The AWARE study: methodology and baseline characteristics
Robert Bissonnette1, Gordon Searles, Ian Landells
1Innovaderm Research Inc., Montreal, QC. rbissonnette@innovaderm.ca
Background:
Alefacept was the first biologic therapy approved by Health Canada for the treatment of moderate to severe chronic plaque psoriasis and is used either alone or as part of combination therapy.
Objective:
AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational phase IV Canadian study of psoriasis patients treated with alefacept. This study's main goals were to develop a shared, real-time, national clinical database to support best practice and optimize the care of patients receiving alefacept and to gain an understanding of how alefacept is used in Canadian clinical practice. Baseline patient demographic data are described herein.
Methods:
Patients with chronic plaque psoriasis were enrolled from 37 clinics across Canada. Subjects received at least one course of alefacept treatment followed by a period of at least 12 weeks off treatment and were prospectively followed for at least 60 weeks. Baseline assessments included patient demographics, relevant medical history, psoriasis and treatment history, reasons for initiating alefacept, enrolling physician's initial alefacept treatment plan and strategy, percent body surface area (BSA) involvement with psoriasis, and physician's baseline assessment of disease control. Subsequent assessments at each follow-up visit included the patient's response and the physician's assessment.
Results:
A total of 426 adult patients with predominantly chronic plaque psoriasis, with or without other types of psoriasis, were enrolled into the AWARE registry. Patients generally had moderate to severe psoriasis, with more than half (55.8%) having little or no disease control at baseline as assessed by their clinician, and 77% had > 10% BSA involvement with psoriasis. All patients in the AWARE patient population were receiving one or more treatments for psoriasis prior to or at the time of enrolment, and the majority continued to receive concomitant treatments at the time of study enrolment.
Conclusion:
The AWARE registry enrolled a broad group of real-world patients with chronic plaque psoriasis treated with alefacept in clinical practices across Canada.
Insights
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.
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.
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