Biomarkers on the clinical usage of biologicals in the EAACI
The EAACI recently published the Guidelines on the use of biologicals in severe asthma. Recommendations were formulated following the GRADE approach338-340 for each biological (benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab) and each outcome (decrease in asthma exacerbations, oral and inhaled corticosteroids and rescue medication use; improvement in asthma control, quality of life and lung function; and, safety).33 The recommendations were informed by 3 systematic reviews.341-343 FeNO, sputum and blood eosinophils were scored as outcomes with low importance, however the evidence was analysed for subgroups based on biomarkers and co-morbidities. The higher the blood eosinophils the higher the expected impact of benralizumab, dupilumab and mepolizumab in reducing severe asthma exacerbations. The improvement in asthma control was significantly better in the high eosinophil subgroup for benralizumab and reslizumab. Lung function increased significantly more in the high eosinophil subgroup for benralizumab, dupilumab and reslizumab. Benralizumab improved QoL better in the high eosinophil subgroup. The effect of omalizumab on exacerbations did not depend on blood eosinophils. Neither the atopic status or total IgE predict the magnitude of effect of benralizumab and serum IgE thresholds (within regulatory limits) did not influence the response to omalizumab (Table 4).
Table 4. Current biologicals, biomarkers, asthma outcomes and GRADE recommendation