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Background <p>Tezepelumab, an anti–TSLP monoclonal antibody, has shown broad efficacy across severe asthma phenotypes. However, real-world evidence evaluating multidomain remission—integrating clinical, functional, and inflammatory domains—remains limited. The primary objective was to assess 12-month effectiveness and multidomain remission (clinical, biological, and complete remission) stratified by inflammatory phenotype, in a prospective multicentre real-world cohort of patients with severe asthma treated with tezepelumab.</p> Methods <p>This prospective observational study included adults with severe asthma initiating tezepelumab across 14 specialised severe asthma units in Spain. Clinical outcomes (exacerbations, ACT, OCS use), lung function, and type 2 (T2) biomarkers (blood eosinophils, FeNO) were evaluated at baseline and 12 months. Clinical remission was defined using strict (no exacerbations, no maintenance OCS, ACT ≥ 20, FEV₁ ≥80%) and pragmatic criteria (no exacerbations, no OCS, ACT ≥ 20, and no FEV₁ decline &gt; 5%). Biological remission required FeNO &lt; 25 ppb and eosinophils &lt; 300/µL.</p> Results <p>Ninety-three patients were included. The annualised exacerbation rate decreased by 68% (3.59 to 1.14; <i>p</i> &lt; 0.001). ACT improved from 13.7 to 19.9 (<i>p</i> &lt; 0.001) and 77.8% of patients achieved an ACT increase ≥ 3 points. Maintenance OCS use fell from 40% to 21% (<i>p</i> &lt; 0.01). FEV₁ (% predicted) increased from 70.7% to 75.6% (<i>p</i> &lt; 0.001). T2 biomarkers significantly decreased (eosinophils <i>p</i> = 0.004; FeNO <i>p</i> = 0.034). Of the 93 patients included, 86 had complete data for strict clinical remission analysis. Among evaluable patients, 22.1% (19/86) achieved strict clinical remission and 38.4% (33/86) pragmatic remission. Biological remission occurred in 73.1% (38/52), and complete remission in 22.0% (11/50).</p> Conclusion <p>In this multicentre real-world cohort, tezepelumab produced sustained multidomain improvements with consistent benefit across phenotypes, including marked exacerbation reductions in allergic biologic-naïve patients. Incorporating biological remission into a multidomain framework provides new insight into the depth and heterogeneity of response achievable with upstream TSLP blockade.</p>

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Multidomain clinical and biological remission with tezepelumab in severe asthma: a 12-month multicentre real-world study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月27日

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  • Juan Luis García-Rivero,
  • Adil Hannaoui Anaaoui,
  • Abel Pallarés-Sanmartín,
  • Marina Blanco-Aparicio,
  • Raquel García-Hernáez,
  • Victoria García-Gallardo Sanz,
  • Uxío Calvo-Álvarez ,
  • Luis Carazo-Fernández,
  • Tamara Hermida-Valverde,
  • Silvia Dorronsoro,
  • Inés Carrascosa-Anguiano,
  • Ignacio Lobato Astiárraga,
  • Idania de los Santos,
  • Ana Isabel Enríquez-Rodríguez,
  • Luis Perez de Llano,
  • Pablo Álvarez Vega,
  • Beatriz Abascal-Bolado,
  • Miguel Santibañez

摘要

Background

Tezepelumab, an anti–TSLP monoclonal antibody, has shown broad efficacy across severe asthma phenotypes. However, real-world evidence evaluating multidomain remission—integrating clinical, functional, and inflammatory domains—remains limited. The primary objective was to assess 12-month effectiveness and multidomain remission (clinical, biological, and complete remission) stratified by inflammatory phenotype, in a prospective multicentre real-world cohort of patients with severe asthma treated with tezepelumab.

Methods

This prospective observational study included adults with severe asthma initiating tezepelumab across 14 specialised severe asthma units in Spain. Clinical outcomes (exacerbations, ACT, OCS use), lung function, and type 2 (T2) biomarkers (blood eosinophils, FeNO) were evaluated at baseline and 12 months. Clinical remission was defined using strict (no exacerbations, no maintenance OCS, ACT ≥ 20, FEV₁ ≥80%) and pragmatic criteria (no exacerbations, no OCS, ACT ≥ 20, and no FEV₁ decline > 5%). Biological remission required FeNO < 25 ppb and eosinophils < 300/µL.

Results

Ninety-three patients were included. The annualised exacerbation rate decreased by 68% (3.59 to 1.14; p < 0.001). ACT improved from 13.7 to 19.9 (p < 0.001) and 77.8% of patients achieved an ACT increase ≥ 3 points. Maintenance OCS use fell from 40% to 21% (p < 0.01). FEV₁ (% predicted) increased from 70.7% to 75.6% (p < 0.001). T2 biomarkers significantly decreased (eosinophils p = 0.004; FeNO p = 0.034). Of the 93 patients included, 86 had complete data for strict clinical remission analysis. Among evaluable patients, 22.1% (19/86) achieved strict clinical remission and 38.4% (33/86) pragmatic remission. Biological remission occurred in 73.1% (38/52), and complete remission in 22.0% (11/50).

Conclusion

In this multicentre real-world cohort, tezepelumab produced sustained multidomain improvements with consistent benefit across phenotypes, including marked exacerbation reductions in allergic biologic-naïve patients. Incorporating biological remission into a multidomain framework provides new insight into the depth and heterogeneity of response achievable with upstream TSLP blockade.