The impact of neutralizing antibodies on the risk of disease worsening in interferon β-treated relapsing multiple sclerosis: A 5 year post-marketing study

Journal of Neurology

Volumn 260, Issue 6, 2013, Pages 1562-1568

  Paolicelli, D ^a   D'Onghia, M ^a   Pellegrini, F ^b   Direnzo, V ^a   Iaffaldano, P ^a   Lavolpe, V ^a   Trojano, M ^a  

^a UNIVERSITY OF BARI   (Italy)

^b CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

Author keywords

Disease activity; Interferon ; Multiple sclerosis; Neutralizing antibodies

Indexed keywords

BETA1A INTERFERON; INTERFERON BETA SERINE; NEUTRALIZING ANTIBODY; REBIF 22; REBIF 44; UNCLASSIFIED DRUG;

ANTIBODY TITER; ARTICLE; CLINICAL EVALUATION; CYTOPATHOGENIC EFFECT; DISEASE DURATION; EXPANDED DISABILITY STATUS SCALE; FOLLOW UP; GENDER; HUMAN; MAJOR CLINICAL STUDY; MULTIPLE SCLEROSIS; OBSERVATIONAL STUDY; ONSET AGE; PRIORITY JOURNAL; PROPENSITY SCORE; RELAPSE; SEROLOGY; TREATMENT RESPONSE;

ADULT; ANTIBODIES, NEUTRALIZING; DISEASE PROGRESSION; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; INTERFERON-BETA; MALE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RECURRENCE; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84878839989     PISSN: 03405354     EISSN: 14321459     Source Type: Journal    
DOI: 10.1007/s00415-012-6829-3     Document Type: Article

References (40)

1. The IFNB Multiple Sclerosis Study Group I (1993) Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43:655-661
2. The Multiple Sclerosis Collaborative Research Group (MSCRG) (1996) Intramuscolar interferon beta 1-a for disease progression in relapsing multiple sclerosis. Ann Neurol 39:285-294 (Pubitemid 26100751)
3. PRISMS Study Group (1998) Randomized, double-blind, placebo-controlled study of interferon beta-1a in relapsing-remitting multiple sclerosis. Lancet 352:1498-1504 (Pubitemid 28512925)
4. Bermel RA, Weinstock-Guttman B, Bourdette D et al (2010) Intramuscular interferon beta-1a therapy in patients with relapsing-remitting multiple sclerosis: a 15-year follow-up study. Mult Scler 16(5):588-596
5. Kappos L, Traboulsee A, Constantinescu C et al (2006) Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology 67:944-953 (Pubitemid 44454583)
6. Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, DeSimone TM, Knappertz V (2012) Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial. Neurology 78(17):1315-1322
7. Trojano M, Pellegrini F, Fuiani A et al (2007) New natural history of interferon beta treated relapsing multiple sclerosis. Ann Neurol 61:300-306 (Pubitemid 46676729)
8. Pachner AR (1997) Anticytokine antibodies in beta interferons-treated MS patients and the need for testing: plight of the practicing neurologist. Neurology 49:647-650 (Pubitemid 27427998)
9. Runkel L, deDios C, Karpusas M, Baker D, Li Z, Zafari M et al (2001) Mapping of interferonβ epitopes important for receptor binding and activation: comparison of results achieved using antibody-based methods and alanine substitution mutagenesis. J Interferon Cytokine Res 21:931-941 (Pubitemid 34048719)
10. The IFNB Multiple Sclerosis Study Group I (1996) Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: experience during the first three years. Neurology 47:889-894
11. Rudick RA, Simonian NA, Alam JA, Campion M, Scaramucci JO, Jones W et al (1998) Incidence and significance of neutralizing antibodies to IFNβ-1a in multiple sclerosis. Multiple sclerosis collaborative research group (MSCRG). Neurology 50:1266-1272 (Pubitemid 28240338)
12. Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P et al (2002) Randomized comparative study of interferon β-1a treatment regimens in MS: the EVIDENCE trial. Neurology 59:1496-1506 (Pubitemid 35387053)
13. Ross C, Clemmesen KM, Svenson M, Sørensen PS, Koch-Henriksen N, Skovgaard GL et al (2000) Immunogenicity of interferon β in multiple sclerosis patients: influence of preparation, dosage, dose frequency, and route of administration. Ann Neurol 48:706-712
14. Hesse D, Sorensen PS (2007) Using measurements of neutralizing antibodies: the challenge of IFNβ therapy. Eur J Neurol 14:850-859 (Pubitemid 47106761)
15. Van der Voort L, Gilli F, Bertolotto A, Knol DL, Uitdehaag B, Polman CH, Killestein J (2010) Clinical effect of neutralizing antibodies to interferon beta that persist long after cessation of therapy for multiple sclerosis. Arch Neurol 67(4):402-407
16. Petkau AJ, White RA, Ebers GC, Reder AT, Sibley WA, Lublin FD et al (2004) Longitudinal analyses of the effects of neutralizing antibodies on interferonβ-1 in relapsing remitting multiple sclerosis. Mult Scler 10:126-138 (Pubitemid 38499903)
17. Sorensen PS, Koch-Hendriksen N, Ross C, Clemmesen KM, Bendtzen K, Danish Multiple Sclerosis Study Group (2005) Appearance and disappearance of neutralizing antibodies during interferon-beta therapy. Neurology 65:33-39 (Pubitemid 40967773)
18. Goodin DS, Frohman EM, Hurwitz B, O'Connor PW, Oger JJ, Reder AT et al (2007) Neutralising 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 68:977-984 (Pubitemid 46569129)
19. Hesse D, Sellebjerg F, Sorensen PS (2009) Absence of MxA induction by interferon beta in patients with MS reflects complete loss of bioactivity. Neurology 73(5):372-377
20. Bertolotto A, Gilli F, Sala A, Capobianco M, Malucchi S, Milano E et al (2003) Persistent neutralizing antibodies abolish the interferon beta bioavailability in MS patients. Neurology 60:634-639 (Pubitemid 36246082)
21. Pachner AR, Cadavid D, Wolansky L, Skurnick J (2009) Effect of anti-IFNβ antibodies on MRI lesions of MS patients in the BECOME study. Neurology 73(18):1485-1492
22. Koch-Henriksen N, Sorensen P, Bendtzen K, Flachs E (2009) The clinical effect of neutralizing antibodies against interferon-beta is independent of the type of interferon-beta used for patients with relapsing-remitting multiple sclerosis. Mult Scler 15:601-606
23. Cutter G (2003) Statistical issues in neutralizing antibodies. Neurology 61(S5): S38-S39 (Pubitemid 37386121)
24. Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L et al (2005) Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol 58(6):840-846 (Pubitemid 41746873)
25. Kurtzke JF (1983) Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33(11):1444-1452 (Pubitemid 14237132)
26. Hansen MB, Ross C, Berg K (1990) A sensitive antiviral neutralization bioassay for measuring antibodies to interferons. J Immunol Methods 127:241-248 (Pubitemid 20082844)
27. Kawade Y (1986) Quantitation of neutralization of interferon by antibody. Meth Enzymol 119:558-573 (Pubitemid 16025159)
28. Sorensen PS, Deisenhammer F, Duda P, Hohlfeld R, Myhr K-M, Palace J et al (2005) Guidelines on use of anti-IFNβ antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFNβ antibodies in multiple sclerosis. Eur J Neurol 12(11):817-827 (Pubitemid 41597593)
29. Singer JD, Willett JB (2003) Applied longitudinal data analysis: modelling change and event occurrence. Oxford University Press, New York
30. Parsons LS (2004) Reducing bias in a propensity score matched-pair sample using greedy matching techniques. In: Proceedings of the twenty-sixth annual SAS users group international conference, Cary
31. Boz C, Oger J, Gibs E, Grossberg SE, Neurologists of the UBC MS clinic (2007) Reduced effectiveness of long-term interferon β treatment on relapses in neutralizing antibody-positive multiple sclerosis patients: a Canadian multiple sclerosis clinic-based study. Mult Scler 13:1127-1137 (Pubitemid 351541416)
32. Goodin DS, Hurwitz B, Noronha A (2007) Neutralizing antibodies to interferonβ-1b are not associated with disease worsening in multiple sclerosis. J Inter Med Res 35(2):173-187 (Pubitemid 46831066)
33. Hartung HP, Freedman M, Polman CH, Edan G, Kappos L, Miller D, Montalban X et al (2007) Interferon β-1b-neutralizing antibodies 5 years after clinically isolated syndrome. Neurology 77(9):835-843
34. Rice GP, Paszner B, Oger J, Lesaux J, Paty D, Eber G (1999) The evolution of neutralizing antibodies in multiple sclerosis patients treated with interferon beta-1b. Neurology 52:1277-1279 (Pubitemid 29177937)
35. Malucchi S, Sala A, Gilli F, Bottero R, Di Sapio A, Capobianco M et al (2004) Neutralizing antibodies reduce the efficacy of betaIFN during treatment of multiple sclerosis. Neurology 62:2031-2037 (Pubitemid 38738217)
36. Sorensen PS, Ross C, Clemmesen KM, Bendtzen K, Frederiksen JL, Jensen K et al (2003) Clinical importance of neutralising antibodies against Interferon beta in patients with relapsing remittent multiple sclerosis. Lancet 362:1184-1191 (Pubitemid 37255344)
37. Goodin D, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S et al (2012) Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler 18(2):181-195
38. Rosenbaum PR (1983) The central role of the propensity score in observational studies for causal effects. Biometrika 70:41-55
39. Sorensen PS (2009) Management of patients with neutralizing antibodies against interferon-beta: stop IFN-beta therapy or wait for the antibodies to go away? Eur J Neurol 16(1):1-2
40. Polman CH, Bertolotto A, Deisenhammer F, Giovannoni G, Hartung HP, Hemmer B, Killestein J et al (2010) Recommendations for clinical use of data on neutralising antibodies to interferon-beta therapy in multiple sclerosis. Lancet Neurol 9:740-750