Table 2.
Influenza strain antibody response for hemagglutination inhibition (vaccine immunogenicity analysis set)
| Antibody response measure | Benralizumab 30 mg Q4W (N=50) | Placebo (N=49) |
|---|---|---|
| GMT Week 8, GM (GSD; CV%) | ||
| Influenza A, H1N1 | 145.9 (3.6; 205.1) | 166.9 (2.8; 136.6) |
| Influenza A, H3N2 | 62.3 (3.7; 209.6) | 67.2 (3.4; 185.3) |
| Influenza B, Yamagata lineage | 16.6 (2.6; 122.6) | 18.5 (2.6; 123.5) |
| Influenza B, Victoria lineage | 13.6 (2.5; 111.2) | 21.4 (3.2; 167.1) |
| GMT Week 12, GM (GSD; CV%) | ||
| Influenza A, H1N1 | 570.2 (2.4; 107.9) | 566.1 (2.2; 93.2) |
| Influenza A, H3N2 | 206.3 (2.9; 146.6) | 263.7 (2.7; 126.7) |
| Influenza B, Yamagata lineage | 60.3 (2.2; 93.1) | 62.0 (2.2; 93.2) |
| Influenza B, Victoria lineage | 57.9 (2.7; 126.2) | 72.8 (2.3; 99.4) |
| GMFR Week 8 to Week 12, GM (GSD; CV%) | ||
| Influenza A, H1N1 | 3.9 (4.1; 251.9) | 3.4 (3.5; 191.3) |
| Influenza A, H3N2 | 3.3 (2.8; 136.2) | 3.9 (3.2; 168.6) |
| Influenza B, Yamagata lineage | 3.6 (2.9; 144.9) | 3.4 (2.5; 115.0) |
| Influenza B, Victoria lineage | 4.2 (3.3; 178.7) | 3.4 (3.1; 162.2) |
| GMT Week 12 geometric LS mean estimate (LS mean ratio; 90% CIa) | ||
| Influenza A, H1N1 | 521.1 (1.00; 0.76–1.31) | 518.6 |
| Influenza A, H3N2 | 170.7 (1.28; 0.93–1.77) | 219.4 |
| Influenza B, Yamagata lineage | 61.5 (1.03; 0.79–1.34) | 63.2 |
| Influenza B, Victoria lineage | 53.1 (1.26; 0.93–1.70) | 66.8 |
| GMFR Week 12 geometric LS mean estimate (LS mean ratio; 90% CIa) | ||
| Influenza A, H1N1 | 3.6 (0.87; 0.56–1.35) | 3.1 |
| Influenza A, H3N2 | 3.3 (1.19; 0.82–1.71) | 3.9 |
| Influenza B, Yamagata lineage | 3.4 (0.93; 0.67–1.29) | 3.2 |
| Influenza B, Victoria lineage | 4.1 (0.8; 0.54–1.19) | 3.3 |
| Antibody titer ≥4-fold rise from Week 8 to Week 12, n (90% CIb) [%] | ||
| Influenza A, H1N1 | 22 (0.32–0.57) [44.0] | 15 (0.20–0.43) [30.6] |
| Influenza A, H3N2 | 25 (0.38–0.62) [50.0] | 24 (0.37–0.62) [49.0] |
| Influenza B, Yamagata lineage | 24 (0.36–0.60) [48.0] | 24 (0.37–0.62) [49.0] |
| Influenza B, Victoria lineage | 28 (0.43–0.68) [56.0] | 20 (0.29–0.54) [40.8] |
| Antibody titer ≥40 at Week 12, n (90% CIb) [%] | ||
| Influenza A, H1N1 | 50 (0.94–1.00) [100.0] | 49 (0.94–1.00) [100.0] |
| Influenza A, H3N2 | 49 (0.91–1.00) [98.0] | 48 (0.91–1.00) [98.0] |
| Influenza B, Yamagata lineage | 43 (0.75–0.93) [86.0] | 39 (0.68–0.88) [79.6] |
| Influenza B, Victoria lineage | 39 (0.66–0.87) [78.0] | 43 (0.77–0.95) [87.8] |
| Antibody titer ≥320 at Week 12, n (90% CIb) [%] | ||
| Influenza A, H1N1 | 42 (0.73–0.92) [84.0] | 42 (0.75–0.93) [85.7] |
| Influenza A, H3N2 | 25 (0.38–0.62) [50.0] | 30 (0.48–0.73) [61.2] |
| Influenza B, Yamagata lineage | 1 (0.00–0.09) [2.0] | 1 (0.00–0.09) [2.0] |
| Influenza B, Victoria lineage | 4 (0.03–0.17) [8.0] | 2 (0.01–0.12) [4.1] |
Notes:
a
90% CIs are for treatment comparison between benralizumab and placebo.
b
Results using the Clopper–Pearson method.
Abbreviations: CV%, geometric coefficient of variation; GM, geometric mean; GMFR, geometric mean fold rise; GMT, geometric mean titer; GSD, geometric standard deviation; LS, least squares; N, number of patients within each treatment group; n, number of patients in analysis; Q4W, every 4 weeks.