Biologics worked as well in smokers and ex-smokers with severe asthma as in never-smokers

Design

Retrospective real-world registry study (ERS SHARP, OMOP common data model)

Population

3,876 adults with severe asthma in 16 European countries, 141 current smokers

Primary outcome

Change in control, exacerbations, quality of life and oral corticosteroid use after 1 year of biologics, by smoking status

Effect

Improvement in all groups; magnitude of change not significantly different between smoking groups

This retrospective real-world study used the ERS SHARP registry of 3,876 adults with severe asthma from 16 European countries, assessed at baseline and after one year of biologic treatment. There were 2,383 never-smokers, 540 ex-smokers with under 10 pack-years, 812 with 10 or more pack-years and 141 current smokers.

In all four groups, symptom control improved, frequent exacerbations (two or more a year) fell, asthma quality of life improved and oral corticosteroid use decreased. Starting points sometimes differed, but the size of change did not differ significantly between groups. A survey of participating countries found that 29% reported opposition to prescribing biologics to current smokers and 59% were dissatisfied with current guidelines.

The authors conclude that withholding biologics from smokers appears unwarranted, while smoking cessation should stay a central goal. This was an observational comparison, not a randomised trial. Smokers who received biologics were selected, and only 141 were current smokers. Eligibility rules and drug access in India differ from those of European countries and are not addressed here.

• Smoking status alone may not be a good reason to withhold a biologic in severe asthma, on this observational evidence.
• Biologic responses were similar in size across smoking groups at one year.
• Offer smoking cessation support alongside any biologic.
• Check local eligibility rules and funding before planning treatment.
• Current smokers were few (141), so estimates for them are less precise.

Why it matters

It challenges a common unwritten rule that smokers are poor candidates for biologics.

Don't overread it

A retrospective registry analysis of selected patients; guidelines have not changed, and the authors call for randomised trials in smokers.

The statistics, in plain English

No statistically significant difference between groups does not prove the responses were identical, especially in the small current-smoker group. Patients chosen to receive biologics are not a random sample of smokers.

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