Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): A randomised, double-blind, placebo-controlled trial

The Lancet

Volumn 381, Issue 9884, 2013, Pages 2167-2175

  Gold, Ralf ^a   Giovannoni, Gavin ^b   Selmaj, Krzysztof ^c   Havrdova, Eva ^d   Montalban, Xavier ^e   Radue, Ernst Wilhelm ^f   Stefoski, Dusan ^g   Robinson, Randy ^h   Riester, Katherine ⁱ   Rana, Jitesh ⁱ   Elkins, Jacob ⁱ   O'Neill, Gilmore ⁱ  

^a ST JOSEF HOSPITAL   (Germany)

^b QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^c MEDICAL UNIVERSITY OF LODZ   (Poland)

^d CHARLES UNIVERSITY   (Czech Republic)

^e HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^f UNIVERSITY HOSPITAL BASEL   (Switzerland)

^g RUSH UNIVERSITY MEDICAL CENTER   (United States)

^h ABBVIE INC   (United States)

ⁱ BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DACLIZUMAB; PLACEBO;

ADULT; ARTICLE; AUTOIMMUNE THYROIDITIS; CONTROLLED STUDY; CROHN DISEASE; CZECH REPUBLIC; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; FEMALE; FOLLOW UP; GERMANY; HERPETIC STOMATITIS; HUMAN; HUNGARY; INDIA; INFECTION; INTERACTIVE VOICE RESPONSE SYSTEM; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE SCLEROSIS; PHARYNGITIS; POLAND; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; RHINOPHARYNGITIS; RUSSIAN FEDERATION; TREATMENT DURATION; TURKEY (REPUBLIC); UKRAINE; UNITED KINGDOM; UPPER RESPIRATORY TRACT INFECTION;

EID: 84879239117     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)62190-4     Document Type: Article

References (29)

1. Dendrou CA, Plagn ol V, Fung E, et al. Cell-specifi c protein phenotypes for the autoimmune locus IL2RA using a genotype-selectable human bioresource. Nat Genet 2009; 41: 1011-15.
2. Hauser SL, Bhan A K, Gilles F, et al. Immunohistochemical analysis of the cellular infi ltrate in multiple sclerosis lesions. Ann Neurol 1986; 19: 578-87.
3. Kreth HW, Dunker R, Rodt H, Meyermann R. Immunohistochemical identifi cation of T-lymphocytes in the central nervous system of patients with multiple sclerosis and subacute sclerosing panencephalitis. J Neuroimmunol 1982; 2: 177-83.
4. Martin JF, Perry JS, Jakhete NR, et al. An IL-2 paradox: blocking CD25 on T cells induces IL-2-driven activation of CD56bright NK cells. J Immunol 2010; 185: 1311-20.
5. Sheridan JP, Zhan g Y, Riester K, et al. Intermediate-affi nity interleukin-2 receptor expression predicts CD56bright natural killer cell expansion after daclizumab treatment in the CHOICE study of patients with multiple sclerosis. Mult Scler 2011; 17: 1441-48.
6. Bielekova B, Cata lfamo M, Reichert-Scrivner S, et al. Regulatory CD56 bright natural killer cells mediate immunomodulatory Effects of IL-2Ralpha-targeted therapy (daclizumab) in multiple sclerosis. Proc Natl Acad Sci USA 2006; 103: 5941-46.
7. Wuest SC, Edwan J H, Martin JF, et al. A role for interleukin-2 trans-presentation in dendritic cell-mediated T cell activation in humans, as revealed by daclizumab therapy. Nat Med 2011; 17: 604-19.
8. Perry JS, Han S, Xu Q, et al. Inhibition of LTi cell development by CD25 blockade is associated with decreased intrathecal infl ammation in multiple sclerosis. Sci Transl Med 2012; 4: 145ra106.
9. Hao JW, Campagnol o D, Liu RL, et al. Interleukin-2/Interleukin-2 antibody therapy induces target organ natural killer cells that inhibit central nervous system infl ammation. Ann Neurol 2011; 69: 721-34.
10. 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: 381-90.
11. Bielekova B, Ric hert N, Howard T, et al. Humanized anti-CD25 (daclizumab) inhibits disease activity in multiple sclerosis patients failing to respond to interferon beta. Proc Natl Acad Sci USA 2004; 101: 8705-08.
12. Rose JW, Watt HE, White AT, et al. Treatment of multiple sclerosis with an anti-interleukin-2 receptor monoclonal antibody. Ann Neurol 2004; 56: 864-67.
13. Polman CH, Reing old SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria. Ann Neurol 2005; 58: 840-46.
14. Kurtzke JF. Rati ng neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444-52.
15. Hobart J, Lampin g D, Fitzpatrick R, et al. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain 2001; 124: 962-73.
16. EuroQol Group. E uroQol-a new facility for the measurement of health-related quality of life. 2011. http://www.euroqol.org/(accessed Oct 30, 2012).
17. Ware J Jr, Kos inski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-33.
18. Smith SM, De Ste fano N, Jenkinson M, et al. Normalized accurate measurement of longitudinal brain change. J Comput Assist Tomogr 2001; 25: 466-75.
19. Castro-Borrero W, Graves D, Frohman TC, et al. Current and emerging therapies in multiple sclerosis: a systematic review. Ther Adv Neurol Disord 2012; 5: 205-20.
20. Ebers GC, Heigen hauser L, Daumer M, et al. Disability as an outcome in MS clinical trials. Neurology 2008; 71: 624-31.
21. Sormani MP, Bonz ano L, Roccatagliata L, et al. Surrogate endpoints for EDSS worsening in multiple sclerosis. A meta-analytic approach. Neurology 2010; 75: 302-09.
22. Lublin FD. The i ncomplete nature of multiple sclerosis relapse resolution. J Neurol Sci 2007; 256 (suppl 1): S14-18.
23. Phillips JT, Gio vannoni G, Lublin FD, et al. Sustained improvement in Expanded Disability Status Scale as a new effi cacy measure of neurological change in multiple sclerosis: treatment Effects with natalizumab in patients with relapsing multiple sclerosis. Mult Scler 2011; 17: 970-79.
24. Malek TR. The bi ology of interleukin-2. Annu Rev Immunol 2008; 26: 453-79.
25. Kundig TM, Schor le H, Bachmann MF, et al. Immune responses in interleukin-2-defi cient mice. Science 1993; 262: 1059-61.
26. de Goer de Herve MG, Gonzales E, Hendel-Chavez H, et al. CD25 appears non essential for human peripheral T(reg) maintenance in vivo. PloS One 2010; 5: e11784.
27. Rech AJ, Mick R, Martin S, et al. CD25 blockade depletes and selectively reprograms regulatory T cells in concert with immunotherapy in cancer patients. Sci Transl Med 2012; 4: 134ra62.
28. Yu A, Zhu L, Alt man NH, et al. A low interleukin-2 receptor signaling threshold supports the development and homeostasis of T regulatory cells. Immunity 2009; 30: 204-17.
29. Oh U, Blevins G, Griffi th C, et al. Regulatory T cells are reduced during anti-CD25 antibody treatment of multiple sclerosis. Arch Neurol 2009; 66: 471-79.