FDA approves dupilumab for children aged 6 to 11 with moderate to severe asthma

Now that another biologic therapy is available for pediatric severe asthma, it is important to look at the indications for add on biologic therapy for asthma.  In general, there are 2 broad categories of asthma that may warrant adding an injectable biologic therapy:

1) Children and adolescents with severe asthma, poorly controlled despite compliance with high dose asthma therapy.  Here, poorly controlled may indicate frequent hospitalization, ER, or urgent care visits.  In addition, systemic steroid use and symptoms that affect quality of life (school, exercise, etc) are important considerations.

2) Children and adolescents with severe asthma that is controlled, but requires high dose asthma controller medication.  This is an important consideration because high dose inhaled glucocorticoids have been associated with a numbers of risks including reduced growth velocity, obesity, adrenal insufficiency, and ocular side effects like cataracts.

The FDA has approved dupilumab as an add-on maintenance treatment for children aged 6 to 11 years with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
The expanded approval of dupilumab (Dupixent, Regeneron/Sanofi) to children aged 6 to 11 was based on data from the phase 3, double-blind, placebo-controlled LIBERTY ASTHMA VOYAGE trial that evaluated efficacy and safety of dupilumab compared with standard care in children with uncontrolled moderate to severe asthma. More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition, according to a company press release.
“I was impressed that dupilumab met not only its primary endpoint of reduction in asthma exacerbations, but also all key secondary endpoints in the pediatric ASTHMA VOYAGE trial,” Leonard B. Bacharier, MD, professor of pediatrics at Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center and principal investigator of the ASTHMA LIBERTY VOYAGE trial, told Healio. “I anticipate that clinicians will begin to include dupilumab in their discussions with families of children with uncontrolled moderate-severe asthma. Many children in this age group continue to experience repeated asthma exacerbations, and experience side effects from frequent courses of systemic corticosteroids. Dupilumab’s demonstrated efficacy in significantly reducing exacerbations will allow such children greater disease control.” 

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It's Here! Home Monitoring For Asthma

 During a period where office visits are reduced when possible and safe, and when some lung function testing maneuvers are avoided (spirometry) because of increased risk for asymptomatic infection spread, it is a great advantage to have quality home monitoring options.  The Capmedic device does this and provides the additional benefit of coaching asthma patients through proper lung function and allowing your asthma doctor to monitor compliance.  Dr. Susarla

CapMedic Measures Lung Function, Makes Sure Inhalers Used Correctly

The FDA has cleared the CapMedic device that helps to make sure that metered dose inhalers (MDIs) are properly used, even by young patients.

MDIs are most commonly employed to deliver asthma medications deep into the lungs, but to work effectively they have to be used correctly and on a consistent schedule.

The CapMedic snaps onto the top of many inhalers and, using built-in lights and a tiny speaker, it works to nudge users to inhale the medication correctly and at the right time. When a person is ready, the device talks them through all the steps, like shaking the inhaler, properly squeezing it while keeping it upright, and timing the inhalation just right.

The same device can snap onto an accompanying plastic adapter to turn it into an accurate at-home spirometer for lung function measurement. It can now measure FEV1, the maximum amount of air that the patient can push in a second, and PEF, the maximum flow one can generate at a steady rate.

Readings about usage and spirometer data are stored on an accompanying smartphone, helping patients, parents, and caretakers, make sure that the inhaled medication regimen is adhered to.

“Decades of studies have shown that almost 90% of patients are unable to use MDIs correctly – a result of their complex, multi-step usage requirements. The Cognita team has conducted drug deposition studies showing a tenfold improvement in the delivery of medication from just 4-5% to 45% when inhalers are used correctly,” said Rajoshi Biswas, Ph.D., Chief Scientific Officer and co-founder at Cognita Labs, in the announcement. “Getting an effective daily dose means patients are more likely to avoid costly, life-threatening hospitalizations.”

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Antibiotics in Childhood Asthma

Most experts agree that there is little role in use of antibiotics in chronic or acute treatment of asthma.  In addition, antibiotic overuse may delay diagnosis and management of a chronic condition and undermine medical provider recommendations. 

After all, if an inflammatory lung condition is repeatedly conflated with an infectious process, families may lose faith in medical care and seek treatment options elsewhere.

Dr. Susarla

Children with asthma are prescribed antibiotics at a higher rate than those without asthma, according to a study published in BMJ Open. Furthermore, the diseases for which they are prescribed typically do not call for antibiotics.

This underscores the importance of measured distribution of antibiotics among physicians to avoid overprescribing and its consequences, which include further infection and microbial resistance.

This population-based retrospective cohort study included data from 26,750 participants with asthma and 330,916 without asthma, all of whom were aged 5 to 18 years old. Asthma was defined by ≥2 respiratory drug prescriptions within 1 year after receiving an asthma code. Data were collected from The Health Improvement Network (THIN) in the UK and Integrated Primary Care Information Database (IPCI) in the Netherlands. Rates of antibiotic prescriptions were compared using a Poisson regression model, and use indications were compared between individuals with and without asthma using Fisher's exact or chi-square tests.

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Excess Weight Increases Asthma Risk

Proximity to holidays purely coincidental.  Nonetheless, watch the pounds folks! Dr. Susarla

Children who are overweight or obese are at increased risk for asthma, researchers report.

A retrospective study, published in Pediatrics, included 507,496 children followed for an average of four years. None of the children had incidents of asthma before the start of the study.

The researchers divided the children into three groups: overweight, defined as the 85th to 94th percentile for weight; obese, the 95th percentile or higher; and normal weight, the 25th to 64th percentile.

The study controlled for age, race, health insurance, food allergies, medications and other factors, and found that compared with children of normal weight, the overweight were 17 percent more likely to have been given a diagnosis of asthma and to take an asthma medication. The obese were 30 percent more likely.

The researchers estimate that 23 to 27 percent of asthma cases in obese children can be attributed to the obesity itself. Among all the children, 10 to 13 percent of asthma cases were attributable to obesity.

Read article here.

10 Treatable Traits That Could Predict Asthma Attacks

The science and art of predicting asthma risk may go beyond asthma symptoms and lung physiology and intersect with the presence of chronic disease. Dr. Susarla

With increasing attention on a “treatable traits”—a new classification and precision medicine strategy for asthma and other chronic airway diseases,1 a team of researchers set out to examine whether and which treatable traits could be identified from registry data in persons with severe asthma and used to predict the future risk of asthma exacerbations.2

In their study, published in the journal Respirology, the investigators recorded the prevalence of the treatable asthma traits of 434 participants with severe asthma and 102 participants with non-severe asthma, all of whom were enrolled in the Australasian Severe Asthma Web‐Based Database. The prevalence of participants’ treatable asthma traits were described. They assessed participants at the study’s outset and then every 6 months thereafter for 24 months.

Of the 24 treatable traits the researchers identified, 10 predicted exacerbation risk in the participants with severe asthma, with the 5 strongest as follows:

• Being prone to exacerbations
• Depression
• Inhaler device polypharmacy
• Vocal cord dysfunction
• Obstructive sleep apnea

“Treatable traits can be assessed using a severe asthma registry,” the authors concluded. “In severe asthma, patients express more treatable traits than non‐severe asthma. Traits may be associated with future asthma exacerbation risk demonstrating the clinical utility of assessing treatable traits.”

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World Lung Day

Awareness about chronic lung conditions can help foster education and prevention strategies for both adult and pediatric disease. Dr. Susarla.

Statement of Harold P. Wimmer, National President and CEO of the American Lung Association, in response on World Lung Day, September 25, 2018, and in response to the pending vote on the declaration on the prevention and control of non-communicable diseases by the United Nations General Assembly:

“Today marks World Lung Day, a day that recognizes a fundamental truth: that breathing is essential to life. Unfortunately, millions of people around the world, including more than 33.6 million Americans, suffer from chronic lung diseases, making the essential act of breathing much more difficult.  The American Lung Association joins with others who have signed the Charter for Lung Health and pledge to continue to work to save lives by improving lung health and preventing lung disease.

“Today, we urge the United Nations to join us in this pledge. We urge the U.N. General Assembly at their meeting this week to adopt a declaration in support of efforts to reduce the burden of non-communicable lung diseases, such as asthma, chronic obstructive pulmonary disease (COPD), and lung cancer. We urge them to fully support measures to tackle the sources that cause or worsen these diseases, especially tobacco use, indoor and outdoor air pollution, and climate change. Too many people die each year from preventable diseases that these sources cause or exacerbate.  

“We have made progress in our fight against lung diseases, but millions of people face threats to their lung health every day, making it more difficult to breathe. We at the American Lung Association urge the United Nations to join in the fight to protect their health.”

Read article here.

Asthma and migraines connected?

To complicate matters, some migraine medication (beta-blockers) can interfere with asthma rescue inhalers and may worsen the disease process.  Dr. Susarla

Adolescents who have asthma or allergic rhinitis may be at higher risk for developing migraine, according to a study published in The Clinical Respiratory Journal.

Previous studies illustrated a relationship between asthma and migraines (primarily in adult populations). This large cross-sectional study also included the classification of specialist-diagnosed asthma and migraine.

Using data from the Israel Defense Forces recruitment database, study authors identified 113,671 adolescent draftees (n=66,547 young men; n=47,124 young women; all were 17 years old) diagnosed with asthma or migraine between 1987 and 2010. Investigators examined migraine prevalence in this cohort. Certified specialists in neurology and pulmonology, respectively, confirmed the diagnoses for migraine and asthma.

Read article here.