Don't withhold biologics from smokers with severe asthma

Design

Retrospective real-world registry study (ERS SHARP), 16 countries

Population

3,876 adults with severe asthma on biologics, by smoking status

Primary outcome

One-year change in control, exacerbations, quality of life and steroid use

Effect

Improvement similar across never-, ex- and current-smokers; no significant between-group difference

Biologics have transformed severe asthma, but clinicians have been unsure whether they work in current or ex-smokers, who were under-represented in the pivotal trials. The SHARP registry looked at 3,876 adults with severe asthma across 16 European countries, treated with a biologic and followed for a year.

Across never-smokers, ex-smokers and current smokers alike, symptom control improved, frequent exacerbations fell, asthma quality of life rose and oral-steroid use dropped, and the magnitude of improvement did not differ significantly between the groups. Yet nearly a third of participating countries reported reluctance to prescribe biologics to current smokers.

The practice point is to judge biologic eligibility in severe asthma on the asthma phenotype, not on smoking status, while still pursuing cessation hard as a parallel goal. This is real-world and non-randomised, so confounding cannot be excluded and the authors call for trials in smokers — but on the current evidence, withholding a biologic purely because a patient smokes is not justified.

• Current and ex-smokers with severe asthma responded to biologics as well as never-smokers.
• Symptom control, exacerbations, quality of life and steroid use all improved similarly across smoking groups.
• Base biologic eligibility on asthma phenotype, not smoking status.
• Keep pursuing smoking cessation as a parallel goal, not a precondition.

Why it matters

It challenges a common reluctance to treat smokers, which this real-world evidence suggests denies effective therapy without justification.

Don't overread it

This is retrospective, real-world data, not a randomised trial, so confounding by indication cannot be excluded; it argues against a blanket exclusion rather than proving equal efficacy.

The statistics, in plain English

That the size of improvement did not differ significantly across smoking groups is reassuring, but a registry cannot match patients as a trial would, so the finding supports not withholding treatment rather than a precise equivalence.

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