The over-production of TNF-α can lead to chronic inflammation and organ damage in immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), axial spondyloarthritis, psoriasis, and inflammatory bowel disease (IBD). Anti-TNF therapy is generally considered to be an effective, well-tolerated treatment option for the management of chronic inflammation in these conditions. Over the past decade, patents for the original reference anti-TNF agents have expired, permitting the development of anti-TNF products that are biologically similar, termed ‘biosimilar’, to the original reference product. Differences in the approval process mean that biosimilars are often available to healthcare services at a considerably lower cost compared with the reference products, providing an opportunity to improve patient access to the benefits of anti-TNF therapy. However, despite the spreading use of biosimilars across healthcare services, some clinicians remain reluctant to prescribe them. The gradual accumulation of long-term data on the real-world use of biosimilars, and an improved understanding of the development and approval process for these products, may help to increase clinicians’ confidence to increase usage of biosimilars. This mini review summarises the current status of anti-TNF biosimilars in clinical practice, including the requirements for regulatory approval, real-word evidence for their equivalence to novel anti-TNFs, guidelines for their use, and challenges to their acceptance by both clinicians and patients.
TNF-α is produced in high concentrations in chronic inflammatory disease, resulting in excessive inflammation which eventually leads to organ damage. The advent of anti-TNF therapy in clinical practice 20 years ago represented a significant change in the management of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis (RA), axial spondylarthritis (SpA), psoriasis, and inflammatory bowel disease (IBD). There are five anti-TNFs approved for use in IMIDs: infliximab, adalimumab, golimumab, etanercept, and certolizumab pegol. The structural and pharmacological differences between these agents mean that they can have differential efficacy across IMIDs, and therefore the indications for which they are approved vary. This mini-review aims to summarise the current understanding of anti-TNF efficacy in those IMIDs for which they are approved, focussing on data from meta-analyses of randomised clinical trials (RCTs), and real-world studies.
In chronic inflammatory disease, TNF-α is produced in high concentrations, leading to excessive inflammation and eventually organ damage. The advent of anti-TNF therapy in clinical practice 20 years ago represented a significant change in the management of immune-mediated inflammatory diseases (IMID). Common concerns regarding the safety profile of anti-TNFs include increased infection rates, associations with cancer, and safety in pregnancy. Regulatory authority guidelines to reduce risk include vaccination and screening for latent infections prior to treatment initiation. In general, pharmacovigilance and tailored medicine are the best methods for optimising anti-TNF therapy while minimising side effects. This mini review aims to summarise the current understanding of the safety profile of this drug class.
This symposium took place during the 28th congress of the European Academy of Dermatology and Venereology (EADV). Dr Seité began the meeting by emphasising the rising incidence of allergy, and the societal and economic impact this has in Europe. This was followed by the presentation of a worldwide epidemiology study conducted this year, which found that 20–42% of the population in the countries surveyed reported being affected by allergies, most commonly skin allergies followed by respiratory and food allergies. Of these individuals, 48–89% in each country experienced skin reactions, and these were treated primarily with oral or topical medication. Dr Lazic Strugar introduced the skin barrier as the first interface between the environment and the immune system, and she explained that its disruption can lead to immune dysfunction, resulting in dermatitis, skin infections, and allergies. Skincare products such as emollients can provide moisture and lipids, supporting bacterial diversity in the microbiome and restoration of the skin barrier. Dr Seité followed up with a report of a recent observational study investigating the benefits of a facial moisturiser designed specifically for sensitive skin and individuals with allergies. In this study, patients with allergies experiencing skin reactions used the product for up to 1 month, in addition to taking antihistamines alone or in combination with steroids. After 4.9 days, all subjects felt their symptoms had improved, and after the full month of treatment, both cutaneous clinical signs and subjective signs had significantly improved in most participants (>95% and 90%, respectively). Dr Seité concluded the meeting by stressing that dermatologists have an important role to play to help patients with allergies to manage their skin reactions.
This plenary session began with a focus on cutting edge research into the role of the immune system in atherosclerotic cardiovascular disease (ASCVD). Firstly, Chiara Giannerelli, New York University (NYU) Langone Health and NYU Grossman School of Medicine, New York, USA, emphasised the value of deep phenotyping of atherosclerotic disease to understand the immune mechanisms involved in cardiovascular (CV) risk. She presented data demonstrating an enrichment of phenotypically distinct cluster of differentiation (CD) 4+ and CD8+ T cells in advanced atherosclerotic plaque compared with paired blood and explained how this data can be used to identify drugs with the potential to be repurposed to reduce CV risk. Secondly, Eicke Latz, Institute of Innate Immunity, University of Bonn, Germany, presented data from his research team that begins to explain how the Western diet might lead to chronic inflammation and atherogenesis, implicating cholesterol crystals and short-chain sphingomyelins in the reprogramming of granulocyte-monocyte precursor cells (GMP) in this process. The arguments for greater use of imaging and molecular biomarkers in clinical practice were presented by Wolfgang Koenig, German Heart Center Munich, Technical University of Munich, Germany, who speculated that the assessment of CV risk in the future is likely to harness big data and machine learning to achieve accurate risk assessment in individual patients. Finally, Amit Khera, Massachusetts General Hospital, Boston, USA, covered the role of genetic factors in the prediction of CV disease (CVD), explaining that a combination of traditional risk factors and polygenic scoring techniques provides the most accurate estimation of CVD risk.
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