AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet's Disease in JapanHUMIRA is the First Biologic Approved to Treat Intestinal Behçet's Disease in Japan

• For Print
• May 24, 2013

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• AbbVie GK

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• Eisai Co., Ltd.

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1. HUMIRA® Pre-filled Syringe 40 mg / 0.8 mL product outline (new prescription information underlined)

• 1)
  Indications

  Rheumatoid arthritis (including inhibition of structural damage)

  Patients who have had an inadequate response to conventional therapy for the following diseases:
  Plaque psoriasis and psoriatic arthritis
  Ankylosing spondylitis
  Juvenile idiopathic arthritis with active polyarthritis
  Intestinal Behçet's disease

  Induction and maintenance therapy for moderate to severely active Crohn's disease (restricted to patients who have had an inadequate response to conventional therapy)

• 2)
  Dosage and administration

  Rheumatoid arthritis
  The dose of adalimumab (recombinant) for adult patients is 40 mg administered every other week (eow) as a subcutaneous injection. The dose may be increased to 80 mg administered eow when the effect of treatment with 40 mg eow is insufficient.
  Plaque psoriasis and psoriatic arthritis
  The dose of adalimumab (recombinant) for adult patients is an initial dose of 80 mg followed by 40 mg administered eow starting two weeks after the initial dose, with both dosages administered as a subcutaneous injection. The dose may be increased to 80 mg administered eow when the effect of treatment with 40 mg eow is insufficient.
  Ankylosing spondylitis
  The dose of adalimumab (recombinant) for adult patients is 40 mg administered eow as a subcutaneous injection. The dose may be increased to 80 mg administered eow when the effect of treatment with 40 mg eow is insufficient.
  Juvenile idiopathic arthritis with active polyarthritis
  The dose of adalimumab (recombinant) for patients with juvenile idiopathic arthritis who weigh over 15 kg but less than 30 kg is 20 mg administered eow and for patients weighing 30 kg or more is 40 mg administered eow as a subcutaneous injection.
  Intestinal Behçet's disease
  The dose of adalimumab (recombinant) for adult patients is an initial dose of 160 mg followed by 80 mg administered two weeks later, with both dosages administered as a subcutaneous injection. Four weeks after the initial dose begin 40 mg administered eow as a subcutaneous injection.
  Crohn's disease
  The dose of adalimumab (recombinant) for adult patients is an initial dose of 160 mg followed by 80 mg administered two weeks later, with both dosages administered as a subcutaneous injection. Four weeks after the initial dose begin a maintenance dose of 40 mg administered eow as a subcutaneous injection.

2. Glossary of terms

• 1)
  Intestinal Behçet's disease

  Behçet's disease (BD), a systemic inflammatory disease that is characterized by aphthous stomatitis, skin symptoms, eye symptoms, and genital ulcers, is often associated with episodes of acute inflammation during its chronic course. BD is prevalent in Asia, the Middle East, and the Mediterranean region, but is quite rare in Europe and the United States. The prevalence of BD in Japan is relatively high, and as of end of March 2012, more than 18,000 patients with BD in Japan are covered by the Specified Disease Treatment Research Program. BD develops in males and females in their late 20s to 40s, who are in their most productive years. Although the etiology of BD is still unknown, involvement of specific genetic factors is suspected since the prevalence of HLA-B51, a major histocompatibility complex class I antigen, is high among patients with BD.
  Patients with BD may experience intestinal symptoms such as abdominal pain, abdominal discomfort, and diarrhea, and may have ulcers in the ileocecum, which is located in the right lower abdomen, in addition to the above-mentioned four main clinical findings. BD associated with intestinal signs/symptoms is referred to as intestinal BD. When intestinal ulcers are worsened, intestinal bleeding and perforation may develop and require urgent surgery.

• 2)
  TNF-α

  The tumor necrosis factors (TNFs) are a group of cytokines (i.e., substances mediating cell-cell interactions) mediating intercellular communication that have been found to damage tumor cells. TNF-α is produced by many types of cells, including macrophages, lymphocytes, and vascular endothelial cells, and is known to cause and enhance inflammatory responses and to activate inflammatory cells.

• 3)
  Monoclonal antibody

  A monoclonal antibody is a protein produced from clones of a single antibody-producing cell (called a monoclone). Using the monoclonal antibody technique, manufacturers can obtain a homologous population of antibody molecules identical in amino acid sequence and other characteristics.

3. About HUMIRA®

4. AbbVie's commitment to immunology

5. Eisai's commitment to immunology

6. About AbbVie

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