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Raptiva (Efalizumab) - 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.

See all Raptiva indications & dosage >>


Media Articles Related to Raptiva (Efalizumab)

CHMP Backs Secukinumab, Apremilast for Psoriasis
Source: Medscape Medical News Headlines [2014.11.21]
The European Medicines Agency committee has recommended secukinumab and apremilast for moderate to severe plaque psoriasis and apremilast for active psoriatic arthritis.
International Approvals

Positive results from second pivotal Phase 3 study of Brodalumab in patients with moderate-to-severe plaque psoriasis announced
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.11.13]
Amgen and AstraZeneca has announced that AMAGINE-3(TM), a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis...

Brodalumab Beats Stelara in Psoriasis Trial, Sponsors Say
Source: MedPage Today Dermatology [2014.11.11]
(MedPage Today) -- More patients achieve total plaque clearance in topline results.

New research reveals true impact of psoriasis
Source: Dermatology News From Medical News Today [2014.11.03]
Innovative research published in the latest edition of the British Journal of Dermatology reveals the causes behind the emotional distress experienced by people with psoriasis.

Lesion-healing mechanism identified in psoriasis
Source: Dermatology News From Medical News Today [2014.10.29]
A UC Irvine-led study has revealed the underlying genetic factors that help repair skin lesions caused by psoriasis, which could engender new methods of controlling the lingering condition.Dr.

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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.

Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells [Not yet recruiting]
The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.

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.

Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis [Not yet recruiting]
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.

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.

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Reports of Suspected Raptiva (Efalizumab) Side Effects

Lymphadenopathy (2)Squamous Cell Carcinoma (2)Lymphocyte Count Increased (1)Polyneuropathy (1)Skin Discolouration (1)Upper Respiratory Tract Infection (1)Oedema Peripheral (1)Hearing Impaired (1)Depression (1)Acute Myocardial Infarction (1)more >>

Page last updated: 2014-11-21

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