Page 71 - Škrgat, Sabina, ed. 2023. Severe Asthma Forum - Monitoring and Treatable Traits in Severe Asthma. Koper: University of Primorska Press. Severe Asthma Forum, 2
P. 71
According to EAACI Guidelines, the ef- markers, there was a significant difference in 71
fect of biologic drugs on the improvement of response rate between the groups of biolog-
lung function is an important but not criti- ics depended on the biomarker on which the mon i tor i ng a n d eva luat ion of t h e r a peu t ic r e sponse i n pat i e n ts w i t h sev e r e a st h m a on biologic s
cal outcome for assessing the effectiveness of drug was selected. When the biologics were
treatment11. selected based on peripheral blood eosinophil
counts (PBEC), IgE and FeNO the response
Effects of biologics and biomarkers rate was 33% (PBEC), 36% (IgE) and 50%
(FeNO) for omalizumab, 65% (PBEC), 67%
According to the Working Group of the Na- (IgE) and 64% (FeNO) for mepolizumab/
tional Institute of Health (NIH), a biomarker benralizumab and 64% (PBEC), 50% (IgE)
is defined as “… a characteristic that is objec- and 73% (FeNO) for dupilumab25. One of the
tively measured and evaluated as an indica- goals of future research is to identify better
tor of normal biologic processes, pathogen- clinically relevant biomarkers in terms of pa-
ic processes, or pharmacologic responses to a tient selection and prognosis of therapeutic re-
therapeutic intervention”. Simply, a biomark- sponse to biologics, and which will better re-
er indicates an alteration in physiology from flect the clinical response during treatment.
normal49. Ideally, a biomarker might be the
pathophysiological therapeutic target itself. Conclusion
Identification of specific biomarkers such as
peripheral blood absolute eosinophil count, All previous clinical studies as well as expe-
total IgE, specific IgE and fractional exhaled riences from everyday practices have shown
nitric oxide (FeNO) in biological materials al- that biologics in severe asthma are highly ef-
lowed precise treatment of patients with severe ficient and safe in precisely selected patients
T2 high asthma. Biomarkers indicate certain with severe T2 high asthma. However, all pa-
asthma endotypes and predict responses to tients treated with biologics are not good re-
biological therapies5). During treatment with sponders and there are still many doubts and
biologics, a reduction or complete eosinophil unknowns regarding the treatment.
depletion is observed which is usually accom-
panied by a good clinical response to treat- It is estimated that the effectiveness of
ment, but this response to biomarkers is con- b iologics on severe asthma in real world set-
sidered a less important outcome than other tings is about 60%11. For now, there are no
clinical outcomes. Routine monitoring of IgE
levels is not recommended during omalizum- clearly defined criteria for assessing the effec-
ab treatment1,9. In many patients with T2 tiveness of b iologics in everyday practice. Pa-
high asthma, known biomarkers overlap as tients treated with biologics should be closely
shown in Figure 2. Overlapping of biomark- monitored and evaluated against baseline and
ers often leads to doubts about drug choice against pre-defined treatment outcome goals.
and existing biomarkers are often considered The critical outcomes of treatment with b io-
insufficient for a precise decision about the logics are considered to be the impact on re-
best biologic to administer. In the current sit- ducing exacerbation, improving symptoms
uation, the overlapping of known biomarkers, and quality of life as well as the safety of bi-
in case of poor response to the initial biologi- ological therapy. Important treatment out-
cal drug allows switching to another biologic comes are considered to be the effect on re-
that targets another capture point, which of- ducing the intensity of treatment (oral and
ten results in a good response. In studies that inhaled corticosteroids, recue medications)
looked at the association between the effica- and the effect on improving lung function11.
cy of biological therapy and predictive bio-
Biologic drugs allow specific inhibition of
certain asthma pathways, which does not al-
ways meet all set treatment goals equally suc-
fect of biologic drugs on the improvement of response rate between the groups of biolog-
lung function is an important but not criti- ics depended on the biomarker on which the mon i tor i ng a n d eva luat ion of t h e r a peu t ic r e sponse i n pat i e n ts w i t h sev e r e a st h m a on biologic s
cal outcome for assessing the effectiveness of drug was selected. When the biologics were
treatment11. selected based on peripheral blood eosinophil
counts (PBEC), IgE and FeNO the response
Effects of biologics and biomarkers rate was 33% (PBEC), 36% (IgE) and 50%
(FeNO) for omalizumab, 65% (PBEC), 67%
According to the Working Group of the Na- (IgE) and 64% (FeNO) for mepolizumab/
tional Institute of Health (NIH), a biomarker benralizumab and 64% (PBEC), 50% (IgE)
is defined as “… a characteristic that is objec- and 73% (FeNO) for dupilumab25. One of the
tively measured and evaluated as an indica- goals of future research is to identify better
tor of normal biologic processes, pathogen- clinically relevant biomarkers in terms of pa-
ic processes, or pharmacologic responses to a tient selection and prognosis of therapeutic re-
therapeutic intervention”. Simply, a biomark- sponse to biologics, and which will better re-
er indicates an alteration in physiology from flect the clinical response during treatment.
normal49. Ideally, a biomarker might be the
pathophysiological therapeutic target itself. Conclusion
Identification of specific biomarkers such as
peripheral blood absolute eosinophil count, All previous clinical studies as well as expe-
total IgE, specific IgE and fractional exhaled riences from everyday practices have shown
nitric oxide (FeNO) in biological materials al- that biologics in severe asthma are highly ef-
lowed precise treatment of patients with severe ficient and safe in precisely selected patients
T2 high asthma. Biomarkers indicate certain with severe T2 high asthma. However, all pa-
asthma endotypes and predict responses to tients treated with biologics are not good re-
biological therapies5). During treatment with sponders and there are still many doubts and
biologics, a reduction or complete eosinophil unknowns regarding the treatment.
depletion is observed which is usually accom-
panied by a good clinical response to treat- It is estimated that the effectiveness of
ment, but this response to biomarkers is con- b iologics on severe asthma in real world set-
sidered a less important outcome than other tings is about 60%11. For now, there are no
clinical outcomes. Routine monitoring of IgE
levels is not recommended during omalizum- clearly defined criteria for assessing the effec-
ab treatment1,9. In many patients with T2 tiveness of b iologics in everyday practice. Pa-
high asthma, known biomarkers overlap as tients treated with biologics should be closely
shown in Figure 2. Overlapping of biomark- monitored and evaluated against baseline and
ers often leads to doubts about drug choice against pre-defined treatment outcome goals.
and existing biomarkers are often considered The critical outcomes of treatment with b io-
insufficient for a precise decision about the logics are considered to be the impact on re-
best biologic to administer. In the current sit- ducing exacerbation, improving symptoms
uation, the overlapping of known biomarkers, and quality of life as well as the safety of bi-
in case of poor response to the initial biologi- ological therapy. Important treatment out-
cal drug allows switching to another biologic comes are considered to be the effect on re-
that targets another capture point, which of- ducing the intensity of treatment (oral and
ten results in a good response. In studies that inhaled corticosteroids, recue medications)
looked at the association between the effica- and the effect on improving lung function11.
cy of biological therapy and predictive bio-
Biologic drugs allow specific inhibition of
certain asthma pathways, which does not al-
ways meet all set treatment goals equally suc-
