Table 2.
Change from Baseline in Health-Related Quality of Life Endpoints (Full Analysis Set)
| Benralizumab 30 mg (n=118) | Placebo (n=115) | |
|---|---|---|
| ACQ-6 score | ||
| Baseline | n=118 | n=115 |
| Mean (SD) | 2.647 (0.877) | 2.613 (0.893) |
| Change from baseline at Day 14 | n=118 | n=113 |
| Mean (SD) | −0.989 (0.901) | −0.665 (0.837) |
| LSM difference (95% CI) | −0.293 (−0.481 to −0.105) | |
| P-value | 0.0024 | |
| Change from baseline at Day 28 | n=118 | n=113 |
| Mean (SD) | −1.126 (0.947) | −0.693 (0.869) |
| LSM difference (95% CI) | −0.402 (−0.609 to −0.195) | |
| P-value | 0.0002 | |
| Change from baseline at Day 56 | n=115 | n=113 |
| Mean (SD) | −1.164 (1.132) | −0.827 (1.023) |
| LSM difference (95% CI) | −0.312 (−0.554 to −0.070) | |
| P-value | 0.012 | |
| Change from baseline at Day 84 | n=114 | n=113 |
| Mean (SD) | −1.355 (1.146) | −0.867 (1.114) |
| LSM difference (95% CI) | −0.472 (−0.731 to −0.213) | |
| P-value | 0.0004 | |
| Average change from baseline (Days 28, 56, and 84) | n=118 | n=113 |
| LSM difference (95% CI) | −0.395 (−0.603 to −0.188) | |
| P-value | 0.0002 | |
| SGRQ total score | ||
| Baseline | n=118 | n=115 |
| Mean (SD) | 51.327 (18.221) | 51.218 (19.305) |
| Change from baseline at Day 28 | n=118 | n=113 |
| Mean (SD) | −16.956 (15.510) | −9.444 (14.136) |
| LSM difference (95% CI) | −7.229 (−10.832 to −3.626) | |
| P-value | 0.0001 | |
| Change from baseline at Day 56 | n=115 | n=113 |
| Mean (SD) | −19.941 (21.528) | −13.802 (16.705) |
| LSM difference (95% CI) | −5.942 (−10.538 to −1.346) | |
| P-value | 0.012 | |
| Change from baseline at Day 84 | n=114 | n=113 |
| Mean (SD) | −23.343 (20.302) | −14.385 (18.836) |
| LSM difference (95% CI) | −8.599 (−13.300 to −3.898) | |
| P-value | 0.0004 | |
| Average change from baseline (Days 28, 56, and 84) | n=118 | n=113 |
| LSM difference (95% CI) | −7.257 (−11.133 to −3.380) | |
| P-value | 0.0003 | |
Notes: LSM, least-squares means difference between benralizumab vs placebo based on repeated-measures analyses. Estimate of the mean change from baseline at each day in the active treatment group was compared with the placebo group via a repeated-measures analysis. Estimates were least-squares means. The model was: change from baseline in ACQ-6 score/SGRQ total score=treatment+baseline ACQ-6 score/SGRQ total score+region+visit+treatment×visit. ACQ-6 score was defined as the average of the first six items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Scores range from 0 (totally controlled) to 6 (severely uncontrolled). SGRQ scores were expressed as a percentage of overall impairment; 100 represented the worst possible health status and 0 indicated the best possible health status. Baseline was defined as the last nonmissing value prior to randomization.
Abbreviations: ACQ-6, Asthma Control Questionnaire 6; LS, least-squares; SGRQ, St. George’s Respiratory Questionnaire.