On March 20, 2024, the Environmental Protection Agency (EPA) finalized the strongest vehicle emissions standards ever. The standards will apply to cars made after 2026.

Vehicle emission standards limit how much pollution vehicles can release into the environment. These standards aim to reduce air and climate pollution and to improve air quality.

The Asthma and Allergy Foundation of America (AAFA) advocated for these standards and will continue to advocate for a future where cars don’t pollute the air or contribute to climate change. You can read AAFA’s full statement below:

Welcome to our April research update! Getting involved with research is an important way to impact asthma and allergy treatments, education, and awareness.

This month, we are highlighting clinical trials, surveys, and news on:

• Adults with asthma
• Approval of a treatment for kids with severe asthma
• Asthma and allergy control and quality of life
• Gaps in care for people with severe uncontrolled asthma
  
  

Note: The links below will take you to external websites.

Latest Asthma and Allergy News

Asthma

FASENRA Approved for Treatment of Children Aged 6 to 11 with Severe Asthma
The Food and Drug Administration (FDA) recently approved AstraZeneca's FASENRA® (benralizumab) as an add-on treatment for kids aged 6 to 11 who have severe asthma with high levels of eosinophils. This approval expands the use of FASENRA, a biologic treatment. It was already approved for people aged 12 and older with the same type of severe asthma.

The decision was based on evidence from a study called TATE, which showed that FASENRA was as safe in younger children as it was in people aged 12 and older. FASENRA is given as an injection under the skin every 4 weeks for the first 3 doses, and then every 8 weeks. This approval offers more treatment options for kids with severe eosinophilic asthma.

Poor Asthma and Allergy Control Is Linked to Lower Health-Related Quality of Life
A new study from Europe looks at how asthma and allergic nasal and eye symptoms affect people's health-related quality of life. The researchers used data from over 7,000 people in Europe with self-reported asthma or allergies who used an app called MASK-air®. This app was developed in Europe and aims to reduce the burden of allergic nasal and asthma symptoms by measuring quality of life through a questionnaire.

The researchers found that when asthma or allergy symptoms were well-controlled, people had a better quality of life. But when they were not well-controlled, their quality of life got worse.

In general, having asthma or nasal and eye allergies has an effect on quality of life, but especially when they're not well-managed. This information can help doctors and scientists understand how to better care for people with asthma and nasal and eye allergies to improve their overall quality of life.

Gaps in Care Among People with Uncontrolled Severe Asthma in the United States
A new study takes a closer look at how non-specialist doctors follow treatment guidelines for severe asthma in the United States. The researchers wanted to see if people with uncontrolled severe asthma got appropriate guidelines-based treatment after having a serious asthma event that resulted in an emergency department visit and/or hospital stay.

Researchers looked at data from over 180,000 patients with severe asthma from 2015 to 2020. Half of the severe asthma patients were considered not well-controlled. They found that many patients didn't see a specialist or increase their medicine after having a severe asthma event. They also found that these patients were more likely to have more asthma attacks later. Severe asthma treatment guidelines include a recommendation for a referral to a specialist after a serious asthma event or attack.

The study authors also found that Black or Hispanic/Latino patients were less likely to get specialist care or a medicine increase after their asthma attack compared to non-Hispanic White patients. The study highlights the need for improved guideline-based care for people with severe asthma, especially if uncontrolled, and for those facing social disparities.

Medical Review: April 2024 by Mitchell Grayson, MD, and Jerry Shier, MD

Teva Pharmaceutical Industries Ltd. plans to discontinue all its Digihaler® products sold in the U.S. on June 1. This includes: ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler. Both ProAir and AirDuo are available in Teva’s Respiclick products – the same medicine formulations without the digital component. Teva does not offer the ArmonAir formulation in a branded alternative or generic.

The ArmonAir Digihaler is an inhaler that had been recommended as another option for Flovent. Brand-name Flovent was discontinued at the end of 2023.

If you currently use a Digihaler product, talk with your health care provider about other options now.

Here are some other possible options for Teva’s Digihaler products:

Possible replacements for ProAir Digihaler (quick-relief inhaler)

Clinical equivalent to ProAir Digihaler:

• ProAir Respiclick (dry powder albuterol inhaler made by Teva)
• ProAir HFA and the authorized generic (albuterol – metered dose inhaler)
• Other generic albuterol HFA inhalers (available as metered dose inhalers but may not be exact equivalents to the ProAir HFA generic, as the inactive ingredients may be different)
  
  

Different but equally effective:

• Xopenex HFA and generic (levalbuterol HCI – metered dose inhaler)
• AIRSUPRA (albuterol/budesonide – a quick-relief medicine that contains two medicines)
  
  

Possible replacements for ArmonAir Digihaler (inhaled corticosteroid)

• Generic fluticasone propionate HFA (metered dose inhaler – doses are slightly different than ArmonAir but equally effective)
• Generic fluticasone propionate Diskus (dry powder inhaler – dosing may be different than ArmonAir and the inactive ingredients may not be exactly the same)
  
  

Other options that are different but equally effective:

• Arnuity Elipta (fluticasone furoate)
• QVAR RediHaler (beclomethasone dipropionate - breath actuated inhaler)
• Alvesco (ciclesonide – metered dose inhaler)
• Pulmicort Flexhaler (budesonide – dry powder inhaler)
• Asmanex HFA (mometasone furoate - metered dose inhaler)
• Asmanex Twisthaler (mometasone - dry powder inhaler)
• ARNUITY ELLIPTA (fluticasone furoate – dry powder inhaler; not equivalent to ArmonAir Digihaler)
  
  

Possible replacements for AirDuo Digihaler

Advair Diskus and Advair HFA and their generics may be an option. They contain the same medicine as AirDuo. The doses are different but equal and can be substituted. The inactive ingredients are different.

• Advair Diskus or generic fluticasone propionate/salmeterol Diskus (dry powder inhaler)
• Wixela Inhub (fluticasone propionate/salmeterol – dry powder inhaler)
• Advair HFA or generic fluticasone propionate/salmeterol HFA (metered dose inhaler)
  
  

Other options that are different but equally effective:

• Symbicort and generic Breyna (budesonide/formoterol - metered dose inhaler)
• Dulera (mometasone/formoterol – metered dose inhaler)

Your doctor can help you choose the best replacement for you.

This is part of a statement Teva sent to health care providers:

“On 6/1/2024 Teva will discontinue distribution of the Digihaler® products in the US [ProAir® Digihaler® (albuterol sulfate) Inhalation Powder, ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder, AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder]. Software and technical support for the Digihaler app and dashboard will end on 6/1/2024.”

AAFA issued the following statement about the discontinuation:

“It is unfortunate to hear that more asthma inhalers are being discontinued. The Teva Digihaler portfolio had offered an innovative approach to encourage adherence to treatment by integrating a digital solution with an inhaler. We hope manufacturers continue to invest in new asthma therapies.

It is imperative that people using Teva’s Digihaler products to treat their asthma reach out to their provider now to determine the best alternative treatment options. Unfortunately, when GSK discontinued Flovent, some people using that inhaler were transitioned to the ArmonAir Digihaler. Some formularies do not cover the authorized generic of Flovent, forcing patients to change treatment. Manufacturers, insurance companies, and pharmacy benefit managers have a responsibility to work together to ensure continued access to life-saving asthma medicines.”

Medical Review: April 2024 by Jerry M. Shier, MD

In 1984, President Ronald Reagan declared a week in May to be National Asthma and Allergy Awareness Week at the request of the Asthma and Allergy Foundation of America (AAFA). Since then, we have expanded our annual awareness campaign to a full month. May is a perfect time to educate patients, family, friends, co-workers, and other people about asthma and allergic diseases that impact more than 100 million people in America.

Each year, AAFA continues to spread awareness in May during National Asthma and Allergy Awareness Month. Recently, AAFA sent a letter to President Biden asking him to declare May to be National Asthma and Allergy Awareness Month (see letter below). The letter highlights the importance of promoting awareness, education, and understanding of these diseases.

You can join our efforts to improve asthma and allergy awareness and health care in three ways.

• Use our simple tool below to send a tweet to President Biden and join AAFA in requesting this important declaration.
• Use the White House contact form to email President Biden using this link: whitehouse.gov/contact
• Call the White House at 202-456-6213.
  
  

Let’s make the 40^th anniversary of National Asthma and Allergy Awareness Month count!

President Joseph R. Biden

The White House

1600 Pennsylvania Avenue, N.W.
Washington, DC 20500

April 4, 2024

Dear Mr. President,

On behalf of the Asthma and Allergy Foundation of America (AAFA), the leading patient organization advocating for people with asthma and allergies and the oldest asthma and allergy patient group in the world, I am writing to request that you issue a proclamation declaring May as “National Asthma and Allergy Awareness Month.” I believe this declaration will support the leadership you’ve already demonstrated, and AAFA has supported, in addressing health equity, climate change, access to health care, and lowering the cost of inhalers.

I was honored to attend your event on April 3 on lowering health care costs where you recognized that in the United States, asthma presents significant burdens for over 27 million adults and children, as well as their families and caregivers. Annually, asthma costs our society an estimated $82 billion in direct and indirect expenses, including medical costs related to 4.9 million office visits, 1.5 million emergency visits, and 169,330 hospitalizations. It is estimated that from 2019 to 2038, the total cost of uncontrolled asthma could exceed $963 billion in direct and indirect costs. Asthma is also the leading chronic disease among children and a top reason for missed school days.

Racial and ethnic disparities in the burden of asthma have long been established and supported by a large body of evidence. Black people in the U.S. have the highest rates of asthma. Black people are nearly three times more likely to die from asthma than White Americans. Black patients are also nearly 6 times more likely to be treated for asthma in hospital emergency rooms compared to White patients. These disparities are largely driven by interrelated and multidimensional social and structural determinants. Long-term systemic racism and discriminatory policies in housing, education, labor, health care, and the environment have created disadvantages for minority populations and exacerbated racial disparities in health.

Food allergies represent another significant burden on over 20 million people in America. Approximately 1 in 16 children and adults in the U.S have food allergies.^1,2 Food allergies can result in a severe reaction caused anaphylaxis that in rare cases can lead to death. Unfortunately, the prevalence and impact of food allergies in the U.S. are increasing; for example, the rate of emergency room visits for food-related anaphylaxis increased by 124% from 2005 through 2014.³ Children with food allergies are also two to four times more likely to have asthma or other allergic diseases.⁴

Raising awareness and educating people on how to manage asthma and allergies is key to beginning to address these longstanding disparities and the burden of disease. National Asthma and Allergy Awareness week was first recognized in 1984 by President Reagan at AAFA’s request. We ask that you continue to recognize the importance of raising awareness for the millions of Americans and their families living with asthma and allergies and have included a draft proclamation for you use to this letter. Thank you for your consideration and leadership.

Sincerely,

Kenneth Mendez

President and CEO

Asthma and Allergy Foundation of America

Download AAFA’s letter to President Biden asking him to declare May to be National Asthma and Allergy Awareness Month.

References
1. Ng, A.E. & Boersma, P. (2023). NCHS Data Brief, no 460: Diagnosed allergic conditions in adults: United States, 2021. National Center for Health Statistics. https://dx.doi.org/10.15620/cdc:122809
2. Zablotsky, B., Black, L.I., & Akinbami, L.J.(2023). NCHS Data Brief, no 459: Diagnosed allergic conditions in children aged 0-17 years: United States, 2021. National Center for Health Statistics. https://dx.doi.org/10.15620/cdc:123250
3. Motosue et al., “Increasing Emergency Department Visits for Anaphylaxis, 2005-2014.” J Allergy Clin Immunol Pract. 2017 Jan - Feb;5(1):171-175.
4. Branum, A., & Lukacs, S. (2019). Food Allergy Among U.S. Children: Trends in Prevalence and Hospitalizations. Centers for Disease Control and Prevention; National Center for Health Statistics. https://www.cdc.gov/nchs/products/databriefs/db10.htm

Asthma is the main reason why children miss school. In fact, children in the U.S. miss about 13.8 million school days each year due to asthma.¹ Missing school can affect many children's grades and well-being.

Controlling asthma triggers at home can help reduce asthma symptoms. But what about at school? If kids are exposed to triggers at school, managing asthma at home will be difficult.

April 9, 2024, is National Healthy Schools Day. The Healthy Schools Network uses this day to highlight how school environments affect the health and learning of school children. This year’s theme is “AIR JUST AIR.”

Children are the most affected by air pollution and poor indoor air quality. The Asthma and Allergy Foundation of America (AAFA) is a supporter of National Healthy Schools Day. We believe healthier schools can help children not only perform better in school but have a better quality of life.

Read more from AAFA on indoor air quality and its impact on school children with asthma.

How Can I Help My Child’s School Be Healthier?

Tell your child's teacher and school administrators about National Healthy Schools Day. Share these websites with your school for more information about healthy school environments and activities:

• nationalhealthyschoolsday.org
• aafa.org/schools
• epa.gov
• cdc.gov
  
  

Help us support National Healthy Schools Day by spreading the word about how we need healthier schools for our children to learn in!

Learn more about National Healthy Schools Day and find a list of resources to improve our schools.

Updated April 2024

Reference
Centers for Disease Control and Prevention. (2015). Asthma-related Missed School Days among Children aged 5-17 years. U.S. Department of Health and Human Services. https://www.cdc.gov/asthma/ast...ats/missing_days.htm

You’ve probably heard the buzz that a trillion cicadas from two different broods are expected to begin appearing in the Midwest and Southeast regions of the United States at the end of April. Some people are obsessed with observing or documenting these periodic cicadas. Other people think they make enticing cuisine.

But the Food and Drug Administration (FDA) says if you have a shellfish allergy, you definitely don’t want to eat cicadas. They are related to shrimp and lobsters. If you see “cicada scampi,” are offered candy choc’ full of cicadas, or even see them served up raw, you may want to steer clear.

Here’s the warning:

Yep! We have to say it!

Don't eat #cicadas if you're allergic to seafood as these insects share a family relation to shrimp and lobsters. https://t.co/UBg7CwrObN pic.twitter.com/3qn7czNg53

— U.S. FDA (@US_FDA) June 2, 2021

David Stukus, MD and a member of the Asthma and Allergy Foundation of America’s (AAFA) Medical Scientific Council, breaks down the reasons for the FDA warning:

Here’s the deal:
🍤People with shrimp, crab & lobster allergy reaction to a muscle protein called tropomyosin
🦞They do not react to the shell
🪰Cicadas also have tropomyosin

⚠️If you have a shellfish allergy, it’s not advisable to eat cicadas.
Casual exposure poses no risk.👍 https://t.co/9HfJAklWum

— Dr. Dave Stukus (@AllergyKidsDoc) June 2, 2021

Dr. Stukus, the Director of the Food Allergy Center and Associate Professor of Pediatrics in the Division of Allergy and Immunology at Nationwide Children’s Hospital in Ohio, told Emily Heil of The Washington Post that allergic reactions to foods occur when people eat proteins. People with a shellfish allergy typically react to a muscle protein called tropomyosin.

“Many insects contain this tropomyosin muscle protein which is very similar to that found in shellfish,” Dr. Stukus noted. “Therefore, if you have a shellfish allergy, it is probably not a good idea to eat cicadas or other insects without at least first discussing it with your allergist.”

There isn’t a lot of research on the risk of allergic reactions to cicadas in people with a shellfish allergy. But Dr. Stukus says when you aren’t certain of any danger, it’s best to leave cicadas out of your diet. So skip the cicadas on the menu, even though they literally may be all over the map.

Oh, and about that general “don’t eat cicadas if you have a seafood allergy” warning from the FDA? It may be broad for a reason. But it also might be a little misleading.

“People who have allergies to finned fish like salmon or tuna tend to react to other proteins which don’t necessarily cross react,” explains Dr. Stukus. “If you have a seafood allergy, you don’t always necessarily have to always avoid crustaceans and finned fish.”

The FDA may have put out the overall “seafood” language as a general precaution. But the warning is specifically for people with shellfish/crustacean allergies.

Also, there’s no muscle protein in the cicada’s shell. The only time cicadas pose a risk for people with a shellfish allergy is if you eat them. So if you can’t resist being around the big bug shells or the carcasses they leave behind, go wild!

“Cicadas are not going to bother anybody with shellfish allergy unless they actively go out of their way to capture them and then ingest them,” Dr. Stukus shares. “That’s the risk for reaction. You can have millions of them on your trees and in your yard − you are going to be fine. The shells they leave behind will not cause any risk for people who want to collect the shells. [Here’s an example:] If you have a lobster allergy, you can hold it in your hands and play with it all day. It’s not going to cause an allergic reaction. You just can’t eat the muscle.”

AAFA is pushing to lower the costs of asthma and allergy medicines, including inhalers. We know the high cost of medicine can be a barrier to treatment.

Some major asthma inhaler manufacturers have announced $35 a month caps on out-of-pocket costs. The price cap will apply to people with commercial/private insurance or no insurance. The inhalers that will be price capped include:

AstraZeneca (effective June 1, 2024):

• AIRSUPRA® (albuterol and budesonide) inhalation aerosol
• BEVESPI AEROSPHERE® (glycopyrrolate and formoterol fumarate) inhalation aerosol
• BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol
• SYMBICORT® (budesonide and formoterol fumarate dihydrate) inhalation aerosol

Boehringer Ingelheim (effective June 1, 2024):

• Atrovent® HFA (ipratropium bromide HFA) inhalation aerosol
• Combivent® Respimat® (ipratropium bromide and albuterol) inhalation spray
• Spiriva® HandiHaler® (tiotropium bromide) inhalation powder
• Spiriva® Respimat®25 mcg (tiotropium bromide) inhalation spray
• Spiriva® Respimat®5 mcg (tiotropium bromide) inhalation spray
• Stiolto® Respimat® (tiotropium bromide and olodaterol) inhalation spray
• Striverdi® Respimat® (olodaterol) inhalation spray

GSK (with price change going into effect no later than Jan. 1, 2025):

• Advair Diskus (fluticasone propionate and salmeterol inhalation powder)
• Advair HFA (fluticasone propionate and salmeterol inhalation aerosol)
• Anoro Ellipta (umeclidinium and vilanterol inhalation powder)
• Arnuity Ellipta (fluticasone furoate inhalation powder)
• Breo Ellipta (fluticasone furoate and vilanterol inhalation powder)
• Incruse Ellipta (umeclidinium inhalation powder)
• Serevent Diskus (salmeterol xinafoate inhalation powder)
• Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder)
• Ventolin HFA (albuterol sulfate inhalation aerosol)

AAFA is leading the way to reduce health care costs for people with asthma

"On behalf of the 27 million people in the United States with asthma, we appreciate the leadership of President Biden and Senator Sanders to bring down costs for asthma treatments. Pricing announcements made in March by some manufacturers of inhalers will mean lower costs and improved access to asthma medicine for many people with asthma starting this June,” said AAFA President and CEO Kenneth Mendez. “As President Biden indicated, more can and should be done. It’s not just drug companies, others need to step forward. We welcome continued efforts to improve affordability and accessibility of these essential medicines so all patients can get the treatment they need.”

AAFA continues to raise the voice of the patient community and draw attention to the ways America’s complex drug pricing ecosystem makes asthma medications more expensive for people who need them most. Drug manufacturers, pharmacy benefit managers, insurers, employers, and the government must work together to improve affordability and access.

Access to affordable drugs is a critical component of reducing racial disparities in asthma. Black and Hispanic individuals not only experience higher rates of asthma but also are more likely to be uninsured or underinsured. Deaths due to asthma – although decreasing overall – occur at a much higher rate in the Black and Puerto Rican populations than in the White population. Black individuals are nearly three times as likely to die from asthma than White individuals.

Last fall, AAFA shared patient stories and its Asthma Disparities in America report with the Senate Health, Education, Labor, and Pensions (HELP) Committee which then launched an investigation into the high price of asthma inhalers early this year.

AAFA’s research indicates that when the cost of medicine becomes a barrier to treatment, people with asthma resort to rationing or simply discontinue use.

Access to asthma medications can save lives, reduce hospitalizations, and lower the more than $82 billion in annual costs to the U.S. economy from this chronic disease. But the U.S. health care system is complex, and often leaves patients with few affordable options.

The health of your home can affect your personal health. April is National Healthy Homes Month, led by the Office of Lead Hazard Control and Healthy Homes (OLHCHH) at the U.S. Department of Housing and Urban Development (HUD).

This year’s theme is “MAKING AN IMPACT: Healthy, Safe, and Resilient Homes.” Each week will have its own focus:

• Week 1 – Healthy Homes Investments Make Local Impact
• Week 2 – Housing Professionals' Role in Healthy Homes
• Week 3 – Impacts of Healthy Homes Interventions on Public Health
• Week 4 – Making Home Healthy, Safe and Resilient
  
  

The Asthma and Allergy Foundation of America (AAFA) joins with HUD and OLHCHH to help raise awareness about ways to make your home healthier, especially for people with asthma and allergies.

Why Is It Important to Have a Healthier Home?

There are many factors that can affect your home’s health. Mold from a leaky roof or lead from old paint are some examples. When you have asthma or allergies, triggers and allergens in your home – such as dust, pests, and mold – can cause asthma and allergy symptoms. In the U.S., people spend about 90% of their time indoors, whether at school, home, or in the workplace.¹ Reducing your exposure to your triggers is an important part of managing your asthma and allergies.

How Does AAFA Advocate for Healthier Homes?

Week 1 of National Healthy Homes Month focuses on the connection between housing and health, especially in marginalized communities.

The quality of housing is a major factor in asthma disparities in the United States. Families living in low-income housing are more likely to be exposed to harmful asthma triggers and are at a greater risk of having severe asthma. These families often don’t have the resources to address health issues in the home.

AAFA advocates for state and federal policies that promote healthy settings for people with asthma or allergies in various settings, including in rental and low-income housing. We also support repayment for preventative services and home assessments that provide asthma education for people with severe asthma.

AAFA is a member of several coalitions that also support improving housing on a national and community level, including the National Safe and Healthy Housing Coalition (NSHHC), DC Healthy Housing Collaborative (DCHHS), and California Asthma Financing Workgroup.

How Can I Make My Home Healthier?

AAFA offers various resources to help improve your indoor environment.

AAFA’s Healthy Settings webpage offers a list of resources and services to promote healthier environments in a variety of settings. If you are a homeowner or renter, the Healthy Housing section of the webpage provides tools, guides, and local and national resources to help make your home healthier.

AAFA’s Healthier Home Checklist is a great tool to help you reduce asthma and allergy triggers in your home. The interactive tool shows you how to tackle these triggers in each room in your home.

AAFA's asthma & allergy friendly® Certification Program helps you make informed decisions on products that can help reduce your exposure to asthma triggers and allergens. When you are shopping for products for your home, look for the CERTIFIED asthma & allergy friendly® mark. It indicates the product has passed our testing standards. Visit aafa.org/certified to search for CERTIFIED products. There you can also learn more about the program.

Here are more resources about making your indoor air healthier:

• Improve Your Indoor Air Quality to Improve Your Health
• Why Healthy Indoor Air Quality Is Important
• Find Out If Your Home Is Asthma and Allergy Friendly with Our Healthier Home Assessment
• Sources of Air Pollution in Your Home That May Cause Asthma and Allergy Symptoms
• Breathe Easier: Improving Indoor Air Quality in Your Bedroom, Living Room, Kitchen, and Attic or Basement

References
1. Environmental Protection Agency. Questions about your Community: Indoor Air. http://www.epa.gov/region1/communities/indoorair.html

Welcome to our March research update! Getting involved with research is an important way to impact asthma and allergy treatments, education, and awareness.

This month, we are highlighting clinical trials, surveys, and news on:

• Adults with asthma
• Epinephrine nasal spray
• Dupilumab for moderate-to-severe asthma and chronic obstructive pulmonary disease (COPD)
• COVID-19 vaccination during pregnancy
• Treatment for chronic spontaneous urticaria (CSU)
  
  

Note: The links below will take you to external websites.

Latest Asthma and Allergy News

Anaphylaxis

News on NDS1C Epinephrine Nasal Spray
Bryn Pharma recently announced new information about their epinephrine nasal spray (NDS1C). The spray is designed to treat severe allergic reactions, also known as anaphylaxis.

The data presented showed the spray is effective in delivering the medicine and is safe for people to use. When given in repeated doses, it also showed no negative effects on safety or effectiveness compared to the single dose.

Data also showed that the spray was absorbed in the body faster than other types of epinephrine injections. This means it could be another option for people who need quick relief from severe allergic reactions if approved.

Asthma

New Research on DUPIXENT® for Adults with Uncontrolled Moderate-to-Severe Asthma
Results from a study on DUPIXENT® (dupilumab) were recently presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The study looked at how the treatment affects the airways in adults aged 21 to 70 years with moderate-to-severe asthma, or with oral steroid dependent asthma. It found that participants taking DUPIXENT had reduced inflammation in the airways and improved breathing after about 6 months. The medicine also helped reduce mucus buildup in the lungs that can make it hard to breathe.

Using a new imaging technology, researchers saw greater improvements in overall lung function and less mucus in people taking DUPIXENT® compared to people who didn’t take this treatment. The medicine's safety profile was similar to what's already known, with some common side effects like infections and injection site reactions. Overall, the study suggests that DUPIXENT® could be a helpful treatment for adults with moderate-to-severe asthma.

Chronic Obstructive Pulmonary Disease (COPD)

DUPIXENT® Accepted for FDA Priority Review for Treatment of COPD With Type 2 Inflammation
The Food and Drug Administration (FDA) is reviewing a new use for DUPIXENT for treating chronic obstructive pulmonary disease (COPD) in certain adults. The application is based on research showing that in adults who were current or former smokers with uncontrolled COPD and who have a certain type of inflammation, the treatment helped reduce serious COPD flare-ups and improved lung function. The participants maintained the improvements for up to one year.

Safety results were in line with what's known about the medicine, with some common side effects including back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Priority Review is given to drugs that could make big improvements in treating, diagnosing, and preventing serious conditions. DUPIXENT has previously been approved for use in certain patients with asthma, atopic dermatitis, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Its use for COPD is still being studied, so its safety and effectiveness haven't been fully confirmed yet by any regulatory authority. The FDA decision is expected by June 27, 2024.

New Clinical Trials for People with COPD
AstraZeneca is starting a new study to see if a medicine called BREZTRI AEROSPHERE® could help people with chronic obstructive pulmonary disease (COPD) who are at risk of serious heart and lung problems including death. They're testing the use of this single inhaler, triple-combination treatment on people with COPD who are more likely to have heart or lung issues, regardless of how often they've had flare-ups in the past. Information from this study will help to provide useful information regarding the overall management of these types of individuals with COPD.

In another study, researchers are also comparing BREZTRI AEROSPHERE® (single inhaler, triple therapy) with another type of treatment (a single inhaler, dual combination) or a placebo inhaler (no treatment) to see which one works better for COPD patients' overall heart and lung health.

COPD affects millions of people around the world. If not treated appropriately, this disease can lead to severe exacerbations of lung and heart problems. Higher risk individuals with this lung disease who are not effectively treated can suffer from severe lung and heart events and even fatalities. These two studies aim to find better treatments to help people with COPD live healthier lives.

COVID-19

COVID-19 Vaccination and Boosting During Pregnancy Protects Infants for 6 Months
A study by the National Institute of Allergy and Infectious Diseases (NIAID) found that pregnant people who get mRNA COVID-19 vaccines can protect their babies from getting sick with COVID-19 for at least six months after birth.

The study looked at 475 babies born to people who were vaccinated during pregnancy. During the study, 271 people got two doses of a COVID-19 vaccine. The remaining 204 got two doses of this vaccine and a COVID-19 booster shot. The results showed that infants of parents who received two COVID-19 vaccine doses during pregnancy had a very good antibody response at birth. In addition, babies born to parents who received two doses of a COVID-19 vaccine with a booster dose during pregnancy had higher levels of antibodies against COVID-19 and greater protections against COVID-19 during their first 6 months of life. Of interest, none of the babies in the study had to go to the hospital because of COVID-19.

This research suggests that getting vaccinated with the COVID-19 vaccine during pregnancy not only protects the parent but also helps protect the baby. Two-dose administration of the vaccine followed by a booster shot during pregnancy provided the best protection for the infants. Finally, this shows that vaccination during pregnancy can help keep newborns safe from COVID-19 until they can get vaccinated themselves.

Chronic Spontaneous Urticaria (CSU)

Results from a Clinical Study on Rilzabrutinib for Chronic Spontaneous Urticaria (CSU)
Positive results from a Phase 2 clinical study called RILECSU show that a medicine called rilzabrutinib can help improve itchiness, hives, and urticaria in adults with CSU.

In the study, different doses of rilzabrutinib were tested. The highest dose showed significant improvement in itchiness, hives severity, and urticaria activity compared to a placebo. Rilzabrutinib was generally well-tolerated, with side effects like diarrhea and nausea reported more often than with the placebo.

Rilzabrutinib is still being studied. Its safety and effectiveness haven't been confirmed by any regulatory authority yet. But these results suggest it could be a helpful treatment for people with moderate-to-severe CSU.

Medical Review: March 2024 by John James, MD; Michael Pistiner, MD, MMSc; and Sarbjit Singh Saini, MD