Media Articles Related to Amevive (Alefacept)
FDA Panel Backs Approval of Psoriasis Drug Brodalumab
Source: Medscape Allergy & Clinical Immunology Headlines [2016.07.20]
The panelists said that patients should be given proper informed consent about the risk for suicide.
Medscape Medical News
FDA Panel Backs Psoriasis Drug With Caveats
Source: MedPage Today Dermatology [2016.07.20]
(MedPage Today) -- Says suicide risk means brodalumab needs careful management
Valeant Psoriasis Drug's Suicide Risk Hard to Assess -FDA Staff
Source: Medscape Dermatology Headlines [2016.07.18]
Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday.
Reuters Health Information
Suicide Risk Jeopardizes Promising New Psoriasis Drug
Source: MedPage Today Dermatology [2016.07.16]
(MedPage Today) -- Six completed suicides among brodalumab trial participants
Psoriasis Rashes, Symptoms, Treatments
Source: MedicineNet Psoriasis Specialty [2016.07.15]
Title: Psoriasis Rashes, Symptoms, Treatments
Created: 8/17/2012 12:00:00 AM
Last Editorial Review: 7/15/2016 12:00:00 AM
Published Studies Related to Amevive (Alefacept)
Patterns of combination therapy with alefacept for the treatment of psoriasis in Canada in the AWARE study. [2009.12]
BACKGROUND: Evidence from clinical trials supports the use of alefacept for the treatment of patients with chronic plaque psoriasis, either as monotherapy or combined with other treatment modalities. OBJECTIVE: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, phase IV Canadian registry of psoriasis patients treated with alefacept... CONCLUSION: Alefacept is commonly added to other antipsoriatic therapies in a broad population of real-world chronic plaque psoriasis patients in Canada and may allow for dosage reduction or discontinuation of concomitant systemic agents or phototherapy.
Efficacy outcomes in patients using alefacept in the AWARE study. [2009.12]
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... 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.
Alefacept for severe alopecia areata: a randomized, double-blind, placebo-controlled study. [2009.11]
OBJECTIVE: To assess the efficacy of alefacept for the treatment of severe alopecia areata (AA)...
Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. [2009.03]
BACKGROUND: A single course of alefacept intramuscularly in combination with methotrexate (MTX) was effective in treating both psoriasis and psoriatic arthritis (PsA). OBJECTIVE: We sought to determine the efficacy and safety of an additional course of alefacept intramuscularly in combination with MTX in patients with PsA... CONCLUSIONS: Patients with psoriasis and PsA on stable doses of MTX derive benefit for both conditions from one or more courses of alefacept, with further benefit in PsA apparent after a second course of treatment. No additional toxicity was observed.
Narrowband UV-B phototherapy, alefacept, and clearance of psoriasis. [2007.08]
OBJECTIVE: To determine whether the addition of 311-nm narrowband UV-B (NB UV-B) phototherapy accelerates and improves the therapeutic efficacy of alefacept, a biological antipsoriatic drug approved for the treatment of moderate to severe psoriasis... CONCLUSIONS: In this randomized half-side comparison of alefacept with and without phototherapy for psoriasis, alefacept with NB UV-B phototherapy accelerated and improved the clearance of psoriasis. This suggests a promising future for this combination as antipsoriatic therapy.
Clinical Trials Related to Amevive (Alefacept)
AMEVIVEďż˝ Pregnancy Registry [Terminated]
This is an observational, exposure-registration and follow-up study, to be conducted in the
United States (US). The AMEVIVEŽ Pregnancy Exposure Registry is designed to monitor
pregnant subjects and fetuses exposed to AMEVIVEŽ in order to detect any potential increase
in the risk of major birth defects.
The AMEVIVEŽ Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development
and will be managed by INC Research. The Registry will be monitored by an independent
Advisory Committee of external experts in relevant specialties of teratology, epidemiology,
maternal and fetal medicine, and infectious disease medicine (external member details
available upon request).
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis [Terminated]
The study is a prospective, multi-centre, observational study designed to assess the
long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic
Long-Term One Year Use of Alefacept (Ameviveďż˝) in Moderate to Severe Chronic Plaque Type Psoriasis [Completed]
The purpose of this research study is to see how well the medication Alefacept (AmeviveŽ)
works for continuous treatment of chronic plaque psoriasis. The US Food and Drug
Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg
weekly injection for 12 weeks followed by 12 weeks off treatment.
Inducing Remission in Type 1 Diabetes With Alefacept [Completed]
The purpose of this trial is to test whether a drug called alefacept will slow or halt
destruction of the beta cells in the pancreas. If the destruction of the beta cells is
stopped, the patients might be able to produce insulin on their own longer, which could
stop or slow the progression of their type 1 diabetes.
This is a multi-center prospective, placebo-controlled, double-blind and randomized trial
to investigate the ability of alefacept to protect residual beta cells from ongoing
autoimmune destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes
A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers [Completed]
Reports of Suspected Amevive (Alefacept) Side Effects
OFF Label USE (14),
Diabetes Mellitus (8),
Kidney Transplant Rejection (7),
Antibody Test Positive (4),
Myocardial Infarction (3),
Cardiac Failure Congestive (3),
Infectious Peritonitis (2),
Cellulitis (2), more >>