Characteristics of severe asthma patients on biologics: a real-life European registry study.

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.

Administration of benralizumab in a patient with severe asthma admitted to the intensive care unit with COVID-19 pneumonia: case report.

A patient with severe asthma on benralizumab therapy was admitted to the intensive care unit (ICU) for a coronavirus disease 2019 (COVID-19) infection. At the end of the 8 week benralizumab dosing interval, discussion arose as to whether benralizumab should be administered or if treatment should be discontinued, due to the lack of experience with benralizumab in this situation. Severe broncho-obstruction developed, and the next injection of benralizumab was administered during ICU admission without detrimental symptoms. With this case report, we would like to share our experience with the safe administration of benralizumab during COVID-19 pneumonia, guiding doctors in future decision making.

Patient-reported outcome measures after 8 weeks of mepolizumab treatment and long-term outcomes in patients with severe asthma: an observational study.

Background The novel anti-IL-5 drug mepolizumab improves asthma outcomes in the majority but not all patients with severe eosinophilic asthma. Currently it is difficult to predict an individuals' chance of being a responder. Early changes in patient-reported outcome measures may contribute to the prediction of long-term outcomes. Aim To compare early changes in patient-reported outcome measures after 8 weeks and long-term response to mepolizumab treatment. Method 22 severe eosinophilic asthma patients starting mepolizumab therapy in a severe asthma centre in the Netherlands were evaluated on baseline, 8 weeks and 52 weeks, collecting questionnaire scores and asthma-related parameters. Well-controlled asthma was defined as an asthma control questionnaire score ≤ 0.75. Long-term treatment response was defined as continuing mepolizumab therapy at 52 weeks. Results Nine patients (41%) had well-controlled asthma at 8 weeks and all were mepolizumab responders at 52 weeks (positive predictive value = 100%, 95%CI 66-100), versus only 5 responders out of 13 patients with not well-controlled asthma at 8 weeks (negative predictive value = 62%, 95%CI 32-86). Conclusion The results in this study suggest that patients receiving mepolizumab therapy with an ACQ-score ≤ 0.75 at 8 weeks are unlikely to need extensive monitoring, for they are very likely to be long-term responders.