Effect of daclizumab high-yield process in patients with highly active relapsing-remitting multiple sclerosis

Journal of Neurology

Volumn 261, Issue 2, 2014, Pages 316-323

  Giovannoni, Gavin ^a   Radue, Ernst Wilhelm ^b   Havrdova, Eva ^c   Riester, Katherine ^d   Greenberg, Steven ^e   Mehta, Lahar ^d   Elkins, Jacob ^d  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

^c CHARLES UNIVERSITY   (Czech Republic)

^d BIOGEN   (United States)

^e ABBVIE INC   (United States)

Author keywords

Drug therapy; Magnetic resonance imaging; Relapsing remitting multiple sclerosis; Safety; Treatment outcome

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; DACLIZUMAB; GADOLINIUM; PLACEBO;

ADULT; ARTICLE; CONTRAST ENHANCEMENT; CONTROLLED STUDY; DISABILITY; DISEASE ACTIVITY; DRUG EFFECT; EXPANDED DISABILITY STATUS SCALE; FEMALE; HEADACHE; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; NEUROIMAGING; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PARESTHESIA; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; RHINOPHARYNGITIS; RISK REDUCTION; SIDE EFFECT; SKIN MANIFESTATION; UPPER RESPIRATORY TRACT INFECTION;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; CONTRAST MEDIA; DISABILITY EVALUATION; DISEASE PROGRESSION; FEMALE; GADOLINIUM; HUMANS; IMAGE PROCESSING, COMPUTER-ASSISTED; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; INJECTIONS, SUBCUTANEOUS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RECURRENCE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84899070305     PISSN: 03405354     EISSN: 14321459     Source Type: Journal    
DOI: 10.1007/s00415-013-7196-4     Document Type: Article

References (20)

1. Disanto G, Berlanga AJ, Handel AE, Para AE, Burrell AM, Fries A, Handunnetthi L, De Luca GC, Morahan JM (2011) Heterogeneity in multiple sclerosis: scratching the surface of a complex disease. Autoimmune Dis. doi:10.4061/2011/932351
2. Scalfari A, Neuhaus A, Degenhardt A, Rice GP, Muraro PA, Daumer M, Ebers GC (2010) The natural history of multiple sclerosis, a geographically based study 10: relapses and long-term disability. Brain 133:1914-1929
3. Confavreux C, Vukusic S, Adeleine P (2003) Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain 126:770-782 (Pubitemid 36372978)
4. Weinshenker BG, Bass B, Rice GP, Noseworthy J, Carriere W, Baskerville J, Ebers GC (1989) The natural history of multiple sclerosis: a geographically based study. 2. Predictive value of the early clinical course. Brain 112:1419-1428 (Pubitemid 20024212)
5. Kantarci O, Siva A, Eraksoy M, Karabudak R, Sütlaş N, Agaoglu J, Turan F, Ozmenoǧlu M, Toǧrul E, Demirkiran M (1998) Survival and predictors of disability in Turkish MS patients. Turkish Multiple Sclerosis Study Group (TUMSSG). Neurology 51:765-772 (Pubitemid 28449257)
6. Brex PA, Ciccarelli O, O'Riordan JI, Sailer M, Thompson AJ, Miller DH (2002) A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med 346:158-164 (Pubitemid 34438881)
7. Losseff NA, Miller DH, Kidd D, Thompson AJ (2001) The predictive value of gadolinium enhancement for long term disability in relapsing-remitting multiple sclerosis - preliminary results. Mult Scler 7:23-25 (Pubitemid 32396575)
8. European Medicines Agency (2012) Summary of product characteristics (Tysabri)
9. European Medicines Agency (2012) Summary of product characteristics (Gilenya)
10. Martin R (2012) Anti-CD25 (daclizumab) monoclonal antibody therapy in relapsing-remitting multiple sclerosis. Clin Immunol 142:9-14
11. Wynn D, Kaufman M, Montalban X, Vollmer T, Simon J, Elkins J, O'Neill G, Neyer L, Sheridan J, Wang C, Fong A, Rose JW, CHOICE investigators (2010) Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol 9:381-390
12. Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G, SELECT study investigators (2013) Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet 381:2167-2175
13. Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS (2005) Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol 58:840-846 (Pubitemid 41746873)
14. Kurtzke JF (1983) Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33:1444-1452
15. Hutchinson M, Kappos L, Calabresi PA, Confavreux C, Giovannoni G, Galetta SL, Havrdova E, Lublin FD, Miller DH, O'Connor PW, Phillips JT, Polman CH, Radue EW, Rudick RA, Stuart WH, Wajgt A, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, AFFIRM and SENTINEL Investigators (2009) The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL. J Neurol 256:405-415
16. Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C, Häring DA, Francis G, Kappos L, FREEDOMS study group (2012) Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol 11:420-428
17. bright NK cells. J Immunol 185:1311-1320
18. bright natural killer cells mediate immunomodulatory effects of IL-2Rα-targeted therapy (daclizumab) in multiple sclerosis. Proc Natl Acad Sci USA 103:5941-5946
19. Bielekova B (2013) Daclizumab therapy for multiple sclerosis. Neurotherapeutics 10:55-67
20. Perry JS, Han S, Xu Q, Herman ML, Kennedy LB, Csako G, Bielekova B (2012) Inhibition of LTi cell development by CD25 blockade is associated with decreased intrathecal inflammation in multiple sclerosis. Sci Transl Med 4:145ra106