Specific inhibition of the cytokine, tumor necrosis factor-Ã?± (TNF), has revolutionized the\ntreatment of patients with several autoimmune diseases, and genetically engineered anti-\nTNF antibody constructs now constitute a heavy medicinal expenditure in many countries.\nUnfortunately, up to 30% of patients do not respond and about 50% of those who do\nloose response with time. Furthermore, safety may be compromised by immunogenicity\nwith the induction of anti-drug-antibodies (ADA). Assessment of drug pharmacokinetics\nand ADA is increasingly recognized as a requirement for safe and rational use of protein\ndrugs.The use of therapeutic strategies based on anti-TNF drug levels and ADA rather than\ndose-escalation has also proven to be cost-effective, as this allows individualized patient tailored\nstrategies rather than the current universal approach to loss of response. The\nobjective of the present article ââ?¬â?? and the accompanying article ââ?¬â?? is to discuss the reasons\nfor recommending assessments of circulating drug and ADA levels in patients treated with\nanti-TNF biopharmaceuticals and to detail some of the methodological issues that obscure\ncost-effective and safer therapies.
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