TABLE 3.
Inclusion criteria for severe asthma biotherapies in Europe
| Biotherapy | Common criteria | Disparities noted between countries | Additional criteria for some countries |
| Omalizumab (n=26 countries) | Severe asthma definition (ATS/ERS) (24/26) Exacerbation rate (24/26) • Four countries required >2 exacerbations/year • 20 countries considered ≤2 exacerbations/year IgE levels (25/26), with very variable threshold (majority >30 or >76 IU·mL−1) |
Age threshold: adults versus children for some countries FEV1 levels: used as criterion in 13/26 countries (50%) |
Adherence is an absolute criterion in two countries Non-smoking status is an absolute criterion in three countries Questionnaire for quality of life (QOL) was used as criterion in one country |
|
Mepolizumab
(n=24 countries) |
Severe asthma definition (ATS/ERS) (21/24) Exacerbation rate (24/24) • Five countries required >2 exacerbations/year • 19 countries considered ≤2 exacerbations/year Blood eosinophils (24/24), with a threshold variable between 150 and 500 cells·µL−1) Of note, one country separated maintenance OCS patients and not on maintenance OCS patients to define threshold |
Age: adult versus children. This was not clearly defined as criterion in some countries FEV1 levels: used as criterion in 5/24 countries (20.8%) |
Adherence is an absolute criterion in four countries Non-smoking status is an absolute criterion in three countries Questionnaire for QOL was used as criterion in one country Two countries offer the possibility of inclusion if sputum eosinophils are high, even if blood eosinophils are below the fixed threshold Cotinine level in saliva is a criterion in one country |
| Benralizumab (n=24 countries) | Severe asthma definition (ATS/ERS) (20/24) Exacerbation rate (22/24) • Five countries required >2 exacerbations/year • 17 countries considered ≤2 exacerbations/year Blood eosinophils (24/24), with a threshold variable between 150 and 500 cells·µL−1) |
Age: adult versus children. This was not clearly defined as criterion in some countries FEV1 levels: used as criterion in 6/24 countries (25%) |
Adherence is an absolute criterion in three countries Non-smoking status is an absolute criterion in three countries Questionnaire for QOL was used as criterion in one country Two countries offer the possibility of inclusion if sputum eosinophils are high, even if blood eosinophils are below the fixed threshold Cotinine level in saliva is a criterion in one country |
| Reslizumab (n=16 countries) | Severe asthma definition (ATS/ERS) (16/16) Exacerbation rate (16/16) • Seven countries required >2 exacerbations/year • Nine countries considered ≤2 exacerbations/year Blood eosinophils (16/16), with a threshold variable between 150 and 400 cells·µL−1) |
Age: adult versus children. This was not clearly defined as criterion in some countries FEV1 levels: used as criterion in 5/16 countries (31.2%) |
Adherence is an absolute criterion in three countries Non-smoking status is an absolute criterion in three countries Questionnaires for QOL were not used Two countries offer the possibility of inclusion if sputum eosinophils are high, even if blood eosinophils are below the fixed threshold Three countries granted the biotherapy if patient was on OCS >50% of the year Cotinine level in saliva was not used |
| Dupilumab (n=11 countries) | Severe asthma definition (ATS/ERS) (10/11) Exacerbation rate (10/11) • One country required >2 exacerbations/year • Nine countries considered ≤2 exacerbations/year • One country had no threshold Blood eosinophils (11/11), with a threshold variable between 150 and 300 cells·µL−1) |
Age: adult versus children. This was not clearly defined as criterion in some countries FEV1 levels: used as criterion in 1/11 countries (9.1%) FENO levels: used in 5/11 countries (45.5%), with threshold >25 ppb for all countries |
Adherence is an absolute criterion in two countries Non-smoking status is an absolute criterion in two countries Questionnaires for QOL were not used Three countries granted the biotherapy if patient was on OCS >50% of the year (without needing exacerbations or high blood eosinophilic count) Cotinine level in saliva is a criterion in one country |
ATS: American Thoracic Society; ERS: European Respiratory Society; FEV1: forced expiratory volume in 1 s; QOL: quality of life; OCS: oral corticosteroids; FENO: fractional exhaled nitric oxide.