Severe asthma is characterized by difficulty to achieve
disease control despite high-dose inhaled glucocorticoids plus long acting β2
–agonists (LABAs) or oral corticosteroids (OCSs). In 2011, the Innovative
Medicine Initiative (IMI) published an international consensus statement in
which a more accurate definition of severe asthma was proposed. In this
statement, a clear distinction was made between “difficult to control asthma”
and “severe refractory asthma.” In patients with difficult to control asthma,
the lack of asthma control is due to other factors than asthma itself, such as
nonadherence to treatment or incorrect inhalation technique. On the other hand,
in patients with severe refractory asthma, the disease remains uncontrolled
despite addressing and removing all possible factors that might aggravate the
underlying disease. Hekking et al
sought to estimate the prevalence of severe refractory asthma as defined by the
IMI consensus (J Allergy Clin Immunol 2015; 135(4): 896-902).
Adult patients with a prescription for high-intensity
treatment were extracted from 65 Dutch pharmacy databases, representing 3% of
the population. Questionnaires were sent to patients and about half (2312) were
analyzed. The diagnosis of asthma and degree of asthma control were derived
from the questionnaires to identify patients with difficult-to-control asthma
and inhalation technique was assessed in a random sample of 60 adherent
patients. The authors determined that patients with difficult to control
asthma, adherence to treatment, and a correct inhalation technique were
qualified as having severe refractory asthma. The results indicated that of
asthmatic adults, 3.6% qualified for a diagnosis of severe refractory asthma,
representing 10.4 patients per 10,000 inhabitants.
The authors speculate about the reasons for the difference
between the prevalence of severe refractory asthma mentioned in the literature
(5%-10%) and their results (3.6%). Estimations in the literature are based on
expert opinion and clinical experience, it is reasonable to believe that not
all factors that negatively influence asthma control are receiving full
attention in the consulting room. Therefore clinical overestimation of the
prevalence of truly severe refractory asthma might easily occur because of
misclassification of patients with difficult-to-control asthma as patients with
severe refractory asthma. Clinicians should be aware of the distinction between
these 2 conditions and check potential aggravating factors, in particular poor
adherence with treatment and inadequate inhalation technique. Another important
result of this study is because the prevalence of this condition might be lower
than previously thought, severe refractory asthma could fulfill the criteria of
a rare disease and qualifies for niche drugs. Together, these data will
hopefully facilitate the development and reimbursement of novel targeted
treatments.
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