Biologic outcomes in severe asthma patients by smoking status: evidence from SHARP
In brief
Severe asthma patients who smoke responded to biologics as well as never-smokers
In a real-world study of 3,876 adults across 16 European countries, smokers and former smokers improved after one year of biologic treatment: symptoms and quality of life improved, while exacerbations and oral steroid use fell. The size of improvement was not statistically different from that in never-smokers, but randomized trials are needed to confirm the finding and guide treatment.
- Journal
- American journal of respiratory and critical care medicine (Q1)
- Published
- 22 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Marco Caminati, Jeremy Charriot, Aruna T Bansal, Shane Hanon, Renaud Louis, Florence Schleich, et al.
- PMID
- 42773700
- DOI
- 10.1093/ajrccm/aamag473
Why clinicians should know about it
- Picked for Pulmonary and Respiratory Medicine (paper of the day, 25 September 2026): Biologics effective regardless of smoking status
Abstract
RATIONALE: The efficacy of biologics remains debatable in current or ex- smokers with severe asthma. OBJECTIVES: This study aimed to evaluate responses to biologics by smoking exposure and to assess variations in management practice across Europe. METHODS: 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. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSION: 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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.