Discrepancies between anti-Intereukin5 (anti-IL5) starters from SHARP central registry and eligible patients in clinical trials

Introduction: The use of anti-IL5 for severe asthma is based on criteria from randomized controlled trials (RCTs). In a recent analysis, Dutch patients with severe asthma did not fulfil eligibility criteria but benefitted from Mepolizumab in real-life.^{(Richards, L.B. et al. J Allergy Clin Immunol Pract 2021;9(1):604)} Aim: To explore the potential contrast between real-life initiation of anti-IL5(R) versus eligibility for trials in patients with severe asthma from different European countries. Methods: This cross-sectional analysis in the Severe Heterogeneous Asthma Research collaboration Patient-centred (SHARP-Central) registry included data from severe asthma patients at the start of anti-IL5. Patients from the registry were evaluated according to the eligibility criteria from the main RCTs on anti-IL5 therapies. Data were summarized using proportions, means and standard deviations. Results: From the 1231 anti-IL5(R) starters from 10 European countries, only 327(26,56%) fulfilled eligibility criteria of all the RCTs; 24 patients were eligible for mepolizumab, 100 for benralizumab and 52 reslizumab. Relevant characteristics of ineligibility were: smoking history of pack/years ≥ 10 (n: 256 – 28.3%); the highest value registered in Poland 27.5(31.8) mean (SD), respiratory diseases other than asthma (n: 394 – 43.6%); the highest number registered in Croatia (46.8%)) Asthma Control score ≤ 1.5 (n: 129 –14.3%), a low dose of inhaled corticosteroids (n: 784 – 86.7%); the lowest dose registered in Latvia (mean (SD) 314.5(230.8) mcg/day). Conclusion: Real life indication for anti-IL5 therapy is highly discordant with the RCT eligibility criteria across European countries.