Abstract
Background The use of anti-IL5 for severe asthma is based on criteria from randomized controlled trials(RCTs) but in real-life patient might not fulfil eligibility criteria but benefit from biologics. We aimed to: characterise patients starting in anti-IL5(R) in Europe and evaluate the discrepancies between initiation of anti-IL5(R) in real-life and in RCTs.
Material 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-centered(SHARP-Central)registry. We compared the baseline characteristics of the anti-IL5(R) from 11 European countries within SHARP with the baseline characteristics of the severe asthma patients from 10 RCTs (4 for mepolizumab, 3 for benralizumab and 3 for reslizumab). Patients were evaluated following eligibility criteria from the RCTs of anti-IL5 therapies.
Results Patients anti-IL5(R) starters in Europe (n=1231) differed in terms of smoking history, clinical characteristics and medication use. The characteristics of severe asthma patients in SHARP Registry differed from the characteristics of patients in RCTs. Only 327(26,56%) 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: pack/years≥10, respiratory diseases other than asthma, ACQ score≤1.5, low dose ICS.
Conclusion A large proportion of patients in the SHARP registry would not have been eligible for anti-IL-5(R) treatment RCTs, demonstrating the importance of real life cohorts in describing the efficacy of biologics in a broader population of patients with severe asthma.
Footnotes
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Conflict of interest: Stefania Principe declares to be employed by the University of Palermo with a co-EU research funds EU-REACT FESR o FSE, PON Ricerca e Innovazione 2014–2020 - DM 1062/2021.
Conflict of interest: Prof. Dr. Celeste Porsbjerg declares, in the past 36 months, grants from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi, ALK, consulting fees from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi, ALK, honoraria for lectures from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi, ALK, participation for advisory boards AZ, GSK, Novartis, TEVA, Sanofi, Chiesi, ALK.
Conflict of interest: Dr. Sabina Skgrat declares, in the past 36 months, honoraria for lectures and educational events from Astra Zeneca, Pliva Teva, Berlin Chemie and Chiesi, Medis. And participation to advisory boards AZ, Berlin Chemie.
Conflict of interest: Dr. ten Brinke reports grants from AstraZeneca, GSK, TEVA, fees for advisory boards and lectures from AstraZeneca, GSK, Novartis, TEVA, Sanofi Genzyme.
Conflict of interest: Dr. Sanja-Popović-Grle declares consulting fees from AZ, GSK, Novartis, Pliva TEVA, Sanofi, ALK and honoraria for lectures from AZ, GSK, Novartis, Pliva TEVA, Sanofi, ALK.
Conflict of interest: Dr. Ineta Grisle declares honoraria for lectures from AZ, Novartis, GSK, Berlin-Chemie, Boerinher- Ingelheim, Norameda.
Conflict of interest: Dr. Piotr Kuna declares honoraria for lectures/presentations from AstraZeneca, GSK, Boehringer Ingelheim, Berlin Chemie Menarini, FAES, Adamed, Polpharma, Glenmark, Novartis, Teva, and support for attending meetings from AstraZeneca, Berlin Chemie, Menarini.
Conflict of interest: All the other authors declare that they have no conflicts of interest.
- Received November 2, 2022.
- Accepted February 21, 2023.
- Copyright ©The authors 2023
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