Introduction

Factors driving asthma exacerbation risk (ExR) are not fully characterised. We modelled ExR in patients (pts) with moderate-severe asthma on regularly dosed inhaled corticosteroid (ICS) mono- or ICS-long-acting beta agonist combination therapy.

Aims

To characterise ExR in moderate-severe asthma.

Methods

Individual pt data (N=6722) from 9 randomised clinical trials were used to build a parametric hazard model of time to first exacerbation, considering symptom control (Asthma Control Questionnaire 5 [ACQ-5]), and baseline clinical/demographic characteristics e.g., body mass index (BMI), exacerbation history, and smoking status. Model validation used standard goodness-of-fit, graphical and statistical criteria.

Results

BMI, ACQ-5, previous exacerbation history, % predicted forced expiratory volume in 1 second (FEV1 % pred), sex, and smoking were risk factors for ?1 exacerbation (p<0.01; Figure). Cumulative exacerbation frequency was lower in pts with well and partially controlled symptoms at baseline vs pts with poorly controlled symptoms (p<0.01). Non-smoking, male pts had a significantly lower risk (p<0.01) relative to smokers and females.

Conclusions

Our drug-disease modelling approach assessed the contribution of pt-specific factors and treatment choices to ExR in moderate-severe asthma. Symptom control, BMI, FEV1 % pred, exacerbation history, and sex contribute to ExR, irrespective of treatment.