The prevalence of severe refractory asthma

J Allergy Clin Immunol. 2015 Apr;135(4):896-902. doi: 10.1016/j.jaci.2014.08.042. Epub 2014 Oct 16.


Background: Severe asthma is characterized by difficulty to achieve disease control despite high-intensity treatment. However, prevalence figures of severe asthma are lacking, whereas longstanding estimates vary between 5% and 10% of all asthmatic patients. Knowing the exact prevalence of severe refractory asthma as opposed to difficult-to-control asthma is important for clinical decision making, drug development, and reimbursement policies by health authorities.

Objective: We sought to estimate the prevalence of severe refractory asthma as defined by the Innovative Medicine Initiative consensus.

Methods: Adult patients with a prescription for high-intensity treatment (high-dose inhaled corticosteroids and long-acting β2-agonists or medium- to high-dose inhaled corticosteroids combined with oral corticosteroids and long-acting β2-agonists) were extracted from 65 Dutch pharmacy databases, representing 3% of the population (500,500 inhabitants). Questionnaires were sent to 5,002 patients, of which 2,312 were analyzed. The diagnosis of asthma and degree of asthma control were derived from questionnaires to identify patients with difficult-to-control asthma. Inhalation technique was assessed in a random sample of 60 adherent patients (prescription filling, ≥80%). Patients with difficult-to-control asthma, adherence to treatment, and a correct inhalation technique were qualified as having severe refractory asthma. Results were mirrored to the Dutch population.

Results: Of asthmatic adults, 3.6% (95% CI, 3.0% to 4.1%) qualified for a diagnosis of severe refractory asthma, representing 10.4 patients per 10,000 inhabitants.

Conclusion: The prevalence of severe refractory asthma might be lower than estimated by expert opinion. This implies that currently recognized severe asthma subphenotypes could meet the criteria of rare diseases.

Keywords: Asthma; difficult-to-control asthma; prevalence; severe asthma; severe refractory asthma.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Aged
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / therapeutic use
  • Asthma / diagnosis
  • Asthma / drug therapy
  • Asthma / epidemiology*
  • Female
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Netherlands / epidemiology
  • Prevalence
  • Risk Factors
  • Severity of Illness Index


  • Anti-Asthmatic Agents