Abstract Rationale Biologics can reduce asthma exacerbations and improve lung function in severe asthma. However, real-world data among patients with biologic use in China are scarce and the clinical characteristics of these patients remain poorly described. Methods PRESENT II (NCT06605885) was a multicentre, prospective, real-world, observational study. Chinese patients with physician-confirmed asthma who were prescribed at least one kind of biologic were enrolled. Data within 12 months before enrolment were collected using electronic case report forms and analysed. This interim analysis of study summarised the baseline characteristics of the enrolled patients. Results By August 28, 2025, 202 patients were enrolled (Table 1). The mean (SD) age was 53.7 (15.6) years, and 48.5% (98/202) were male. Overall, 33.2% (67/202) reported requiring high-dose ICS/LABA to achieve asthma control or remaining uncontrolled; 46.5% (94/202) had asthma exacerbations within the 12 months before enrolment, with an annualised exacerbation rate (AAER) of 75.0%. During the three months before enrolment, 80.7% (163/202) had been receiving biologics. Among patients with available data, median pre-bronchodilator FEV1%pred was 73.8% (IQR, 49.7-91.9%), and median pre-bronchodilator FEV1/FVC was 0.7 (IQR, 0.6-0.8). Mean Asthma Control Test score was 17.8 (SD: 5.1), and mean AQLQ (+12) total score was 4.9 (SD: 1.2). For biomarkers, median blood eosinophil (bEOS) count was 260.0 cells/μL (IQR, 90.0-520.0 cells/μL), with 64.3% (119/185) having a bEOS count ≥150 cells/μL. Median FeNO level was 32.5 ppb (IQR, 20.0-61.0 ppb), with 65.3% (77/118) having a FeNO level ≥25 ppb. Median total immunoglobulin E (IgE) level was 296.6 IU/mL (IQR, 115.0-626.6 IU/mL). Use of ICS/LABA was reported in 94.1% (190/202), with most of the asthmatics using medium or high dose ICS/LABA. The proportions of patients treated with anti-IgE, anti-interleukin-4 receptor (IL-4R), anti-interleukin-5 (IL-5), anti-thymic stromal lymphopoietin, and anti-IL-5R were 41.6%, 25.2%, 22.3%, 1.0%, and 0.5%, respectively, due to the launch sequence of biologics in the market. Common baseline comorbidities were rhinitis (66.3%), chronic rhinosinusitis (35.1%), chronic obstructive pulmonary disease (31.2%), atopic dermatitis (20.3%), and chronic spontaneous urticaria (12.4%). Conclusion In these asthmatics with biologic prescriptions, the most commonly used targets were anti-IgE, anti-IL-4R, and anti-IL-5. Approximately one third of asthmatics reported requiring biologics are under the step of high-dose ICS/LABA. Overall, patients demonstrated moderate lung function impairment, suboptimal symptom control and quality of life, elevated levels of bEOS, FeNO and IgE, and considerable high comorbidity burden, indicating substantial unmet needs of the best clinical practice and asthma management in China. This abstract is funded by: AstraZeneca
Guo et al. (Fri,) studied this question.
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