D2.157 - Clinical remission with tezepelumab in severe asthma: prevalence and predictors in a real-world multicentre study

Biological therapies have transformed the therapeutic landscape of severe asthma, positioning clinical remission as an emerging and increasingly relevant treatment goal. Tezepelumab, an anti–thymic stromal lymphopoietin (TSLP) monoclonal antibody approved for the treatment of severe asthma, has demonstrated encouraging efficacy in clinical trials; however, real-world evidence regarding remission outcomes remains scarce+. This study aimed to determine the prevalence of clinical remission in patients with severe asthma treated with tezepelumab and to identify demographic and clinical factors associated with remission achievement.

We conducted a multicentre retrospective study including 156 patients with severe asthma who received tezepelumab between October 2023 and December 2024. Demographic data and clinical characteristics were collected at baseline and after 6 and 12 months of treatment. Clinical remission was defined according to GEMA criteria as an Asthma Control Test (ACT) score >20, absence of exacerbations or systemic corticosteroid use, and a forced expiratory volume in one second (FEV₁) ≥80% of the predicted value sustained over one year.

The mean age of the cohort was 55.9 years, with a marked female predominance (76%). Clinical remission was achieved in 9.6% of patients. Baseline demographic variables, including age, sex, smoking status, body mass index, and asthma duration, were comparable between patients who achieved remission and those who did not. Treatment-naïve status (73.3% vs 34.1%, p<0.05) and the presence of rhinoconjunctivitis (93.3% vs 63.4%, p<0.005) were significantly more prevalent among patients in remission. No significant associations were observed with the presence or severity of other comorbid conditions.

Remission was more frequently observed in patients with a type 2 (T2)–high inflammatory profile, reflected by a higher prevalence of positive skin prick tests (92.8% vs 66.9%), predominantly to pollen allergens, and higher blood eosinophil counts (300 vs 100 cells/µL). This subgroup also exhibited significantly lower baseline neutrophil counts (3400 vs 4600 cells/µL) and superior baseline lung function parameters (FEV₁, FVC, FEV₁/FVC ratio, and FEF25–75), with no significant differences in other inflammatory biomarkers, including fractional exhaled nitric oxide (FeNO) and total IgE levels. In multivariable analyses, clinical remission was independently associated with sustained reductions in neutrophilia and higher baseline lung function, even after adjustment for treatment duration.

Clinical remission with tezepelumab is attainable in a subset of patients with severe asthma, particularly those characterised by a T2-high profile, lower neutrophilic inflammation, preserved baseline lung function, and a lower overall disease burden. These findings underscore the relevance of specific clinical and biological markers as predictors of remission in real-world settings.