Adalimumab

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[edit] BRAND NAMES

[edit] STRUCTURE

Adalimumab.jpg

[edit] MECHANISM OF ACTION

Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Adalimumab has been designed to attach to a chemical messenger in the body called tumor necrosis factor-α (TNF-α).

Adalimumab binds specifically to TNF-α and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF-α receptors. TNF-α is involved in causing inflammation. By blocking TNF-α, adalimumab reduces the inflammation and other symptoms of many diseases

[edit] INDICATIONS

  • Rheumatoid Arthritis: Treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDS) including methotrexate has been inadequate. To ensure maximum efficacy, Adalimumab is given in combination with methotrexate. Adalimumab can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate
  • Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 4 years of age and older who have not responded adequately to DMARDs. Adalimumab can be used alone or in combination with methotrexate
  • Psoriatic Arthritis (PsA): Adult patients with active PsA who have not responded adequately to other treatments;
  • Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
  • Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in ADULT patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
    In europe it is also indicated the treatment of severe active Crohn's disease in PEDIATRIC patients (6 to 17 years of age) who have had an inadequate response to conventional therapy
  • Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers.
  • Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who have not responded to other systemic therapy.

[edit] DOSAGE

Adalimumab is administered by subcutaneous injection

  • Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.
  • Juvenile Idiopathic Arthritis:
    • 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
    • ≥ 30 kg (66 lbs): 40 mg every other week
  • Crohn's Disease and Ulcerative Colitis:
    • Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
    • Second dose two weeks later (Day 15): 80 mg
    • Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.
      For patients with Ulcerative Colitis only: Only continue Adalimumab in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.
  • Plaque Psoriasis:
    • 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

[edit] CONTRAINDICATIONS

  • Adalimumab must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure

[edit] WARNINGS AND PRECAUTIONS

  • Serious infections: Patients taking TNF-antagonists are more susceptible to serious infections. Do not start Adalimumab during an active infection. If an infection develops, monitor carefully, and stop Adalimumab if infection becomes serious
  • Invasive fungal infections: For patients who develop a systemic illness on Adalimumab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic
  • Malignancies: Incidence of malignancies was greater in Adalimumab treated patients than in controls
  • Anaphylaxis or serious allergic reactions may occur
  • Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Adalimumab and begin anti-viral therapy
  • Demyelinating disease: Adalimumab has been associated in rare instances with exacerbation or new onset, of demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
  • Haematologic reactions (Cytopenias, pancytopenia): Advise patients to seek immediate medical attention if symptoms develop, and consider stopping Adalimumab
  • Heart failure: Worsening or new onset, may occur
  • Lupus-like syndrome: Stop Adalimumab if syndrome develops

[edit] INTERACTIONS

  • Abatacept: Increased risk of serious infection
  • Anakinra: Increased risk of serious infection
  • Live vaccines: Avoid use with Adalimumab

[edit] PREGNANCY AND LACTATION

[edit] SIDE EFFECTS

The most common side effects with Adalimumab (seen in more than 1 patient in 10) were respiratory tract infections (infections of the lungs and airways), leucopenia (low white blood cell counts), anemia, increased blood levels of lipids, headache, abdominal pain, nausea and vomiting, rash, musculoskeletal pain, injection site reactions (including redness) and increased levels of liver enzymes

[edit] RELATED LINKS

Novel Treatments for Rheumatoid Arthritis

[edit] BIBLIOGRAPHY

[edit] REFERENCES