Dupilumab Cuts Severe Asthma Exacerbations by 59% in Children Aged 6 to 11

By Gene Emery

December 09, 2021

(Reuters Health) - Adding dupilumab to conventional therapy for children with uncontrolled moderate-to-severe asthma reduces the risk of severe exacerbations by 59%, according to results from a year-long study.

The annualized rate of severe exacerbations was 0.31 among the 273 children aged 6 to 11 who received the subcutaneous injection every two weeks versus 0.75 among the 135 who received a matched placebo (P<0.001), according to the report in the New England Journal of Medicine.

The researchers, led by Leonard Bacharier of Vanderbilt University Medical Center in Nashville, said the side effects in the two groups were similar.

About 1 in 12 U.S. children has asthma and the disease is characterized as severe in 5% to 10% of cases.

Dupilumab is already approved as an asthma therapy for adults and adolescents, along with other type-2 inflammatory diseases. The new study, known as Liberty Asthma VOYAGE, was designed to assess the monoclonal antibody's effect on younger children.

All the children had experienced at least one severe exacerbation within the previous year.

During the 52 weeks of treatment, 59.6% of children who received placebo had no exacerbations compared with 77.1% of dupilumab recipients.

Among children whose blood had at least 300 eosinophils per cubic millimeter at baseline, the percentages were 58.3% and 79.0%, respectively.

In addition to fewer exacerbations, the treatment produced an improvement from baseline in the forced expiratory volume metric of 10.5 percentage points versus 5.3 percentage points with placebo (P<0.001).

Asthma was considered to be better controlled among dupilumab recipients based on the Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) score, which ranges from 0, meaning complete asthma control, to 6, meaning severely uncontrolled. A change at week 24 of one-half point or more was considered clinically important.

Among children with less than 300 eosinophils per mm3, the least-square mean changes were −1.33±0.05 in the dupilumab group and −1.00±0.07 in the placebo group; and among those with the more severe phenotype, −1.34±0.06 and −0.88±0.09, respectively (P<0.001 for both comparisons).

"Longer-term studies are needed to determine whether dupilumab leads to sustained improvements in lung function and whether it can restore normal patterns of lung growth" in these young patients, the researchers said.

The findings were originally released by sponsor Sanofi 14 months ago.

SOURCE: https://bit.ly/3GgxQt5 The New England Journal of Medicine, online December 8, 2021.