Abbott Japan and Eisai Receive Approval for Additional Indications of Humira®, a Fully Human Anti-TNFα Monoclonal Antibody, for the Treatment of Crohn's Disease and Ankylosing Spondylitis

• For Print
• October 29, 2010

Contacts:

• Eisai Co., Ltd.

  Public Relations Department

  +81-(0)3-3817-5120

• Abbott Japan Co., Ltd.

  Public Affairs Department

  +81-(0)3-4588-4602

< Notes to editors >

1. About Humira® pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (Underlined information indicates newly approved indications/dosage and administration)

• 1)
  Indications

  Humira® is indicated for:
  Treatment of the following diseases in patients who have had an inadequate response to conventional therapy:

  Rheumatoid arthritis
  Plaque psoriasis, psoriatic arthritis
  Ankylosing spondylitis

  Induction and maintenance of clinical remission in patients with moderately to severely active Crohn's disease (only in patients who have had an inadequate response to conventional therapy)

• 2)
  Dosage and Administration

  Rheumatoid Arthritis

  The recommended dose of adalimumab (genetical recombination) in adult patients with rheumatoid arthritis is 40 mg administered subcutaneously every other week. The dose may be increased up to 80 mg when effects are insufficient.

  Plaque psoriasis and psoriatic arthritis

  The recommended dose of adalimumab (genetical recombination) in adult patients with plaque psoriasis or psoriatic arthritis is an initial dose of 80 mg administered subcutaneously, followed by 40 mg every other week. The dose may be increased up to 80 mg when effects are insufficient.

  【Ankylosing spondylitis

  The recommended dose of adalimumab (genetical recombination) in adult patients with Anklosing spondylitis is 40 mg administered subcutaneously every other week. The dose may be increased up to 80 mg when effects are insufficient.

  Crohn's disease

  The recommended dose of adalimumab (genetical recombination) in adult patients with Crohns disease is an initial dose of 160 mg administered subcutaneously, followed by 80 mg two weeks later. Beginning four weeks after the initial dose, a dose of 40 mg is administered subcutaneously every other week.

2. Glossary of Terms

• 1)
  Crohn's disease

  Crohn's disease is a chronic autoimmune disease of unknown etiology that is characterized by ulceration and inflammatory lesions most commonly in the small and large intestines. This inflammation is often accompanied by diarrhea and abdominal pain. The Japanese Ministry of Health, Labour, and Welfare has designated Crohn's disease as a “Specified Disease,” a rare and intractable disease for which financial support is provided to those patients afflicted with it. Crohn's disease has become increasingly common over the last 10 years. As of the end of 2008, approximately 29,000 patients were registered as having the disease (data from the Japan Intractable Disease Information Center).

  Crohn's disease is more prevalent among males, with a male/female ratio of 2:1, and a peak age of onset of late teens to early twenties. Crohn's disease is characterized by intestinal stenosis, ileus, intestinal abscesses (collections of pus resulting from infection) and perianal fistulas (ulcers in the intestine that form tunnels to surrounding intestinal wall or skin). When signs and symptoms cannot be controlled with nutrition or drug therapy, patients may require surgical treatment. Since patients with Crohn's disease often experience periods of both flare-ups and remission, long-term treatment is required to prevent recrudescence (recurrence of gastrointestinal inflammation) and recurrence (occurrence of inflammation in a new region) even after achieving remission.

• 2)
  Ankylosing spondylitis

  Ankylosing spondylitis (AS) is a chronic systemic inflammatory disease that manifests first as joint pain and stiffness in the neck, lower back, and hips, and in some cases the hands and feet, followed by fusion and rigidity of affected joints over time. In rare cases, patients may develop severe AS with bony ankylosis or deformation of the spine and other joints. AS typically develops in young individuals, most often men, in their teens and twenties, and progresses slowly over several decades. Although the cause of AS is unknown, it is believed that genetic factors play an important role in the etiology of the disease. The prevalence of AS differs among ethnic groups, and is lower in Japanese (0.0065%) than Caucasians (0.9%).

  The most commonly observed initial signs/symptoms of AS are inflammation of ligaments and tendons at their attachments to bone. Affected joints mainly include those of the spine, back joints, sacroiliac joints, and joints between the trunk and the extremities such as shoulder joints and hip joints. Inflammation of affected ligaments and tendons leads to severe degeneration of tissues. Regeneration of degenerated tissue to normal tissue does not occur, and instead calcification or ossification develops, eventually causing fusion of joint bone tissues and resulting in complete rigidity of the joints (on X-ray, rigid spine in AS is termed “bamboo spine”). It sometimes causes systemic symptoms such as mild fever, general malaise and weight loss in addition to pain, limitation of motility, oppressive pain and exercise pain. Patients with AS may also experience various complications such as uveitis, a disorder of the eye.

  As for the treatment of AS, it is believed that neutralization of TNFα may alleviate inflammation of affected joints, since concentration of TNFα, an inflammatory cytokine, is found at high levels in affected areas such as the sacroiliac joint.

• 3)
  TNFα

  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. TNFα 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.

• 4)
  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 affinity and specificity for the target antigen.

3. About Humira®

4. Eisai's Commitment to Immunology

5. About Abbott

6. Abbott's Commitment to Immunology

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