Alefacept: Its safety profile, off-label uses, and potential as part of combination therapies for psoriasis

Journal of Dermatological Treatment

Volumn 18, Issue 4, 2007, Pages 197-208

  Scheinfeld, Noah ^a  

^a ST LUKE S ROOSEVELT HOSPITAL CENTER   (United States)

Author keywords

Alefacept; Biologic therapy; Combination therapy for psoriasis; Drug safety; Psoriasis

Indexed keywords

ALEFACEPT; AZATHIOPRINE; COAL TAR; CYCLOSPORIN; EMOLLIENT AGENT; ETANERCEPT; ETRETIN; FUMARIC ACID; KERATOLYTIC AGENT; METHOTREXATE; PLACEBO; RETINOID; STEROID; TETANUS TOXOID; TIOGUANINE; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; VITAMIN D;

ABDOMINAL PAIN; ACCIDENTAL INJURY; ALOPECIA AREATA; ARTHRALGIA; ASTHENIA; BIOLOGICAL THERAPY; BLEEDING; BRONCHITIS; CD4 LYMPHOCYTE COUNT; CELLULITIS; CHILL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DIARRHEA; DISEASE SEVERITY; DRUG EFFECT; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; FATIGUE; FLU LIKE SYNDROME; GERIATRIC CARE; GRAFT VERSUS HOST REACTION; HEADACHE; HIGH RISK POPULATION; HIGH RISK PREGNANCY; HUMAN; HYPERTENSION; INFLUENZA; INJECTION SITE PAIN; LICHEN PLANUS; LIPODERMATOSCLEROSIS; LIVER INJURY; MYALGIA; NAUSEA; PHARYNGITIS; PHOTOTHERAPY; PRIORITY JOURNAL; PRURITUS; PSORIASIS; PUSTULOSIS PALMOPLANTARIS; PUVA; RANDOMIZED CONTROLLED TRIAL; REVIEW; RHINITIS; SCLERODERMA; SIDE EFFECT; SINUSITIS; SKIN ALLERGY; UPPER RESPIRATORY TRACT INFECTION; VIRUS INFECTION;

ADOLESCENT; ADULT; ANIMALS; BIOLOGICAL RESPONSE MODIFIERS; CD4 LYMPHOCYTE COUNT; CLINICAL TRIALS; COMBINED MODALITY THERAPY; FEMALE; HUMANS; INFECTION; MALE; NAIL DISEASES; PSORIASIS; RECOMBINANT FUSION PROTEINS; SKIN DISEASES; T-LYMPHOCYTES;

EID: 34547615153     PISSN: 09546634     EISSN: 14711753     Source Type: Journal    
DOI: 10.1080/09546630701247955     Document Type: Review

References (45)

1. Package Insert AMEVIVE® (alefacept). Biogen, Inc. URL: http://www.fda.gov/cder/foi/label/2003/alefbio013003LB.htm (accessed August 1, 2005).
2. Wong VK, Lebwohl M. The use of alefacept in the treatment of psoriasis. Skin Therapy Lett. 2003;8:1-2, 7.
3. Krueger GG, Papp KA, Stough DB, Loven KH, Gulliver WP, 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 plaque psoriasis. J Am Acad Dermatol. 2002;47:821-33.
4. Lowe NJ, Gonzalez J, Bagel J, Caro I, Ellis CN, Menter A. Repeat courses of intravenous alefacept in patients with chronic plaque psoriasis provide consistent safety and efficacy. Int J Dermatol. 2003;42:224-30.
5. 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;139:1563-70.
6. Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J, Griffiths CE; Alefacept Clinical Study Group. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol. 2003;139:719-27.
7. COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms. 5th ed. Rockville, MD: Food and Drug Administration; 1995. Publication FDA/CDER-95/24.
8. Gordon KB, Langley RG. Remittive effects of intramuscular alefacept in psoriasis. J Drugs Dermatol. 2003;2:624-8.
9. Gribetz CH, Blum R, Brady C, Cohen S, Lebwohl M. An extended 16-week course of alefacept in the treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2005;53:73-5.
10. Goffe B, Papp K, Gratton D, Krueger GG. Long-term safety of alefacept in patients who have received up to nine courses of therapy. J Am Acad Dermatol. 2005;52:P190. Abstract P2773.
11. Margolis D, Bilker W, Hennessy S, Vittorio C, Santanna J, Strom BL. The risk of malignancy associated with psoriasis. Arch Dermatol. 2001;137:778-83.
12. Gelfand JM, Berlin J, Van Voorhees A, Margolis DJ. Lymphoma rates are low, but increased in psoriasis patients. Arch Dermatol. 2003;139:1425-9.
13. Krueger GG, Callis KP. Development and use of alefacept to treat psoriasis. J Am Acad Dermatol. 2003;49(2 suppl): S87-97.
14. Gottlieb AB, Casale TB, Frankel E, Goffe B, Lowe N, Ochs HD, et al. CD4+ T-cell-directed antibody responses are maintained in patients with psoriasis receiving alefacept: Results of a randomized study. J Am Acad Dermatol. 2003;49:816-25.
15. Biogen, Inc. Amevive (Alefacept) briefing document. Dermatologic and Ophthalmic Drugs Advisory Committee Meeting. URL: www.fda.gov/ohrms/dockets/ac/ 02/briefing/3865B1_01_Biogen.pdf (accessed May 23, 2002).
16. Menter MA, Cather JC, Abromovits W. Tuberculosis testing and the use of biologic therapies for the treatment of psoriasis. J Am Acad of Dermatol. 2004;50:P176. Poster 687 (abstract).
17. 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 J Dermatol. 2005;152:1048-50.
18. Gottlieb A. Safety and efficacy of alefacept in patients older than 60 years of age and in patients with diabetes. J Am Acad of Dermatol. 2005;52(3), P175. Poster 2716 (abstract).
19. Chamian F, Lowes MA, Lin SL, Lee E, Kikuchi T, Gilleaudeau P, et al. Alefacept reduces infiltrating T cells. Proc Natl Acad Sci U S A. 2005;102:2075-80.
20. Da Silva AJ, Brickelmaier M, Majeau GR, Li Z, Su L, Hsu YM, et al. Alefacept, and immunomodulatory recombinant LFA-3/IgG1 fusion protein, induces CD16 signaling and CD2/CD16 dependent apoptosis of CD2+ cells. J Immunol. 2002;168:4462-71.
21. Haider A, Garder H, Bandaru R, Kikuchi T, Lowes M, Cardinale I, 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).
22. Goffe B, Papp K, Gratton D, Krueger GG, Darif M, Lee S, et al. An integrated analysis of thirteen trials summarizing the long-term safety of alefacept in psoriasis patients who have received up to nine courses of therapy. Clin Ther. 2005;29:1912-21.
23. Scheinfeld N. Alefacept: A safety profile. Expert Opin Drug Saf. 2005;4:975-85.
24. Fivenson DP, Mathes B. Treatment of generalized lichen planus with alefacept. Arch Dermatol. 2006;142:151-2.
25. Heffernan MP, Hurley MY, Martin KS, Smith DI, Anadkat MJ. Alefacept for alopecia areata. Arch Dermatol. 2005;141:1513-16.
26. Shapira MY, Resnick IB, Bitan M, Ackerstein A, Tsirigotis P, Gesundheit B, et al. Rapid response to alefacept given to patients with steroid resistant or steroid dependent acute graft-versus-host disease: A preliminary report. Bone Marrow Transplant. 2005;36:1097-101.
27. Chi GC, Hsu FS, Yang CC, Wei JC. Scleroderma and failed response to alefacept. Rheumatology (Oxford). 2005;44:1328-30.
28. Korver JE, van de Kerkhof PC, Pasch MC. Alefacept treatment of psoriatic nail disease: How severe should nail psoriasis be? J Am Acad Dermatol. 2006;54:742-3.
29. Parrish CA, Sobera JO, Robbins CM, Cantrell WC, Desmond RA, Elewski BE. Alefacept in the treatment of psoriatic nail disease: A proof of concept study. J Drugs Dermatol. 2006;5:339-40.
30. Myers W, Christiansen L, Gottlieb AB. Treatment of palmoplantar psoriasis with intramuscular alefacept. J Am Acad Dermatol. 2005;53(2 suppl 1):S127-9.
31. Sweetser MT, Woodworth J, Swan S, Ticho B. Results of a randomized open-label crossover study of the bioequivalence of subcutaneous versus intramuscular administration of alefacept. Dermatol Online J. 2006;12(3):1.
32. Strober BE. Successful treatment of plaque psoriasis with self-administered subcutaneous alefacept. Arch Dermatol. 2005;141:1602.
33. Goffe B, Papp K, Gratton D, Krueger GG, Darif M, Lee S, et al. An integrated analysis of thirteen trials summarizing the long-term safety of alefacept in psoriasis patients who have received up to nine courses of therapy. Clin Ther. 2005;27:1912-21.
34. Schmidt A, Robbins J, Zic J. Transformed mycosis fungoides developing after treatment with alefacept. J Am Acad Dermatol. 2005;53:355-6.
35. Prasertsuntarasai T, Bello EF. Mycobacterium avium complex olecranon bursitis in a patient treated with alefacept. Mayo Clin Proc. 2005;80:1532-3.
36. Gottlieb AB, Boehncke WH, Darif M. Safety and efficacy of alefacept in elderly patients and other special populations. J Drugs Dermatol. 2005;4:718-24.
37. Nash P. Alefacept plus methotrexate for psoriatic arthritis. Nat Clin Pract Rheumatol. 2006;2:470-1.
38. Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: Results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. ;54:1638-45.
39. Scheinfeld N. Therapy-resistant psoriasis treated with alefacept and subsequent narrow band ultraviolet B phototherapy with total clearing of psoriasis. Dermatol Online J. 2005;11(2):7.
40. Koo JY, Bagel J, Sweetser MT, Ticho BS. Alefacept in combination with ultraviolet B phototherapy for the treatment of chronic plaque psoriasis: Results from an open-label, multicenter study. J Drugs Dermatol. 2006;5:623-8.
41. Ortonne JP, Khemis A, Koo JY, Choi J. An open-label study of alefacept plus ultraviolet B light as combination therapy for chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2005;19:556-63.
42. Krell JM. Use of alefacept and etanercept in 3 patients whose psoriasis failed to respond to etanercept. J Am Acad Dermatol. 2006;54:1099-101.
43. Hodulik SG, Zeichner JA. Combination therapy with acitretin for psoriasis. J Dermatolog Treat. 2006;17:108-11.
44. Bovenschen HJ, Gerritsen WJ, de Jong EM, van de Kerkhof PC. Addition of a topical corticosteroid in the early phase of alefacept treatment for psoriasis. Acta Derm Venereol. 2006;86:281-2.
45. Van Duijnhoven MW, Korver JE, Vissers WH, van Vlijmen-Willems IM, Pasch MC, van Erp PE, et al. Effect of calcipotriol on epidermal cell populations in alefacept-treated psoriatic lesions. J Eur Acad Dermatol Venereol. 2006;20:27-33.