Drugs like the blockbuster biologic Humira (adalimumab), an injectable first approved by the U.S. Food and Drug Administration (FDA) in 2002 to treat rheumatoid arthritis and now widely prescribed for plaque psoriasis and a wide range of other autoimmune disorders, have transformed modern medicine. But for physicians who treat severe allergies, asthma, and other immunologic conditions — a category that includes atopic dermatitis (eczema), chronic idiopathic urticaria (hives), and hereditary angioedema (HAE) — biologics are a relatively new treatment trend that is generating enormous excitement. Two leading figures in allergy, asthma, and immunology recently spoke with Everyday Health about biologics, giving an overview of the available therapies, describing the research underway, and offering their thoughts about what lies ahead. RELATED: 9 Things People With Severe Asthma Wish You Knew
A Recent Biologics Boom
Paul V. Williams, MD, a physician at the Northwest Asthma and Allergy Center in Seattle, explains that until about five years ago, the biologics options for people with asthma were limited to a single drug: Xolair (omalizumab), which was approved by the FDA in 2003 for patients with allergic asthma triggered by pet dander, dust mites, pollen, mold, or other substances. More than a decade passed without any new biologics for asthma, Dr. Williams says. Then, in fairly quick succession, the FDA approved three for people with eosinophilic asthma, a type marked by high levels of a type of white blood cell called an eosinophil. Nucala (mepolizumab) came first, in 2015, followed by Cinqair (reslizumab) in 2016 and Fasenra (benralizumab) in 2017. People with severe eosinophilic asthma got another biologic option in 2018 when the FDA approved Dupixent (dupilomab). All these biologics are directed towards the allergic or eosinophilic asthmatic, Williams notes. “That’s about half of all severe asthmatics. The problem is that we don’t have anything yet for the other half.” Research on new biologics that could benefit a higher proportion of patients is ongoing. “There are actually several drugs in the pipeline,” Williams says. One of the most anticipated is an experimental drug called tezepelumab. The FDA granted Breakthrough Therapy designation to tezepelumab in 2018, about a year after a study, published in September 2017 in The New England Journal of Medicine, showed promising results. RELATED: Asthma Complications: What You Might Run Into Now and Later
Picking the Right Biologic
As the biologic treatment options expand, doctor are facing a new question: How do they decide what biologic is best for each patient? “It’s not a totally simple picture,” says David D. Chaplin, MD, PhD, professor of microbiology and medicine at the University of Alabama at Birmingham. In the case of asthma, the first step in treating the disease with biologics is identifying the subtype (also called a phenotype and, if researchers know its molecular pathway, an endotype). “You would expect that a specific biologic might work better for a person with a particular endotype, whereas a different biologic might work better for a person with some other endotype,” Dr. Chaplin says. Over the last several years asthma researchers have made significant progress in understanding different endotypes, Chaplin says, adding that there are likely to be many more phenotypes and endotypes that have yet to be identified. “It’s possible that what we call severe asthma with high eosinophils may turn out to have two or three different subtypes that may behave differently in the way they respond to treatment,” Chaplin says. As researchers delve into this area, the hope is that they’ll be able to develop new biologics where appropriate ones don’t already exist, and that physicians will be able to prescribe existing biologics with more precision. RELATED: 7 Ways Your Doctor Can Help if Your Current Asthma Treatment Isn’t Working
Figuring Out How Biologics Can Do More
One particular area of interest in the field of allergy and immunologic disorders is broadening the use of FDA-approved biologics to treat a wider range of conditions. This is already the case for omalizumab, prescribed in recent years to treat chronic hives as well as asthma; and dupilomab, utilized not just for asthma but also for eczema and chronic rhinosinusitis with nasal polyps. Researchers are also looking into whether biologics can be used to improve the effectiveness of an emerging method of treating food allergy called oral immunotherapy, which involves feeding an allergic person a small amount of an allergen, such as peanuts, in order to increase the threshold that triggers a reaction, according to the American Academy of Allergy, Asthma, and Immunology. One concern with oral immunotherapy, says Williams, is that it can cause the allergic reactions it is aiming to treat. “Some treatment centers have been looking at using drugs like omalizumab or dipilumab just before and during the early phases of oral immunotherapy to prevent those reactions,” Williams says. Researchers are also in very early stages of investigating whether omalizumab and dupilomab can prevent food allergies from developing in children. “That would, of course, requiring giving biologics to infants, so that’s going to be a slow development process,” Williams says. RELATED: Peanut Allergy Treatment Palforzia One Step Closer to Market
Asthma, Biologics, and Coronavirus
As the coronavirus pandemic continues, people with severe asthma and other allergic disorders may be concerned that they are especially vulnerable. The Centers for Disease Control and Prevention (CDC) considers asthma to be an underlying medical condition that may raise the risk of more serious COVID-19 complications. People who take biologics for asthma may want to talk with their doctors about balancing the significant benefits of these drugs with the potential for some of them to increase susceptibility to certain types of potentially serious infections. “Biological agents work in asthma because they block some of the body’s immune or inflammatory mechanisms that are overactive,” Chaplin says. Most of these mechanisms also contribute to protective immunity that could defend the body against the coronavirus or other infections. According to the CDC, people with asthma and others at higher risk of getting very sick from COVID-19 should take extra precautions, including stocking up on supplies, washing hands often, and staying home as much as possible if there is an outbreak in their community. RELATED: Expert Tips on the Coronavirus Crisis: Be Prepared, Don’t Panic
