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The introduction of the biological response modifiers has revolutionized the management of a number of previously difficult-to-treat conditions such as Crohn’s disease, rheumatoid arthritis and severe psoriasis. Biologics are based on recombinant cytokines, fusion proteins and mouse or human monoclonal antibodies that interfere with the immunological mechanisms, such as tumour necrosis factor-α (TNF-α), cytokines and T cells (and their receptors), involved in the pathogenesis of several diseases.
Enthusiasm for biologics must be tempered by adherence to the criteria for their use and awareness of their potentially serious side effects. Pre-treatment screening and monitoring are vital. Prior to initiating treatment, patients are counselled about potential side effects of biologics and screened for other risk factors or contraindications, as follows:
Severe cardiac failure (New York Health Association classes III and IV) is a contraindication to the use of TNF antagonists.
Demyelinating disease is a contraindication to the use of biologics and must be stopped at once if such symptoms develop.
Consider past history or future risk of cancer. Previous psoralen with ultraviolet A (PUVA) is a risk factor for skin cancer.
Coexisting joint disease or inflammatory bowel disease may influence the selection of biologic.
Screen for infections including viral hepatitis, HIV and tuberculosis (the latter by chest X-ray and interferon-gamma release assay).
Caution against the use of live vaccines in someone on a biologic.
In females of child-bearing age, exclude pregnancy.
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