D1.93 - ICS use trajectories in severe asthma patients on benralizumab: real-life data from 3-years follow-up

Inhaled steroids (ICS) represent the cornerstone of asthma treatment. Recent evidence highlighted a not negligible systemic absorption of high-dose ICS in terms and a questionable added value in improving asthma control when increasing ICS dose. Those findings suggest to consider the ICS reduction as a major goal in asthma management. We aimed to investigate the trajectories of ICS use in severe asthma patients on benralizumab treatment, and to explore the trend of clinical and inflammatory parameters over a three-years follow-up (FU) by comparing patients on stable or variable ICS dose.

Data from 9 Italian Referral Centres for severe asthma part of SANI were retrospectively collected between January 2018 and February 2021. Patients’ characteristics, namely age, gender, BMI, smoking habit, age at asthma diagnosis, and comorbidities were considered for the analysis. Inflammation (blood eosinophil count), functional (pre- and post-BD FEV1) and clinical (ACT, ACQ, AQLQ, AER) parameters were analysed at baseline and 6, 12, 24, and 36 months after benralizumab initiation. Inhaled therapy and systemic steroid use at the same time points were evaluated. ICS dose was expressed as mcg fluticasone or equivalent daily.

Detailed data on baseline inhaled therapy was available for 92 out of 108 patients included in the study. At basal evaluation, 46 patients were on 500-1000 mcg inhaled fluticasone, followed by 40 of them taking >1000 mcg. Only 6 patients used < 500 mcg per day. 3 groups of patients based on ICS use over the study time frame could be identified: “stable” (the same dose in at least 80% of the FU); “decreasing” (at least 50% of the FU assessments had a lower ICS dose compared to baseline); “increasing” (at least 50% of the follow up assessments had a higher ICS dose compared to baseline). No differences characterized  the ICS groups based on sex, age, BMI, smoking history, age at diagnosis, or CRSwNP. Baseline BEC was higher in the ICS decreasing group than in the stable one, and the improvement of BEC was significantly more evident. Regarding lung function, no differences in pre- and post-BD FEV1 could be described at baseline by ICS dose group. The pre-BD FEV1 showed no significant differences at any point during the FU period, even when considering the decreasing group. The post-BD FEV1 had a similar significant  increase from baseline to 36 months in all the  ICS groups. A similar trend could be observed in terms of ACT (15>22), ACQ (2,4>0,6), ACLQ (4,4>5,5), AER (2,7>0,2). According to our findings, the overall probability of decreasing ICS dose in the whole sample was 19.0% at 12 months and 37.4% at 36 months

To the best of our knowledge our report firstly provides a real-life focused analysis on ICS-sparing effect of benralizumab in severe asthma patients, over a long-term FU (36 months).Further real-word evidence is needed to confirm our results and to explore whether the best candidate for a safe and effective ICS tapering can be identified in advance relying on a specific baseline profile.