Biologic outcomes in severe asthma patients by smoking status: evidence from SHARP

The efficacy of biologics remains debatable in current or ex- smokers with severe asthma.

This study aimed to evaluate responses to biologics by smoking exposure and to assess variations in management practice across Europe.

This was a retrospective real-world study of adults with severe asthma from 16 European countries assessed at baseline and after 1-year of biologic treatment. Data were collected within the ERS SHARP (Severe Heterogeneous Asthma Research-Patient Centred) registry, applying the OMOP Common Data Model.

Of the 3,876 adult patients, 2,383 were never-smokers, 540 ex-smokers (<10 pack-years), 812 (≥10 pack-years), and 141 current-smokers. In all 4 groups, symptom control (ACT≥20/ACQ≤1.5) improved, frequent exacerbations (≥2/year) decreased, asthma quality of life (AQLQ) improved, and oral corticosteroid use decreased. While the starting point sometimes differed, the order of magnitude of change was not statistically different between groups. A country-averaged analysis of the SHARP survey revealed that 29% of participating nations reported opposition to prescribing biologics to current smokers, while 59% expressed dissatisfaction with current treatment guidelines.

Our study reveals a lower prevalence of biologic therapy among adults with severe asthma who smoke and provides evidence suggesting this practice is unwarranted. Former/current smokers who underwent biologic therapy for one year responded as effectively as never-smokers. Recognising the complexity of nicotine dependence, smoking cessation should remain a central goal in asthma management. This study underscores the need for randomized controlled trials in smokers to enable more robust and inclusive scientific conclusions and guidelines.