A comprehensive literature search was conducted on the PubMed databases to identify relevant studies for the identification of literature based on various themes of the position statements and objectives of the study. The methodology included search terms used across databases, countries/regions covered in the review, timeframe for the literature search, outcomes and populations considered and clear definition of who the authors would be, how they were selected, and their roles in the review process. The Position Statement attempts to:

Review the recent evidence in Asia on the following topics: (i)

Disease burden

The search was restricted to studies conducted in human populations, full-text articles, and the English language; however, no time period restriction was applied.

A diverse group of key opinion leaders in the field of Pulmonology from several regions across Asia collaborated over a series of virtual monthly meetings between September 2024 and March 2025 to define the topics for the position statement, identify and review existing literature, develop position statements, and write, review, and approve the statements.

A short survey was also conducted to gather experts' opinions on topics such as the potential definition of clinical remission from an Asian perspective, as well as the availability and accessibility of biologics in their respective countries. The survey was administered online in December 2024.

Mortality data on SA in the Asia region is limited. In Japan, between 2013 and 2019, the proportion of all-cause deaths among patients with SA ranged between 10.29% and 11.20% (17). However, in Korea, the asthma-associated death rate increased significantly, rising from 1,917.3 per 100,000 asthmatics in 2003 to 2,650.2 per 100,000 in 2015, according to the study conducted using the National Health and Injury Surveillance System (NHISS) database, suggesting concerns over asthma control (20). The lack of data in other countries underscores the need for comprehensive research on asthma to better understand and address SA-related mortality.

Figure 2 summarises the most common challenges that pose as barriers to optimal SA management.

Clinical remission in severe asthma is defined differently across various studies and guidelines. However, key features considered for the definition of clinical remission include ACT score, exacerbation status, and lung function. Table 1 summarises the prevalent definitions used across studies and guidelines worldwide.

Considering the distinct clinical characteristics discussed earlier, the definition of clinical remission should be re-evaluated with a focus on Asian patients. While all prevalent definitions concur on the criteria related to exacerbations, use of oral corticosteroids, and symptoms, a notable difference in lung function criteria is evident. It may not be possible for the patient to achieve optimal lung function as defined by the prevailing definitions, considering the possibility of existing airway remodelling (77). The experts opined that a more realistic and achievable target may be beneficial instead of the pre-set criteria currently utilised in other geographies.

In order to understand the lung function criterion for defining clinical remission, the experts in the panel answered a survey (Figure 3). In the survey, most experts suggested that the lung function criterion should be incorporated into the definition of clinical remission, alongside the other three criteria: Exacerbations, OCS use, and symptoms. Additionally, experts suggested that the lung function criterion should encompass either the stabilization of lung function alone or both stabilization and normalization. They also proposed that a lack of bronchodilator response and declined lung function could be included in the lung function criterion, and regular monitoring of Peak Expiratory Flow Rate (PEFR) could provide insight into daily lung function changes, especially in patients with asthma. Regarding the optimal value of pre- or post-bronchodilator FEV₁ for a patient to be classified as being in clinical remission, experts had diverse opinions, with a few mentioning >80% pre/post-FEV₁, others mentioning >60% pre/post-FEV₁, and some mentioning >70% pre/post-FEV₁. Experts also suggested that, along with FEV₁ value, the presence or absence of symptoms such as cough or dyspnoea should be considered. In light of the inadequate data currently available to achieve an Asia-specific definition for clinical remission, further studies in the region are desirable. The experts also highlighted having a robust lung function criterion, considering the evolving treatment landscape with the availability of biologics, which may make the lung function targets achievable in the future.

The presence of various co-morbidities complicates the management of SA (Table 2).

The Treat-to-Target approach in asthma is a management strategy that involves systematically assessing specific characteristics across respiratory, extra-respiratory, and behavioural domains and focuses on achieving and maintaining clinical remission by setting individualized goals and tailoring therapy accordingly to reach and maintain those targets (87, 88). Adopting a treat-to-target approach can achieve clinical remission in severe asthma. Precision medicine represents a promising way, marking a shift from “treat-to-failure” to “treat-to-target,” with clinical remission as the ultimate goal for SA management (72). In the SHAMAL study, 92% of patients successfully reduced their high-dose ICS, with over 60% transitioning to using only anti-inflammatory relievers without any loss of asthma control. Despite significant reductions in ICS, more than 87% of patients in the treatment-reduction group remained free from exacerbations by week 48. Additionally, over half of the patients who reduced their background medications achieved clinical remission by week 48. There was a decline in FEV₁ in some patients, reducing their ICS as-needed only (89). Considering these findings, GINA recommends stopping other add-on medications, especially OCS, and reducing the ICS-LABA dose in SA patients on biologic therapy plus high-dose ICS-LABA who show a good response to the treatment. However, it also recommends that the ICS-LABA dose should not be completely stopped (1).

In addition to clinical remission as a target, additional targets such as eosinophils, lung function, and type-2 inflammation are also being increasingly considered as targets for treatment (90–92).

Various biologics, including anti—Ig E (Omalizumab), IL-5 inhibitors (mepolizumab and reslizumab), IL-5 receptor inhibitors (benralizumab), anti-IL-4Rα inhibitors (dupilumab), and anti-thymic stromal lymphopoietin (Tezepelumab), have become available in many Asian countries. Similar to Western populations, these biologics have shown comparable effectiveness among Asian patients. Studies conducted in Thailand (93), South Korea (94, 95) and China (4) highlighted that omalizumab reduces asthma exacerbations, hospitalization rates, and the use of OCS while enhancing asthma symptom control, quality of life, lung function, and reducing airway remodelling.

Similarly, benralizumab has been shown to decrease peripheral blood eosinophils, acute asthma attacks, and OCS use, with improvements in lung function and symptom control (96). The MIRACLE study conducted in Asia demonstrated that benralizumab significantly reduced annual exacerbation rates and improved lung function, asthma symptoms, and health-related quality of life (97). The TOAST study, a prospective real-world trial in Japan, also confirmed the effectiveness of benralizumab in improving asthma control, quality of life, and lung function while reducing OCS use; higher baseline eosinophil counts (≥400/μL) and FeNO levels (≥22 ppb) were associated with better response (98).

In the post hoc analysis of the Korean cohort from the DREAM and MENSA studies, mepolizumab improved lung function and quality of life in patients with severe eosinophilic asthma (99).

Dupilumab has also proven effective in reducing the risk of acute asthma attacks and improving asthma control, quality of life, and lung function while reducing the OCS dependency. Additionally, in the Korean subgroup of the LIBERTY ASTHMA TRAVERSE study, dupilumab was associated with improvements in lung function and exacerbation rates (100).

Data from the KoSAR Biologics Registry further corroborate the benefits of these biologics, demonstrating significant improvements in asthma control and patient quality of life (35). ISAR studies, which include 23 countries (from the APAC region: India, Malaysia, Japan, Korea, Singapore, Taiwan) and 323 patients from the APAC region, further highlight the benefits of biologics in patients. Patients treated with anti-IgE, anti-IL5/5R, and anti-IL4Rα achieved four-domain remission within a year of initiation, with greater chances of remission seen in those with less severe impairment and shorter asthma duration (68). Anti-IgE and anti-IL5/5R were effective in reducing exacerbations, hospitalizations, and long-term oral corticosteroids (LTOCS); however, anti-IL5/5R was more effective when compared with a generally improving anti-IgE (101).

A meta-analysis by Kyriakopoulos et al, demonstrated that Anti-IL4α (dupilumab) and anti-Thymic stromal lymphopoietin (TSLP) (Tezepelumab) were the most effective in reducing exacerbations and improving FEV₁. Anti-TSLP was particularly effective in reducing hospitalizations. Anti-IgE (Omalizumab) notably reduced the ACQ score and improved the AQLQ score. Anti-IL5/5Rα agents (Mepolizumab, Reslizumab, and Benralizumab) were effective in reducing OCS use and facilitating discontinuation (102).

Experts concurred on the efficacy of biologics but highlighted the key limiting factors for greater utilisation are limited access and lack of reimbursement of biologics in the Asia-Pacific region. In order to achieve the treatment targets and select the appropriate biologic for the right patient, it is important to have all the possible biologics available.

Tables 3, 4 demonstrate the availability and reimbursement status of Biologics in Asian countries as mentioned by the experts as of January 2025.

As summarized by Brusselle et al., there are no direct comparisons from randomized controlled trials (RCTs) on the effectiveness and safety of monoclonal antibodies for severe asthma; there is a lack of strong evidence to guide treatment choices. Before starting biologic therapy, it is important to record the number of asthma attacks in the past year, use of OCS, biomarkers (like blood eosinophil count, FeNO, and specific IgE levels), lung function (FEV₁), asthma control, and quality of life. When selecting a therapy, several factors should be considered, including biomarkers, comorbidities (such as eczema and nasal polyps), dosing frequency and schedule, route of administration, the need for healthcare staff monitoring, the age of asthma onset, as well as the availability and affordability of the biologic. Insurance coverage, cost, and patient preferences are also important factors. These factors, along with clinical characteristics, guide the choice of the initial biologic therapy (1, 103) The expert panel recommended assessing coexisting allergic or immunologic conditions (e.g., chronic rhinosinusitis, urticaria), comorbidities, and the specific treatment indication before starting therapy. A possible treatment algorithm considering the currently available classes of biologics and based on the concept presented by Brusselle et al. (103) is summarised in Figure 4. However, it should be noted that the utility of this algorithm may be considered limited, considering the limitations on availability and access to these treatments in Asian countries.

Prioritizing individualized care and actively involving patients in decisions around monoclonal antibody therapies for severe asthma is essential. Patient preferences should be respected when initiating biologics, selecting specific agents, and defining treatment goals. In India, this patient-centred approach is gaining increasing recognition (40). Similarly, Japan has called for early intervention, enhanced education on biologics, and flexibility in switching treatments as needed. Improved communication with patients, especially those facing income constraints, is vital, alongside more lenient approval criteria for biologics. Policymakers and governments must take steps to ease the financial approval process for biologics, ensuring that patients in need have better access to these treatments.

There is a clear need for evidence-based validation of biologics and development of novel treatments beyond traditional treatments (32). Liano et al. demonstrated that only a small proportion of patients on biologics achieve remission, underscoring the potential need for therapy switches, combination therapies, or earlier interventions to improve remission rates, using ISAR data (68). Le et al. further highlighted the persistent high disease burden among patients with severe asthma who lack access to T2-targeted biologics, emphasizing the critical unmet medical need. This underscores the importance of regulators increasing and standardizing access to biologics and researchers developing more effective treatment options for better asthma management (44).

Recent data from ISAR demonstrated that biologics can prevent several OCS-related comorbidities, including diabetes mellitus, major cardiovascular events, and anxiety/depression, highlighting the need for early access and treatment of SA before irreversible damage and harm are done (104).

In many LMICs, high costs, insufficient resources, lack of proper asthma management tools, limited physician expertise, and patients' financial constraints further hinder the availability and effective use of biologics (105). According to Swarnakar et al., though certain biologics are available through India's public healthcare system, the high costs of these treatments in private markets remain a barrier to broader access (33).

To improve the management of severe asthma, advocacy for equitable access to biologic therapies, earlier intervention, and greater flexibility in treatment options is imperative. Policymakers and governments must ease the approval criteria for biologics, reducing financial barriers and ensuring access to life-changing treatments.

Implementing OCS stewardship is key to improving the management of SA in Korea by addressing the risks associated with frequent OCS use and ensuring patient awareness (106). Japan similarly prioritizes reducing systemic corticosteroid dependence among SA patients and highlights the need to overcome barriers to biologic adoption, especially due to high costs and low uptake among OCS-dependent patients (17).

In China, there is a strong emphasis on advancing research into the clinical phenotypes and endotypes of severe asthma. This includes a focus on developing biomarkers accurately, completely, and repeatedly to improve diagnosis and classification (4).

In Korea, a strong referral system from primary care to asthma specialists, supported by partnerships between general practitioners and asthma clinics and reinforced through education initiatives, is advocated to enhance referral rates (35). In Japan, interprofessional cooperation among doctors, nurses, and pharmacists is emphasized to support patient adherence to long-term asthma management, fostering a more coordinated and effective care approach (107).

Venkitakrishnan et al. propose that shared decision-making between patients and physicians may help align treatment goals effectively (40), while increasing insurance coverage, negotiating lower drug prices, and funding research into affordable options can improve access (33). Kim et al. suggest the establishment of specialty severe asthma clinics that include multidisciplinary teams to aid in offering several services such as smoking cessation support, patient education, and inhaler use correction. Expanded insurance reimbursement for eligible patients and a streamlined approval process are also recommended (35). Consensus statements from Chinese experts recommend collaborative research on severe asthma to better understand its clinical and socioeconomic impact. Additionally, evidence-based, individualized therapy is suggested in order to improve quality of life and lower the disease burden (4).

The following strategies are proposed to improve the accessibility and affordability of biologics in the Asia-Pacific region:

Tiered Pricing: Tiered pricing (selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries) allows pharmaceutical companies to set different prices for the same medication based on the patient's ability to pay or the economic status of different regions. However, tiered pricing should only be used as a short-term measure, applied in cases of limited market volume or production capacity, while planning for long-term affordability. Promoting competition by encouraging multi-source production and generic entry is critical to achieving the lowest sustainable prices. Additionally, avoiding arbitrary market segmentation through fair pricing policies can prevent disproportionately high costs for middle-income countries. This makes essential drugs more affordable for low-income patients (108).

In China, there is a call for collaborative research to establish baseline data on severe asthma, identify risk factors, and develop individualized, evidence-based treatment plans. Key research focus areas include type 2 inflammation-targeted biologics, maintenance strategies, and long-term treatment effectiveness to improve asthma control and patient quality of life (4).

In many LMICs across Asia, a lack of data and resources hinders the advancement of severe asthma care. The establishment of specialized asthma and allergy care facilities in these areas would aid in bridging gaps in diagnosis and care (10).

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