Welcome to our October 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:
- New treatment options for eczema, chronic spontaneous urticaria (CSU), chronic obstructive pulmonary disease (COPD), eosinophilic granulomatosis with polyangiitis (EGPA), and nasal polyps
- The impact of climate change and environment on asthma and allergies
- Safety of direct penicillin challenges
Note: The links below will take you to external websites.
Asthma and Allergy Clinical Trials
Participate in Research for Potential Asthma Treatments
Individuals living with asthma have hope. A clinical trial seeking volunteers who have experienced an asthma flare-up in the past year despite taking a daily management medication. Compensation may be available for eligible individuals.Sponsored by Antidote
Surveys
Community Asthma Survey
If you are over 18 and have asthma, we want to hear about how the environment affects your breathing. By telling your story, you can help others understand and manage asthma better!
The Asthma and Allergy Foundation of America (AAFA) has a participating member on the survey steering committee and appreciates your support!
Participants Needed for Eczema Study
If you are a caregiver for a child under 18 with moderate to severe eczema, we would love to hear your opinions and perspectives. Your feedback can help impact guidelines for childhood eczema. Your child can take the survey too with your help.
Take a 15-minute online survey for a research study on using systemic (oral or injectable) medicines for eczema.
Your voice makes a difference! Each participant will be entered into a drawing for a reward.
Principal Investigator: Dr. Joy Wan (Johns Hopkins Medicine IRB00397225)
Interviews and Focus Groups
Opportunity for Our Asthma Community
If you’re living with moderate to severe asthma, or are a care partner for someone who is, we have a unique opportunity just for you!
We are looking for people with asthma, ages 12-64, to take part in a virtual workshop over the next month. Your stories and feedback will help create vital resources to improve care and support for asthma patients – and you’ll be compensated for your time!
Who Can Participate?
- People with moderate to severe asthma
- Care partners for patients with moderate to severe asthma
- Ages 12-64
By participating, you’ll be making a meaningful impact on the asthma community.
Latest Asthma and Allergy News
Anaphylaxis
neffy® Epinephrine Nasal Spray Now Available in the U.S.
In August 2024, the Food and Drug Administration (FDA) approved the epinephrine nasal spray, neffy®, for adults and children over 66 pounds for the treatment of severe allergic reactions, including anaphylaxis. The treatment is now available by prescription in the United States. Through the neffyConnect program, eligible people with commercial insurance can purchase 2 single-use devices for $25. Uninsured people can buy them for $199. Neffy is also available free to people who qualify for the ARS Patient Assistance Program. The nasal spray offers a needle-free alternative to epinephrine auto-injectors. Experts believe neffy will encourage more people to carry and use their epinephrine earlier during an allergic reaction. This can lead to treatment outcomes and fewer emergency room visits.
Allergy
How Climate Change Impacts Allergies
A recent article examined the impact of increased use of fossil fuels on the environment and allergic conditions. Increased use of fossil fuels has led to global warming, causing more extreme weather events like wildfires and storms. This results in higher levels of air pollutants, including particulate matter, greenhouse gases, and pollen. Together, these factors worsen allergic diseases.
Factors like droughts, floods, heat waves, pollution, and deforestation also add to the rise in allergies. As global warming and extreme weather continue to worsen, allergic diseases are expected to increase, which can put more strain on health care systems.
To improve health, the authors say we need to address climate change by reducing fossil fuel use and promoting biodiversity. Health care providers can also play a key role in educating patients about climate change's effects on health and advocating for policy changes to create a healthier, more sustainable future.
Safety of Direct Penicillin Challenges
In a direct penicillin challenge, a patient is given a small dose of penicillin and is monitored for signs of an allergic reaction. A recent study looked at how often people labeled as allergic to penicillin have allergic reactions during direct penicillin challenges.
The researchers analyzed data from 56 studies involving 9,225 participants. It found that only 3.5% of people experienced a reaction, most of which were mild. Children, outpatients, and people receiving graded or prolonged challenges had higher rates of reaction. Only 5 severe reactions were reported, including 3 cases of anaphylaxis, but none were fatal. These findings suggest that direct penicillin challenges are generally safe and could be widely used to evaluate penicillin allergies, helping reduce unnecessary allergy labels in both children and adults.
Asthma
Risk Factors for Missing Appointments Among Children with Asthma
Missing scheduled asthma appointments has been linked to more asthma flare-ups in children and higher health care costs. This study reviewed 17 studies involving 27,023 children to identify risk factors for missing appointments. It found that teenagers, non-White children, and children with less severe asthma were more likely to miss appointments. The analysis did not find significant differences based on insurance, allergies, gender, or rural living.
The study also showed that children who missed appointments had a higher risk of acute asthma events. These findings highlight the need to develop strategies to reduce missed appointments in children with asthma, which could lower the risk of severe asthma episodes.
A Look at Azithromycin as a Low-Cost Asthma Treatment
New treatments for severe asthma have greatly improved how the condition is managed, leading to better quality of life and fewer asthma attacks. Some treatments aim for “remission,” meaning patients experience no symptoms and do not need steroids. But defining remission is challenging, and it’s unclear what helps people reach this state.
One potential treatment is azithromycin, an antibiotic that may help reduce asthma attacks, especially for people with non-type 2 asthma. A study found that people with asthma taking azithromycin had higher rates of clinical remission compared to people who didn’t take the treatment. While azithromycin is affordable and widely available, it can have side effects and may lead to antibiotic resistance. More research is needed to fully understand its long-term effects and how it works with other asthma treatments.
Atopic Dermatitis (Eczema)
FDA Approves EBGLYSS™ for People 12 Years and Older with Moderate-to-Severe Atopic Dermatitis
In September, the FDA approved EBGLYSS for moderate to severe atopic dermatitis (AD) in people aged 12 and older who weigh at least 88 pounds and have not found relief with creams. EBGLYSS is an injectable biologic that can be used alone or with topical steroids. EBGLYSS works by blocking a protein that causes excessive inflammation. Treatment begins with two injections at weeks 0 and 2, followed by one every 2 weeks until week 16, after which patients can switch to a monthly dose. In clinical trials with over 1,000 participants, 38% of those on EBGLYSS had clear or almost clear skin by week 16, compared to 12% who did not take the treatment. Also, 43% of participants had itch relief at week 16. Common side effects include redness, swelling, and skin irritation.
Chronic Spontaneous Urticaria (CSU)
Dupixent® Phase 3 Trial Shows Improvements in Itch and Hives for Patients with Chronic Spontaneous Urticaria (CSU)
Chronic spontaneous urticaria (CSU) is a condition that causes sudden hives and intense itching, affecting quality of life. Regeneron Pharmaceuticals and Sanofi have announced that their drug Dupixent® (dupilumab) has successfully completed a Phase 3 trial for treating uncontrolled chronic spontaneous urticaria (CSU) in patients who have not previously used biologics. The trial showed that Dupixent significantly reduced itch and hive activity compared to non-treatment.
In the study, 30% of patients treated with Dupixent reported no urticaria at 24 weeks, compared to 18% who did not take the treatment. The safety of Dupixent was consistent with its known profile, with similar rates of side effects for both groups. The results will be submitted to the U.S. Food and Drug Administration by the end of 2024 to seek approval for CSU treatment.
COPD
FDA Approves Dupixent as the First-Ever Biologic Medicine for Patients with COPD in the U.S.
The FDA has approved Dupixent (dupilumab) as a maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype. This makes Dupixent the first biologic medicine approved in the U.S. for these patients. COPD can cause severe symptoms like breathlessness, coughing, and fatigue, making daily activities difficult. The approval is based on 2 major studies showing Dupixent significantly reduces severe COPD flare-ups and improves lung function compared to non-treatment. Patients taking Dupixent experienced a 30% to 34% decrease in annual flare-ups and better quality of life scores. Common side effects included viral infections, headaches, and back pain. This approval offers new hope for better managing COPD symptoms and improving patients’ lives.
EGPA
FDA Approves FASENRA for Eosinophilic Granulomatosis with Polyangiitis (EGPA) in the U.S.
AstraZeneca’s FASENRA® (benralizumab) has been approved in the U.S. to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and serious condition that can harm multiple organs. The approval followed the MANDARA Phase III trial, which compared FASENRA with the only other approved EGPA treatment, mepolizumab. In this trial, nearly 60% of patients treated with FASENRA achieved remission, similar to those on mepolizumab. Also, 41% of FASENRA patients could stop using oral corticosteroids, compared to 26% of those taking mepolizumab. This new treatment offers a convenient monthly injection and may help patients reduce reliance on long-term steroids, which can have severe side effects. FASENRA is also approved for severe eosinophilic asthma in over 80 countries.
Nasal Polyps
FDA Approves Dupixent® as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in the U.S.
Approximately 9,000 adolescents in the U.S. have chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a long-term condition that blocks nasal passages, causing breathing issues and affecting the sense of smell and taste. Regeneron Pharmaceuticals and Sanofi recently announced that the U.S. FDA has approved Dupixent (dupilumab) as a treatment for adolescents aged 12 to 17 with CRSwNP that isn't well controlled. This approval expands Dupixent's use, which was initially approved in 2019 for adults with CRSwNP. The approval is based on two clinical trials that showed Dupixent significantly reduced nasal congestion and polyp size while decreasing the need for surgery or steroids. Dupixent has a proven safety record, with common side effects like injection site reactions and insomnia. This new approval provides adolescents with a treatment option beyond current standard therapies.
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