Anti-Tumor Necrosis Factor (TNF) Biosimilars Virtual Clinic

Optimizing the Management of Immune-mediated Inflammatory Diseases (IMIDs)

Immune-mediated inflammatory diseases (lMIDs) are thought to arise in genetically susceptible individuals when exposure to an environmental trigger generates a pro-inflammatory state that is not adequately controlled by regulatory mechanisms. Central to the pathophysiological process is activation of a pro-inflammatory cytokine loop that amplifies and perpetuates the immune response. Over-expression of cytokines such as tumor necrosis factor (TNF) has led to the successful approval of various biological agents that block TNF. These TNF inhibitors have revolutionized the treatment of IMIDs, such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), and psoriasis (PsO). While TNF inhibitors may improve clinical signs and symptoms and may lead to low disease activity and remission, they have posed a significant economic burden to healthcare systems, and, subsequently, to the achievement of therapeutic goals. The advent of more cost-efficient anti-TNF biosimilars is providing more affordable and sustainable options for reducing disease burden in patients with unmet medical needs. In this podcast series on IMIDs, provided by Howitreat.MD by SEI Healthcare, three esteemed clinical experts will discuss opportunities in daily clinical practice to optimize treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis.

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Disease Management Optimization in Rheumatoid Arthritis

Peter Taylor

Rheumatoid Arthritis (RA) is a chronic and difficult to treat inflammatory disease. The available treatments target several disease-associated dysregulated pathways, and include the use of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), of biologic DMARDs (bsDMARDs) such as anti-tumor necrosis factor (TNF), including biosimilars, and targeted synthetic DMARDs (tsDMARDs). Patients’ responses to therapy are heterogeneous and dependent on many factors, including the presence of comorbidities and/or extra-articular manifestations. The treat-to-target approaches with an emphasis on early intervention should aim to improve disease control, achieve remission, increase the quality of life, and reduce mortality rates of patients with RA. However, their adoption in clinical practice is still challenging. Here, we will examine how RA management can be optimized, including topics focusing on early intervention, the treat-to-target approach, wellness beyond pharmacological intervention, and treatment strategies for rheumatologists in different settings.

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  1. Conigliaro P, Triggianese P, De Martino E, et al. Challenges in the treatment of Rheumatoid Arthritis. Autoimmun Rev. Jul 2019;18(7):706-713. doi:10.1016/j.autrev.2019.05.007

  2. Overman CL, Jurgens MS, Bossema ER, Jacobs JW, Bijlsma JW, Geenen R. Change of psychological distress and physical disability in patients with rheumatoid arthritis over the last two decades. Arthritis Care Res (Hoboken). May 2014;66(5):671-8. doi:10.1002/acr.22211

  3. Lacaille D, Avina-Zubieta JA, Sayre EC, Abrahamowicz M. Improvement in 5-year mortality in incident rheumatoid arthritis compared with the general population-closing the mortality gap. (1468-2060 (Electronic))

  4. Solomon DH, Bitton A, Katz JN, Radner H, Brown EM, Fraenkel L. Review: treat to target in rheumatoid arthritis: fact, fiction, or hypothesis? Arthritis Rheumatol. Apr 2014;66(4):775-82. doi:10.1002/art.38323

  5. Ford JA, Solomon DH. Challenges in Implementing Treat-to-Target Strategies in Rheumatology. Rheum Dis Clin North Am. Feb 2019;45(1):101-112. doi:10.1016/j.rdc.2018.09.007

  6. Hock ES, Martyn-St James M, Wailoo A, et al. Treat-to-Target Strategies in Rheumatoid Arthritis: a Systematic Review and Cost-Effectiveness Analysis. SN Comprehensive Clinical Medicine. 2021/03/01 2021;3(3):838-854. doi:10.1007/s42399-021-00727-4

Disease Management Optimization in Crohn’s Disease

Raja Atreya

Crohn’s disease (CD) is a chronic inflammatory disease that affects any part of the gastrointestinal tract. Several factors are associated with the development of CD, including a dysregulated immune system, genetic susceptibility, and environmental factors.Early diagnosis and an intensified treatment approach with combined anti-tumor necrosis factor (TNF) biologics and immunomodulators seem to be necessary in a subgroup of patients to change the natural course of the disease, prevent disease flare, halt progression and avoid intestinal complications and need of surgery. Here, we will examine key topics surrounding the management of CD, including diagnostics, current treatment and the role of anti-TNFs (including biosimilars), the management of extraintestinal manifestations, the relevance of therapeutic drug monitoring, and key research areas.

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  1. Adegbola SO, Sahnan K, Warusavitarne J, Hart A, Tozer P. Anti-TNF Therapy in Crohn's Disease. Int J Mol Sci. Jul 31 2018;19(8)doi:10.3390/ijms19082244

  2. Roda G, Chien Ng S, Kotze PG, et al. Crohn's disease. Nat Rev Dis Primers. Apr 2 2020;6(1):22. doi:10.1038/s41572-020-0156-2

  3. Gomollón F, Dignass A, Annese V, et al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis. Jan 2017;11(1):3-25. doi:10.1093/ecco-jcc/jjw168

  4. Armuzzi A, Bouhnik Y, Cummings F, Bettey M, Pieper B, Kang T. Enhancing treatment success in inflammatory bowel disease: Optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice. Dig Liver Dis. Nov 2020;52(11):1259-1265. doi:10.1016/j.dld.2020.06.008

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Disease Management Optimization in Psoriasis

Francesca Prignano

Psoriasis is a chronic immune-mediated inflammatory skin disease. Its management should aim to minimize both physical disease-associated and psychological outcomes through an early diagnosis, the prevention of associated comorbidities and extra-cutaneous manifestations, and the provision of early personalized treatment.2 Biologic treatments against dysregulated cytokines, such as tumor necrosis factor (TNF) or interleukins 17 and 23, have revolutionized the care of patients with moderate-to-severe psoriasis. Anti-TNF biologics are recommended mainstay treatments for psoriasis, and the advent of several biosimilars of these agents has led to improved treatment accessibility. Here, we will provide an in-depth look into the management of moderate-to-severe psoriasis. This includes diagnostics, the importance of early treatment, the relationship with psoriatic arthritis and other comorbidities, the role of biologics (including biosimilars), treatment adherence, and the impact of the COVID-19 pandemic.

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  1. Lowes MA, Suárez-Fariñas M, Krueger JG. Immunology of psoriasis. Annu Rev Immunol. 2014;32:227-55. doi:10.1146/annurev-immunol-032713-120225

  2. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker J. Psoriasis. Lancet. Apr 3 2021;397(10281):1301-1315. doi:10.1016/s0140-6736(20)32549-6

  3. Rønholt K, Iversen L. Old and New Biological Therapies for Psoriasis. Int J Mol Sci. Nov 1 2017;18(11)doi:10.3390/ijms18112297

  4. Barker J, Girolomoni G, Egeberg A, Goncalves J, Pieper B, Kang T. Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience. J Dermatolog Treat. Dec 2020;31(8):794-800. doi:10.1080/09546634.2019.1610553

  5. Prignano F, Choi J, Pieper B, Iversen L. Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars. Expert Opin Biol Ther. Jan 2021;21(1):75-80. doi:10.1080/14712598.2020.1812576

Learning Goal / Purpose

The goal of this activity is to educate rheumatologists, gastroenterologists and dermatologists on various topics of IMIDs management, including treatment optimization of psoriasis, Crohn’s disease, and rheumatoid arthritis.

Target Audience

This activity is intended for rheumatologists, gastroenterologists and dermatologists in Europe.

Objectives

After completing this educational activity, the participant will be able to:

  • Identify patients’ pathways and gatekeepers to disease screening and specialist referral

  • Recognize the importance of early diagnosis and treatment of IMIDs, and identify current challenges and solutions to overcome them

  • Recognize other comorbidities and clinical manifestations (i.e., extracutaneous or extraintestinal, in psoriasis and Chrohn’s disease, respectively) associated with IMIDs and summarize the benefits of using biologics to tackle common inflammatory pathways, such as anti-TNFs

  • Describe the biosimilarity concept, list the regulatory requirements, and identify the main similarities and differences between the regulatory frameworks in Europe versus the United States

  • Compare and contrast the benefits of using biosimilars for the treatment of IMIDs

  • List current treatment armamentarium, apply guideline recommendations and algorithms to the treatment, and identify their most effective sequential use

  • Recognize the evolution of IMID treatment towards a treat to target approach

  • Identify issues around COVID-19 vaccination in patients receiving biological treatment for the treatment of IMIDs

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Professor Raja Atreya

Gastroenterologist and Head of the Inflammatory Bowel Disease (IBD) Unit, Outpatient Clinic, and Clinical Study Centre at the University Hospital Erlangen in Germany, and Professor of Translational Immunology in IBD at Erlangen University, Erlangen,
Germany

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Professor Francesca Prignano

Associate Professor of Dermatology Department of Health Sciences Section of Dermatology University of Florence, Florence,
Italy

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Professor Peter Taylor

Head of Clinical Sciences at the Botnar Research Centre within the Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences in Oxford,
United Kingdom