Dupilumab Demonstrates Significant Efficacy and Safety in Phase 3 Trial for Asthma in Asia-Pacific Region, Paving Way for New Treatment Option in China

2022Year10Month31Today, Sanofi announced that dupilumab has been tested in a multicenter, randomized, double-blind, placebo-controlled, parallel-group key trial involving adult and adolescent asthma patients in the Asia-Pacific region.3Phase Clinical Study (NCT03782532) have achieved positive results.

The study results showed that dupilumab can significantly improve lung function and asthma control in patients with asthma.ACQ-5), reducing acute asthma attacks; moreover, the safety data of Dupilumab is consistent with its known characteristics, showing good overall tolerance; the efficacy and safety results in the Chinese subgroup are consistent with the overall results of the Asia-Pacific study and previous global pivotal studies. Dupilumab is a fully human monoclonal antibody that inhibits2Key and Core Factors of Inflammatory Types——Interleukin4（IL-4) and Interleukin13（IL-13) Signal transduction pathway.

As the principal investigator of this study, Academician Zhong Nanshan from the National Center for Respiratory Medicine and Guangzhou Institute of Respiratory Health stated,“China has approximately6000Millions of adults and children suffer from asthma. Although the diagnosis and treatment of asthma in China have improved in the past few decades, according to our2012-2013A cross-sectional survey conducted in the year showed that only40%About half of the asthma patients achieved asthma control.70%The patient has in the past4Symptoms occur within weeks, with the proportion of nighttime symptoms reaching60%, and nearly50%Asthma patients experience limitations in daily life. When existing treatment options are difficult to help patients achieve asthma control, I believe dupilumab will provide clinicians and asthma patients with an additional treatment option. In the near future, it is expected to become a new personalized treatment solution for adult and adolescent asthma patients in China.”

“This study confirmed the good efficacy and tolerability of dupilumab in the Chinese population.”Professor Zhang Qingling from the National Center for Respiratory Medicine and Guangzhou Institute of Respiratory Health pointed out:“Based on this result, I believe dupilumab will become an ideal treatment for asthma in the future and provide guidance for clinical practice in China. Meanwhile, considering the heterogeneity and dynamic changes in the pathophysiology of asthma, dupilumab will offer a reasonable treatment option for physicians and deliver tangible benefits to our patients.”

Dr. Huang Junming, Head of Clinical Research and Development at Sanofi China, stated that the study results are encouraging:“Dupilumab with dual inhibition IL-4 And IL-13 Mechanism of signaling pathways in the Asia-Pacific region3In the Phase III clinical study, Dupixent (dupilumab) achieved both the primary endpoint and key secondary endpoints. These robust data demonstrate the efficacy and safety of Dupixent for asthma patients in the Asia-Pacific region, especially in China, fully showcasing its potential to become a leading, personalized therapy that could benefit more asthma patients across the Asia-Pacific region.”

The Asia-Pacific3The study focuses on the Chinese population and aims to evaluate Dupilumab in“12Adolescents and adults aged 12 years and above, treated with moderate to high doses of inhaled corticosteroids (ICS`) Combined with other control medications (with or without oral corticosteroids`OCS) Remains uncontrolled after treatment, with2Type inflammation characteristics (increased blood eosinophils and/Or exhaled nitric oxide[FeNO]Increase)”Safety, efficacy, and pharmacokinetic characteristics of asthmatic patients.

The study compared data from the dupilumab group and the placebo group in the main study population, and the results showed:

1. The12At weeks, the dupilumab group showed significant improvement in lung function from baseline. FEV1Improved0.37L, while the placebo group only showed an increase in0.06L(The least squares mean difference is 0.31L，P<0.0001）。

2, The24At weeks, dupilumab group showed significant improvement in asthma control,ACQ-5*Score (Secondary Endpoint) Decreased on Average1.29, the average score reduction in the placebo group1.09(The least squares mean difference is -0.20，P<0.0097）。

3. The annualized rate of severe asthma exacerbations in the dupilumab group was reduced compared to the placebo group.62%(NominalP=0.0020）。

4. The safety profile of Dupilumab in this study is consistent with the known safety profiles from global pivotal studies and previously approved indications.

5. The efficacy and safety results of Dupilumab in the Chinese subgroup were consistent with the overall results of the Asia-Pacific study and the previous global pivotal studies.

*ACQ-5Score from0-6The lower the score, the more ideal the control of asthma symptoms.

About Dupilumab in the Asia-Pacific Region3Phase Research (NCT03782532）

This Asia-Pacific3The Phase study is a randomized, double-blind, placebo-controlled, parallel-group clinical study, consisting of three phases. In the study, dupilumab was used as an add-on therapy to inhaled corticosteroids (ICS) in combination with at least one controller medication, with or without oral corticosteroids (OCS) on the basis of adding use. Eligible patients were randomly assigned to the dupilumab group or the placebo group, and received24Weeks of intervention and observation.

The primary endpoint of the study is12Before bronchodilator at weekFEV1Absolute change from baseline. Secondary key endpoints include Week24Weekly Asthma Control Questionnaire (ACQ）-5Change in score from baseline, and in24Annualized rate of severe asthma exacerbations during the treatment period.

About Dupilumab

Dupilumab is not an immunosuppressant, but a fully human monoclonal antibody that targets and inhibits interleukin.-4（IL-4) and Interleukin-13（IL-13) signaling pathway.IL-4AndIL-13As2The key and core driving factors of type inflammation, in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP) and other diseases play an important role in the pathogenesis.

Dupilumab has been approved for marketing in the United States, Europe, Japan and other countries, and can be used to treat atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. In the United States, dupilumab was recently approved for the treatment of eosinophilic esophagitis (EoE) and prurigo nodularis. In China, dupilumab has been approved for the treatment of6Years and above with atopic dermatitis. So far, Dupilumab has been globally 60 Multiple countries/The region has received approval for one or more indications, widely benefiting more than50Ten thousand patients.