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Expert Opinion on Drug Safety Volume 4, 2005 - Issue 6
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Review

Alefacept: a safety profile

Noah Scheinfeld St Lukes Hospital, Dept of Dermatology, 1090 Amsterdam Avenue Suite 11D, NYC, NY 10025, USA. [email protected]
Pages 975-985 | Published online: 28 Oct 2005

Bibliography

  • WONG VK, LEBOWHLM: The use of alefacept in the treatment of psoriasis. Skin Therapy Lett. (2003) 8:1-2, 7.
  • KRUEGER GG, PAPP KA, STOUGH DB, LOVEN KH,GULLIVERWP, ELLIS CN: Alefacept Clinical Study Group. A randomized, double-blind, placebo-controlled Phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plague psoriasis. J. Am. Acad. Dermatol (2002) 47:821–833.
  • LOWE NJ, GONZALEZ J, BAGEL J, CARO I, ELLIS CN, MENTER A: Repeat courses of intravenous alefacept in patients with chronic plague psoriasis provide consistent safety and efficacy. Int. J. Dermatol. (2003) 42:224–230.
  • GORDON KB, VAISHNAW AK, O'GORMAN J, HANEY J, MENTER A: Alefacept Clinical Study Group. Treatment of psoriasis with alefacept: correlation of clinical improvement with reductions of memory T-cell counts. Arch. Dermatol (2003) 139:1563–1570.
  • LEBWOHL M, CHRISTOPHERS E, LANGLEY R, ORTONNE JP, ROBERTS J, GRIFFITHS CE: Alefacept Clinical Study Group. An international, randomized, double-blind, placebo-controlled Phase III trial of intramuscular alefacept in patients with chronic plague psoriasis. Arch. Dermatol (2003) 139:719–727.
  • COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms. 5th ed. Rockville, Md: Food and Drug Administration (1995). Publication FDA/CDER–95/24.
  • GORDON KB, LANGLEY RG: Remittive effects of intramuscular alefacept in psoriasis. J. Drugs Dermatol (2003) 2:624–628.
  • GRIBETZ CH, BLUM R, BRADY C, COHEN S, LEBWOHL M: An extended 16-week course of alefacept in the treatment of chronic plague psoriasis. J. Am. Acad. Dermatol (2005) 53:73–75.
  • GOFFE B, PAPP K, GRATTON D, KREGER GG: Long-term safety of alefacept in patients who have received up to nine courses of therapy. J. Am. Acad. Dermatol. (2005) 52:190. Abstract P2773.
  • •Most valuable compilation of data regarding the long-term safety of alefacept.
  • MARGOLIS D, BILKER W, HENNESSY S, VITTORIO C, SANTANNA J, STROM BL: The risk of malignancy associated with psoriasis. Arch. Dermatol (2001) 137:778–783.
  • GEFLAND JM, BERLIN J, VAN VOORHEES A, MARGOLIS DJ: Lymphoma rates are low, but increased in psoriasis patients. Arch. Dermatol (2003) 139:1425–1429.
  • KRUEGER GG, CALLIS KP: Development and use of alefacept to treat psoriasis. J. Am. Acad. Dermatol (2003) 49(2 Suppl.):587–597.
  • •Useful summary of efficacy and side effects of alefacept.
  • GOTTLIEB AB, CASALE TB, FRANKEL E et al.: CD4+ T-cell-directed antibody responses are maintained in patients with psoriasis receiving alefacept: results of a randomized study. I Am. Acad. Dermatol. (2003) 49:816–825.
  • MENTER MA, CATHER JC, ABROMOVITS W: Tuberculosis testing and the use of biological therapies for the treatment of psoriasis. J. Am. Acad. Dermatol (2004) 50:176. Poster 687 (abstract).
  • THACI D, PATZOLD S, KAUFAMAN R, BOEHNCKE H: Treatment of psoriasis with alefacept in patients with hepatitis C infection: a report of two cases. Br. J. Dermatol. (2005) 152:1048–1050.
  • GOTTLIEB A: Safety and Efficacy of alefacept in patients older than 60 years of age and in patients with diabetes. J. Am. Acad. Dermatol (2005) 52:175. Poster 2716 (abstract).
  • CHAIMAN F, LOWES MA, UN SL et al: Alefacept reduces infiltrating T cells. Proc. Nati Acad. Sci. USA (2005) 102:2075–2080.
  • DA SILVIA AJ, BRICKELMAIER M, MAJEAU GR et al.: Alefacept, and immunomodulatory recombinant LFA-3/IgG1 fusion protein, induces CD16 signaling and CD2/CD16 dependent apoptosis of CD2+ cells. Immunol (2002) 168:4462–4471.
  • HAIDER A, GARDER H, BANDARU R et al: Rapid modulation of T cell associated genes after in vivo administration of Alefacept may predict clinical response. J. Invest. Dermatol (2005) 124(S4):A47. Poster 282 (abstract).
  • THACI D, PATZOLD S, KAUFMANN R, BOEHNCKE WH: Treatment of psoriasis with alefacept in patients with hepatitis C infection: a report of two cases. Br. Dermatol (2005) 152:1048–1050.
  • SCHEINFELD N: Therapy-resistant psoriasis treated with alefacept and subsequent narrow band ultraviolet B phototherapy with total clearing of psoriasis. Dermatol Online (2005) 11:7.

Websites

  • http://www.fda.gov/cder/foillabe1/2003/ alefbio013003LB.htm Package Insert AMEVIVE@ (alefacept) Biogen, Inc. (2005).
  • www.fda.goviohrms/dockets/ac/02/ briefing/3865B1_01_Biogen.pdf Biogen, Inc. Amevive (Alefacept) briefing document. Dermatologic and ophthalmic drugs advisory committee meeting (2002). Affiliation

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