Dupilumab Safe, effective in children with moderate to severe asthma

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Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared to placebo in children aged 6 to 11 with moderate to severe asthma in a phase 3 trial.

A fully human monoclonal antibody, dupilumab also improved lung function compared to placebo at week 12, an improvement that lasted for the duration of the 52-week trial.

Dupilumab has previously been shown to be safe and effective in adolescents and adults with moderate to severe asthma, patients 6 years and older with moderate to severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and efficacy for moderate to severe asthma in the 6 to 11 year age group was not known.

The results of the randomized, double-blind VOYAGE study conducted in several countries were presented on Saturday July 10 at the 2021 hybrid congress of the European Academy of Allergy and Clinical Immunology (EAACI).

Leonard B. Bacharier, MD, professor of pediatrics, allergy / immunology / pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results of the trial, funded by Sanofi / Regeneron.

The researchers recruited 408 children aged 6 to 11 with moderate to severe uncontrolled asthma. Children receiving high dose inhaled corticosteroids (ICS) alone or medium to high dose ICS with a second controller were randomized to either receive supplemental dupilumab 100 mg or 200 mg, based on body weight at the start of the day. study, either for placebo every 2 weeks for 52 weeks.

Analyzes were performed in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥ 150 cells / μl or fractionated expired nitric oxide [FeNO] ≥ 20 ppb) and 259 patients with baseline blood eosinophils ≥ 300 cells / µl.

“The primary endpoint was the annualized rate of severe asthma exacerbations,” Bacharier said. “The key secondary endpoint was the change in the percentage of predicted prebronchodilator FEV1. [forced expiratory volume at 1 second] from baseline to week 12. “

At week 12, the annualized rate of severe asthma exacerbations was reduced by 59% (P

The results also indicate a favorable safety profile for dupilumab.

Board. Safety profile of dupilumab compared to placebo
Event Placebo (number of patients [%]) Dupilumab (number of patients [%])
Any treatment-related adverse event (TEAE) 107 (79.9) 225 (83)
Any serious adverse event related to the treatment 6 (4.5) 13 (4.8)
Any TEAE resulting in death 0 (0) 0 (0)
Any AEI resulting in permanent discontinuation of treatment 2 (1.5) 5 (1.8)

James M. Tracy, DO, an expert from the American College of Allergy, Asthma, and Immunology, said Medscape Medical News that the addition of the dupilumab option for children 6 to 11 years old is “huge”.

Tracy, who was not in the study, said that although omalizumab (Xolair, Genentech) is also available for these children, dupilumab is distinguished by the range of comorbidities it can treat.

“[Children] don’t have the same rhinosinusitis and polyposis as adults, but a lot of them have eczema, and this multi-tooth drug is incredibly helpful and treats a wide range of allergic conditions, ”said Tracy.

Over 90% of the children in the study had at least one concomitant type 2 inflammatory disease, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared interleukin (IL) -4 / IL-13 receptor, which is the primary driver of type 2 inflammation in several diseases.

Tracy said that while dupilumab is not the only drug available to treat children aged 6 to 11 with moderate to severe asthma, it is “an important and unique addition to the practitioner’s arsenal. individual caring for these very severe asthmatics in the 6-11 age group. “

Dupilumab also led to rapid and lasting improvement in lung function. At 12 weeks, children who received dupilumab improved their lung function as measured by FEV1 by 5.21% (P = 0.0009) and this continued throughout the 52 week study period.

“What we know is [improved lung function] the effect is sustained. What we don’t know is how long you need to keep the drug on for a more permanent effect, which is a problem with all of these biologics, ”Tracy said.

Bacharier reported speaker fees and research support from Sanofi / Regeneron. Tracy did not disclose any relevant financial relationship.

European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021: poster n ° 938. Presented July 10, 2021.

Marcia Frellick is a freelance journalist based in Chicago. She previously wrote for the Chicago Tribune, Science News and Nurse.com, and was an editor for the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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