TY - JOUR
T1 - Characteristics of severe asthma patients on biologics
T2 - a real-life European registry study
AU - Principe, Stefania
AU - Richards, Levi B
AU - Hashimoto, Simone
AU - Kroes, Johannes Anthon
AU - Van Bragt, Job J M H
AU - Vijverberg, Susanne J
AU - Sont, Jacob K
AU - Scichilone, Nicola
AU - Bieksiene, Kristina
AU - Ten Brinke, Anneke
AU - Csoma, Zsuzsanna
AU - Dahlén, Barbro
AU - Gemicioglu, Bilun
AU - Grisle, Ineta
AU - Kuna, Piotr
AU - Lazic, Zorica
AU - Mihaltan, Florin
AU - Popović-Grle, Sanja
AU - Škrgat, Sabina
AU - Marcon, Alessandro
AU - Caminati, Marco
AU - Djukanovic, Ratko
AU - Porsbjerg, Celeste
AU - Maitland Van Der Zee, Anke-Hilse
N1 - Copyright ©The authors 2023.
PY - 2023/7
Y1 - 2023/7
N2 - BACKGROUND: The use of anti-interleukin-5 (IL5) for severe asthma is based on criteria from randomised controlled trials (RCTs), but in real-life patients might not fulfil the eligibility criteria but may benefit from biologics. We aimed to characterise patients starting anti-IL5(R) in Europe and evaluate the discrepancies between initiation of anti-IL5(R) in real life and in RCTs.MATERIALS AND METHODS: We performed a cross-sectional analysis with data from the severe asthma patients at the start of anti-IL5(R) in the Severe Heterogeneous Asthma Research collaboration Patient-centred (SHARP Central) registry. We compared the baseline characteristics of the patients starting anti-IL5(R) from 11 European countries within SHARP with the baseline characteristics of the severe asthma patients from 10 RCTs (four for mepolizumab, three for benralizumab and three for reslizumab). Patients were evaluated following eligibility criteria from the RCTs of anti-IL5 therapies.RESULTS: Patients starting anti-IL5(R) in Europe (n=1231) differed in terms of smoking history, clinical characteristics and medication use. The characteristics of severe asthma patients in the SHARP registry differed from the characteristics of patients in RCTs. Only 327 (26.56%) patients fulfilled eligibility criteria of all the RCTs; 24 patients were eligible for mepolizumab, 100 for benralizumab and 52 reslizumab. The main characteristics of ineligibility were: ≥10 pack-years, respiratory diseases other than asthma, Asthma Control Questionnaire score ≤1.5 and low-dose inhaled corticosteroids.CONCLUSION: A large proportion of patients in the SHARP registry would not have been eligible for anti-IL5(R) treatment in RCTs, demonstrating the importance of real-life cohorts in describing the efficacy of biologics in a broader population of patients with severe asthma.
AB - BACKGROUND: The use of anti-interleukin-5 (IL5) for severe asthma is based on criteria from randomised controlled trials (RCTs), but in real-life patients might not fulfil the eligibility criteria but may benefit from biologics. We aimed to characterise patients starting anti-IL5(R) in Europe and evaluate the discrepancies between initiation of anti-IL5(R) in real life and in RCTs.MATERIALS AND METHODS: We performed a cross-sectional analysis with data from the severe asthma patients at the start of anti-IL5(R) in the Severe Heterogeneous Asthma Research collaboration Patient-centred (SHARP Central) registry. We compared the baseline characteristics of the patients starting anti-IL5(R) from 11 European countries within SHARP with the baseline characteristics of the severe asthma patients from 10 RCTs (four for mepolizumab, three for benralizumab and three for reslizumab). Patients were evaluated following eligibility criteria from the RCTs of anti-IL5 therapies.RESULTS: Patients starting anti-IL5(R) in Europe (n=1231) differed in terms of smoking history, clinical characteristics and medication use. The characteristics of severe asthma patients in the SHARP registry differed from the characteristics of patients in RCTs. Only 327 (26.56%) patients fulfilled eligibility criteria of all the RCTs; 24 patients were eligible for mepolizumab, 100 for benralizumab and 52 reslizumab. The main characteristics of ineligibility were: ≥10 pack-years, respiratory diseases other than asthma, Asthma Control Questionnaire score ≤1.5 and low-dose inhaled corticosteroids.CONCLUSION: A large proportion of patients in the SHARP registry would not have been eligible for anti-IL5(R) treatment in RCTs, demonstrating the importance of real-life cohorts in describing the efficacy of biologics in a broader population of patients with severe asthma.
UR - http://www.scopus.com/inward/record.url?scp=85164259482&partnerID=8YFLogxK
U2 - 10.1183/23120541.00586-2022
DO - 10.1183/23120541.00586-2022
M3 - Journal article
C2 - 37143845
SN - 2312-0541
VL - 9
JO - ERJ Open Research
JF - ERJ Open Research
IS - 3
M1 - 00586-2022
ER -