Page 64 - Škrgat, Sabina, ed. 2023. Severe Asthma Forum - Monitoring and Treatable Traits in Severe Asthma. Koper: University of Primorska Press. Severe Asthma Forum, 2
P. 64
Patients with “problematic” asthma can be tested in randomized controlled tri-
should be carefully examined and distin- als (RCTs) under controlled study conditions.
severe asthma forum 2: severe asthma - monitoring and treatable traits in severe asthma guished from those whose asthma is uncon- Effectiveness can be tested in real-life trials
trolled due to poor adherence and/or poor in- under real living conditions. Efficacy results
halation technique as well as difficult to treat show what we can expect in a population that
for other reasons such as uncontrolled asthma has the characteristics of the examined sam-
triggers and comorbidities. Comorbidities in ple, and effectiveness results show what we
patients with asthma need to be treated ap- have really observed8. Both types of research
propriately. Some comorbidities, such as nasal
polyps, allergic rhinitis, or atopic dermatitis, have shown that b iologics are very successful
are favorably affected by b iologics, while oth- in treating patients with severe asthma1. Bi-
ers, such as gastroesophageal reflux disease,
obesity, and bronchiectasis, do not diminish ologics have good potential for achieving re-
the therapeutic response to biologics. Before mission during treatment, but not all patients
assessing the severity of asthma itself, it is nec- are good responders and usually not all cri-
essary to address all factors that have a poten- teria for complete remission or good asth-
tial effect on health status, and also to have ma control are met9. An important task for
them under control during treatment with bi-
ologics1,4. clinicians is to properly assess the therapeu-
tic response to b iologics and to identify which
It is well known that asthma is a heter- patients have a satisfactory response to treat-
ogeneous disease. Clinical diversity and in- ment and which do not.
flammatory phenotype are reflected as a con-
sequence of the pathogenetic mechanism and Licensed biologics for uncontrolled
histopathological characteristics of asthma. s evere asthma
Clinical features such as frequent exacerba-
tions, emergency room visits, hospital admis- A years ago, five biological drugs with differ-
sions, lost days from work, school, or leisure ent mechanisms of action are available in clin-
time, poor asthma symptom control, poor ical settings worldwide for uncontrolled severe
lung function and poor quality of life, as well asthma with high T2. These are: omalizumab
as oral corticosteroid use are characteristics of (Xolair, Genentech/Novartis), mepolizum-
severe asthma5. The clinical features and in- ab (Nucala, GlaxoSmithKline), reslizumab
flammatory phenotype of severe asthma are (Cinqair, Teva), benralizumab (Fasenra, As-
currently fundamental determinants for as- traZeneca) and dupilumab (Dupixent, Sa-
sessing the indication for introduction as well nofi/Regeneron). Tezepelumab (Tezspire,
as assessing the effect of treatment with bio- Amgen/Astra Zeneca) is available in clinical
logic drugs. The phenotyping of severe asth- practice from the beginning of 2022 in the
ma is today embedded in clinical practice and United States of America.
is used to assess the feasibility of available bi-
ologics6. The use of monoclonal antibodies The Institute for Clinical and Econom-
against immunoglobulin E (IgE) and interleu- ic Review (ICER) analyzes the value of first
kin (IL) -5 and recently IL-13/IL-4 has been five biological drugs treating moderate to se-
shown to be efficient and safe in clinical trials vere asthma associated with T2 inflamma-
as well as in everyday clinical practice7. tion. The ICER Report suggests that all five
approved b iologics are effective and safe.
Efficacy and effectiveness are not identi- Each of the five analyzed drugs significant-
cal concepts and it is not possible to investigate ly reduced the exacerbation of asthma com-
both in the same type of research. Efficacy pared with placebo and improved patient
quality of life. Treatment with omalizumab
and mepolizumab is carried out for the great-
est length of time. Thanks to long-term effi-
should be carefully examined and distin- als (RCTs) under controlled study conditions.
severe asthma forum 2: severe asthma - monitoring and treatable traits in severe asthma guished from those whose asthma is uncon- Effectiveness can be tested in real-life trials
trolled due to poor adherence and/or poor in- under real living conditions. Efficacy results
halation technique as well as difficult to treat show what we can expect in a population that
for other reasons such as uncontrolled asthma has the characteristics of the examined sam-
triggers and comorbidities. Comorbidities in ple, and effectiveness results show what we
patients with asthma need to be treated ap- have really observed8. Both types of research
propriately. Some comorbidities, such as nasal
polyps, allergic rhinitis, or atopic dermatitis, have shown that b iologics are very successful
are favorably affected by b iologics, while oth- in treating patients with severe asthma1. Bi-
ers, such as gastroesophageal reflux disease,
obesity, and bronchiectasis, do not diminish ologics have good potential for achieving re-
the therapeutic response to biologics. Before mission during treatment, but not all patients
assessing the severity of asthma itself, it is nec- are good responders and usually not all cri-
essary to address all factors that have a poten- teria for complete remission or good asth-
tial effect on health status, and also to have ma control are met9. An important task for
them under control during treatment with bi-
ologics1,4. clinicians is to properly assess the therapeu-
tic response to b iologics and to identify which
It is well known that asthma is a heter- patients have a satisfactory response to treat-
ogeneous disease. Clinical diversity and in- ment and which do not.
flammatory phenotype are reflected as a con-
sequence of the pathogenetic mechanism and Licensed biologics for uncontrolled
histopathological characteristics of asthma. s evere asthma
Clinical features such as frequent exacerba-
tions, emergency room visits, hospital admis- A years ago, five biological drugs with differ-
sions, lost days from work, school, or leisure ent mechanisms of action are available in clin-
time, poor asthma symptom control, poor ical settings worldwide for uncontrolled severe
lung function and poor quality of life, as well asthma with high T2. These are: omalizumab
as oral corticosteroid use are characteristics of (Xolair, Genentech/Novartis), mepolizum-
severe asthma5. The clinical features and in- ab (Nucala, GlaxoSmithKline), reslizumab
flammatory phenotype of severe asthma are (Cinqair, Teva), benralizumab (Fasenra, As-
currently fundamental determinants for as- traZeneca) and dupilumab (Dupixent, Sa-
sessing the indication for introduction as well nofi/Regeneron). Tezepelumab (Tezspire,
as assessing the effect of treatment with bio- Amgen/Astra Zeneca) is available in clinical
logic drugs. The phenotyping of severe asth- practice from the beginning of 2022 in the
ma is today embedded in clinical practice and United States of America.
is used to assess the feasibility of available bi-
ologics6. The use of monoclonal antibodies The Institute for Clinical and Econom-
against immunoglobulin E (IgE) and interleu- ic Review (ICER) analyzes the value of first
kin (IL) -5 and recently IL-13/IL-4 has been five biological drugs treating moderate to se-
shown to be efficient and safe in clinical trials vere asthma associated with T2 inflamma-
as well as in everyday clinical practice7. tion. The ICER Report suggests that all five
approved b iologics are effective and safe.
Efficacy and effectiveness are not identi- Each of the five analyzed drugs significant-
cal concepts and it is not possible to investigate ly reduced the exacerbation of asthma com-
both in the same type of research. Efficacy pared with placebo and improved patient
quality of life. Treatment with omalizumab
and mepolizumab is carried out for the great-
est length of time. Thanks to long-term effi-
