Characteristics of Patients With and Without Allergic Disease From Benralizumab Phase III Severe Asthma Trials

Introduction Allergic disease is commonly associated with asthma. We compared demographics and baseline clinical characteristics of patients with and without allergic disease from the benralizumab SIROCCO (48 weeks; NCT01928771; Lancet. 2016;388 : 2115 – 27) and CALIMA (56 weeks; NCT01914757; Lancet. 2016;388 : 2128 – 41) Phase III trials.

Methods Patients were aged 12 – 75 years and had severe, uncontrolled asthma despite receiving high-dosage inhaled corticosteroids/long-acting β₂-agonists. The incidence of allergic disease was determined from medical history and respiratory disease characteristics in trial databases.

Results Of 2,295 patients, 1,908 (83.1%) had ≥ 1 allergic condition and 387 (16.9%) had no allergic conditions. Key baseline characteristics differed between patients with and without allergic disease. Compared with patients without allergic disease, patients with allergic disease had greater blood eosinophil counts, serum immunoglobulin E (IgE) concentrations, incidence of experiencing ≥ 3 exacerbations in the previous year, and incidence of nasal polyposis (nasal polyposis was not a search term for allergy incidence). Patients with allergic disease also had longer time since asthma diagnosis than patients without allergic disease (mean [standard deviation]: 20.0 [14.8] years vs. 15.8 [13.8] years, respectively) and younger age at asthma diagnosis (29.5 [18.5] years vs. 37.1 [17.8] years, respectively). There were no differences in any baseline lung function criteria, score on the 6-item version of the Asthma Control Questionnaire, or body mass index.

Conclusion Most patients in SIROCCO and CALIMA had comorbid allergic disease. Baseline characteristics associated with enhanced response to benralizumab were distributed across populations with and without allergic disease. Patients with allergic disease had greater blood eosinophil counts and incidences of previous exacerbations and nasal polyps. In addition, patients without allergic disease had later onset of asthma.