"Dupixent reimb for severe asthma… access to targeted therapy"

Dupixent was confirmed to improve lung function and reduce exacerbation rates…effective in patients with Type 2 inflammation

Therapies based on blood eosinophil count or FeNO…expected to improve accessibility

The biological agent 'Dupixent' has secured reimbursement for severe asthma, expanding patient access. Given that many patients did not respond to existing treatments, the field evaluates that this will be a therapeutic turning point that addresses long-standing unmet needs.

On the 5th, Sanofi-Aventis Korea held a press conference at the Lotte Hotel in Seoul to commemorate the reimbursement of Dupixent (dupilumab) in Korea. 

Professor Ji-yong Moon of the Department of Pulmonary, Allergy and Critical Care Medicine at Konkuk University Medical Center 

Dupixent is the first biological agent to target the signaling of interleukin (IL)-4 and IL-13, which are major drivers of Type 2 inflammation.

Various immunce disease indications for ​Dupixent has been added, including severe asthma, atopic dermatitis, prurigo nodularis, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD). However, reimbursement had been limited to the treatment of atopic dermatitis.

In December last year, patient accessibility was expanded as Dupixent became reimbursed for severe asthma. This comes about six years after the indication was added in 2020.

The expanded reimbursement covers cases ▲where the blood eosinophil count is 150 cells/µL or higher, or fractional exhaled nitric oxide (FeNO) is 25 ppb or higher within 12 months before starting treatment, and at least four acute asthma exacerbations requiring systemic corticosteroids occurred within those 12 months ▲where oral corticosteroids equivalent to 5mg/day of prednisolone or higher have been continuously administered since six months before starting treatment.

The evaluation method involves assessing the patient every year before and after drug administration (every six months for oral corticosteroid-dependent asthma), and the patient is approved if they meet one of the two conditions.

Through the Phase 3 QUEST clinical study, Dupixent was confirmed to improve lung function and reduce exacerbation rates.

The data show that the Dupixent group showed an annualized exacerbation rate reduction of more than 45% at 52-week compared to the placebo group. Additionally, significant improvement in lung function was observed from the second week of Dupixent administration. This effect was maintained throughout the 52 weeks.

Notably, it significantly reduced the annualized severe asthma exacerbation rate compared with the placebo group in patients with baseline eosinophil (EOS) counts of 150 cells/µL or higher.

Professor Moon stated, "Dupixent showed meaningful asthma control indicators and quality of life improvement in patients with increased Type 2 inflammatory biomarkers, and explained, "This reimbursement has opened the way for medical staff to select patients expected to respond to treatment based on clinical indicators such as blood eosinophil counts and FeNO, connecting them to targeted therapy at the appropriate time."

"Symptom management is difficult to achieve with a single treatment…various options must be secured"

An opinion was also presented that symptom control is difficult with a single treatment, necessitating the securing of various options. Type 2 inflammatory asthma is characterized by excessive cytokine activation, including IL-4, IL-5, and IL-13. It not only carries a high risk of repeated exacerbations and loss of lung function but also triggers various immune comorbidities, such as atopic dermatitis, chronic rhinosinusitis, and COPD, which generally diminish the patient's quality of life.

Accordingly, various biological agents are being utilized for severe asthma, including interleukin-targeting Dupixent, Novartis's Xolair (omalizumab)', GSK's 'Nucala (mepolizumab)', and AstraZeneca's 'Fasenra (benralizumab)', as well as AstraZeneca's 'Tezspire (tezepelumab)', which targets thymic stromal lymphopoietin (TSLP).

Unlike general asthma, severe asthma is difficult to control, and experts argue that more medications, such as oral steroids (OCS) or additional biological agents, must be secured. However, because OCS can cause various side effects, its use is currently declining.

Biological agents have strengths in terms of safety and the ability to reduce dependence on oral steroids.

Professor Moon stated, "Due to the characteristics of asthma, not all patients are treated with the same drug. Therefore, the Global Initiative for Asthma (GINA) guidelines recommend assessing for Type 2 inflammation when treating severe asthma and selecting the appropriate medication."

Professor Moon added, "A significant number of patients undergoing treatments have a poor prognosis due to repeated acute exacerbations despite existing treatments," and emphasized, "The reimbursement of Dupixent, which targets the cause of disease, holds great clinical value in providing better treatment options to patients who experienced limitations of existing therapies."