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.” 

Read article here.

Sleeping for Better Cardiovascular Health in Children and Adolescents

There is a reason why personal sleep monitoring devices have proliferated in the wearable technology space.  Poor sleep health is linked to reduced cognitive function, quality of life, and cardiovascular outcomes.  Children are not immune to these complications, but they may present differently.  Obesity, hypertension, insulin resistance, and dyslipidemia have all been correlated in some form to obstructive sleep apnea or sleep disordered breathing.

Be on the lookout for the any of the following:

1) Chronic snoring, mouth breathing, pauses in breathing during sleep especially when associated with tonsillar enlargement

2) Signs of daytime sleepiness despite adequate sleep time.  Sleep needs in children vary by age, so it is important that sleep times reflect that.  Also, it is common for sleepiness to look completely different in children.  Problems with focus, attention and labile emotions and irritability in the second half of the day are quite common.

3) Special risk populations, including children that are obese, or those that have other medical disorders known to predispose to sleep apnea, such as Down Syndrome or other craniofacial abnormalities.

Any of the above warrants evaluation with a pediatric sleep specialist to discuss testing.

AHA Releases Scientific Statement on Obstructive Sleep Apnea and Cardiovascular Health in Children and Adolescents

 In a recent scientific statement, the American Heart Association (AHA) outlined evidence highlighting the effect of obstructive sleep apnea (OSA) on the cardiovascular health of children and adolescents. The full statement was published in Journal of the American Heart Association.

The AHA noted that this statement may be used to develop future guidelines in managing OSA with regard to cardiovascular disease (CVD) risk in the pediatric population.

Epidemiology and Risk Factors

Patients with OSA experience disruption during sleep caused by upper airway obstruction. In children and adolescents, the clinical presentation of the condition can vary by age, but it is generally characterized by habitual snoring, labored breathing, gasps/snorting noises, and daytime sleepiness. According to the AHA, 1% to 6% of children and adolescents have OSA. Current evidence suggests that the OSA prevalence in a pediatric population peaks between 2 and 8 years of age and corresponds to a peak in adenotonsillar hypertrophy prevalence.

Primary risk factors for OSA in the pediatric population include obesity, allergic rhinitis, upper and lower airway disease, enlarged tonsils and adenoids, low muscle tone, neuromuscular disorders, and craniofacial malformations. In addition, sickle cell disease (SCD) may be an independent risk factor for OSA. Premature birth, or birth that occurs prior to 37 weeks’ gestation, may also be associated with an increased risk for sleep-disordered breathing among children, partially because of delayed development of respiratory control.

Read article here.

Severe COVID 19 In Children and Young Adults

Here is a look at pediatric and young adult cases of COVID 19 from Washington, DC.  Note the higher percentage of cases in infants and older teenagers, in addition to asthma as the most common comorbidity.  Other chronic conditions more likely to be associated with ICU admission.

Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Read article here.

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.