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

Abstract

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.

Rituximab, a Safer Option for Rheumatoid Arthritis: A Comparison of the Reported Adverse Events of Approved Monoclonal Antibodies

“…These changes suggest that biotherapeutics have an impact on the medicine's safety and efficacy, and they can cause AEs in patients. 31 mAbs have a highly selective mechanism of action, a rapid onset, and a high rate of response. However, they are associated with high production costs and an increased risk of AEs, particularly infections, but not as much as cDMARDs.…”

“…These changes suggest that biotherapeutics have an impact on the medicine’s safety and efficacy, and they can cause AEs in patients. 31…”

Pharmacovigilance in Serbia: a Ten-Year Pharmacoepidemiologic Analysis

“…analysis, understanding and prevention of adverse drug reactions (ADRs) is one of the most important professional activities in all healthcare professions, and has great clinical, as well as public health significance globally. The activities of ADR monitoring and reporting, or pharmacovigilance, do not refer only to medicines but also to vaccines, blood and blood products, biological therapy, herbal medicines and supplements, as well as medical devices [2][3][4] . Nowadays, pharmacovigilance is an essential activity in the regulatory system of drugs of any country, which enables early detection of unexpected, delayed or severe adverse reactions to all preparations and agents used in preventive and clinical medicine.…”