, cyclophosphamide, fluorouracil and radiation therapy. Ann. Oncol. 11(10), 1289-1294 (2000).
81. Ghalie RG, Mauch E, Edan G et al. A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis. Mult. Scler. 8(5), 441-445 (2002).
82. Rice GP, Hartung HP, Calabresi PA. Anti-α4 integrin therapy for multiple sclerosis: mechanisms and rationale. Neurology 64(8), 1336-1342 (2005).
83. Tysabri (package insert). Biogen Idec, Inc., MA, USA (2004).
84. Miller DH, Khan OA, Sheremata WA et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. 348(1), 15-23 (2003).
85. Elan Corporation www.elan.com/news/print_full.asp?ID = 784434 (Accessed 29th November 2005)
86. Elan Corporation www.elan.com/news/full.asp?ID = 740984 (Accessed 29th November 2005)
87. Elan Corporation www.elan.com/news/full.asp?ID = 768099 (Accessed 29th November 2005)