Abstract
<b>Introduction:</b> Factors driving exacerbation risk (ExR) are not fully characterised in asthma. We developed a model describing ExR in patients (Pts) on regularly dosed fluticasone propionate (FP), or combination therapy with FP-salmeterol (FP/SAL) or budesonide-formoterol (BUD/FOR). <b>Aims and objectives:</b> To quantify the effects of symptom control (assessed by the Asthma Control Questionnaire [ACQ-5]) and treatment on ExR in moderate-severe asthma. <b>Methods:</b> Exacerbations and ACQ-5 profiles were simulated over 1 year using time-to-event and longitudinal model-based parallel study designs. In addition, to reflect clinical practice, Pts on FP without adequate symptom control after 3 months were switched to FP/SAL (FP<sub>NR</sub> → FP/SAL). A log-rank test analysed cumulative exacerbation data. Heat maps separated effects of baseline characteristics from treatment effects. <b>Results:</b> ACQ-5, body mass index (BMI), sex and % predicted FEV1 were ExR factors distinct from treatment effect (p<0.01). Cumulative exacerbation events (%) were fewer in Pts with well and not well controlled symptoms at baseline vs poor control (p<0.01). Switching from FP to FP/SAL significantly reduced ACQ-5 scores (p<0.01; Fig 1). <b>Conclusions:</b> Symptom control, BMI and sex contribute to ExR, irrespective of treatment. These scenarios quantify the effect of treatable traits and treatment choices in moderate-severe asthma. <b>Funding:</b> GlaxoSmithKline (Study 215310)
Published Version
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