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The AWARE study: methodology and baseline characteristics.

Robert Bissonnette1, Gordon Searles, Ian Landells

  • 1Innovaderm Research Inc., Montreal, QC. rbissonnette@innovaderm.ca

Journal of Cutaneous Medicine and Surgery
|January 8, 2010
PubMed
Summary
This summary is machine-generated.

The AWARE study tracked 426 Canadian patients with moderate to severe chronic plaque psoriasis treated with alefacept. This real-world evidence provides insights into alefacept"s use and patient outcomes in clinical practice.

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Area of Science:

  • Dermatology
  • Immunology
  • Pharmacology

Background:

  • Alefacept is a Health Canada-approved biologic for moderate to severe chronic plaque psoriasis.
  • It can be used as monotherapy or in combination treatments.

Purpose of the Study:

  • Establish a national clinical database for alefacept use in Canada.
  • Optimize patient care and understand real-world alefacept application.
  • Describe baseline demographic and clinical data of enrolled patients.

Main Methods:

  • Multicenter, observational, phase IV Canadian study (AWARE).
  • Enrolled 426 adult patients with chronic plaque psoriasis from 37 clinics.
  • Prospective follow-up for at least 60 weeks, including off-treatment periods.

Main Results:

  • Patients had moderate to severe psoriasis, with 55.8% reporting little/no disease control at baseline.
  • 77% had over 10% body surface area (BSA) involvement.
  • Most patients received concomitant psoriasis treatments.

Conclusions:

  • The AWARE registry successfully enrolled a diverse group of Canadian patients with chronic plaque psoriasis treated with alefacept.
  • Provides valuable real-world data on alefacept utilization in clinical settings.