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

The Lancet Neurology

Volumn 8, Issue 11, 2009, Pages 987-997

  Kappos, Ludwig ^a   Freedman, Mark S ^b   Polman, Chris H ^c   Edan, Gilles ^d   Hartung, Hans Peter ^e   Miller, David H ^f   Montalbán, Xavier ^g   Barkhof, Frederik ^c   Radü, Ernst Wilhelm ^a   Metzig, Carola ^h   Bauer, Lars ^h   Lanius, Vivian ^h   Sandbrink, Rupert ^e,h   Pohl, Christoph ^h,i  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

^b UNIVERSITY OF OTTAWA   (Canada)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d RENNES UNIVERSITY HOSPITAL   (France)

^e HEINRICH HEINE UNIVERSITY   (Germany)

^f NATIONAL HOSPITAL FOR NEUROLOGY AND NEUROSURGERY   (United Kingdom)

^g HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^h BAYER PHARMA AG   (Germany)

ⁱ UNIVERSITY HOSPITAL BONN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

GADOLINIUM; INTERFERON BETA SERINE; PLACEBO; BETA INTERFERON; INTERFERON BETA-1B;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SCORING SYSTEM; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; DISABILITY; DOUBLE BLIND PROCEDURE; KAPLAN MEIER METHOD; PROPORTIONAL HAZARDS MODEL; QUESTIONNAIRE; RISK ASSESSMENT; STATISTICAL ANALYSIS;

ADULT; DATA INTERPRETATION, STATISTICAL; DISABILITY EVALUATION; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTERFERON-BETA; KAPLAN-MEIERS ESTIMATE; MAGNETIC RESONANCE IMAGING; MALE; MULTIPLE SCLEROSIS; PROPORTIONAL HAZARDS MODELS; QUESTIONNAIRES; RISK ASSESSMENT; YOUNG ADULT;

EID: 70449713830     PISSN: 14744422     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1474-4422(09)70237-6     Document Type: Article

References (41)

1. Brex P.A., Ciccarelli O., O'Riordan J.I., Sailer M., Thompson A.J., and Miller D.H. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med 346 (2002) 158-164
2. Tintoré M., Rovira A., Rio J., et al. Baseline MRI predicts future attacks and disability in clinically isolated syndromes. Neurology 67 (2006) 968-972
3. Fisniku L.K., Brex P.A., Altmann D.R., et al. Disability and T2 MRI lesions: a 20-year follow-up of patients with relapse onset of multiple sclerosis. Brain 131 (2008) 808-817
4. 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 343 (2000) 898-904
5. Comi G., Filippi M., Barkhof F., et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 357 (2001) 1576-1582
6. 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 67 (2006) 1242-1249
7. Comi G., and Fillippi M. Treatment with glatiramer acetate delays conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome (CIS). Neurology 71 (2009) 153-156
8. 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 370 (2007) 389-397
9. Poser C.M., Paty D.W., Scheinberg L., et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann Neurol 13 (1983) 227-231
10. Senn S. Chapter 6.2.5 Minimisation. Statistical issues in drug development (1997), John Wiley and Sons, Chichester 77-81
11. Kurtzke J.F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33 (1983) 1444-1452
12. Cutter G.R., Baier M.L., Rudick R.A., et al. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain 122 (1999) 871-882
13. Cella D.F., Dineen K., Arnason B., et al. Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology 47 (1996) 129-139
14. The EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16 (1990) 199-208
15. Neurostatus.net. Neurostatus scoring. http://www.neurostatus.net/scoring/index.php (accessed Sept 3, 2009).
16. Pungor Jr. E., Files J.G., Gabe J.D., et al. A novel bioassay for the determination of neutralizing antibodies to IFN-beta1b. J Interferon Cytokine Res 18 (1998) 1025-1030
17. Sidak Z. Rectangular confidence region for the means of multivariate normal distributions. J Am Stat Assoc 67 (1967) 626-633
18. McDonald W.I., 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 (2001) 121-127
19. Smith S.M., Zhang Y., Jenkinson M., et al. Accurate, robust and automated longitudinal and cross-sectional brain change analysis. NeuroImage 17 (2002) 479-489
20. Miller D., Barkhof F., Montalban X., Thompson A., and Filippi M. Clinically isolated syndromes suggestive of multiple sclerosis, part I: natural history, pathogenesis, diagnosis, and prognosis. Lancet Neurol 4 (2005) 281-288
21. O'Connor, Kinkel R.P., Kremenchutzky M., et al. Efficacy of intramuscular interferon beta-1a in patients with clinically isolated syndrome: analysis of subgroups based on new risk criteria. Mult Scler 15 (2009) 728-734
22. 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 66 (2006) 678-684
23. Kappos L., Traboulsee A., Constantinescu C., et al. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology 67 (2006) 944-953
24. Ebers G., Rice G., Konieczny A., et al. The interferon beta-1b 16-year long-term follow-up study: the final results. Neurology 66 suppl 2 (2006) A32
25. Noseworthy J.H. How much can we learn from long-term extension trials in multiple sclerosis?. Neurology 67 (2006) 930-931
26. Kappos L., Weinshenker B., Pozzilli C., et al. Interferon beta-1b in secondary progressive MS: a combined analysis of the two trials. Neurology 63 (2004) 1779-1787
27. Filippi M., Bozzali M., Rovaris M., et al. Evidence for widespread axonal damage at the earliest clinical stage of multiple sclerosis. Brain 126 (2003) 433-437
28. Pantano P., Iannetti G.D., Caramia F., et al. Cortical motor reorganization after a single clinical attack of multiple sclerosis. Brain 125 (2002) 1607-1615
29. Nielsen J.M., Pohl C., Polman C.H., et al. MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome. BMC Neurol 9 (2009) 19
30. Polman C., Kappos L., Freedman M.S., and the BENEFIT investigators. Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. J Neurol 255 (2008) 480-487
31. Rao S.M., Leo G.J., Bernardin L., and Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology 41 (1991) 685-691
32. Amato M.P., Portaccio E., Goretti B., et al. The Rao's Brief Repeatable Battery and Stroop Test: normative values with age, education and gender corrections in an Italian population. Mult Scler 12 (2006) 787-793
33. Audoin B., Van Au Duong M., Malikova I., et al. Functional magnetic resonance imaging and cognition at the very early stage of MS. J Neurol Sci 245 (2006) 87-91
34. Feuillet L., Reuter F., Audoin B., et al. Early cognitive impairment in patients with clinically isolated syndrome suggestive of multiple sclerosis. Mult Scler 13 (2007) 124-127
35. Freedman M.S., Edan G., Hartung H.-P., et al. The impact of neutralizing antibodies within 5 years of treatment with interferon beta-1b initiated at the first event suggestive of multiple sclerosis. Neurology 72 suppl 3 (2009) A197-A198
36. Barkhof F., Polman C.H., Radue E.W., et al. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol 64 (2007) 1292-1298
37. Filippi M., and Grossman R.I. MRI techniques to monitor MS evolution: the present and the future. Neurology 58 (2002) 1147-1153
38. Filippi M., Rovaris M., Inglese M., et al., for the ETOMS Study Group. Interferon beta-1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet 364 (2004) 1489-1496
39. Miller D.H. Brain atrophy, interferon beta, and treatment trials in multiple sclerosis. Lancet 364 (2004) 1463-1464
40. Kappos L., Moeri D., Radue E.W., et al. Predictive value of gadolinium-enhanced magnetic resonance imaging for relapse rate and changes in disability or impairment in multiple sclerosis: a meta-analysis. Lancet 353 (1999) 964-969
41. Daumer M., Neuhaus A., Morrissey S., Hintzen R., and Ebers G.C. MRI as an outcome in multiple sclerosis clinical trials. Neurology 72 (2009) 705-711