메뉴 건너뛰기




Volumn 21, Issue 8, 2015, Pages 650-660

Postmarketing safety profile of subcutaneous interferon beta-1a given 3 times weekly: A retrospective administrative claims analysis

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; CORTICOSTEROID; ALPHA INTERFERON; IMMUNOLOGIC FACTOR; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE;

EID: 84938915217     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2015.21.8.650     Document Type: Article
Times cited : (18)

References (38)
  • 1
    • 55549087746 scopus 로고    scopus 로고
    • Geneva: WHO Press, Available at, Accessed June 16, 2015
    • World Health Organization. Atlas: Multiple Sclerosis Resources in the World 2008. Geneva: WHO Press; 2008. Available at: http://whqlibdoc.who.int/publications/2008/9789241563758_eng.pdf?ua=1. Accessed June 16, 2015.
    • (2008) Atlas: Multiple Sclerosis Resources in the World 2008
  • 2
    • 33644872974 scopus 로고    scopus 로고
    • Multiple sclerosis: advances in understanding, diagnosing, and treating the underlying disease
    • Fox RJ, Bethoux F, Goldman MD, Cohen JA. Multiple sclerosis: advances in understanding, diagnosing, and treating the underlying disease. Cleve Clin J Med. 2006;73(1):91-102.
    • (2006) Cleve Clin J Med , vol.73 , Issue.1 , pp. 91-102
    • Fox, R.J.1    Bethoux, F.2    Goldman, M.D.3    Cohen, J.A.4
  • 3
    • 84897026062 scopus 로고    scopus 로고
    • Established and novel disease-modifying treatments in multiple sclerosis
    • Cross AH, Naismith RT. Established and novel disease-modifying treatments in multiple sclerosis. J Intern Med. 2014;275(4):350-63.
    • (2014) J Intern Med , vol.275 , Issue.4 , pp. 350-363
    • Cross, A.H.1    Naismith, R.T.2
  • 4
    • 84938939232 scopus 로고    scopus 로고
    • Rebif sales report. Company data on file. Merck KGaA
    • Rebif sales report. Company data on file. Merck KGaA. 2014.
    • (2014)
  • 5
    • 0345601517 scopus 로고    scopus 로고
    • Randomized double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis
    • PRISMS Study Group. Randomized double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet. 1998;352(9139):1498-504.
    • (1998) Lancet , vol.352 , Issue.9139 , pp. 1498-1504
  • 6
    • 0037180479 scopus 로고    scopus 로고
    • Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE Trial
    • Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE Trial. Neurology. 2002;59(10):1496-506.
    • (2002) Neurology , vol.59 , Issue.10 , pp. 1496-1506
    • Panitch, H.1    Goodin, D.S.2    Francis, G.3
  • 7
    • 0023925775 scopus 로고
    • Spontaneous reporting of adverse drug reactions I: the data
    • Rawlins MD. Spontaneous reporting of adverse drug reactions I: the data. Br J Clin Pharmacol. 1988;26(1):1-5.
    • (1988) Br J Clin Pharmacol , vol.26 , Issue.1 , pp. 1-5
    • Rawlins, M.D.1
  • 8
    • 30644462726 scopus 로고    scopus 로고
    • Post-marketing survey on clinical response to interferon beta in relapsing multiple sclerosis: the Roman experience
    • Pozzilli C, Propserini L, Sbardella E, et al. Post-marketing survey on clinical response to interferon beta in relapsing multiple sclerosis: the Roman experience. Neurol Sci. 2005;26(Suppl 4):S174-78.
    • (2005) Neurol Sci , vol.26 , pp. S174-S178
    • Pozzilli, C.1    Propserini, L.2    Sbardella, E.3
  • 9
    • 22144447781 scopus 로고    scopus 로고
    • Interferon beta in relapsing-remitting multiple sclerosis. An eight years experience in a specialist multiple sclerosis centre
    • Río J, Tintoré M, Nos C, Téllez N, Galán I, Montalban X. Interferon beta in relapsing-remitting multiple sclerosis. An eight years experience in a specialist multiple sclerosis centre. J Neurol. 2005;252(7):795-800.
    • (2005) J Neurol , vol.252 , Issue.7 , pp. 795-800
    • Río, J.1    Tintoré, M.2    Nos, C.3    Téllez, N.4    Galán, I.5    Montalban, X.6
  • 10
    • 0348012903 scopus 로고    scopus 로고
    • A post-marketing study on interferon beta 1b and 1a treatment in relapsing-remitting multiple sclerosis:different response in drop-outs and treated patients
    • Milanese C, La Mantia, Palumbo R, et al. A post-marketing study on interferon beta 1b and 1a treatment in relapsing-remitting multiple sclerosis:different response in drop-outs and treated patients. J Neruol Neruosurg Psychiatry. 2003;74(12):1689-92.
    • (2003) J Neruol Neruosurg Psychiatry , vol.74 , Issue.12 , pp. 1689-1692
    • Milanese, C.1    Mantia, L.2    Palumbo, R.3
  • 11
    • 30644468000 scopus 로고    scopus 로고
    • The INFbeta treatment of multiple sclerosis (MS) in clinical practice: the experience at the MS center of Bari Italy
    • Trojano M, Paolicelli D, Zimatore GB, et al. The INFbeta treatment of multiple sclerosis (MS) in clinical practice: the experience at the MS center of Bari Italy. Neurol Sci. 2005;26(Suppl 4):S179-82.
    • (2005) Neurol Sci , vol.26 , pp. S179-S182
    • Trojano, M.1    Paolicelli, D.2    Zimatore, G.B.3
  • 12
    • 0036835959 scopus 로고    scopus 로고
    • A 6-year clinical and MRI followup study of patients with relapsing-remitting multiple sclerosis treated with interferon-beta
    • Paolillo A, Pozzilli C, Giugni, E, et al. A 6-year clinical and MRI followup study of patients with relapsing-remitting multiple sclerosis treated with interferon-beta. Eur J Neurol. 2002;9(6):645-55.
    • (2002) Eur J Neurol , vol.9 , Issue.6 , pp. 645-655
    • Paolillo, A.1    Pozzilli, C.2    Giugni, E.3
  • 13
    • 34347273391 scopus 로고    scopus 로고
    • Immunomodulating drugs in multiple sclerosis: compliance, satisfaction and adverse effects evaluation in a German multiple sclerosis population
    • Twok S, Nippert I, Scherer P, Haas J, Pohlau D, Kugler J. Immunomodulating drugs in multiple sclerosis: compliance, satisfaction and adverse effects evaluation in a German multiple sclerosis population. Curr Med Res Opin. 2007;23(6):1209-15.
    • (2007) Curr Med Res Opin , vol.23 , Issue.6 , pp. 1209-1215
    • Twok, S.1    Nippert, I.2    Scherer, P.3    Haas, J.4    Pohlau, D.5    Kugler, J.6
  • 14
    • 81055124138 scopus 로고    scopus 로고
    • The prevalence of injectionsite reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study
    • Available at, Accessed June 16, 2015
    • Beer K, Müller M, Hew-Winzeler AM, et al. The prevalence of injectionsite reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study. BMC Neurol. 2011;11:144. Available at: http://www.biomedcentral.com/1471-2377/11/144. Accessed June 16, 2015.
    • (2011) BMC Neurol , vol.11 , pp. 144
    • Beer, K.1    Müller, M.2    Hew-Winzeler, A.M.3
  • 15
    • 1342266970 scopus 로고    scopus 로고
    • Liver injury associated with the β-interferons for MS: a comparison between the three products
    • Tremlett HL, Yoshida EM, Oger J. Liver injury associated with the β-interferons for MS: a comparison between the three products. Neurology. 2004;62(4):628-31.
    • (2004) Neurology , vol.62 , Issue.4 , pp. 628-631
    • Tremlett, H.L.1    Yoshida, E.M.2    Oger, J.3
  • 16
    • 33847138511 scopus 로고    scopus 로고
    • Quality Assessment in Multiple Sclerosis Therapy (QUASIMS): a comparison of interferon beta therapies for relapsing-remitting multiple sclerosis
    • Limmroth V, Malessa R, Zettl UK, et al. Quality Assessment in Multiple Sclerosis Therapy (QUASIMS): a comparison of interferon beta therapies for relapsing-remitting multiple sclerosis. J Neurol. 2007;254(1):67-77.
    • (2007) J Neurol , vol.254 , Issue.1 , pp. 67-77
    • Limmroth, V.1    Malessa, R.2    Zettl, U.K.3
  • 17
    • 33645470729 scopus 로고    scopus 로고
    • Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis
    • Etemadifar M, Janghorbani M, Shaygannejad V. Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis. Acta Neurol Scand. 2006;113(5):283-87.
    • (2006) Acta Neurol Scand , vol.113 , Issue.5 , pp. 283-287
    • Etemadifar, M.1    Janghorbani, M.2    Shaygannejad, V.3
  • 18
    • 33749135029 scopus 로고    scopus 로고
    • Treatment of multiple sclerosis with interferon beta in clinical practice: 2-year follow-up data from the South Italy Mobile MRI Project
    • Bonavita S, Dinacci D, Lavorgna L, et al. Treatment of multiple sclerosis with interferon beta in clinical practice: 2-year follow-up data from the South Italy Mobile MRI Project. Neurol Sci. 2006;27(Suppl 5): S365-68.
    • (2006) Neurol Sci , vol.27 , pp. S365-S368
    • Bonavita, S.1    Dinacci, D.2    Lavorgna, L.3
  • 19
    • 33646117499 scopus 로고    scopus 로고
    • A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis
    • Koch-Henriksen N, Sørensen PS, Christensen T, et al. A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis. Neurology. 2006;66(7):1056-60.
    • (2006) Neurology , vol.66 , Issue.7 , pp. 1056-1060
    • Koch-Henriksen, N.1    Sørensen, P.S.2    Christensen, T.3
  • 20
    • 20044388168 scopus 로고    scopus 로고
    • Twenty-four-month comparison of immunomodulatory treatments-a retrospective open label study in 308 RRMS patients treated with beta interferons or glatiramer acetate (Copaxone)
    • Haas J, Firzlaff M. Twenty-four-month comparison of immunomodulatory treatments-a retrospective open label study in 308 RRMS patients treated with beta interferons or glatiramer acetate (Copaxone). Eur J Neurol. 2005;12(6);425-31.
    • (2005) Eur J Neurol , vol.12 , Issue.6 , pp. 425-431
    • Haas, J.1    Firzlaff, M.2
  • 21
    • 33744808980 scopus 로고    scopus 로고
    • Immunodulatory treatment of multiple sclerosis in Denmark: a prospective nationwide survey
    • Sorenson PS, Koch-Henriksen N, Rovnborg M, et al. Immunodulatory treatment of multiple sclerosis in Denmark: a prospective nationwide survey. Mult Scler. 2006;12(3):253-64.
    • (2006) Mult Scler , vol.12 , Issue.3 , pp. 253-264
    • Sorenson, P.S.1    Koch-Henriksen, N.2    Rovnborg, M.3
  • 22
    • 84883191581 scopus 로고    scopus 로고
    • Swiss analysis of multiple sclerosis:a multicenter, non-interventional, retrospective cohort study of diseasemodifying therapies
    • Gobbi C, Zecca C, Linnebank M, et al. Swiss analysis of multiple sclerosis:a multicenter, non-interventional, retrospective cohort study of diseasemodifying therapies. Eur Neurol. 2013;70(1-2):35-41.
    • (2013) Eur Neurol , vol.70 , Issue.1-2 , pp. 35-41
    • Gobbi, C.1    Zecca, C.2    Linnebank, M.3
  • 23
    • 84918533784 scopus 로고    scopus 로고
    • The STAR Study: a real-world, international, observational study of the safety and tolerability of, and adherence to, serum-free subcutaneous interferon β-1a in patients with relapsing multiple sclerosis
    • Hupperts R, Ghazi-Vissier L, Martins Silva A, et al. The STAR Study: a real-world, international, observational study of the safety and tolerability of, and adherence to, serum-free subcutaneous interferon β-1a in patients with relapsing multiple sclerosis. Clin Ther. 2014;36(12):1946-57.
    • (2014) Clin Ther , vol.36 , Issue.12 , pp. 1946-1957
    • Hupperts, R.1    Ghazi-Vissier, L.2    Martins Silva, A.3
  • 24
    • 84920806308 scopus 로고    scopus 로고
    • November 21, Available at, Accessed June 16, 2015
    • U.S. Food and Drug Administration. FDA's Sentinel Initiative. November 21, 2014. Available at: http://www.fda.gov/Safety/FDAsSentinelinitiative/ucm2007250.htm. Accessed June 16, 2015.
    • (2014) FDA's Sentinel Initiative
  • 25
    • 84938923712 scopus 로고    scopus 로고
    • REBIF (interferon beta-1a), for subcutaneous injection. EMD Serono, Inc. Revised March, Available at, Accessed June 16, 2015
    • REBIF (interferon beta-1a), for subcutaneous injection. EMD Serono, Inc. Revised March 2015. Available at: http://emdserono.com/cmg.emdserono_us/en/images/Rebif%20PI_Jun2014_tcm115_19765.pdf. Accessed June 16, 2015.
    • (2015)
  • 27
    • 6444241927 scopus 로고    scopus 로고
    • Clinical and economic impact of glatiramer acetate versus beta interferon therapy among patients with multiple sclerosis in a managed care population
    • Ollendorf DA, Jilinskaia E, Oleen-Burkey M. Clinical and economic impact of glatiramer acetate versus beta interferon therapy among patients with multiple sclerosis in a managed care population. J Manag Care Pharm. 2002;8(6):469-76. Available at: http://www.amcp.org/data/jmcp/Research-469-476.pdf.
    • (2002) J Manag Care Pharm , vol.8 , Issue.6 , pp. 469-476
    • Ollendorf, D.A.1    Jilinskaia, E.2    Oleen-Burkey, M.3
  • 28
    • 78650041753 scopus 로고    scopus 로고
    • Medical chart validation of an algorithm for identifying multiple sclerosis relapse in healthcare claims
    • Chastek BJ, Oleen-Burkey M, Lopez-Bresnahan MV. Medical chart validation of an algorithm for identifying multiple sclerosis relapse in healthcare claims. J Med Econ. 2010;13(4):618-25.
    • (2010) J Med Econ , vol.13 , Issue.4 , pp. 618-625
    • Chastek, B.J.1    Oleen-Burkey, M.2    Lopez-Bresnahan, M.V.3
  • 29
    • 0031046049 scopus 로고    scopus 로고
    • The assessment of refill compliance using pharmacy records: methods, validity, and applications
    • Steiner JF, Prochazka AV. The assessment of refill compliance using pharmacy records: methods, validity, and applications. J Clin Epidemiol. 1997;50(1):105-16.
    • (1997) J Clin Epidemiol , vol.50 , Issue.1 , pp. 105-116
    • Steiner, J.F.1    Prochazka, A.V.2
  • 30
    • 0033980617 scopus 로고    scopus 로고
    • Managing the adverse effects of interferon beta therapy in multiple sclerosis
    • Bayas A, Rieckmann P. Managing the adverse effects of interferon beta therapy in multiple sclerosis. Drug Saf. 2000;22(2):149-59.
    • (2000) Drug Saf , vol.22 , Issue.2 , pp. 149-159
    • Bayas, A.1    Rieckmann, P.2
  • 31
    • 77954595101 scopus 로고    scopus 로고
    • Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence
    • Patti F. Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence. Patient Prefer Adherence. 2010;4:1-9.
    • (2010) Patient Prefer Adherence , vol.4 , pp. 1-9
    • Patti, F.1
  • 32
    • 0035954361 scopus 로고    scopus 로고
    • PRISMS-4: Long-term tolerability of interferon beta-1a in relapsing MS
    • PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term tolerability of interferon beta-1a in relapsing MS. Neurology. 2001;56(12):1628-36.
    • (2001) Neurology , vol.56 , Issue.12 , pp. 1628-1636
  • 33
    • 33749027200 scopus 로고    scopus 로고
    • Long-term subcutaneous interferon-beta-1a in patients with relapsing-remitting MS
    • Kappos L, Traboulsee A, Constantinescu C, et al. Long-term subcutaneous interferon-beta-1a in patients with relapsing-remitting MS. Neurology. 2006;67(6):944-53.
    • (2006) Neurology , vol.67 , Issue.6 , pp. 944-953
    • Kappos, L.1    Traboulsee, A.2    Constantinescu, C.3
  • 34
    • 0030912908 scopus 로고    scopus 로고
    • Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis
    • Mohr DC, Goodkin DE, Likosky W, et al. Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis. Arch Neurol. 1997;54(5):531-33.
    • (1997) Arch Neurol , vol.54 , Issue.5 , pp. 531-533
    • Mohr, D.C.1    Goodkin, D.E.2    Likosky, W.3
  • 35
    • 0034742275 scopus 로고    scopus 로고
    • Interferon-β and depression in relapsing-remitting multiple sclerosis: an analysis of depression data from the PRISMS clinical trial
    • Patten SB, Metz LM. Interferon-β and depression in relapsing-remitting multiple sclerosis: an analysis of depression data from the PRISMS clinical trial. Mult Scler. 2001;7(4):243-48.
    • (2001) Mult Scler , vol.7 , Issue.4 , pp. 243-248
    • Patten, S.B.1    Metz, L.M.2
  • 36
    • 4344629219 scopus 로고    scopus 로고
    • Haematological effects of interferon-β-1a (Rebif) therapy in multiple sclerosis
    • Rieckmann P, O'Connor P, Francis GS, Wetherill G, Alteri E. Haematological effects of interferon-β-1a (Rebif) therapy in multiple sclerosis. Drug Saf. 2004;27(10):745-56.
    • (2004) Drug Saf , vol.27 , Issue.10 , pp. 745-756
    • Rieckmann, P.1    O'Connor, P.2    Francis, G.S.3    Wetherill, G.4    Alteri, E.5
  • 37
    • 0041854172 scopus 로고    scopus 로고
    • Hepatic reactions during treatment of multiple sclerosis with interferon-β-1a: incidence and clinical significance
    • Francis GS, Grumser Y, Altieri E, et al. Hepatic reactions during treatment of multiple sclerosis with interferon-β-1a: incidence and clinical significance. Drug Saf. 2003;26(11):815-27.
    • (2003) Drug Saf , vol.26 , Issue.11 , pp. 815-827
    • Francis, G.S.1    Grumser, Y.2    Altieri, E.3
  • 38
    • 0035207682 scopus 로고    scopus 로고
    • Data validity issues in using claims data
    • Strom BL. Data validity issues in using claims data. Pharmacoepidemiol Drug Saf. 2001;10(5):389-92
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , Issue.5 , pp. 389-392
    • Strom, B.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.