Biologics for severe asthma: The real-world evidence, effectiveness of switching, and prediction factors for the efficacy

Biologics have been a key component of severe asthma treatment, and there are currently biologics available that target IgE, IL-5, IL-4/IL-13, and TSLP. Randomized controlled trials have established clinical evidence, but a significant portion of patients with severe asthma in real-life settings would have been excluded from those trials. Therefore, real-world research is necessary, and there is a growing body of information about the long-term efficacy and safety of biologics.Multiple clinical phenotypes of severe asthma exist, and it is crucial to choose patients based on their phenotypes. Blood eosinophil count is an important biomarker for anti-IL-5 therapies, and FeNO and eosinophil counts serve as prediction markers for dupilumab. Reliable markers for predicting response, however, have not yet been fully established for omalizumab. Identification of clinical or biological prediction factors is crucial for the path toward clinical remission because the current treatment goal includes clinical remission, which is defined as a realistic goal for remission off treatment.Additionally, since there are now multiple biologic options and overlaps in eligibility for biologics in clinical practice, the evidence regarding the effectiveness of switching the biologics is crucial. In-vestigations into the clinical trajectory following the cessation of biologics are another important issue.Recent research on omalizumab, mepolizumab, benralizumab and dupilumab's real-world effective-ness, the prediction factor for the efficacy, and the impact of switching or discontinuation will be reviewed and discussed in this review.(c) 2022 Japanese Society of Allergology. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Automated summary

Biologics, such as anti-IgE, anti-IL-5, anti-IL-4/IL-13, and anti-TSLP, have been effective in the treatment of severe asthma. However, real-world research is needed to include patients who may have been excluded from clinical trials. The identification of biomarkers for predicting response to different biologics is crucial, and there is a need to evaluate the effectiveness and safety of switching biologics and discontinuation.