Table 4.
Secondary and exploratory efficacy and pharmacodynamic endpoints
| Placebo | Lebrikizumab | |||
|---|---|---|---|---|
| 37.5 mg | 125 mg | 250 mg | ||
| Change in FEV1 from baseline to week 12 (%) | ||||
| Periostin-high patients (≥50 ng/mL), n | 32 | 42 | 34 | 37 |
| Mean (SD) | 4.8 (16.1) | 11.7 (16.0) | 15.5 (24.1) | 14.9 (20.6) |
| Difference in means vs placebo (95% CI) | – | 6.8 (−0.7 to 14.4) | 10.7 (0.6 to 20.7) | 10.1 (1.3 to 18.9) |
| Periostin-low patients (<50 ng/mL), n | 54 | 41 | 50 | 44 |
| Mean (SD) | 7.3 (16.2) | 5.4 (15.4) | 9.6 (12.8) | 14.5 (22.1) |
| Difference in means vs placebo (95% CI) | – | −1.9 (−8.3 to 4.6) | 2.2 (−3.4 to 7.9) | 7.2 (−0.7 to 15.2) |
| Change in morning peak expiratory flow from baseline to week 12 (L/min) | ||||
| Periostin-high patients (≥50 ng/mL), n | 41 | 49 | 40 | 48 |
| Mean (SD) | −2.54 (55.30) | 0.40 (52.04) | 14.44 (62.72) | 8.64 (86.84) |
| Difference in means vs placebo (95% CI) | – | 2.95 (−19.72 to 25.61) | 16.98 (−9.20 to 43.16) | 11.18 (−19.10 to 41.47) |
| Periostin-low patients (<50 ng/mL), n | 67 | 52 | 61 | 60 |
| Mean (SD) | −3.84 (62.11) | −0.67 (42.42) | 4.29 (42.67) | 17.08 (44.97) |
| Difference in means vs placebo (95% CI) | – | 3.17 (−15.84 to 22.19) | 8.13 (−10.38 to 26.65) | 20.92 (2.00 to 39.84) |
| Time to first asthma exacerbation during the placebo-controlled period | ||||
| Periostin-high patients (≥50 ng/mL), n | 42 | 57 | 43 | 53 |
| HR (95% CI) | – | 0.23 (0.07 to 0.74) | 0.30 (0.10 to 0.95) | 0.85 (0.37 to 1.92) |
| Periostin-low patients (<50 ng/mL), n | 74 | 60 | 69 | 65 |
| HR (95% CI) | – | 0.69 (0.29 to 1.64) | 1.21 (0.59 to 2.48) | 0.95 (0.44 to 2.05) |
| Change in AQLQ(S) from baseline to week 12 | ||||
| Periostin-high patients (≥50 ng/mL), n | 34 | 44 | 34 | 39 |
| Mean (SD) | 0.7 (0.7) | 0.6 (0.7) | 1.0 (1.1) | 0.8 (0.8) |
| Difference in means vs placebo (95% CI) | – | −0.1 (−0.4 to 0.3) | 0.3 (−0.1 to 0.8) | 0.1 (−0.3 to 0.5) |
| Periostin-low patients (<50 ng/mL), n | 55 | 43 | 53 | 46 |
| Mean (SD) | 0.6 (0.9) | 0.7 (0.8) | 0.5 (0.7) | 0.8 (0.8) |
| Difference in means vs placebo (95% CI) | – | 0.2 (−0.2 to 0.5) | 0.0 (−0.3 to 0.3) | 0.3 (−0.1 to 0.6) |
| Change in asthma rescue medication use from baseline to week 12 (inhalations per day) | ||||
| Periostin-high patients (≥50 ng/mL), n | 41 | 49 | 40 | 49 |
| Mean (SD) | −1.0 (1.3) | −0.4 (4.1) | −1.3 (2.4) | −0.9 (1.6) |
| Difference in means vs placebo | – | 0.6 (−0.6 to 1.8) | −0.3 (−1.2 to 0.6) | 0.0 (−0.6 to 0.6) |
| Periostin-low patients (<50 ng/mL), n | 67 | 52 | 61 | 60 |
| Mean (SD) | −0.5 (1.4) | −0.7 (1.5) | −0.7 (1.4) | −1.1 (1.7) |
| Difference in means vs placebo | – | −0.2 (−0.7 to 0.3) | −0.2 (−0.7 to 0.3) | −0.6 (−1.1 to 0.0) |
| Rate of urgent asthma-related healthcare use during placebo-controlled period | ||||
| Periostin-high patients (≥50 ng/mL), n | 42 | 57 | 43 | 53 |
| Event rate/year | 0.58 | 0.08 | 0.19 | 0.41 |
| Rate reduction vs placebo (95% CI), % | – | 87 (31 to 99) | 67 (−25 to 94) | 28 (−88 to 74) |
| Periostin-low patients (<50 ng/mL), n | 74 | 60 | 69 | 65 |
| Event rate/year | 0.31 | 0.18 | 0.42 | 0.23 |
| Rate reduction vs placebo (95% CI), % | – | 43 (−73 to 84) | −36 (−265 to 47) | 27 (−130 to 79) |
AQLQ(S), Asthma Quality-of-Life Questionnaire (standardised).