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Amevive (Alefacept) - Summary

 
 



AMEVIVE SUMMARY

AMEVIVE® (alefacept) is an immunosuppressive dimeric fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fc (hinge, CH 2 and CH 3 domains) portion of human IgG1. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) mammalian cell expression system.

AMEVIVE® is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


See all Amevive indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Amevive (Alefacept)

FDA Panel to Consider New Psoriasis Tx
Source: MedPageToday.com - medical news plus CME for physicians [2014.10.17]
(MedPage Today) -- Secukinumab on the agency's docket next week.

BP Control Poor in Psoriasis Patients
Source: MedPageToday.com - medical news plus CME for physicians [2014.10.17]
(MedPage Today) -- Extensive skin involvement linked with uncontrolled hypertension.

Psoriasis severity linked to high blood pressure risk
Source: Dermatology News From Medical News Today [2014.10.16]
Previous studies have found links between psoriasis and risk of high blood pressure. Now, researchers show that this risk is also influenced by the severity of psoriasis.

Psoriasis Tied to Raised Risk of Uncontrolled Blood Pressure
Source: MedicineNet Low Blood Pressure Specialty [2014.10.16]
Title: Psoriasis Tied to Raised Risk of Uncontrolled Blood Pressure
Category: Health News
Created: 10/15/2014 12:00:00 AM
Last Editorial Review: 10/16/2014 12:00:00 AM

New data reveal two thirds of UK moderate to severe psoriasis patients are failing to reach or maintain effective control of their symptoms
Source: Anxiety / Stress News From Medical News Today [2014.10.14]
New UK data from the PICTURE study released at the European Academy of Dermatology and Venereology (EADV) annual congress in Amsterdam show that two thirds of UK moderate to severe psoriasis...

more news >>

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.

more studies >>

Clinical Trials Related to Amevive (Alefacept)

Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis [Recruiting]
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 plaque psoriasis.

AMEVIVEďż˝ Pregnancy Registry [Recruiting]
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).

Long-Term One Year Use of Alefacept (Ameviveďż˝) in Moderate to Severe Chronic Plaque Type Psoriasis [Recruiting]
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 [Recruiting]
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 proposal is for a multi-center prospective, placebo-controlled, double-blind and randomized, controlled trial to investigate the ability of alefacept to protect residual beta cells in adolescents and young adults with newly diagnosed Type 1 diabetes mellitus from ongoing autoimmune destruction.

Community Based Trial for AMEVIVEŽ [Completed]
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

more trials >>

Reports of Suspected Amevive (Alefacept) Side Effects

OFF Label USE (14)Diabetes Mellitus (8)Kidney Transplant Rejection (7)Death (4)Antibody Test Positive (4)Myocardial Infarction (3)Cardiac Failure Congestive (3)Depression (2)Infectious Peritonitis (2)Cellulitis (2)more >>


Page last updated: 2014-10-17

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