A landmark study from the German Asthma Net (GAN) registry has found that biologic therapies are just as effective in former smokers with severe asthma as they are in patients who have never smoked, challenging long-standing assumptions in asthma treatment.
The study, “Impact of Smoking on Biological Treatment Response in Patients From the German Severe Asthma (GAN) Registry,” was recently published in the Journal of Allergy and Clinical Immunology. Researchers analyzed data from 1,129 patients with severe asthma who were treated with biologics, such as benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab. The study offers the most comprehensive, real-world evidence to date on the impact of smoking history on biologic therapy outcomes.
Key findings from the study include:
- Equal efficacy across smoking histories: After one year of treatment, ex-smokers (ExS) showed similar improvements in asthma control, lung function, exacerbation rates and biomarker levels as never-smokers (NS).
- No long-term impact from smoking: Even patients with a heavy smoking history (over 20-pack years) experienced comparable benefits from biologics, despite having worse baseline lung function and asthma control.
- Consistent biomarker response: All groups experienced a reduction in eosinophils and exhaled nitric oxide (FeNO) — key indicators of type 2 inflammation.
- Oral steroid use reduction: Both NS and ExS significantly reduced their reliance on daily oral corticosteroids, with no disadvantage observed in ExS.
- Safety profile: Adverse events were rare and consistent with known safety profiles of the biologics used.
Historically, clinical trials for biologics have excluded patients with a smoking history exceeding 10-pack years due to concerns of overlapping chronic obstructive pulmonary disease (COPD). This exclusion left a critical knowledge gap about how these therapies perform in real-world populations, where smoking is common among asthma patients.
“This study offers valuable insights into biological treatment outcomes for patients with a smoking history and characterizes a specific population of individuals with severe asthma who can benefit from this therapy,” said lead investigator Slagjana Stoshikj, MD, attending physician at the Medical University of Vienna, Austria. “This might help identify patients for upcoming severe asthma trials and clarify the smoking impact on asthma, particularly regarding T2-inflammation.”
According to the study’s authors, the findings suggest that clinicians should not hesitate to prescribe biologics to eligible patients with a smoking history, provided they exhibit markers of type 2 inflammation. The study also highlights the need for more inclusive clinical trials and better characterization of asthma phenotypes in smokers and ex-smokers. It also sets the stage for future studies to explore the nuances of asthma treatment in diverse patient populations, including those with complex smoking histories.
