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.

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.

Clinic Update During COVID 19 Pandemic

We have stepped up to protect our patients, our staff and the community during the coronavirus (COVID-19) pandemic.  Houston Specialty Clinic has CHANGED almost all clinic office visits to telemedicine, effective immediately due to the urgent need for all of us to reduce the risk of infection. 

   We will still be OPEN for the following patient visit types: 

• Patients requiring regular injections for asthma management  
• Urgent visits

Fortunately, the State of Texas has issued an emergency declaration waiving many restrictions on telemedicine.  Therefore, our providers are available during office hours for telemedicine consultation for both new AND existing patients. 

Please see the following links for useful resources infection prevention: 

https://www.cdc.gov/coronavirus/2019-nCoV/index.html 

https://www.thoracic.org/patients/patient-resources/resources/coronavirus-patient.pdf