OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Alefacept – Amevive®

DRUG CLASS

Dermatologic Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

ANNOTATED BIBLIOGRAPHY

References updated: 15 September 2021

• Reuben A. Hepatotoxicity of immunosuppressive drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2011, pp. 569-91.

  (Review of hepatotoxicity of immunosuppressive agents mentions that "the biological immunosuppressants are largely free from hepatotoxicity, with the exception of the TNF alpha antagonists").
• Krensky AM, Azzi JR, Hafler DA. Immunosuppressants and tolerogens. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 637-53.

  (Textbook of pharmacology and therapeutics).
• Ellis CN, Krueger GG., Alefacept Clinical Study Group. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med. 2001;345:248–55. [PubMed: 11474662]

  (Among 229 patients with psoriasis treated with various doses of intravenous alefacept or placebo weekly for 12 weeks, clinical responses occurred in 38-53% of alefacept vs 21% of placebo recipients, adverse events were generally mild and "laboratory tests showed no significant changes in serum chemical... values in any study groups").
• 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. [PubMed: 12451365]

  (Abstract; among 553 patients with chronic plaque psoriasis treated with two 12 week courses of one weekly alefacept or placebo, clinical responses occurred in 28% of alefacept vs 8% of placebo treated subjects and side effects were mild; no mention of ALT elevations or hepatotoxicity).
• Ortonne JP. Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2003;17 Suppl 2:12–6. [PubMed: 12795770]

  (Among 507 patients with psoriasis treated with 10 or 15 mg per week of alefacept or placebo for 12 weeks, clinical responses occurred in 12% and 21% of alefacept vs 5% of placebo recipients, and "minor elevations in serum aminotransferase levels were noted in all 3 groups", but there were no hepatic severe adverse events).
• Alefacept (Amevive) for treatment of psoriasis. Med Lett Drugs Ther. 2003;45(1154):31–2. [PubMed: 12717339]

  (Concise summary of the mechanism of action, efficacy, safety and cost of alefacept shortly after its approval for use in psoriasis in the US, does not mention ALT elevations or liver injury as side effects).
• Goffe B, Papp K, Gratton D, Krueger GG, Darif M, Lee S, Bozic C, 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. [PubMed: 16507377]

  (In a pooled analysis of adverse events from 13 controlled trials of alefacept which enrolled 1869 patients with psoriasis, common side effects were headache and nasopharyngitis and pruritus, but were rarely severe or required discontinuation and there were "no clinically relevant trends with respect to changes from baseline in laboratory parameters"; no mention of ALT elevations or hepatotoxicity).
• Scheinfeld N. Alefacept: a safety profile. Expert Opin Drug Saf. 2005;4:975–85. [PubMed: 16255657]

  (Review of clinical trials of alefacept mentions that ALT elevations have occurred on treatment "but do not appear to be clinically significant" and that cases of hepatitis with jaundice have been reported; in clinical trials in more than 2000 patients, there have been no cases of exacerbation of hepatitis B or C).
• Thaçi D, Pätzold 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. [PubMed: 15888169]

  (Two men, ages 29 and 63 years, with chronic hepatitis C and psoriasis were treated with weekly injections of alefacept for 12 weeks and had no worsening in serum ALT or HCV RNA levels or other adverse reaction).
• 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. 2006;54:1638–45. [PubMed: 16646026]

  (Among 146 patients with psoriatic arthritis and normal liver tests in a 12 week controlled trial, 1 of 93 treated with alefacept and methotrexate vs 1 of 59 on methotrexate alone developed ALT elevations above 3 times ULN, but both patients recovered without intervention or stopping therapy).
• Perlmutter A, Cather J, Franks B, Jaracz E, Menter A. Alefacept revisited: Our 3-year clinical experience in 200 patients with chronic plaque psoriasis. J Am Acad Dermatol. 2008;58:116–24. [PubMed: 17997502]

  (Analysis of 201 patients with psoriasis treated with alefacept in a total of 296 courses, therapy was stopped early in one patient who was also on methotrexate because of serum enzyme elevations, but no details provided).
• Castelo-Soccio L, Van Voorhees AS. Long-term efficacy of biologics in dermatology. Dermatol Ther. 2009;22:22–33. [PMC free article: PMC2880851] [PubMed: 19222514]

  (Review of long term efficacy of various biologics used to treat psoriasis, including alefacept and the anti-tumor necrosis factor agents; no discussion of hepatotoxicity).
• Mease PJ, Reich K., Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009;60:402–11. [PubMed: 19028407]

  (Among 160 patients who enrolled in an extension phase study of alefacept for psoriatic arthritis, increased AST levels [1-3 times ULN] occurred in 30% of patients, but were above 3 times ULN in only 2% during the open-label extension phase).
• Ahn CS, Gustafson CJ, Sandoval LF, Davis SA, Feldman SR. Cost effectiveness of biologic therapies for plaque psoriasis. Am J Clin Dermatol. 2013;14:315–26. [PubMed: 23696234]

  (In a systematic review and assessment of five biologic agents approved for use in the therapy of psoriasis [adalimumab, etanercept, infliximab, ustekinumab, and alefacept], alefacept was found to be the least cost effective).
• Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al. United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology. 2015;148:1340–1352. [PMC free article: PMC4446235] [PubMed: 25754159]

  (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, no cases were attributed to alefacept).
• Rønholt K, Iversen L. Old and new biological therapies for psoriasis. Int J Mol Sci. 2017;18:2297. [PMC free article: PMC5713267] [PubMed: 29104241]

  (Review of biologics used to treat psoriasis; alefacept was the first biologic approved for use in psoriasis in the US, but was withdrawn because of relative lack of efficacy compared to other biologics).