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Open AccessReview

Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

Evidence-Based Therapeutics Group, Clinical Pharmacology, Universidad de La Sabana, Chía 140013, Colombia
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Biomedicines 2020, 8(9), 303; https://doi.org/10.3390/biomedicines8090303
Received: 13 July 2020 / Revised: 7 August 2020 / Accepted: 17 August 2020 / Published: 23 August 2020
Since we have gained an understanding of the immunological pathophysiology of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus, treatment based on biological drugs has become a fundamental axis. These therapies are oriented towards the regulation of cytokines such as tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-1, and the modulation of cell-mediated immunity (B cells and T cells) by anti CD20 or anti CTAL-4 agents, and can increase the risk of associated infections or adverse events (AE). In this context, the entry of biotherapeutics represented a challenge for pharmacovigilance, risk management and approval by the main global regulatory agencies regarding biosimilars, where efficacy and safety are based on comparability exercises without being an exact copy in terms of molecular structure. The objective of this review is divided into three fundamental aspects: (i) to illustrate the evolution and focus of pharmacovigilance at the biopharmaceutical level, (ii) to describe the different approved recommendations of biopharmaceuticals (biological and biosimilars) and their use in rheumatic diseases (RDs) such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) and other less frequent RD like cryopyrin-associated autoinflammatory syndromes (CAPS), and (iii) to identify the main AE reported in the post-marketing phase of RD biopharmaceuticals. View Full-Text
Keywords: biopharmaceuticals; biologics; monoclonal antibodies; pharmacovigilance; rheumatologic diseases; biosimilars biopharmaceuticals; biologics; monoclonal antibodies; pharmacovigilance; rheumatologic diseases; biosimilars
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MDPI and ACS Style

Rodríguez, S.; Muñoz, A.; Bustos, R.-H.; Jaimes, D. Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview. Biomedicines 2020, 8, 303. https://doi.org/10.3390/biomedicines8090303

AMA Style

Rodríguez S, Muñoz A, Bustos R-H, Jaimes D. Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview. Biomedicines. 2020; 8(9):303. https://doi.org/10.3390/biomedicines8090303

Chicago/Turabian Style

Rodríguez, Sandra; Muñoz, Andrés; Bustos, Rosa-Helena; Jaimes, Diego. 2020. "Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview" Biomedicines 8, no. 9: 303. https://doi.org/10.3390/biomedicines8090303

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