Real-life effectiveness of benralizumab in severe asthma: 12-month data from the RAMSES cohort in France

<bold>Background:</bold> Clinical trials have demonstrated benralizumab efficacy in patients (pts) with severe asthma (SA). However there is a lack of data in real-life settings in France where benralizumab is marketed since January 2019. <bold>Aims:</bold> To describe benralizumab effectiveness in real-life pts with SA followed during 12 months (Mo) after treatment initiation. <bold>Methods:</bold> RAMSES is a descriptive, observational, multicenter French cohort that enrolled 2049 pts with SA between September 2019 and September 2022. The present analysis includes pts enrolled prior to November 20th 2021 and treated with benralizumab for 12 Mo. <bold>Results:</bold> 212 pts initiated treatment with benralizumab at enrollment or during follow-up in RAMSES (T0). 49 pts (23%) discontinued treatment. Data after 12 Mo of treatment (T12) with benralizumab were available for 136 pts. Mean number of asthma exacerbations in the past 12 Mo were reduced from 3.4 at T0 to 0.7 at T12, with 72.8% of pts exacerbation-free at T12 (vs 27.9% at T0). The number of pts who required an emergency room visit for asthma in the last 12 Mo was reduced from 40 pts to 7 pts. The proportion of pts with “well controlled asthma” (ACT score ≥ 20) increased from 13.8% (T0) to 56.9% (T12). 44.9% of pts achieved a 10% improvement of FEV1 and 24.5% of pts achieved a 20% improvement. 56.8% of SA pts with concomitant nasal polyposis (NP) demonstrated a reduction of ≥ 9 points in the SNOT-22 score. <bold>Conclusion:</bold> This first analysis of real-life data from the RAMSES cohort in France demonstrates benralizumab treatment is highly effective after 12 Mo of treatment in pts with SA, including on nasal symptoms in pts with concomitant NP.