Real world evidence on time to relapse of plaque psoriasis after discontinuation of biologic treatment in Poland

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.

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Update on Alefacept Safety

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2009.00032 ◽

2009 ◽

Vol 13 (6_suppl) ◽

pp. S139-S147 ◽

Cited By ~ 6

Author(s):

Denise Wexler ◽

Gordon Searles ◽

Ian Landells ◽

Neil H. Shear ◽

Robert Bissonnette ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Plaque Psoriasis ◽

Safety Data ◽

Study Drug ◽

Chronic Plaque Psoriasis ◽

Serious Adverse Events ◽

Patient Request ◽

Real World Evidence

Background: Alefacept has been demonstrated in clinical trials to be an effective, safe, and well-tolerated treatment strategy when used alone or in combination with other antipsoriatic therapies in patients with chronic plaque psoriasis. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, Canadian phase IV registry evaluating the efficacy and safety of alefacept, alone or in combination with other antipsoriatic therapies, in patients with psoriasis. Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept followed by an off-treatment period, typically lasting 12 or more weeks. Prospective follow-up was at least 60 weeks, depending on when patients presented for retreatment. Safety data collected throughout the study included the incidence of serious adverse events (SAEs), dosing suspensions, and withdrawals owing to adverse events. Results: Twelve SAEs were reported in psoriasis patients treated with at least one course of alefacept, with only one considered to be possibly related to the study drug. Approximately one-quarter of patients missed at least one dose of alefacept during the course of the study. A total of 291 doses of alefacept were missed, representing almost 4% of the total doses administered in this group of patients. Low CD4+ count was the most frequent reason for missed doses; however, no patient had persistently low CD4+ counts requiring permanent discontinuation of alefacept treatment. Seven patients in the AWARE registry discontinued treatment with alefacept, with the most common reason being patient request. Conclusion: The AWARE study supports the safety of alefacept used alone or in combination with other antipsoriatic therapies, in a broad population of real-world chronic plaque psoriasis patients in Canada.

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Real‐world evidence of biologic treatments in moderate–severe psoriasis in Italy: Results of the CANOVA ( EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real‐life clinical practice) study

Dermatologic Therapy ◽

10.1111/dth.15166 ◽

2021 ◽

Author(s):

Delia Colombo ◽

Luca Bianchi ◽

Gabriella Fabbrocini ◽

Salvatore Corrao ◽

Annamaria Offidani ◽

...

Keyword(s):

Clinical Practice ◽

Longitudinal Study ◽

Real World ◽

Plaque Psoriasis ◽

Real Life ◽

Severe Psoriasis ◽

Real World Evidence ◽

Practice Study

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Efficacy Outcomes in Patients Using Alefacept in the AWARE Study

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2009.00030 ◽

2009 ◽

Vol 13 (6_suppl) ◽

pp. S122-S130 ◽

Cited By ~ 2

Author(s):

Ian Landells ◽

Gordon Searles ◽

Robert Bissonnette ◽

Neil H. Shear ◽

Ronald Vender ◽

...

Keyword(s):

Real World ◽

Plaque Psoriasis ◽

Rating Scales ◽

Treatment Modalities ◽

Chronic Plaque Psoriasis ◽

Response Data ◽

Improved Outcomes ◽

Real World Evidence ◽

Interrater Variability

Background: Alefacept has demonstrated efficacy in clinical trials of patients with chronic plaque psoriasis, either as monotherapy or combined with other treatment modalities such as phototherapy. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, phase IV Canadian registry of psoriasis patients treated with alefacept. Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept, either alone or added on to their existing antipsoriatic treatment regimen. Each course of alefacept was followed by a period of at least 12 weeks off treatment. Efficacy outcomes included physicians' and patients' assessments of response at week 18, as well as change in percent body surface area (BSA) involvement with psoriasis. The time to retreatment was assessed in patients receiving a second course of alefacept during at least 60 weeks of prospective follow-up. Results: The majority of patients received alefacept in combination with other antipsoriatic therapies. Physicians' and patients' assessments of response at 18 weeks showed that 42% and 41% of patients, respectively, had a “cleared to marked response” and a further 42% had a “moderate to some response.” Among those patients whose psoriasis was moderately controlled or not controlled at baseline, 49 to 51% and 33 to 36%, respectively, improved to “cleared to marked response” at 18 weeks. A substantial shift in percent BSA involvement with psoriasis was observed at 18 weeks, with 55% of patients having a BSA involvement of < 10% at week 18 compared to only 20% having this level of BSA involvement at baseline. The mean time to retreatment among the 60% of patients who received a second course of alefacept was 19.3 weeks (range 2–47 weeks). Conclusion: A single course of alefacept therapy improved outcomes in this broad population of real-world chronic plaque psoriasis patients. Study Limitations: The limitations of this study include its nonrandomized, noncontrolled, noncomparative design, which allowed multiple different treatment approaches across all patients. The rating scales used in this study have not been previously validated, and ranges were assigned to baseline control and response data that are not specifically defined. Clinicians did not receive specific training in using these scales; therefore, interrater variability could not be assessed.

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