Table 2. Summary of Efficacy Outcomes in the mITT Population.
| Variable | Analysis results | ||
|---|---|---|---|
| PBO + TCS (N = 66) | LEB + TCS (N = 145) | Treatment difference | |
| Primary end points | |||
| IGA (0,1) and ≥2-point improvement from baseline at week 16 | |||
| No./No. | 15/66 | 60/145 | |
| % (95% CI) | 22.1 (11.6 to 32.7) | 41.2 (33.0 to 49.4) | 18.3 (5.1 to 31.5) |
| Key secondary end points | |||
| EASI-75 at week 16a | |||
| No./No. | 28/66 | 101/145 | |
| % (95% CI) | 42.2 (30.1 to 54.4) | 69.5 (61.9 to 77.2) | 26.4 (12.1 to 40.8)b |
| EASI-90 at week 16 | |||
| No./No. | 14/66 | 60/145 | |
| % (95% CI) | 21.7 (11.4 to 32.0) | 41.2 (33.0 to 49.3) | 18.9 (6.1 to 31.7) |
| EASI %CFB at week 16 | |||
| No. | 66 | 145 | |
| LS mean (SE) [95% CI] | −53.1 (5.1) | −76.8 (4.1) | −23.6 (5.1) [−33.6 to −13.7]b |
| Pruritus NRS ≥4-point improvement from baseline at week 16c | |||
| No./No. | 18/57 | 66/130 | |
| % (95% CI) | 31.9 (19.3 to 44.4) | 50.6 (41.8 to 59.4) | 19.2 (4.3 to 34.1) |
| Pruritus NRS % CFB at week 16 | |||
| No. | 63 | 139 | |
| LS mean (SE) [95% CI] | −35.5 (6.4) | −50.7 (4.5) | −15.2 (6.4) [−27.7 to −2.7] |
| EASI-75 and Pruritus NRS ≥4-point improvement from baseline at week 16c | |||
| No./No. | 10/57 | 50/130 | |
| % (95% CI) | 16.8 (6.7 to 27.0) | 38.3 (29.8 to 46.9) | 21.6 (8.3 to 35.0) |
| Sleep-Loss Scale CFB at week 16 | |||
| No. | 63 | 139 | |
| LS mean (SE) [95% CI] | −0.8 (0.1) | −1.1 (0.1) | −0.3 (0.1) [−0.6 to −0.0] |
| DLQI- ≥4-point improvement from baseline at week 16d | |||
| No./No. | 28/48e | 81/105f | |
| % (95% CI) | 58.7 (44.1 to 73.2) | 77.4 (69.3 to 85.5) | 17.2 (0.1 to 34.3) |
| DLQI CFB at week 16 | |||
| No. | 51 | 109 | |
| LS mean (SE) [95% CI] | −6.5 (1.9) | −9.8 (1.8) | −3.33 (1.0) [−5.3 to −1.3] |
| Other secondary endpoints | |||
| Proportion of TCS/TCI-free days from baseline to week 16 | |||
| No. | 53 | 131 | |
| LS mean (SE) [95% CI] | 23.9 (4.8) | 31.2 (3.5) | 7.3 (5.1) [−2.78 to 17.4] |
| SCORAD % CFB at week 16g | |||
| No. | 65 | 140 | |
| LS mean (SE) [95% CI] | −37.4 (4.4) | −55.0 (3.5) | −17.7 (4.4) [−26.4 to −9.0]b |
| Change in EQ-5D-5L (VAS) at week 16 | |||
| No. | 65 | 143 | |
| LS mean (SE) [95% CI] | 6.5 (2.4) | 10.1 (1.8) | 3.6 (2.4) [−1.1 to 8.3] |
| Change in EQ-5D-5L (UK Health Index) at week 16 | |||
| No. | 65 | 143 | |
| LS Mean (SE) [95% CI] | 0.05 (0.03) | 0.15 (0.02) | 0.1 (0.03) [0.06 to 0.16]b |
| Change in EQ-5D-5L (US Health Index) at week 16 | |||
| No. | 65 | 143 | |
| LS mean (SE) [95% CI] | 0.03 (0.02) | 0.1 (0.01) | 0.07 (0.02) [0.04 to 0.1]b |
| Change in POEM at week 16 | |||
| No. | 40 | 101 | |
| LS mean (SE) [95% CI] | −6.2 (1.04) | −10.2 (0.7) | −4 (1.1) [−6.3 to −1.7]b |
| Change in PROMIS adults anxiety at week 16 | |||
| No. | 43 | 101 | |
| LS mean (SE) [95% CI] | −1.1 (1.4) | −1.9 (1.0) | −0.8 (1.4) [−3.6 to 2.0] |
| Change in PROMIS adults depression at week 16 | |||
| No. | 43 | 101 | |
| LS mean (SE) [95% CI] | −1.2 (1.1) | −1.4 (0.8) | −0.2 (1.1) [−2.4 to 2.1] |
| Change in CDLQI at week 16 | |||
| No. | 11 | 24 | |
| LS mean (SE) [95% CI] | −4.7 (1.2) | −9.3 (0.9) | −4.6 (1.3) [−7.2 to −2.0]b |
Abbreviations: CFB, change from Baseline; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EMA, European Medicines Agency; IGA, Investigator’s Global Assessment; LEB, lebrikizumab; LSM, least squares mean; mITT, modified intent-to-treat; NRS, numeric rating scale; PBO, placebo; TCS, topical corticosteroid; TCI, topical calcineurin inhibitor; VAS, visual analogue scale.
Coprimary end point for EMA.
P<.001.
Patients with baseline Pruritus NRS score ≥4.
Patients with baseline DLQI ≥4. For primary or key secondary end points, analyses are based on data imputed with (1) nonresponder imputation for patients who use rescue medication or discontinue study drug due to lack of efficacy; (2) other missing data were imputed with MI. For other secondary end points, analyses are based on LOCF if data are planned to be collected once during the treatment period; analyses are based on MMRM model if data are planned to be collected multiple times during the treatment period.
Patients (>16 years of age) who answered DLQI at baseline: n = 48.
Patients (>16 years of age) who answered DLQI at baseline: n = 105.
ADhere used a modified version of the SCORAD with a maximum point score of 101 rather than 103. Due to a system setup error in the electronic data collection tool, the actual maximum score for each of the symptoms in Part C was 9 instead of 10, which resulted in the total maximum SCORAD score of 101 instead of 103. While this error directly impacted only Part C of the SCORAD, the measure is calculated as one total score, so the total SCORAD score collected could have been up to 2% lower than would have been expected if the error had not occurred.