Clinical Overview of Inflammatory Diseases

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EP: 1.Clinical Overview of Inflammatory Diseases

EP: 2.Humanistic and Economic Impact of Inflammatory Diseases

EP: 3.Cost Drivers Contributing to the Economic Impact of Inflammatory Diseases

EP: 4.Biologics Used in Inflammatory Diseases

EP: 5.Barriers to Biologics Access

EP: 6.Savings Potential With Biosimilars

EP: 7.Opportunities Provided By Biosimilars

EP: 8.Challenges Associated With Biosimilars

EP: 9.Challenges Payers Face With Biosimilars

EP: 10.Existing FDA-Approved Biosimilars

EP: 11.Interchangeability In Biosimilars

EP: 12.Patient and Provider Education on Biosimilars

EP: 13.Cost and Time Benefits of Interchangeable Biosimilars

EP: 14.Challenges of Biosimilars With Interchangeable Designations

EP: 15.Interchangeable Biosimilar Automatic Substitution

EP: 16.Addressing the Increased Amount of Interchangeable Biosimilars in the Market

EP: 17.Future Opportunities With Interchangeable Biosimilars

Ryan Haumschild, PharmD, MS, MBA: Hello and welcome to this AJMC® stakeholder summit program titled “Interchangeable Biosimilars in Inflammatory Diseases.” I am Dr Ryan Haumschild, director of pharmacy services at Emory Healthcare and the Winship Cancer Institute in Atlanta, Georgia.

Joining me today in this discussion are my colleagues, Dr Jonathan Kay, the Timothy S. and Elaine L. Peterson Chair in Rheumatology; professor of medicine and [of] population and quantitative health sciences, director of clinical research in rheumatology, and the executive codirector of the MD-PhD program at UMass Chan Medical School, UMass Memorial Medical Center [in Worcester, Massachusetts].

Dr Maia Kayal, assistant professor [at the] The Susan and Leonard Feinstein IBD [Inflammatory Bowel Disease] Center [and in the] Dr Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai [in New York, New York].

Dr Kimberly Chen, senior health plan executive, expertise in Medicare, dual Medicaid commercial market.

Today our panel of experts will provide an overview of the clinical, economic, and humanistic burden of inflammatory conditions in the US, discuss the role of biologics and biosimilars in disease management and practical considerations for drug selection, define interchangeable biosimilars, and finally discuss the potential value of these agents to patients, payers, and providers in the treatment of inflammatory diseases. Thank you and let’s begin.

As we start this discussion today, I think it’d be really important to provide an overview of the clinical, economic, and humanistic burden of inflammatory conditions in the United States. Dr Kayal, could you give an overview of the clinical manifestation of these inflammatory diseases, focusing on the prevalence, some of the clinical impact, and even risk factors that we should be considering?

Maia Kayal, MD, MS: Of course, thank you for the question. We know that immune- mediated inflammatory diseases have a prevalence of about 5% to 7% in the United States. The type of immune-mediated inflammatory diseases can be grouped based on the primary system that’s involved.

So in gastroenterology, which is, of course, my specialty and the area that I know the most about, we can group them according to inflammatory bowel diseases. This includes [Crohn] disease and ulcerative colitis. In rheumatology, Dr Kay’s specialty, of course, we have spondyloarthropathies, and these include ankylosing spondylitis, psoriatic arthritis, and then in addition to [those], rheumatoid arthritis. There are also immune-mediated inflammatory diseases in dermatology. These are psoriasis and hidradenitis suppurativa. Of course, the clinical manifestations vary for all of these diseases according to the systems that are involved. There’s no one risk factor for all of these diseases, of course, because they are across a wide spectrum of organ systems.

We do think that there might be a genetic predisposition to many of these conditions. Across the board, we think that tobacco use might be associated as a risk factor with some of these conditions, obesity, and age, but truly we haven’t figured out the precise risk factors for all of them. Again, we do know that perhaps in more cases than not, there is a genetic predisposition.

Ryan Haumschild, PharmD, MS, MBA: That was an excellent overview, and obviously there’s a lot to consider. When we think about that, there’s also the consideration of comorbid diseases. We know that these comorbid diseases are on the rise, causing considerations for payers and providers, and uniquely there’s becoming more literature around metabolic disease and other things that we’ve really got to think about when we’re treating the patient as a whole. Dr Kay, maybe I can transition to you. What are some of the comorbid conditions that are typically seen in patients with inflammatory disease?

Jonathan Kay, MD: Inflammatory diseases tend to increase the risk for cardiovascular disease. Atherosclerosis accelerates with chronic inflammation and malignancies. Lymphoma is also increased in its incidence in patients with inflammatory diseases, typically with more active inflammation.

For example, in rheumatoid arthritis, with the most active rheumatoid arthritis, the risk of lymphoma is markedly increased; however, with control of the disease and those comorbid conditions, the risk is decreased. In rheumatoid arthritis, interstitial lung disease is a major comorbidity that occurs in about 7% of patients with rheumatoid arthritis. Again, [it’s] treated the same way as rheumatoid arthritis, with anti-inflammatory therapy.

There are also comorbidities such as depression, which can occur as a reactive depression. We’re not really sure as to what the pathophysiology of depression associated with inflammatory diseases might be. We just presented a study at the European Alliance of Associations for Rheumatologymeeting that showed that there’s a 1.2-fold increased hazard ratio of postpartum depression among women with inflammatory arthritis compared to women without rheumatic disease. The risk of depression is increased in patients with inflammatory disease.

So atherosclerotic cardiovascular disease, lymphoma, interstitial lung disease, depression, and then of course the comorbid conditions that are associated with heart diseases, such as spondylarthritis, [which] is associated with inflammatory bowel disease or with uveitis or psoriasis. There [are] a number of comorbid conditions, most of them are shared pathophysiology and shared risk, but some of them are a result of chronic inflammation.

Ryan Haumschild, PharmD, MS, MBA: Based on that response, there’s a lot to consider. I think one of the things you really highlight is the importance of mental health. We know with these patients, a lot of them are going to be on more chronic treatment, and if we want them to be successful, sometimes you got to really improve some of those underlying comorbid diseases to have a good proportion of days covered, adherence so a patient can really have better resolution of disease and better control.

Hopefully, that’s something that we can discuss more today because I feel like not only is it choosing the right treatment, it’s maintaining the right motivation and really focusing on all aspects of that patient as you so eloquently pointed out.

Transcript edited for clarity.

This activity is supported by an educational grant from Boehringer Ingelheim.