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The Pharmaceutical Journal
Vol 271 No 7267 p358
20 September 2003

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Human monoclonal antibody licensed for rheumatoid arthritis

A fully human monoclonal antibody has been licensed for the treatment of rheumatoid arthritis. Adalimumab (Humira) inhibits tumour necrosis factor alpha (TNF-a), a protein with a central role in the inflammation of rheumatoid arthritis.

Ron Pate, head of pharmacy services for the Dudley group of hospitals, told The Journal that because adalimumab is a human-derived form, it should have less potential for immunogenic problems than other agents.

The recommended dose of 40mg should be administered once a fortnight by subcutaneous injection. Adalimumab can be self-administered at home, and is available in a pre-filled syringe for easier administration, especially by patients whose hands are badly affected by the disease. Clinical trials of the drug showed significant improvements in symptoms of rheumatoid arthritis, namely tender joints, swollen joints and pain. Adalimumab has also been shown to reduce fatigue and inhibit progression of structural joint damage by helping to prevent bone and cartilage erosion.

The drug is licensed for the treatment of moderate to severe active rheumatoid arthritis in adults who have not responded to disease modifying antirheumatic drugs, including methotrexate. It is given in combination with methotrexate, but is also licensed for monotherapy when methotrexate is inappropriate. Mr Pate noted that all anti-TNF-a agents are expensive, and said: “Hospitals will need to examine the benefits of these in terms of managing activity capacity. Adalimumab does appear to offer some advantage here in that frequency of administration is fortnightly.”

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