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Induction and Clinical Scoring of Chronic-Relapsing Experimental Autoimmune Encephalomyelitis
26:48

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Published on: July 4, 2007

Progressive multifocal leukoencephalopathy associated with efalizumab use in psoriasis patients

Namita Kothary1, Ida-Lina Diak1, Allen Brinker1

  • 1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.

Journal of the American Academy of Dermatology
|April 26, 2011
PubMed
Abstract

Insights

Prolonged efalizumab therapy for psoriasis increased the risk of progressive multifocal leukoencephalopathy (PML), a fatal brain disease. Efalizumab was withdrawn from the market due to these PML risks.

Area of Science:

  • Neuroimmunology
  • Demyelinating Diseases
  • Pharmacovigilance

Background:

  • Progressive multifocal leukoencephalopathy (PML) is a rare, fatal demyelinating disease primarily affecting immunocompromised individuals.
  • Efalizumab (Raptiva), a biologic agent for psoriasis, was associated with PML reports.
  • Efalizumab was voluntarily withdrawn from the US market in July 2009 due to PML risks.

Observation:

  • The study analyzed post-marketing reports of PML in patients treated with biologic agents for psoriasis.
  • Twelve cases suggestive of PML were identified across several biologic agents.
  • Efalizumab was the only agent with confirmed PML cases in psoriasis patients.

Findings:

  • All PML cases in efalizumab-treated psoriasis patients occurred after 3 years of treatment and were fatal.
  • PML cases in patients treated with other agents (adalimumab, etanercept, infliximab) were for non-psoriasis conditions and confounded by other immunosuppressants or unconfirmed.
  • Data limitations include underreporting and variable quality in spontaneous adverse event reports.

Implications:

  • Prolonged efalizumab therapy appears to be a risk factor for developing PML.
  • The specific duration of efalizumab treatment that poses a risk for PML remains undefined.
  • These findings underscore the importance of pharmacovigilance for biologic therapies and potential risks in immunocompromised patients.

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