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 - Brinke, Anneke Ten

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

AU - SHARP Clinical Research Collaboration

N1 - Publisher Copyright: © The authors 2023.

PY - 2023

Y1 - 2023

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.

U2 - 10.1183/23120541.00586-2022

DO - 10.1183/23120541.00586-2022

M3 - Journal article

C2 - 37143845

AN - SCOPUS:85164259482

VL - 9

JO - ERJ Open Research

JF - ERJ Open Research

SN - 2312-0541

IS - 3

M1 - 00586-2022

ER -