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definition of atopic status, eosinophil count, clinical outcomes (lung function parameters,
frequency and severity of exacerbations, and number of exacerbations), but also includes
severe asthma forum 2: severe asthma - monitoring and treatable traits in severe asthma duration of asthma1,11. Due to this, the expert subjective outcomes assessed by the patient,
opinion is that the indirect treatment compar- such as symptoms, activity level, quality of
ison between these five biologics may be er- life and satisfaction.
roneous or biased and should not be done11.
Studies that directly compare the therapeu- Assessments of the therapeutic response
tic response of approved biologics have not yet could be hampered by disease heterogeneity,
been performed. comorbidities, complexity of care, and differ-
ences in national and regional health systems.
Key elements for evaluating responses The recommendations for assessing the ther-
to biological treatment in clinical apeutic response to b iologics assumes that the
practice. How and when to evaluate? diagnosis of severe asthma is correct and all
Estimation of response sizes to co-morbidities and factors influencing asthma
biological treatment of s evere asthma control are correctly addressed. Baseline asth-
ma severity and duration, dose of oral corti-
The effectiveness of all the biologics in severe costeroid, atopic status definition, eosinophil
asthma is approximately 60% in a real-world cut-off, exacerbation severity and rate histo-
setting23,24,25. Most of the afore mentioned ry as well as lung function are all important in
clinical features of severe asthma represent assessing treatment efficacy or effectiveness11.
the elements for assessing the outcomes and
clinical benefits from treatment with biologics The therapeutic response to biologics
(Figure 1.). Asthma control includes objective should be assessed individually according to
pre-defined limits for outcomes focused on the

Figure 1. Monitoring of the therapeutic response after the introduction of biological drugs for s evere asthma
(10) (Taken with permission from ICER Rewier 2018).

Note: AEs: adverse effects; FENO: fractional exhaled nitric oxide; FEV1: forced expiratory volume in one second; SAEs: severe
adverse effects
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