A recent study released at the American Asthma, Allergy and Immunology (ACAAI) American annual meeting in Seattle, Washington suggested that omalizumab (Xolair, Genentech) reduces the prevalence of fall, winter and worsening the spring against placebo in adolescent and adults with severe asthma, and corresponding results of the ICATA study in children.
Bill Busse, MD, was a medicine professor in the Department of Allergy, Pulmonary and Critical Care Department at the University of Wisconsin, School of Medicine and Public Health, to explain how therapy can be used to help patients suffering seasonal asthma aggravated.
Why should doctors consider omalizumab for severe or seasonal asthma cases?
As a background for this, we have published 2 papers. First of all, you certainly know about the seasonal variation in asthma aggravated reported out of Canada. He is called a "September epidemic of asthma aggravating," and he has been described since about 1990.
Within about 2 weeks of children going back to school in early September, emergency room visits for asthma are increasing. The mind behind this is 2 years. Number 1 is when children go back to school, rhinofirus infections spread, so we've exacerbated their disease. The second idea is that this is the time of the year when the symptoms of allergy are intensified.
So, both of these factors come together during this time, and I'm giving the children – and I think to some extent that the adults – are at greater risk o get asthma worse.
We reported in 2010 or 2011 in the New England Journal of Medicine, the study of the inner city asthma consortium, sponsored by National Institutes of Allergy and Infectious Disease with omalizumab. These are children living in inner cities across the country that are at great risk of aggravating asthma, and all are likely to be allergic as long as the characteristics of the disease cause anxiety
What was discovered is that omalizumab has greatly reduced the frequency these older children got worse. But when we looked at the data and mapped on a monthly basis, what you see is that the differences are noted in the ability of omalizumab to reduce asthma flame, which occurs in spring and # 39 ; r fall – this is when children come back from holiday vacations and also the time when rhinofirus infections are more likely to occur.
The importance of this observation of perspective is that it really shows that the allergic antibody IgG is associated with a risk factor for aggravating asthma when children get cold.
Then we made a second publication, which I announced in 2015 or 2014 in the Journal of Alergy and Clinical Imunology, was the study on pre-time asthma treatment with either an omalizumab or a small boost in respiratory corticosteroids. The study was designed to look at the seasonal dresses that children had. We started treatment one month before they returned to the school in September and continued for the first 3 months of being at school, so there were 4 months of treatment during this high risk period. We have seen that it significantly reduces the risk of aggravating asthma, stating that the seasonal aspect is important.
So, those were the observations we received, and that's why these summaries were looked at to try to build one of two aspects – and I think that only one of them can go to & # 39 – can it be connected to blocking the IgE path with some improvement in the function of the lungs.
We see data that omalizumab improves the function of the lungs in children and in some adults. This is an indication that suggests, by reducing inflammation by using this monoclonal antibodies, that we will get some relief in the inflammation of the airway.
Why is it important to have omalizumab as an additional treatment option?
There are a number of reasons, and I would like to address this in broad terms with all our biologists now available, as most of them hit the T2 path of allergic inflammation. I believe that having this 3 class biology offers an option: the anti IgE; the anti-lower route 5; and the anti 413 path with dupilumab.
Why is this important? O perspective – and I believe that the epidemiological data supports this – worsening the task is a major cause of burden and risk for patients with asthma. They are expensive, they endanger their lifestyle, and there is data to suggest that repetitive periods of asthma aggravation lead to a greater likelihood of losing the function of the lungs over time.
The other aspect is that the standard treatment is currently with systemic corticosteroids, and again, we get good data to suggest that using multiple courses of systemic corticosteroids in a short period of time is not an unfair situation. It really leads to increased risk for other consequential diseases such as high blood pressure, diabetes, osteoporosis, etc. and changes in levels of growth in children.
Even more importantly, these biolegascics may be more target-specific for the events that lead to aggravating asthma or creating systemic corticosteroids. The children and adults in danger of exacerbating this are at high levels of treatment, and the treatments do not prevent them from the main risk factor of asthma aggravating. Therefore, having a treatment that, in my opinion, is more specific, and where the mechanical events that lead to asthma exacerbation, are extremely important. In terms of improving disease control, and also to reduce the likelihood that these individuals will have side effects from taking high doses of asthma medications, and may not be as effective as their disease.
What are the best practices for prescribing omalizumab in the clinic?
First of all we have to ask ourselves: Is the person with a serious disease? Are they at GINA 4 or 5? If yes, these are potential candidates for omalizumab. The second thing you need to define is if they meet the criteria for serious diseases because they have a serious illness or because they have either had diseases that are consistent, or if they do not take their medications, or even do not have asthma. So, I think we need to look at those things quickly.
The other thing we need to start doing is profiling these individuals. With omalizumab, it is predominantly prescribed in individuals with evidence of apparent IgE sensitivity. Here are the criteria established 20 years ago, yet these are prescribing practices.
Data that appears in the literature suggests that IgE, which is related to allergic sensitivity can also be the same as omalizumab criteria. But prescribing practices require allergic sensitivity to at least 1 allergen.
My reflection would also be to look at other marks such as levels of eosinophilia in the peripheral blood, and also exhaled nitric oxide. An American Journal of Resinratory Critical Care published a few years ago looking at data from the EXTRA trial, and what was shown was, in an adult, those individuals that were higher than median level of peripheral blood etrophils – and cut off 260 cells per cubic millimeter or above median value for nitric oxide exhaled (19.5 parts per billion) – these are the individuals that # 39; n responding to a higher degree with omalizumab. So, I believe you not only want to look at the standard recommendations (allergic sensitivity), yet if they have other marks that suggest they are more in the type of air route distribution type . Therefore, I think that these are the factors that all doctors who consider biological, including omalizumab, should be considering.