Humanized anti-CD2 monoclonal antibody treatment of plaque psoriasis: Efficacy and pharmacodynamic results of two randomized, double-blind, placebo-controlled studies of intravenous and subcutaneous siplizumab

Archives of Dermatological Research

Volumn 301, Issue 6, 2009, Pages 429-442

  Bissonnette, Robert ^a   Langley, Richard G ^b   Papp, Kim ^c   Matheson, Robert ^d   Toth, Darryl ^e   Hultquist, Micki ^f   Geba, Gregory P ^f   White, Barbara ^f  

^a INNOVADERM RESEARCH   (Canada)

^b DALHOUSIE UNIVERSITY   (Canada)

^c PROBITY MEDICAL RESEARCH   (Canada)

^d OREGON MEDICAL RESEARCH CENTER   (United States)

^e MedImmune LLC ^*  (Canada)

^f MEDIMMUNE   (United States)

Author keywords

Biological therapies; CD2 antigen; Psoriasis; T cells

Indexed keywords

CD14 ANTIGEN; CD16 ANTIGEN; CD19 ANTIGEN; CD2 ANTIGEN; CD3 ANTIGEN; CD45RA ANTIGEN; CD45RO ANTIGEN; CD56 ANTIGEN; CYTOKERATIN 16; INTERCELLULAR ADHESION MOLECULE 1; PLACEBO; SIPLIZUMAB;

ADULT; ARTICLE; BODY SURFACE; CD8+ T LYMPHOCYTE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG EFFICACY; DRUG WITHDRAWAL; EPIDERMIS; FEMALE; HEADACHE; HUMAN; HUMAN TISSUE; LYMPHOCYTE COUNT; LYMPHOCYTE SUBPOPULATION; LYMPHOCYTIC INFILTRATION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPPORTUNISTIC INFECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; PSORIASIS VULGARIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT RESPONSE;

ADULT; ANTIBODIES, MONOCLONAL; ANTIGENS, CD2; CELL MOVEMENT; DISEASE PROGRESSION; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; INTERCELLULAR ADHESION MOLECULE-1; KERATIN-16; LYMPHOCYTE ACTIVATION; MALE; MIDDLE AGED; PLACEBO EFFECT; PSORIASIS; RECOMBINANT FUSION PROTEINS; SEVERITY OF ILLNESS INDEX; SKIN; T-LYMPHOCYTES;

EID: 68149165153     PISSN: 03403696     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00403-009-0961-7     Document Type: Article

References (23)

1. BE Bierer WC Hahn 1993 T cell adhesion, avidity regulation and signaling: a molecular analysis of CD2 Semin Immunol 5 249 261 10.1006/smim.1993.1029
2. L Branco P Barren SY Mao D Pfarr R Kaplan C Postema S Langermann S Koenig S Johnson 1999 Selective deletion of antigen-specific, activated T cells by a humanized MAB to CD2 (MEDI-507) is mediated by NK cells Transplantation 68 1588 1596 10.1097/00007890-199911270-00026
3. CN Ellis GG Krueger Alefacept Clinical Study Group 2001 Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes N Engl J Med 345 248 255 10.1056/NEJM200107263450403
4. CN Ellis JN Barker AE Haig CA Parker S Daly DA Jayawardene Avandia Psoriasis Study Group 2007 Placebo response in two long-term randomized psoriasis studies that were negative for rosiglitazone Am J Clin Dermatol 8 93 102 10.2165/00128071-200708020-00005 (Pubitemid 46998552)
5. R Gniadecki MJ Calverley 2002 Emerging drugs in psoriasis Expert Opin Emerg Drugs 7 69 90 10.1517/14728214.7.1.69
6. KB Gordon RG Langley C Leonardi D Toth MA Menter S Kang M Heffernan B Miller R Hamlin L Lim J Zhong R Hoffman MM Okun 2006 Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study J Am Acad Dermatol 55 598 606 10.1016/j.jaad.2006.05.027
7. J Koo 1996 Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment Dermatol Clin 14 485 496 10.1016/S0733-8635(05)70376-4
8. GG Krueger KA Papp DB Stough KH Loven WP Gulliver CN Ellis Alefacept Clinical Study Group 2002 A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis J Am Acad Dermatol 47 821 833 10.1067/mjd.2002.127247
9. GG Krueger RG Langley C Leonardi N Yeilding C Guzzo Y Wang LT Dooley M Lebwohl CNTO 1275 Psoriasis Study Group 2007 A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis N Engl J Med 356 580 592 10.1056/NEJMoa062382
10. JG Krueger 2002 The immunologic basis for the treatment of psoriasis with new biologic agents J Am Acad Dermatol 46 1 23 10.1067/mjd.2002.120568
11. M Lebwohl E Christophers R Langley JP Ortonne J Roberts CE Griffiths Alefacept Clinical Study Group 2003 An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis Arch Dermatol 139 719 727 10.1001/archderm.139.6.719
12. A Menter A Gottlieb SR Feldman AS Van Voorhees CL Leonardi KB Gordon M Lebwohl JY Koo CA Elmets NJ Korman KR Beutner R Bhushan 2008 Guidelines of care for the management of psoriasis and psoriatic arthritis: Sect. 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics J Am Acad Dermatol 58 826 850 10.1016/j.jaad.2008.02.039
13. A Nast 2007 German evidence-based guidelines for the treatment of psoriasis vulgaris (short version) Arch Dermatol Res 299 111 138 10.1007/s00403-007-0744-y
14. K Papp 2001 The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody J Am Acad Dermatol 45 665 674 10.1067/mjd.2001.117850
15. KA Papp 2006 The long-term efficacy and safety of new biological therapies for psoriasis Arch Dermatol Res 298 7 15 10.1007/s00403-006-0660-6
16. K Reich FO Nestle K Papp JP Ortonne R Evans C Guzzo S Li LT Dooley CE Griffiths EXPRESS study investigators 2005 Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial Lancet 366 1367 1374 10.1016/S0140-6736(05)67566-6
17. MP Schon WH Boehncke 2005 Psoriasis N Engl J Med 352 1899 1912 10.1056/NEJMra041320
18. CH Smith AV Anstey JN Barker AD Burden RJ Chalmers D Chandler AY Finlay CE Griffiths K Jackson NJ McHugh KE McKenna NJ Reynolds AD Ormerod British Association of Dermatologists 2005 British association of dermatologists guidelines for use of biological interventions in psoriasis 2005 Br J Dermatol 153 486 497 10.1111/j.1365-2133.2005.06893.x
19. Spuls PI, Witkamp L, Bossuyt PM, Bos JD (2004) The course of chronic plaque-type psoriasis in placebo groups of randomized controlled studies. Arch Dermatol 140:338-344 (discussion 344). doi: 10.1001/archderm.140.3.338 (Pubitemid 38337406)
20. W Sterry 2004 Biological therapies in the systemic management of psoriasis: International consensus conference Br J Dermatol 151 3 17 10.1111/j.1365-2133.2004.06070.x (Pubitemid 39215184)
21. VD Thomas FC Yang JC Kvedar 2005 Biologics in psoriasis: a quick reference guide J Am Acad Dermatol 53 346 351 10.1016/j.jaad.2005.04.011
22. DC Torti SR Feldman 2007 Interleukin-12, interleukin-23, and psoriasis: current prospects J Am Acad Dermatol 57 1059 1068 10.1016/j.jaad.2007.07.016
23. GA Vena N Cassano 2006 Emerging drugs for psoriasis Expert Opin Emerg Drugs 11 567 596 10.1517/14728214.11.4.567