Humira is a fully human monoclonal antibody that inhibits TNFα. Together with infliximab and etanercept, it forms the drug class of the "biologicals" for the treatment of moderate to severe rheumatoid arthritis. Humira's manufacturer is Abbott Laboratories. Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. ... In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... Infliximab (Remicade®) is a powerful drug used to treat auto-immune disorders like Crohns disease and rheumatoid arthritis. ... Etanercept (Enbrel®, co-marketed by Amgen and Wyeth) is a recombinant human soluble tumor necrosis factor-alpha (TNFα) receptor. ... Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints. ... Abbott Laboratories (NYSE: ABT) is a pharmaceuticals and health care company. ...
The safety profile of HUMIRA in the psoriatic arthritis population was similar to that observed with HUMIRA in the rheumatoid arthritis population.
HUMIRA is the only fully human monoclonal antibody approved by the FDA and the EMEA for reducing the signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs).
HUMIRA is the first fully human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor-alpha (TNF-α;) antagonist approved with an indication for use with methotrexate or as monotherapy.
HUMIRA also is approved in the European Union for the treatment of severe, active and progressive rheumatoid arthritis and psoriatic arthritis.
Rheumatoid Arthritis: HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs including methotrexate has been inadequate as well as for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment of methotrexate is inappropriate.
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