Biologics: What They Are, How They Work, and Who Might Benefit (Recording)
This webinar was recorded on October 31, 2024
A biologic drug is developed using cells from living organisms such as human, animals, bacteria, and viruses. They target inflammation in the body at the source. Biologics are now available to treat all sort of conditions including asthma, allergies, atopic dermatitis, diabetes, cancer, and autoimmune conditions. In this webinar, learn all about biologics, how they work and who might benefit from using them as a treatment.
Speaker:
- Rajan Merchant, MD, FACAAI
Woodland Clinic Medical Group, Woodland, CADignity Health Medical FoundationCommon Spirit Heath Research InstituteCommon Spirit Health
Dr. Merchant is an Allergy, Asthma and Clinical Immunology Specialist at the Woodland Clinic Medical Group which is part of Common Spirit Health and Dignity Health Medical Foundation in Woodland, California. Dr. Merchant focuses on adult and pediatric seasonal and perennial allergic rhinitis, asthma diagnosis and management, food allergies, drug allergies and immunodeficiency disorders. He is a fellow of the American College of Allergy, Asthma and Immunology and won the Sacramento Magazine’s Top Doctors Allergy award from 2016 to 2022.
CE is not available for this webinar.
CME is available through ACAAI for this webinar.
Special thanks to Sanofi/Regeneron who has provided funding support to make this webinar possible.
Transcript: While this transcript is believed to be accurate, errors sometimes occur. It remains your responsibility to evaluate the accuracy and completeness of the information in this transcript. This transcript is not intended to substitute for professional medical advice.
Catherine: Hello and thank you for joining us today. I am the chief health equity echo there for the allergy and asthma network. We are in for achieved today. We have a few housekeeping items before we start today’s program. First, everyone will be on mute for the webinar. We will record today’s webinar and posted on her website within a few days. You can find all of our recorded webinars on her website. All you have to do was scroll down to the bottom of the page to find our recorded webinars and pick the one that resonates with you and any upcoming webinars you would like to see. This will be an hour-long. That includes time for questions. We will take these questions at the end of the webinar but you can put your questions in the Q&A at any time you want. The Q&A boxes at the bottom of the screen. We will have someone monitoring the chat if you have questions or need help. We will get to as many questions as we can before we conclude the webinar. We will not be offering continuing education credits for this webinar but we have a certificate of attendance if you need it for your records. A few days after the webinar, you will receive an email with supplement till information and a link to download the certificate of attendance. We will try to add the link to the certificate in the chat. Let’s get started. Today’s topic is Biologics. What are they? Who might benefit. A biologic drug is developed using cells from humans, animals, bacteria and viruses. They target information in the body at the source. Biologics are now available to treat all sorts of conditions including asthma, allergies, atopic dermatitis, diabetes, cancer and autoimmune conditions. In this webinar we will learn all about Biologics, how they work and who might benefit. It is my esteemed pleasure to introduce today’s speaker Dr. merchant. Dr. merchant is a criminal immunology specialist at the Woodland clinic medical group, which is part of spirit health and dignity health medical foundation in Woodland, California. Dr. Merhant focuses on allergic , allergies, and immediate disorders. He is a fellow of the American College of allergy asthma and immunology and won the Sacramento magazine top doctors allergy award from 2016 to 2022. Special thanks to Regineron who provided funding support to make this possible today. Thank you so much are being here and I will turn it over to you now.
Dr. Merchart: Thank you. Good morning or good afternoon to those on the East Coast. I want to thank the Allergy & Asthma Network for allowing me an opportunity to speak to you during this webinar, biologics, what they are, and who they might benefit. The webinars part of the Allergy & Asthma Network outline to provide education on topics focused on allergic conditions. Before we begin I want to say happy Halloween to all. I’m hoping this will be a treat for you all. Today we will explore cutting-edge approaches to managing allergic disease. These therapies are revolutionizing how we treat conditions like asthma, atopic dermatitis and many more by targeting the immune system’s key inflammatory pathways.
Most treatment have been around only over the last five to 10 years. As we go through the webinar there may be some things that feel spooky but we will keep it as simple as possible. Thank you for that introduction as well. I’m a practicing allergist. That picture of me might be from a costume from 20 years ago when I first started my fellowship in allergy. I have no financial conflicts or disclosures as to this topic. Let us begin. Over the course of this webinar we will break down what Biologics are. Some early biological treatments that are still commonly used and we will talk about inflammation specific to allergic conditions and finally review specific Biologics and how these new Biologics work and how they are transforming the treatment landscape for patients and who benefits. What are Biologics? Biologics are special medicines derived from living organisms or their components, proteins or cells, or genetically engineered material which we will get to. Biologics can either stimulate or inhibit specific parts of the immune system. These are usually large complex molecules. Because of their size they require treatment as injections or infusions compared to most traditional medicines that we take as oral treatments. With new technology and genetic engineering we can now create specific Biologics that target the immune system. This can offer a more personalized precise treatment approach than traditional therapies.
Specific types of Biologics. Biologic treatment is as old as the field of medicine and goes back over centuries. Clearly Truman’s laid the foundation for current Biologics . Biologics can be classified into several major categories. Outline here. Blood products, vaccines, immunotherapy, hormones and monoclonal antibodies which be the focus of this webinar. Blood products are some of the earliest biologic treatments. As I’m looking at this slide I’m wondering why they did not put up a vampire or some bloodsucking leeches a visual, but I digress. Specific to the field of allergy is the use of immunoglobulin proteins that fight infections. These treat immune deficiencies. Imino globulins were first committed in 1952, proved in 1980 and sub bikini list — subcutaneous treatment was approved in last 20 years and is now the preferred method for achieving for immune deficiency disorders. Did you know the vaccines and, no therapy also considered — immunotherapy is also considered Biologics? Several forms of allergy immunotherapy are approved and used in everyday care. Subcutaneous immunotherapy, allergy shots, were introduced over a century ago. Among the first Biologics use for treatment for allergic rhinitis. Venom immunotherapy approved in 1979 is commonly used for treating individuals with stinging insect allergy. Sublingual Inyo therapy — immunotherapy approved for Mono alleging she meant for ragweed, pollen and dust mites involves placing a small amount of the allergens under the town to build immune tolerance — r tongue to build immune tolerance. And oral immunotherapy. We have one approved OIT for peanut allergy that’s been available for the last four years. Going back to her list, hormones are classified as Biologics we want to talk about that. Before we move to the last category of monoclonal antibodies, a quick recap. Biologics have been used for centuries.
The early history has included blood products, vaccines and immunotherapy. These treatments are still critical and used in disease management today. A lot of treatment are also relatively new and exciting. They have helped laid the groundwork for understanding immune system and many of the today’s Biologics targeting immune system components. Today Biologics are more synonymous with monoclonal antibodies. You can see a visualization of what they look like. They were first developed back in 1970 to target disease pathways with greater precision. The first therapeutic monoclonal antibody was approved in 1986 for transplant rejection. This laid the groundwork for additional Biologics we use today in allergic conditions. Before we talk about specific monoclonals, I want to share how to identify a monoclonal antibody. It is at the end of the name. The drug — mab at the end of the name stands for monoclonal antibody. Dividends and ma — if it ends in mab, that is a monoclonal antibody. They are classified based on their source of where the antibodies were initially created or now genetically engineered. First, again, used in mouse models to create the antibodies.
Then more recently we have fully human antibodies now available for use. We can see this in this visual. The mouse antibodies, then having a chimeric antibody, a humanized antibody or a fully human antibody. These are most of our treatments now lie. The importance of this is as we use foreign proteins or antibodies these can actually stimulate your immune system. The more closely they resemble our own human antibodies the less immunogenicity we can see is depicted. One more piece of information on what to talk about before we go into Pacific — specific drugs or monoclonal antibodies. We have talked about — brought up the concept that the monoclonal antibodies target specific parts of the admin system. I want to explain what we are targeting. Understanding inflammation is the body’s natural response to infection or injury that involves specific cells with specific targets. In allergic disease like asthma and atopic dermatitis, the responses become chronic and are considered to be harmful. This is a really great slide. Not scary at all. There’s a lot of information on here. You will hear me repeat multiple times the targets of inflammation as we go forward. Inflammation is broken down into three types. Most of us are going to focus on this middle section, type 2 inflammation which is what drives allergic disease. It is characterized by cytokines. Primarily IL-4, 5, and 13. We will go through these and subsequent slides. This is the key piece of what we are targeting and how the Biologics basically work. This slide shows how type 2 inflammation is connected to many disease states we have outlined. Asthma, atopic dermatitis, food allergy are now all tied to or related to type 2 inflammation. It is central to the treatment of paradigms we are now able to use when we target the immune system. All this inflammation is driven by cytokines which involve specific cells.
Now we will go through a couple of specific monoclonal antibodies and the specific targets associated with those. Omalizumab was the first monoclonal antibody in the field of allergy. It targets IgE. We have Mepolizumab that reduces EO center fills — eosi nophils. Reslilzumab reduces essin ophils. Benralizumab. We have Dupilumab which targets receptor alpha that targets IL-4 and IL-13. Tralokinumab which targets IL- 13. And we have Tezepelumab. We have humanized antibodies. The column on the left of the fully human antibodies that are genetically engineered today. It looks scary but we will try to continue to keep it simple and walk through how these drugs work and who will benefit. What is asthma? A chronic disease characterized by inflammation of the airways leading to symptoms like coughing, wheezing and shortness of breath which we are familiar with. It is triggered by allergies, infection and environment of factors. It affects about 25 million individuals. Biologics block specific molecules involved in type 2 information that reduces the airway narrowing, the frequency of asthma attacks, the need for oral steroids and/or emergency care. This is a very nice illustration that depicts the inflammation in asthma. IL-4, 5 and 13 and the cells eos inophils that leads to increase in mucus production. This slide has more details. Not all the details are important but highlights a lot more targets, specifically IgE and as we identify targets we can classify the disease states in more detail for personalized treatments.
We have an allergic asthma or eosinophil asthma. These are gaining traction as we continue to identify or determine how information is affecting the airways. We are continuing to identify new targets and that is where ongoing research continues to occur. Who benefits from these drugs? The Gino guidelines recommend patients with about moderate to severe asthma not controlled at step four treatment. Up to about 5 million individuals can benefit from these drugs. We can see they listed a bunch of them here as anti-IgE, immunoglobulin –IL-4. These fall into this category. Similarly for children six and older that are not controlled on step four, medium to high doses of inhaled steroids or bronchodilators are now available for treatment. A quick summary of the Biologics currently approved for asthma, they were approved. Omalizumab was the oldest. Benralizumab approved just over 10 years ago. Back in 2010, it was approved in 2019. It was initially approved or other clinical conditions. As we go through a number of these next few slides we will see that these drugs do have overlap. That is how the drugs will now will gain traditional indications. A quick recap of the specific targets. Omalizumab targeting Ige. Benralizumab targetingL IL-5 receptor. Dupilimab effects IL-4 and IL- 13.
The next topic for treatment is atopic dermatitis. A chronic skin inflammatory condition driven by type two inflammation leads to reaching, redness, skin — itching, redness, and can be triggered by food, environment or infection. We see a nice illustration of a severe case of atopic dermatitis involving the entire skin. Biologics block or target the specific cytokines we have talked about that because the inflammation. This leads to improvement in the skin barrier function, decreaseds the flares individuals experience and shown to increase quality of life. A nice illustration that shows the inflammation in the targets that affect atopic dermatitis. IgE down here. TSLP in the middle. IL-4, IL-13 and other targets we will not focus on but these are the primary ones being used or have been developed for treatment. Who benefits? 10% to 30% of children have atopic dermatitis. Individuals with severe eczema not controlled with topical medications are where the medications provide the greatest benefit. Medications like Dupilumab has been approved for as young as six months for treatment. The main stay our patients that are severe and not controlled with other treatment options or modalities. We have Omalizumab that targets IgE. It is being studied for atopic dermatitis. We have Dupilumab which blocks IL-4 receptor alpha that reduces skin information improves the skin barrier, decreasing the flareups. Again, decreases IL-4 and IL-13 specifically. Tezepelumab that targets TSLP. These are the current Biologics that are approved in treating severe atopic otitis. It targets the type two inflammatory markers.
Next clinical state. Nasal polyps. Characterized by inflammation and growth leading to congestion, loss of smell and difficulty breathing. Similarly characterized by the type 2 markers of IgE, IL-4, IL-5, and IL-13. Treatment similar to other conditions where severe persistent symptoms despite treatment with topical steroids or need for recurrent or oral steroids or frequency or nasal or sinus surgery is when these Biologics are usually indicated or considered. Additionally we have comorbidities associated with chronic rhino sinusitis. Also asthma or they tend to be more refractory in disease, as well as the category of respiratory disease. They have more frequency of nasal polyp recurrence. These individuals are patients that benefit greater with treatment with current Biologics. The specific targets for current treatment. Dupilumab targets IL-4, IL-13. Omalizumab has now been approved for treatment as well targeting IgE. We have Mepolizumab for inflammation and reducing the Senate for levels. All these Biologics help reduce or shrink nasal polyps and improve breathing, sense of smell and decrease the need for surgery. The next one is eosinophil esophagitis.
This manifest as dysphagia or food impaction for most individuals. Sometimes triggered by food allergy. We have an inflammatory change generally seen on endoscopy with narrowing of the esophagus. Driven by the same inflammatory mediators of EIgE, IL-4, IL-5, IL-13. Indications for treatment for Biologics refractory two standard therapies. Individuals with high levels of eosinophils on biopsy or need oral steroids, as well as frequent dilation of the esophagus. Most are considered severe patients. The difference with chronic sinusitis is these are actually now more preferred. They are much more effective than some of the topical treatments that have been used previously. Currently the only approved treatment is Dupilumab. Multiple Biologics are in clinical trials targeting those specific markers or cytokines we mentioned and are seeking approval for this condition as well. I won’t be surprised that we will have some additional medications in the near future. Almost through the homestretch. We will not go over a little bit on food allergy. Adverse immune response to specific involving IgE typically leads to symptoms from hives. Itching to severe symptoms of anaphylaxis, including drops in blood pressure. Food allergy has a significant impact on quality of life across all age groups. The main difference here for food allergy compared to the other conditions is this targets or is usually manifested by mass cells that reduce death release histamine versus other conditions based on those eosinophils and cytokines causing inflammation. Skin symptoms, G.I. symptoms, respiratory issues can be present in anaphylaxis and require immediate treatment. Currently we have most recently medication with Omalizumab, which was approved for treatment in reducing the risk of anaphylaxis from accidental exposure or consumption in pediatrics older than one.
It is also currently being used in conjunction with oral immunotherapy to reduce the risk of anaphylaxis for individuals who are undergoing immunotherapy treatments. This comes directly from the Journal that was published earlier this year where we can see the treatment arm of individuals with Omalizumab versus placebo were able to tolerate a greater number of patients able to tolerate a higher threshold of consumption of specific food allergens. We can see here that patients who were given Omalizumab, 67% were able to consume a higher threshold of peanut compared to the placebo arm. Across all of the different food groups that were tested or evaluated, Omalizumab created or provided a greater level of protection with regards to reducing the risk for anaphylaxis. Just to summarize, we have a lot of key similarities. Hopefully I have outlined a lot of the central components to the treatment for these conditions. All around Type 2 inflammation which is manifested by the cytokines we have talked about. IgE, IL-4, IL-5, and IL-13, as well as eosinophils and mass cells involved with the type of information. The treatment are indicated for moderate to severe cases that have been refractory.
Typically other treatments generally improve quality of life significantly, reduce the need for oral steroids, decrease hospitalizations, surgeries. As the treatments expand over get more clinical evidence they may be approved for a lower level of severity. As future discussion potentially things like permission for disease states are being considered. Just as a final summary and conclusion, Biologics target key molecules driving inflammation. They offer more personalized treatment across asthma, atopic dermatitis, chronic rhino sinusitis with nasal polyps, eosinophilic esophagitis and food allergy by addressing the specific underlying immune responses. The Biologics improve patient outcome, reduce the need for steroids and other traditional therapies. I want to say thank you for joining today’s webinar. I hope you have a clear understanding of how Biologics work across these various allergic conditions. We will now open it up to any questions.
Catherine: Thank you, Dr. merchant. That was great. I learned a lot so thank you. We have some questions in the Q&A. I have severe asthma and my doctor has suggested these biologic drugs. My asthma is well-controlled by the traditional drugs I have been taking. I have been told Biologics can cause an anaphylactic incident which is the reason I have resisted taking them. What is your opinion on this?
Dr. Merchart: Most of the drugs now, especially with the more — what are considered fully human antibodies like Dupilumab or Benralizumab have lower risk for creating an immune response, including producing IgE against those specific drugs that cause anaphylaxis. The overall risk for anaphylaxis is relatively very low for these fully humanized antibodies or monoclonal antibodies. The initial concern with Omalizumab specifically, because that was a humanized antibody, had a little bit of a greater risk for anaphylaxis. The risk is actually not that much greater than what we see with traditional immunotherapy treatment. Most of the medications, especially as a result of the pandemic where injections cannot be administered in the office we re developed to be administered at home with some precautions for managing anaphylaxis. Generally safe enough they can be administered with a very, very low risk profile. The newer, more humanized — human antibodies have again very low risk for anaphylaxis.
Catherine: Dr. Merchant, I have heard that a lot from not just this person here on the webinar but from other patients. They are afraid of them. There is a fear of Biologics. If they are explained better and I’m sure you do that in your office, giving them a basic understanding of what Biologics are, they are more apt to want to try and not fear it as much. I do hear that a lot.
Dr. Merchart: Yeah. Again, we continue to learn to understand what the risks and benefits of medications are going to be, where they will be most appropriately indicated. I think traditionally before most of the medicines have been approved over the last five years, you know, most individuals or patients with asthma were on oral steroids, chronic steroid use and treatments — we can get off of daily oral steroids which is very important. Daily oral steroids have a lot of risk factors. The other piece we sometimes don’t think about even with the topical steroids is that when we think about nasal steroids, inhaled steroids, a topical steroids to treat the skin for atopic, that is a high steroid burden we place on patients over a long period of time. Biologics decrease the burden whether it is oral or multiple topical steroids that are currently used based on the different comorbidities. We can target very specific areas that have multiple areas of benefit.
Catherine: OK. Second question. How do you know what type of asthma someone has? Is this determined with bloodwork?
Dr. Merchart: Yeah. There are a couple of different components. It all starts with the history of asthma symptoms. Looking at whether they have allergies as a component or trigger. Looking for the IgE target. Bloodwork to look at the eosinophil count. Those are the primary things we sort of look at. We can also use fractional exhaled nitric Occidental marker for eosinophil ic asthma. There are a couple of markers to determine or help us to classify where the asthma is within the new categories of asthma definitions.
Catherine: OK. Another question. I am seeing physicians are prescribing COPD patients with depiction — Dupixen. Is this new? Other Biologics being treated for COPD?
Dr. Merchart: Great question. Dupixen was most recently approved for individuals who have type two inflammation and COPD as a component of their disease. The they are have a height eosinophil — high eosinophil count or other features that would help target where it would be beneficial. There are Biologics being looked at for similar indications among the ones that are currently available and new ones that are being targeted for some of those other inflammatory pathway targets that are now identified. There is a lot of work going on in the field for COPD and ongoing work in asthma. Currently there’s about two or three additional Biologics targeting various inflammatory markers in asthma and multiple studies being done in COPD to see if we can get better targets for treatment. As mentioned and we will talk about over the years, do these Biologics help to put individuals into remission? Not just treatment but remission states or conditions — for conditions like asthma.
Catherine: Are Biologics, used on or off label — ever used on or off label? Is there a reason they could not be?
Dr. Merchart: It is a condition that is treated with I believe Dupilumab for this indication as well. I did not focus on it from initially. It is not a large population I see. Biologics are being looked at across all of the type to inflammatory conditions –Type 2 inflammatory conditions.
Catherine: This question has a lot of acronyms and I’m sure you are going to know what they are because I don’t. With the new PPE3 and PBE4 inhibitors approved for COPD, using it being used with IL-4 and 5.
Dr. Merchart: Those are the phosphodiesterase treatments that are available or now approved. As we get more specific treatments and we understand the combinations of different pathways for inflammation, I think we will get more clinical experience on which drugs or combinations of drugs will work over time. Similar to how our current combinations for COPD with long-acting inhaled steroids and a long-acting aganis. I think we will continue to evolve how we put these different drugs together or in what combinations to provide an optimal response.
Catherine: One question here, and I’m going to add onto this questions you can may be hit both of them at the same time. How long do you continue? When you consider stopping Biologics? I’m thinking if you’re on it for asthma or atopic dermatitis or any of the diseases Biologics are intended for, the question, is there a way you can stop it and kinda go off it because it’s getting better? Or is it lifetime?
Dr. Merchart: Great questions. I think because these medications are so new we don’t have that historical longevity of how long treatment is necessary for. Typically, what I tell individuals and patients is these treatments will help make you feel better because most of these individuals are uncontrolled. Like every other treatment we monitor to see how long we think we want to consider treatment for. Most of the clinical studies went for about a year on treatment. There were a lot of extension studies to determine ongoing needs. I think we are still trying to come up with ideal recommendations for duration of treatment. I certainly would not consider treating a one-year-old with life on Biologics for atopic dermatitis. Some disease states have natural progression for remission. I think as we learn or understand how remission for inflammation may work over time we will have a better understanding. Typically, I recommend, like all treatments, especially for asthma, after a period of stability you look for de-escalation and whether that de-escalation is reducing inhalers or stopping the Biologics. Parts of shared decision-making we have to look at on an individual basis.
Catherine: OK. The Biologics contain blood fractions?
Dr. Merchart: I am not entirely sure what that refers to in terms of blood fractions. Specific blood products like immunoglobulins come from whole blood and are separated to contain only purified immunoglobulins. It’s a part of blood, yes, there are certain Biologics that are — that come from blood products we currently use. The monoclonal antibodies are not in that category of a blood fraction. These are genetically engineered. The fully human antibodies are genetically engineered. They are created in laboratories for administration. The early models were where these antibodies were generated in mice and extracted from mice for administration. Maybe that’s considered a blood fraction because they had to be extracted from the serum. The current technology in treatments don’t involved — and treatments don’t involve direct blood.
Catherine: Here is a two-part question. Our Biologics effective to treat allergies and if I am taking allergy shot are they still needed — do I need to get the allergy shot if I start Biologics?
Dr. Merchart: Yeah. Great questions. Generally, again, current Biologics, specifically Omalizumab has been used off label for treatment in conjunction with individuals receiving allergic immunotherapy or subcutaneous imino therapy where they have had — immunotherapy where they have had an extreme reaction to reduce the risk of anaphylaxis associated with immunotherapy. The key difference between Biologics and immunotherapy is the immunotherapy is stimulating the immune system to sort of change the inflammatory response to be more protective versus the Biologics that are targeting those markers for inflammation to reduce that inflammatory state. Both are currently used in combination, off label for oral immunotherapy and subcutaneous immunotherapy to reduce the risk for anaphylaxis. I think we will learn with time how these medications — if one option is a better option or not. Immunotherapy traditionally has been around for a century. It works extremely well. The other key piece — I did not really talk about it. Biologics are expensive. These medications cost several thousand dollars. We don’t jump through them right at the beginning because it would bankrupt the systems we live in with regards to the cost of medications. If we treated 25 million asthmatics with Biologics we would be spending well over — all the treatments for allergic conditions. There is a place where Biologics provide a tremendous benefit but cost is always a factor. We try to balance those pieces in the traditional treatments are very cost effective options and work well with good adherence and other considerations.
Catherine: I was going to say that’s one of the questions in the chat about cost. They are expensive. I would add onto that as well depending on what kind of insurance you have. I know some people get their insurance at the transition years and don’t bother to check to see whether or not they are approved. This is a specialty drug. It would just behoove you to check your insurance coverage as well. Adding on to what you said, Dr. Merchant. That was one of the questions in the chat, that and access to Biologics.
Dr. Merchart: I think Biologics do have good access. They have good coverage when you have insurance. There are programs that help to provide access for most of the pharmaceuticals for patients that really would benefit from it. I think as we continue to have more medications available I think costs likely will decrease over time, both based on the ability of the technology to reduce costs becomes cheaper and competition among pharmaceuticals will potentially drive down costs as well.
Catherine: OK. One of the questions. Are all Biologics all injectable?
Dr. Merchart: Yes. Biologics, because of their complex molecules involved are all injectable. Either an IV or sub continuous injections for all — subcutaneous injections for all monoclonal antibodies.
Catherine: I think it is worth repeating. One of the questions is, what are some of the common side effects of Biologics and who should not be prescribed them?
Dr. Merchart: Yeah. The most common side effect typical with most injections are pain, redness, swelling at the injection sites. It is usually a mild symptoms that are experienced and depending on the frequency of the injections some of the Biologics are administered every two weeks. Some are administered every two months. Some of the newer ones are even every six months. That is generally the most common side effect. A very, very small risk of having anaphylaxis to some of the Biologics, not all. If there has been any previous history of having anaphylaxis to a biologic, that would be a counter indication to potentially using a different biologic. That is not an absolute risk to say if you had a reaction to an5 — an IL-5 that he would have a similar risk to a TSLP monoclonal antibody. We are still learning but that’s always where we would be most cautious of having some sort of severe adverse effect and then be able to say do we apply that across all monoclonals or not.
Catherine: One thing I wanted to mention in the chat. If you’re interested in learning more about Biologics, there is a link that you can click on. You will learn more about it, as well as an insurance and access webinar that we had that you can take a look at. There were a lot of questions in the chat about that. One other question we have, Dr. Merchant. What is the risk of immune suppression and cancer with Biologics? This is a major concern for people taking Biologics.
Dr. Merchart: Yeah. As with any manipulation of the immune system we are always trying to be aware of the unintended consequences. Most of the Biologics — before they even get to clinical trials for consideration have been weeded out to say these side effects or these parameters are not things that warrant further development of the drug. The current ones we have have gone through a pretty rigorous process to look at the overall benefits and the targets and trying to make sure there are no unintended significant consequences. Cancer has not been identified particularly as a risk factor. Omalizumab has been around for about 20 years and we have not seen a specific increase or risk for any major organ problem like liver or kidney disease or anything associated with cancer. Depends on the target. The more target specific monoclonals are the more likely for severe implications versus oral steroids and steroids in general are highly immunosuppressive at high doses where we block everything and have greater risk for infection. We see less of those issues with most Biologics. The biggest risk factor for infection comes from blocking the IL-5 pathway and eosinophil s, which are typically used to fight parasitic infections. Not generally a major concern for us in the U.S. but certainly in other countries. Parasites are things we need to be aware of. If there is a travel history or something we want to be a little more aware of that risk factor. Parasites being more likely to maybe cause problems if we have suppressed the eosinophil pathway.
Catherine: OK. Dr. Merchant, you had a slide up, and informative slide were you listed all the mabs. I will call them mabs because I have trouble pronouncing the whole thing. The mab slide listed what it was and what pathway it was intended for. This question is interesting. It says, have any of the mabs been used in combination to cover different pathways? Do you know of any studies or that has happened? — where that has happened?
Dr. Merchart: I don’t know of any specific studies that have looked at those combinations. There are case reports and case studies that have been published where one monoclonal antibody did not work and where a second monoclonal antibody was used in combination with one. There are case reports. As clinical experience and expertise among clinicians and some of the academic centers for refractory cases come into play there is more and more awareness that monoclonals can be used together and can be used safely. They may provide a smaller subset of patients that did not benefit from one or two different monoclonal pathways. That may be a combination would be a beneficial. That is something that is ongoing in terms of the overall understanding of the disease pathways.
Catherine: Dr. Merchant, this has been a great webinar. I want to give a special shout out and big thank you to all that attended. Everyone was so engaged. There are very thought-provoking questions and good questions. Thank you to the audience for joining us. Really informative. Just wanted to let you know we have several webinars coming up in November and December. First of all, join us please on November 5 at 4:30 p.m. Eastern standard Time for the next webinar in the black people like me conference series focusing on addressing COPD in the black community. I can’t tell you how much I’m looking forward to this one. We actually have a patient a story you want to share with you. You will get live experience with that. Really excited about that. Join us on November 12 at noon Eastern standard Time when Dr. Michael Blaise will review the consensus statement. On December 5, we welcome Dr. Pervi Perik to talk about how to address vaccine hesitancy. You will receive any mail from Zoom with a link to the recording and evaluation. Really important so fill that out so we can make sure what we are giving you resonates with you and something you really need. We will have supplement of resources. With that I want to say thank you again from all of us at the allergy and asthma network. Join us always as we work every day to breathe better together. Have a good afternoon.
Dr. Merchart: Thank you.
