Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory
Rheumatic Diseases: Risks and their Minimization Measures

Rim      Lakhmiri; Yahia      Cherrah; Samira      Serragui
doi:10.2174/0115748863274863231222023853
Abstract

Tumor necrosis factor alpha (TNF- α) inhibitors are widely employed for the management of chronic inflammatory rheumatism. However, their usage carries significant risks, including site and infusion reactions, serious infections, malignancy, heart failure autoimmune and demyelinating disorders. These risks are comprehensively outlined in risk management plans (RMPs) associated with these molecules. RMP provides information on the safety profile of a medicinal product as well as the measures that will be taken to minimize risks; these are known as risk minimization measures. These measures are divided into routine measures related to elements, such as the summary of product characteristics, labeling, pack size, package leaflet, or legal supply status of the product, while additional measures may include educational programs, including tools for healthcare providers and patients, controlled access or pregnancy prevention programs, among others. Additional measures can consist of one or more interventions that need to be implemented in a sustainable way in a defined target group, while respecting the timing and frequency of any intervention and procedures to reach the target population. An evaluation of the effectiveness of these measures is required to determine whether or not an intervention has been effective. This comprehensive review offers an in-depth exploration of the current treatment, uses, and associated risks of TNF-α inhibitors. Additionally, it provides a detailed account of risk minimization measures and risk management practices while shedding light on their real-world implementation and effectiveness.
Keywords: TNF-α inhibitors, chronic inflammatory rheumatism, risk, risk management plan, risk minimization measures, safety, infections.
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DOI https://dx.doi.org/10.2174/0115748863274863231222023853	Print ISSN 1574-8863
Publisher Name Bentham Science Publisher	Online ISSN 2212-3911
Current Drug Safety

Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory Rheumatic Diseases: Risks and their Minimization Measures

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