Improvements in SGRQ Total and Domain Scores with Benralizumab Treatment for Patients with Asthma

Introduction: SOLANA (NCT02869438), a 12-week, multinational, randomized, double-blind, placebo-controlled, Phase III b onset-of-effect characterization study, was the first benralizumab study for patients with asthma to include the St. Georgeʼs Respiratory Questionnaire (SGRQ). The SGRQ is a 50-item health status assessment tool developed for respiratory conditions involving chronic airflow limitation. Total and domain (symptom, activity, and psychosocial impact) scores are weighted and expressed as percentages (0 – 100), with larger values indicating greater impairment. The objective of this analysis was to evaluate effect onset and maintenance as measured by SGRQ total and domain scores for patients enrolled in SOLANA receiving benralizumab vs. placebo.

Methods: We conducted a post-hoc analysis of SGRQ total and domain scores for patients in SOLANA with baseline blood eosinophil counts ≥ 300 cells/µL.

Results: Improvements in SGRQ total and domain scores were greater for patients who received benralizumab compared with placebo as early as 4 weeks after treatment initiation ([Fig. 1]). At Week 4, least squares mean differences (95% confidence intervals) in change from baseline with benralizumab vs. placebo for total, symptom, activity, and psychosocial impact scores were − 7.23 (− 10.83, − 3.63), − 7.87 (− 13.06, − 2.69), − 8.52 (− 13.40, − 3.63), and − 6.05 (− 9.73, − 2.38), respectively (all p ≤ 0.005). Improvements with benralizumab compared with placebo were consistently observed for all domains at all post-baseline time points.

Abb. 1 Change from baseline in SGRQ total, symptom, activity, and psychosocial impact scores.

Conclusions: Benralizumab is associated with substantial improvement in SGRQ total score, with similar improvements observed in all domains. Improvements were observed by Week 4 for total, symptom, activity, and psychosocial impact scores and remained consistent across all post-baseline time points.