Biologics for severe asthma: control and quality of life in real-life settings

<bold>Background:</bold> biologics are a key component of severe asthma treatment. Randomized controlled trials established clinical efficacy but evidences in real-life settings are scarce. <bold>Aim:</bold> to assess the efficacy of biologics on asthma control and quality of life (QoL) in severe/uncontrolled asthma (SUA) patients in real-life settings. <bold>Methods:</bold> RISER is an observational study in an epidemiological sample and in clinical cases with SUA (uncontrolled asthma with GINA step 4 or controlled asthma with step 5) investigated through questionnaires and routine clinical/functional assessments in Pisa and Ancona. The first 74 patients attending the Pisa center were analyzed through spirometry and Fractional exhaled Nitric Oxide (FeNO) and a questionnaire on descriptive characteristics, risk factors, therapy, asthma control, QoL. Analysis of variance, adjusted for sex, age and school level, was run to assess the relationship between use of biologics and asthma control or QoL scores. <bold>Results:</bold> users (n=52) vs non-users (n=22) of biologics had a higher ACT asthma control (20.9±5.2 vs 18.1±5.9, p 0.056), a better QoL by miniAQLQ (total score 5.6±1.1 vs 4.7±1.3, p 0.003; symptoms 5.6±1.4 vs 4.8±1.5, p 0.033; activity limitations 5.8±1.4 vs 4.9±1.3, p 0.041; emotional domain 5.8±1.2 vs 4.6±1.7, p 0.002), a higher FEV1 (86.3±22.6 vs 76.6±20.2, p 0.151) and a lower FENO level (32.4±33.4 vs 56.0±49.8, p 0.026). <bold>Conclusions:</bold> we confirm the beneficial effects of biologics on SUA patients in a real-life setting. Information on long-term efficacy will be obtained after the planned follow-ups. Funding provided by GSK (study id 213698). GSK provided a review of publication accuracy; authors are responsible for content and interpretation.