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Humira (Adalimumab) - Summary

 

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BOXED WARNING

RISK OF INFECTIONS

TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS RECEIVING HUMIRA. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH LATENT TUBERCULOSIS INFECTION REDUCES THE RISK OF REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH HUMIRA. HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS RECEIVING HUMIRA WHOSE SCREENING FOR LATENT TUBERCULOSIS INFECTION WAS NEGATIVE.

PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION WITH A TUBERCULIN SKIN TEST. TREATMENT OF LATENT TUBERCULOSIS INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH HUMIRA. PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING HUMIRA FOR SIGNS AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE TUBERCULIN SKIN TEST NEGATIVE

 

HUMIRA SUMMARY

HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). HUMIRA was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1: [kgr ] constant regions. HUMIRA is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.

HUMIRA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. HUMIRA can be used alone or in combination with MTX or other DMARDs.

HUMIRA NEWS HIGHLIGHTS

Media Articles Related to Humira (Adalimumab)

Adalimumab (Humira) Demonstrates Biologic Efficacy in Juvenile RA
Source: MedPage Today Rheumatology [2008.08.20]

Humira Approved for Children's Arthritis
Source: MedicineNet adalimumab Specialty [2008.02.25]

Humira receives FDA approval for psoriatic arthritis
Source: The Doctors Lounge - Rheumatology

Adalimumab plus methotrexate effective for rheumatoid arthritis
Source: The Doctors Lounge - Rheumatology

Study Examines How Rheumatoid Arthritis Destroys Bone
Source: MedicineNet Arthritis Specialty [2008.08.25]

more>>

Published Studies Related to Humira (Adalimumab)

Efficacy of adalimumab in the treatment of axial spondylarthritis without radiographically defined sacroiliitis: results of a twelve-week randomized, double-blind, placebo-controlled trial followed by an open-label extension up to week fifty-two. [2008.07]

Adalimumab reduces pain, fatigue, and stiffness in patients with ankylosing spondylitis: results from the adalimumab trial evaluating long-term safety and efficacy for ankylosing spondylitis (ATLAS). [2008.07]

Adalimumab Reduces Pain, Fatigue, and Stiffness in Patients with Ankylosing Spondylitis: Results from the Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis (ATLAS). [2008.05.15]

Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis. [2008.03]

Relative efficiencies of physician/assessor global estimates and patient questionnaire measures are similar to or greater than joint counts to distinguish adalimumab from control treatments in rheumatoid arthritis clinical trials. [2008.02]

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Clinical Trials Related to Humira (Adalimumab)

Humira in Rheumatoid Arthritis - Do Bone Erosions Heal? [Completed]

A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis [Active, not recruiting]

Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis [Completed]

Trial of Adalimumab in Progressive Sarcoidosis [Terminated]

Adalimumab in Adult Japanese Subjects With Psoriasis [Active, not recruiting]

more>>

Page last updated: 2008-08-25

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