Combined MRI lesions and relapses as a surrogate for disability in multiple sclerosis

Neurology

Volumn 77, Issue 18, 2011, Pages 1684-1690

  Sormani, M P ^a   Li, D K ^b   Bruzzi, P ^c   Stubinski, B ^d   Cornelisse, P ^d   Rocak, S ^d   De Stefano, N ^e  

^a UNIVERSITY OF GENOA   (Italy)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c UNIVERSITY OF GENOA   (Italy)

^d MERCK SERONO S A   (Switzerland)

^e UNIVERSITY OF SIENA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; PLACEBO;

ARTICLE; CONTROLLED STUDY; DISABILITY; DOUBLE BLIND PROCEDURE; EXPANDED DISABILITY STATUS SCALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 82955243995     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0b013e31823648b9     Document Type: Article

References (27)

1. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983;33:1444-1452. (Pubitemid 14237132)
2. Goodin DS. Magnetic resonance imaging as a surrogate outcome measure of disability in multiple sclerosis: have we been overly harsh in our assessment? Ann Neurol 2006; 59:597-605.
3. Petkau J, Reingold S, Held U, et al. Magnetic resonance imaging as a surrogate outcome for multiple sclerosis relapses. Mult Scler 2008;14:770-778.
4. Sormani MP, Bruzzi P, Comi G, Filippi M. MRI metrics as surrogate markers for clinical relapse rate in relapsingremitting MS patients. Neurology 2002;58:417-421. (Pubitemid 34150916)
5. Sormani MP, Bruzzi P, Beckmann K, et al. MRI metrics as surrogate endpoints for EDSS progression in SPMS patients treated with IFN beta-1b. Neurology 2003;60: 1462-1466. (Pubitemid 36554807)
6. Sormani MP, Stubinski B, Cornelisse P, et al. Magnetic resonance active lesions as individual-level surrogate for relapses in multiple sclerosis. Mult Scler 2011;17:541-549.
7. Sormani MP, Bonzano L, Roccatagliata L, Cutter GR, Mancardi GL, Bruzzi P. Magnetic resonance imaging as a potential surrogate for relapses in multiple sclerosis: a meta-analytic approach. Ann Neurol 2009;65:268-275.
8. Sormani MP, Bonzano L, Roccatagliata L, Mancardi GL, Uccelli A, Bruzzi P. Surrogate endpoints for EDSS worsening in multiple sclerosis: a meta-analytic approach. Neurology 2010;75:302-309.
9. Miller DH, Khan OA, Sheremata WA, et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2003;348:15-23. (Pubitemid 36026342)
10. Kappos L, Antel J, Comi G, et al. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med 2006;355:1124-1140. (Pubitemid 44394919)
11. Comi G, Pulizzi A, Rovaris M, et al. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet 2008;371:2085-2092. (Pubitemid 351842581)
12. O'Connor PW, Li D, Freedman MS, et al. A phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology 2006;66:894-900. (Pubitemid 43739766)
13. Wynn D, Kaufman M, Montalban X, et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol 2010;9: 381-390.
14. Kappos L, Gold R, Miller DH, et al. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet Neurol 2009; 372:1463-1472.
15. Kappos L, Radue EW, O'Connor P, et al. A placebocontrolled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401.
16. Giovannoni G, Comi G, Cook S, et al. A placebocontrolled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010;362:416-426.
17. Scalfari A, Neuhaus A, Degenhardt A, et al. The natural history of multiple sclerosis, a geographically based study 10: relapses and long-term disability. Brain 2010;133: 1914-1929.
18. Daumer M, Neuhaus A, Morrissey S, Hintzen R, Ebers GC. MRI as an outcome in multiple sclerosis clinical trials. Neurology 2009;72:705-711.
19. Sormani M, Filippi M, De Stefano N, M.A.GNIMS Steering Committee MRI as an outcome in multiple sclerosis clinical trials. Neurology 2009;73:1932.
20. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-440. (Pubitemid 19105891)
21. PRISMS (Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-1504.
22. Li DK, Paty DW. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebocontrolled study of interferon-beta1a in relapsingremitting multiple sclerosis: Prevention of Relapses and Disability by Interferon-beta1a Subcutaneously in Multiple Sclerosis. Ann Neurol 1999;46:197-206.
23. Sormani MP, Bruzzi P, Miller DH, Gasperini C, Barkhof F, Filippi M. Modelling MRI enhancing lesion counts in multiple sclerosis using a negative binomial model: implications for clinical trials. J Neurol Sci 1999;163:74-80. (Pubitemid 29155420)
24. Lin DY, Fleming TR, De Gruttola V. Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med 1997;16:1515-1527. (Pubitemid 27322655)
25. Burzykowski T, Molenberghs G, Buyse M, eds. The Evaluation of Surrogate Endpoints. New York: Spinger Science-Business Media, Inc.; 2005.
26. Ebers GC, Heigenhauser L, Daumer M, Lederer C, Noseworthy JH. Disability as an outcome in MS clinical trials. Neurology 2008;71:624-631.
27. Ebers G, Daumer M, Scalfari A. Surrogate endpoints for EDSS worsening in multiple sclerosis: a meta-analytic approach: measuring disability in relapsing-remitting MS. Neurology 2011;76:1025. Letter.