Dupixent shows marked effect in Korean severe asthma patient

You-Sook Cho, Professor of Asan Medical Center, discloses results of a subgroup analysis of Korean patients from a global Phase III trial

“Reduces rate of exacerbation and improves lung function in Korean patients… the limited reimbursement criteria leave room for regrets”

Study analysis results on Sanofi’s allergic disease treatment ‘Dupixent (dupilumab)’ have shown that the drug has a superior effect on severe asthma patients in Korea.

 

Based on the sub-analysis results, Sanofi is pursuing a reimbursement extension for Dupixent in asthma in Korea.

 

At the webinar on the ‘Present state of severe asthma treatment in Korea’ that was held by Sanofi on the 29th, Professor You-Sook Cho, Division of Allergy and Clinical Immunology at Asan Medical Center, disclosed the first-ever Korean sub-analysis data from the global Phase III QUEST trial on Dupixent that was conducted on asthma patients.

 

The QUEST trial compared the efficacy and safety of Dupixent and placebo in 1,902 patients with moderate-to-severe type 2 asthma.

 

Its primary efficacy endpoint was were annualized rate of severe exacerbation events during the 52-week study period and changes from baseline in pre-bronchodilator FEV1 which is commonly used to test liver functions.

 

Of the enrolled patients, 74 were Korean, and most were severe asthma patients who have experienced severe asthma exacerbation twice.

 

사노피 듀피젠트 온라인 미디어 세미나 캡처

The Korean subanalysis results showed that annualized severe exacerbation rates were significantly reduced with Dupixent compared to placebo (0.259 vs 1.942).

 

Also, in patients with baseline blood eosinophil count of ≥150 cells/μL and baseline FeNO ≥ 25 ppb, the severe exacerbation rates fell 94% and 92%, respectively, compared to placebo with the use of Dupixent.

 

Cho said, “I could feel the reduction in asthma exacerbations in the field while treating patients with Dupxient for the trial” In terms of Pre-bronchodilator FEV1, the Dupixent-treated group showed significant improvement from week 2, the effects of which lasted during the treatment period.

 

At week 12, the Dupixent-treated group showed a mean improvement of 560mL, and a significant improvement of up to 380mL compared to placebo at week 52.

 

Cho said, “We obtained very encouraging results that Dupixent can maintain lung function through the FEV1 test.

 

Usually, patients feel an improvement from 120mL, and therefore the 560 mL improvement in the Dupixent group is very significant.” The incidence of treatment-related adverse events and serious adverse events in the Korean sub-analysis was comparable in the Dupixent group and the placebo group.

 

Comparing the Korean sub-analysis results with the total clinical trial results, Dupixent showed a higher effect on Koreans.

 

Cho said, “Korean asthma patients had shown less symptom control than in Western countries before Dupxient, I believe that’s why Koreans were able to get a greater effect using a good drug.

 

Study results showed a very significant effect in Korean patients with severe asthma, and even compared to the results of the entire study, the severity of asthma exacerbation rate and FEV1 were more significantly improved in Korean patients.” Cho added, “Before the introduction of new biologics, we could only prescribe steroids to severe asthma patients.

 

After using Dupixent for 3 years, not only did I experience a reduction in the use of steroids in my patients, but their lung function had also improved, with less symptom exacerbation.

 

However, it is a shame that we cannot easily prescribe the drug due to limited reimbursement standards,” Currently, Dupixent is not reimbursed for severe asthma.

 

Cho said, “I wish we could use this strong and effective weapon, Dupixent, in a more broad range of patients.” Sanofi said, “We have applied for the reimbursement expansion in March last year, and will make our best efforts to bring good news to our patients in Korea."