• Giuseppe TridenteEmail author


Efalizumab (Raptiva®, Genentec) is an immunosuppressive recombinant humanized IgG1k monoclonal antibody that binds the CD11a component of the lymphocyte function-associated antigen-1 (LFA-1) receptor expressed on all human leukocytes. Approval by FDA was given in 2003, followed by EMEA in 2004, for the treatment of adult patients with chronic moderate to severe plaque psoriasis (Ps), who are candidates for systemic therapy or phototherapy. However, FDA issued a warning in October 2008 after three cases of fatal progressive multifocal leukoencephalopathy (PML) following treatment with efalizumab. In December 2008 Health Canada warned for serious infections, including PML. In February 2009 EMEA recommended the suspension of marketing the product for serious safety concerns, including the occurrence of PML. In April 2009, although efalizumab showed high efficacy in controlling Ps, the producer spontaneously withdrew the product from the US market, and in May 2009 from the EU area [1, 2, 3, 4, 5, 6].


Progressive Multifocal Leukoencephalopathy Necrotizing Fasciitis Aseptic Meningitis Marketing Authorization Progressive Multifocal Leukoencephalopathy 
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  1. 1.
    Efalizumab (Raptiva®) BLA125075 Medical Review, Oct 2003Google Scholar
  2. 2.
    Efalizumab (Raptiva®) EMEA WC500057849 Scientific Discussion, 2004Google Scholar
  3. 3.
    Efalizumab (Raptiva®) Product Information, Genentech, Mar 2009Google Scholar
  4. 4.
    Efalizumab (Raptiva®) Statement of voluntary withdrawal, FDA, Apr 2009Google Scholar
  5. 5.
    Efalizumab (Raptiva®) Voluntary US market withdrawal, Genentec, Apr 2009Google Scholar
  6. 6.
    Efalizumab (Raptiva®) EMEA WC50009129 Withdrawal in EU, Aug 2009Google Scholar
  7. 7.
    Efalizumab (Raptiva®) EMEA WC500057855 Assessment Report, Apr 2008Google Scholar
  8. 8.
    Efalizumab (Raptiva®) EMEA WC500057855 Scientific conclusions, Apr 2009Google Scholar
  9. 9.
    Johnson-Huang LM, Pensabene CA, Shah KR et al (2012) Post-therapeutic relapse of psoriasis after CD11a blockade is associated with T cells and inflammatory myeloid DCs. PLoS ONE 7:e3038CrossRefGoogle Scholar
  10. 10.
    Efalizumab (Raptiva®) Product Information, Genentech, Oct 2003Google Scholar
  11. 11.
    Efalizumab (Raptiva®) Product Information, Genentech, Jun 2005Google Scholar
  12. 12.
    Kothary N, Diak IL, Brinker A et al (2011) Progressive multifocal leukoencephalopathy associated with efalizumab use in psoriasis patients. J Am Acad Dermatol 65:546–551PubMedCrossRefGoogle Scholar
  13. 13.
    Schwab N, Ulzheimer JC, Fox RJ et al (2012) Fatal PML associated with efalizumab therapy. Insights into integrin αLβ2 in JC virus control. Neurology 78:458–467CrossRefGoogle Scholar
  14. 14.
    Morse LG, Yarbrough L, Hogan DJ (2005) Cervical cancer in a woman associated with long-term efalizumab therapy. J Amr Acad Dermatol 53:354–355CrossRefGoogle Scholar
  15. 15.
    Leonardo A, Nascimbeni F, Ballestri S et al (2012) Hepatocellular carcinoma in a patient treated with efalizumab for psoriasis. Hepatol Res 42:945CrossRefGoogle Scholar
  16. 16.
    Penz S, Pelletier F, Riou-Gotta M et al (2012) Sequential therapy in plaque psoriasis using the “Hit and Run” approach: infliximab followed by efalizumab. Int J Dermatol 51:233–237Google Scholar
  17. 17.
    Goddard A, Borovicka JH, West D et al (2011) Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term postmarketing safety surveillance. J Drugs Dermatol 10:80–83PubMedGoogle Scholar

Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

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