AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe 40 mg / 0.8 mL, a Fully Human Monoclonal Anti-TNF-α Antibody Formulation, Has Received Approval for the Treatment of Moderate to Severe Ulcerative Colitis (UC) in JapanHUMIRA Becomes the First and Only Self-Injectable Biologic Therapy for the Treatment of Moderate to Severe UC

• For Print
• June 14, 2013

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[ Notes to editors ]

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)
  • Treatment of moderate to severe ulcerative colitis (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 40 mg administered eow as a subcutaneous injection.
  Ulcerative colitis
  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.

2. Glossary of terms

• 1)
  Ulcerative colitis (UC)

  UC is a chronic inflammatory bowel disease that causes inflammation in the rectum and colon, resulting in frequent diarrhea, rectal bleeding and abdominal cramping. The symptoms of UC tend to come and go, with varying periods of clinical stability. The number of patients with UC in Japan (patients receiving treatment for UC under the Specified Disease Treatment Research Program) amounts to more than 130,000 and this figure increases every year by approximately 8,000 cases¹.

• 2)
  TNF-α

  The tumor necrosis factors (TNFs) are a group of cytokines 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 characteristicss.

3. About HUMIRA®

4. AbbVie's commitment to immunology

5. Eisai's commitment to immunology

6. About AbbVie

• Full text