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More about Adalimumab

What is/are Adalimumab?

Adalimumab (HUMIRA, AbbVie) is the third TNF inhibitor, after infliximab and etanercept, to be approved in the United States. Like infliximab and etanercept, adalimumab binds to Tumor necrosis factor-alpha (TNFα), preventing it from activating TNF receptors. Adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept is a TNF receptor-IgG fusion protein. TNFα inactivation has proven to be important in downregulating the inflammatory reactions associated with autoimmune diseases. As of 2008 adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Although only approved for ulcerative colitis from late 2012 by the FDA in the disease's management, it has been used for several years in cases that have not responded to conventional treatment at standard dosing for Crohn's Disease.

However, because TNFα is part of the immune system that protects the body from infection, treatment with adalimumab may increase the risk of infections.

HUMIRA ("Human Monoclonal Antibody in Rheumatoid Arthritis") is marketed in both preloaded 0.8 mL syringes and also in preloaded pen devices (called Humira Pen), both injected subcutaneously, typically by the patient at home. It cannot be administered orally because the digestive system would destroy the drug.

Adalimumab was the first fully human monoclonal antibody drug approved by the FDA. It was derived from phage display, and was discovered through a collaboration between BASF Bioresearch Corporation (Worcester, Massachusetts, a unit of BASF) and Cambridge Antibody Technology as D2E7, then further manufactured at BASF Bioresearch Corporation and developed by BASF Knoll (BASF Pharma) and, ultimately, manufactured and marketed by Abbott Laboratories after the acquisition of BASF Pharma by Abbott.

In 2009, HUMIRA had over $5 billion in annual sales., whilst in 2012 the drug reached $4.3 billion of sales in the US alone, achieving $9.3 billion in worldwide sales for that year.

Medical uses

dalimumab, like its TNF inhibitor competitors, infliximab and etanercept, has proven versatile in its effectiveness in treating several conditions.

Rheumatoid arthritis

Adalimumab has been shown to reduce the signs and symptoms of moderate-to-severe rheumatoid arthritis (RA) in adults. It has also been shown to have efficacy in moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older, and is approved for use in the treatment of that condition. In RA it can be used alone or with methotrexate or similar medicines.

Psoriatic arthritis

Adalimumab (HUMIRA, Abbott Laboratories) is a fully human TNF-alpha monoclonal antibody approved for the treatment of rheumatoid arthritis and undergoing trials for use in treating other conditions, including psoriasis and psoriatic arthritis.

Ankylosing spondylitis

Adalimumab has been shown to reduce the signs and symptoms of, and is approved for treatment of, ankylosing spondylitis (AS) in adults.

Crohn’s disease

Adalimumab has been shown to reduce the signs and symptoms of, and is approved for treatment of, moderate to severe Crohn's disease.

Ulcerative colitis

Adalimumab may be effective and well tolerated in Ulcerative colitis. Its efficacy in maintaining clinical remission needs to be confirmed in a randomized controlled trial. It has been approved by the FDA for treatment of moderate-to-severe cases in adults.

Plaque psoriasis

Adalimumab has been shown to treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). Adalimumab has been shown to be effective therapy when used either continuously or intermittently in patients with moderate to severe psoriasis.

Juvenile idiopathic arthritis

Adalimumab has been shown to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children four years of age and older. For patients 15 kg (33 lbs) to 30 kg (66 lbs) administer 20 mg subcutaneously every other week. For patients weighing more than 30 kg (66 lbs) administer 40 mg subcutaneously every other week.

Adverse effects

  •     Fever, night sweats, weight loss, tiredness;
  •     Feeling full after eating only a small amount;
  •     Pain in your upper stomach that may spread to your shoulder;
  •     Easy bruising or bleeding, pale skin, feeling light-headed, rapid heart rate; or
  •     Liver problems--nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using adalimumab and call your doctor at once if you have any of these other serious side effects:

  •     Signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
  •     Shortness of breath with swelling of your ankles or feet;
  •     Confusion, neck stiffness, seizure (convulsions);
  •     Pain or burning when you urinate;
  •     Sudden numbness or weakness, sudden severe headache, problems with vision or balance;
  •     Chest pain, sudden or ongoing cough, wheezing, rapid breathing, coughing up mucus or blood;
  •     Tingly feeling, weakness or prickly feeling in your fingers or toes;
  •     Problems with balance or eye movement, trouble speaking or swallowing;
  •     Severe lower back pain, loss of bladder or bowel control;
  •     Pain, swelling, warmth, or redness in one or both legs;
  •     Red, purple, or scaly skin rash, hair loss, muscle pain, mouth sores;
  •     Joint pain or swelling, swollen glands, muscle aches, unusual thoughts or behavior; or
  •     Patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Other common side effects may include:

  •     Headache;
  •     Stuffy nose, sinus pain;
  •     Mild stomach pain; or
  •     Pain, redness, itching, swelling, or bleeding where you injected the medication.

This article uses material from the Wikipedia article Adalimumab, which is released under the Creative Commons Attribution-Share-Alike License 3.0.

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