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Despite the accepted standard of care, suffering from moderate to severe asthma in children will still be complications of the disease
.
The monoclonal antibody dupiluzumab has been approved for the treatment of adults and adolescents with asthma and other type 2 inflammatory diseases
child
Recently, a research article was published in the top medical journal NEJM.
In this 52-week randomized, double-blind, placebo-controlled phase 3 trial, researchers assigned 408 uncontrolled patients aged 6 to 11 Of children with moderate to severe asthma receive subcutaneous injections of dupirumumab every 2 weeks (100 mg for patients with a body weight of ≤ 30 kg and 200 mg for patients with a body weight of> 30 kg) or a matching placebo
.
All children continue to receive a stable dose of standard background therapy
The primary endpoint of the study is the annualized rate of severe asthma attacks.
The secondary endpoints include the predicted percentage of forced expiratory volume in 1 second before bronchodilator (ppFEV1) at week 12 relative to baseline and the Asthma Control Questionnaire 7 interview at week 24 The change in the score of the actor management (ACQ-7-IA)
.
Have a type 2 inflammatory asthma phenotype (eosinophils ≥150/mm3 or exhaled nitric oxide fraction at baseline ≥20ppb) or an eosinophil count of at least 300/mm3 at baseline
manage
Among patients with type 2 inflammatory phenotypes, the annualized rate of severe asthma attacks in the dupiluzumab group was 0.
31 (95% confidence interval [CI] 0.
22 to 0.
42), and the placebo group was 0.
75 (95% CI 0.
54 to 1.
03) (relative risk reduction in the dupilumab group was 59.
3%; 95% CI was 39.
5 to 72.
6; P<0.
001)
.
The mean (±SE) change in ppFEV1 from baseline was 10.
It can be seen that among children with uncontrolled moderate to severe asthma, children who received dupilumab had fewer asthma attacks and better lung function and asthma control compared with children who received placebo
.
.
Original source:
Leonard B.
Bacharier, et al.
Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma .