The safety and efficacy of IFN-β products for the treatment of multiple sclerosis

Expert Opinion on Drug Safety

Volumn 6, Issue 3, 2007, Pages 279-288

  Kremenchutzky, Marcelo ^a   Morrow, Sarah ^a   Rush, Carolina ^a  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

Author keywords

Adverse events; Efficacy; IFN ; Multiple sclerosis; Safety

Indexed keywords

ALPHA INTERFERON; ANTICONVULSIVE AGENT; BETA INTERFERON; BETA1A INTERFERON; GLATIRAMER; INTERFERON; INTERFERON BETA SERINE; MUSCLE RELAXANT AGENT; NEFAZODONE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PLACEBO; PREDNISONE; RECOMBINANT BETA INTERFERON; ANTIBODY;

ABNORMAL LABORATORY RESULT; ANAPHYLACTIC SHOCK; ANEMIA; ANTIINFLAMMATORY ACTIVITY; APLASTIC ANEMIA; ARTHRALGIA; AUTOIMMUNE DISEASE; AUTOIMMUNE HEMOLYTIC ANEMIA; BLOOD TOXICITY; CANCER RISK; CAPILLARY LEAK SYNDROME; CHILL; CLINICAL TRIAL; CORRELATION ANALYSIS; DEMYELINATION; DISABILITY; DISEASE ACTIVITY; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG MEGADOSE; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EARLY INTERVENTION; EVIDENCE BASED MEDICINE; FATIGUE; FLU LIKE SYNDROME; HEADACHE; HEMATOLOGIC DISEASE; HEMOLYTIC UREMIC SYNDROME; HIGH RISK POPULATION; HUMAN; HYPERTHYROIDISM; HYPOTHYROIDISM; IMMUNOMODULATION; INJECTION SITE ABSCESS; INJECTION SITE ATROPHY; INJECTION SITE BLEEDING; INJECTION SITE ERYTHEMA; INJECTION SITE INFECTION; INJECTION SITE INFLAMMATION; INJECTION SITE NECROSIS; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE ULCER; LACTATION; LEUKOPENIA; LIVER DISEASE; LIVER DYSFUNCTION; LIVER INJURY; LIVER TRANSPLANTATION; LOW DRUG DOSE; LYMPHOCYTOPENIA; MALAISE; MENTAL DISEASE; META ANALYSIS; MIGRAINE; MULTIPLE SCLEROSIS; MYALGIA; MYASTHENIA GRAVIS; NEPHROTIC SYNDROME; NEUTROPENIA; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PATIENT EDUCATION; PREGNANCY; RAYNAUD PHENOMENON; REVIEW; RHEUMATOID ARTHRITIS; SARCOIDOSIS; SCLERODERMA; SIDE EFFECT; SKIN BRUISING; SKIN INFECTION; SKIN MANIFESTATION; SKIN REDNESS; SYSTEMATIC REVIEW; SYSTEMIC DISEASE; SYSTEMIC LUPUS ERYTHEMATOSUS; TENSION HEADACHE; THROMBOCYTOPENIA; THROMBOTIC THROMBOCYTOPENIC PURPURA; THYROID DISEASE; THYROID FUNCTION TEST; BLOOD; CHEMICALLY INDUCED DISORDER; CHEMISTRY; DEPRESSION; DRUG EFFECT; DRUG INTERACTION; IMMUNOLOGY; INJECTION; LIVER; THYROID GLAND;

ANTIBODIES; CHEMISTRY, PHARMACEUTICAL; DEPRESSION; DRUG INTERACTIONS; HUMANS; INJECTIONS; INTERFERON-BETA; LIVER; MULTIPLE SCLEROSIS; THYROID GLAND;

EID: 34248597542     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.6.3.279     Document Type: Review

References (75)

1. WINGERCHUK DM: Multiple sclerosis and disease-modifying therapies: adverse effect surveillance and management. Expert Rev. Neurother. (2006) 6(3):333-346.
2. 1b, (Betaseron) in multiple sclerosis. J. Neurol. (2005) 252(Suppl.):iii28-iii33.
3. 1a (Rebif): a review of its use in relapsing-remitting multiple sclerosis. Drugs (2005) 65(9):1295-1312.
4. JAVED A, REDER AT: Therapeutic role of β-interferons in multiple sclerosis. Pharmacol. Ther. (2006) 110(1):35-56.
5. MARRIE RA, RUDICK RA: Drug Insight: Interferon treatment in multiple sclerosis. Nat. Clin. Pract. Neurol. (2006) 2(1):34-44.
6. 1b is effective in relapsing-remitting multiple sclerosis: I. Clinical results of a multicentre, randomized, double-blind, placebo-controlled trial. Neurology (1993) 43:655-661.
7. 1a for disease progression in relapsing multiple sclerosis. Ann. Neurol. (1996) 39:285-294.
8. 1a in relapsing/remitting multiple sclerosis. Lancet (1998) 352:1498-1504.
9. KURTZE JF: Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology (1983) 33(11):1444-1452.
10. 1a dose response in relapsing-remitting MS, The OWIMS Study. Neurology (1999) 53:679-686.
11. 1a, therapy in relapsing multiple sclerosis: three-year data from the OWIMS study. Mult. Scler. (2005) 11(1):41-45.
12. 1a in relapsing MS. Neurology (2002) 59:1507-1517.
13. HARTUNG HP: Early treatment and dose optimization BENEFIT and BEYOND. J. Neurol. (2005) 252(Suppl. 3):iii44-iii50.
14. 1a. regiments in MS: the EVIDENCE Trial. Neurology (2002) 59:1496-1506.
15. 1a for multiple sclerosis: results of a 2-year prospective randomized multicentre trial (INCOMIN). Lancet (2002) 359:1453-1460.
16. DE STEFANO N, NARAYANAN S, FRANCIS GS et al.: Evidence of axonal damage in the early stages of multiple sclerosis and its relevance to disability. Arch. Neurol. (2001) 58:65-70.
17. TRAPP BD, PETERSON J, RANSOHOFF RM: Axonal transaction in the lesion of multiple sclerosis. N. Engl. J. Med. (1998) 338:278-285.
18. ZAJICEK J: Diagnosis and disease modifying treatments in multiple sclerosis. Postgrad. Med. J. (2005) 81(959):556-561.
19. 1a in relapsing MS. Neurology (2001) 56:1628-1636.
20. 1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N. Engl. J. Med. (2000) 343:898-904.
21. 1a. delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology (2006) 66:678-684.
22. COMI G, FILIPPI M, BARKHOF F et al.: Effect of early interferon treatment on conversion to definite multiple sclerosis. Lancet (2001) 357:1576-1582.
23. 1b delays conversion to clinically definite and McDonald MS in patients with clinically isolate syndromes. Neurology (2006) 67:1242-1249.
24. 1b in treatment of secondary progressive multiple sclerosis. Lancet (1998) 352:1491-1497.
25. 1b in secondary progressive MS: results from a 3 year controlled study. Neurology (2004) 63:1786-1795.
26. 1a in secondary progressive MS: clinical results. Neurology (2001) 56:1496-1504.
27. 1a on MSFC progression in secondary progressive MS. Neurology (2002) 59:679-687.
28. CUTTER GR, BAIER ML, RUDICK RA et al.: Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain (1999) 122(Pt 5):871-882.
29. 1a in secondary progressive multiple sclerosis. J. Neurol. Neurosurg. Psychiatry (2004) 75:706-710.
30. FROHMAN E, BRANNON K, ALEXANDER S et al.: Disease modifying agent related skin reactions in multiple sclerosis: prevention, assessment and management. Mult. Scler. (2004) 10(3):302-307.
31. 1b: the clinical and histological spectrum. J. Am. Acad. Dermatol. (1997) 37:553-558.
32. 1b injections. J. Am. Acad. Dermatol. (1998) 39:1024-1028.
33. 1b in the treatment of MS: final outcome of the randomized controlled trial. Neurology (1995) 45:1277-1285.
34. 1a (Rebif) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis. Mult. Scler. (2005) 11:585-591.
35. 1b induced ulcerative skin lesions in MS. J. Neuroimmunology (1994) 54:173 Abstract.
36. FROHMAN E, PHILLIPS T, KOKEL K et al.: Disease modifying therapy in multiple sclerosis: strategies for optimizing management. Neurologist (2002) 8(4):227-236.
37. 1b and review of the literature. Acta Derm. Venerol. (Stockh) (1997) 77:146-148.
38. WALTHER EU, HOHFELD R. Multiple sclerosis side effects of interferon β therapy and their management. Neurology (1999) 53:1622-1627.
39. 1b for multiple sclerosis: report of a consensus conference. Neurology (1996) 46:12-18.
40. 1b in patients with MS. Neurology (1999) 52:1893-1895.
41. 1b in relapsing remitting MS. Neurology (1998) 50:1910-1912.
42. 1b: relationship to adherence to treatment. Mult. Sclerosis (1996) 2(5):222-226.
43. FILIPPINI G, MUNARI L, INCORVAIA B et al.: Interferons in relapsing remitting multiple sclerosis: a systematic review. Lancet (2003) 361:545-552.
44. LA MANTIA L, D'AMICO D, RIGAMONTI A, MASCOLI N, BUSSONE G, MILANESE C: Interferon treatment may trigger primary headaches in multiple sclerosis patients. Mult. Scler. (2006) 12:476-480.
45. D'AMICO D, LA MANTIA L, RIGAMONTI A et al.: Prevalence of primary headaches in people with multiple sclerosis. Cephalagia (2004) 24:980-984.
46. POLLMANN W, ERASMUS LP, FENEBERG W, THEN BERGH F, STRAUBE A: Interferon β but not glatiramer acetate therapy aggravates headaches in MS. Neurology (2002) 59:636-639.
47. 1a (Rebif) therapy in multiple sclerosis. Drug Saf. (2004) 27(10):745-756.
48. 1a. Am. J. Ther. (2002) 9:522-523.
49. KAZUTA Y, WATANABE N, SAGAWA K et al.: A case of autoimmune haemolytic anemia induced by IFN β therapy for chronic hepatitis. Fukushima J. Med. Sci. (1995) 41:43-49.
50. 1a. Drug Saf. (2003) 26(11):815-827.
51. TREMLETT H, YOSHIDA EM, OGER J: Liver injury associated with the β interferons for MS: a comparison between the three products. Neurology (2004) 62:628-631.
52. YOSHIDA EM, RASMUSSEN SL, STEINBRECHER UP et al.: Fulminant liver failure during interferon β treatment of multiple sclerosis. Neurology (2001) 56:1416.
53. YOSHIDA EM, RASMUSSEN SL, STEINBRECHER UP et al.: Correction: fulminant liver failure during interferon β treatment of multiple sclerosis. Neurology (2001) 57:2153.
54. ARANDA-MICHAEL J, KOEHLER A, BEJARANO PA et al.: Nefazodone-induced liver failure: report of three cases. Ann. Intern. Med. (1999) 130:285-288.
55. KARNI A, ABRAMSKY O: Association of MS with thyroid disorders. Neurology (1999) 53:883-885.
56. MONZANI F, CARACCIO N, MEUCCI G et al.: Fffect of 1-year treatment with interferon β on thyroid function and autoimmunity in patients with multiple sclerosis. Eur. J. Endocrinol. (1999) 141:325-331.
57. 1b treatment for multiple sclerosis. J. Neurol. Sci. (1999) 162:74-83.
58. 1b treatment for MS. Neurology (2001) 57:1363-1370.
59. 1b therapy for MS: is routine thyroid assessment always useful? Neurology (2000) 55:549-552.
60. MONZANI F, CARACCIO N, DARDANO A, FERRANNINI E: Thyroid autoimmunity and dysfunction associated with type I interferon therapy. Clin. Exp. Med. (2004) 3(4):199-210.
61. SADOVNIK AD, EISEN K, EBERS GC, PATY DW: Cause of death in patients attending multiple sclerosis clinics. Neurology (1991) 41:1193-1196.
62. GOEB JL, EVEN C, NICOLAS G, GOHIER B, DUBAS F, GARRE JB: Psychiatric side effects of interferon β in multiple sclerosis. Eur. Psychiatry (2006) 21(3):186-193.
63. 1b and depression. A prospective investigation. J. Neurol. (2002) 249:815-820.
64. 1a, treatment for multiple sclerosis. Arch. Neurol. (1999) 56:1263-1265.
65. 1b therapy for multiple sclerosis. Arch. Neurol. (1997) 54:531-533.
66. SANDBERG-WOLLHEIM M, FRANK D, GOODWIN TM et al.: Pregnancy outcomes during treatment with interferon β in patients with multiple sclerosis. Neurology (2005) 65(6):802-805.
67. BOSKOVIC R, WADE R, WOLPIN J, BAUER G, KOREN G: The reproductive effects of β interferon therapy in pregnancy: a longitudinal cohort. Neurology (2005) 65:807-811.
68. NIELSEN N, ROSTGAARD K, RASMUSSEN S et al.: Cancer risk among patients with multiple sclerosis: a population-based register study. Int. J. Cancer (2006) 118:979-984.
69. SEGA S, HORVAT A, POPOVIC M: Anaplastic oligodendroglioma and gliomatosis type 2 in interferon-β treated multiple sclerosis. Report of 2 cases. Clin. Neurol. Neurosurg. (2006) 108(3):259-265.
70. 1b treated multiple sclerosis: coincidence or relationship? Neuroradiology (2005) 47(7):516-519.
71. ACHIRON A, BARAK Y, GAIL M et al.: Cancer incidence in multiple sclerosis and effects of immunomodulatory treatments. Breast Cancer Res. Treat. (2005) 89(3):265-270.
72. 1a. J. Neurol. (2003) 250:768-769.
73. 1b in pediatric multiple sclerosis. Neurology (2006) 66(4):472-476.
74. 1a treatment in childhood and juvenile-onset multiple sclerosis. Neurology (2006) 67(3):511-513.
75. SORENSEN PS, DEISENHAMMER F, DUDA P et al.: Guidelines on use of anti-IFN-β antibody measurements in multiple sclerosis; report of an EFNS Task force on IFN-β antibodies in multiple sclerosis. Eur. J. Neurol. (2005) 12:817-827.