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[In-label treatment of inflammatory joint diseases]
1Rheumatologische Facharztpraxis Schwerin, Beethovenstr. 3, 18053, Schwerin, Deutschland. christian.kneitz@t-online.de.
Abstract:
The correct use of therapeutic agents in accordance with their approved label is a requirement for a safe therapy and is often linked to the possibility of reimbursement; however, the use of drugs outside the label approval (off-label treatment) is a commonly used practice in rheumatology. This occurs because sufficient clinical trials are often lacking, particularly for rare diseases. This overview gives an insight into the correct use of disease-modifying antirheumatic drugs (DMARDs). It should be noted that there are divergent treatment guidelines that are based on guidelines or recommendations from public authorities, such as the Federal Joint Committee (GBA). A further example is that modifying the dose when the treatment goal is reached is only intended for some of the drugs in the course of the disease. Clinical trials which address such questions could help to modify or add to the label, as for example has now been successfully achieved for the treatment with certolizumab in pregnancy.
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