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Raptiva (Efalizumab) - Summary

 



RAPTIVA SUMMARY

RAPTIVA™ (efalizumab) is an immunosuppressive recombinant humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a (1).

RAPTIVA™ (efalizumab) is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.


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NEWS HIGHLIGHTS

Media Articles Related to Raptiva (Efalizumab)

International Psoriasis Council Hosts Second Educational Symposium To Increase Global Knowledge Of Psoriasis
Source: Dermatology News From Medical News Today [2009.11.18]
Beginning Thursday, Nov. 19, 2009, the International Psoriasis Council (IPC) will host its second symposium at Baylor University Medical Center in Dallas. The two-day conference brings together dermatologists from Asia, Eastern Europe and Spain to elevate the global understanding of psoriasis and its treatment. Sessions will be facilitated by leading dermatologists and nurses dedicated to psoriasis management and research.

Psoriatic arthritis common in people with psoriasis (Reuters)
Source: Y! Health Arthritis News [2009.11.05]
Reuters - As many as 14 percent of people with psoriasis may also have psoriatic arthritis, research shows.

EADV: Psoriasis Comorbidities May Cut Longevity (CME/CE)
Source: MedPage Today Dermatology [2009.10.14]
BERLIN (MedPage Today) -- Psoriasis patients have a substantial comorbidity burden that can reduce life expectancy by 10 years or more, according to data presented here.

EADV: Benefit of Methrotrexate in Psoriasis Will Show Up Early (CME/CE)
Source: MedPage Today Dermatology [2009.10.14]
BERLIN (MedPage Today) -- A suboptimal response to methotrexate at 12 weeks identified psoriasis patients who were unlikely to benefit from continued therapy at higher doses, a retrospective analysis of clinical-trial data showed.

EADV: Anti-TNF Exposure Does Not Rule out TNF Inhibitor for Psoriasis (CME/CE)
Source: MedPage Today Dermatology [2009.10.13]
BERLIN (MedPage Today) -- Prior exposure to anti-tumor necrosis factor (TNF) therapy does not rule out potential benefits from additional anti-TNF therapy for patients with psoriasis, according to data presented here.

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Published Studies Related to Raptiva (Efalizumab)

A short cycle of narrow-band UVB phototherapy in the early phase of long-term efalizumab can provide a quicker remission of moderate and severe psoriasis: a pilot study. [2009]
CONCLUSION: This pilot study indicates that the combination with NB-UVB improves the efficacy of efalizumab monotherapy in the treatment of moderate to severe psoriasis. Copyright 2009 S. Karger AG, Basel.

Effect of therapeutic integrin (CD11a) blockade with efalizumab on immune responses to model antigens in humans: results of a randomized, single blind study. [2008.11]
Efalizumab is a humanized monoclonal CD11a antibody approved for treatment of psoriasis. Its immunomodulatory effects led us study how immune responses are modified and the possible consequences for vaccinations in clinical practice... These results expand our knowledge of how immune responses are modulated in humans by CD11a blockade and have implications for vaccinations of patients treated with this agent.

Long-term efficacy of up to 15 months' efalizumab therapy in patients with moderate-to-severe chronic plaque psoriasis. [2008.11]
The efficacy and safety of efalizumab in the treatment of moderate-to-severe chronic psoriasis has been established in studies of up to 3 years' duration. This study aims to describe the efficacy of up to 15 months' treatment with efalizumab and the convenience of therapy in patients with moderate-to-severe chronic plaque psoriasis.

Subcutaneous efalizumab is not effective in the treatment of alopecia areata. [2008.03]
BACKGROUND: Alopecia areata (AA) is a T-cell-mediated autoimmune disease. Efalizumab is a T-cell-targeted therapy approved for the treatment of psoriasis. OBJECTIVE: To assess the efficacy and safety of efalizumab in the treatment of moderate-to-severe AA... CONCLUSION: A 3- to 6-month trial of efalizumab was not effective in promoting hair regrowth in this small cohort of patients with moderate-to-severe AA.

Safety of Efalizumab Therapy in Patients with Moderate to Severe Psoriasis: An Open-Label Extension of a Phase IIIb Trial. [2008]
BACKGROUND: Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombinant, T-cell targeting monoclonal antibody, approved for use in adults with chronic moderate to severe plaque psoriasis. OBJECTIVE: To assess the safety of continued or newly initiated treatment with efalizumab for up to 48 weeks in patients with psoriasis who were treated previously with efalizumab or placebo... CONCLUSIONS: These results support the short-term safety profile demonstrated for efalizumab over a longer-term therapy period of up to 60 weeks.

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Clinical Trials Related to Raptiva (Efalizumab)

Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy [Active, not recruiting]
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva [Terminated]
The purpose of this study is to investigate the efficacy of Raptiva (efalizumab) in the treatment of discoid lupus erythematosus (DLE). Discoid lupus erythematosus is a chronic disorder, which may lead to permanent and progressive loss of hair. Lupus is a condition of chronic inflammation cause by an autoimmune disease. Autoimmune diseases are illnesses which occur when the body's tissues are attacked by its own immune system. The immune system is a complex system within the body that is designed to fight infectious agents, for example, bacteria, and other foreign invaders.

One of the mechanisms that the immune system uses to fight infections is the production of antibodies. Patients with lupus produce abnormal antibodies in their blood that target tissues within their own body rather than foreign infectious agents. Lupus can cause disease of the skin, heart, lungs, kidneys, joints, and nervous system. When only the skin is involved, the condition is called discoid lupus erythematosus (DLE).

Raptiva (efalizumab) is a humanized immunoglobulin(a protein extract from blood which fights off infection-sometimes called "antibody"), which targets the immune cells that are activated in inflammation. Raptiva has been approved for use in the management of psoriasis at doses of 1mg/kg, but is not approved for the treatment of DLE.

A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g [Completed]
This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1. 0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.

Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes [Recruiting]
The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection of islet transplants in type 1 diabetic recipients.

A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis [Completed]
This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1. 0 mg/kg efalizumab in subjects with moderate plaque psoriasis.

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Page last updated: 2009-11-18

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