TABLE 2.
Primary and secondary efficacy endpoints
| Comparison | LS mean (SE) | Comparison of LS mean | ||||
|---|---|---|---|---|---|---|
| MMRM analysis of change from baseline in ISS7 at week 12 | ||||||
| Test | Reference | Difference (SE) | 95% CI | Adjusted p value | ||
| OMA 300 (n = 167) versus placebo (n = 83) | −10.11 (0.43) | −5.87 (0.60) | −4.23 (0.75) | (−5.70, −2.77) | <0.001 | |
| OMA 150 (n = 166) versus placebo (n = 83) | −9.66 (0.42) | −5.87 (0.60) | −3.79 (0.74) | (−5.24, −2.33) | <0.001 | |
| MMRM analysis of change from baseline in UAS7 at week 12 | ||||||
| Test | Reference | Difference (SE) | 95% CI | Adjusted p value | ||
| OMA 300 (n = 167) versus placebo (n = 83) | −21.82 (0.90) | −11.62 (1.26) | −10.19 (1.56) | (−13.25, −7.14) | <0.001 | |
| OMA 150 (n = 166) versus placebo (n = 83) | −20.74 (0.88) | −11.62 (1.26) | −9.12 (1.54) | (−12.14, −6.10) | <0.001 | |
| MMRM analysis of change from baseline in NHS7 at week 12 | ||||||
| Test | Reference | Difference (SE) | 95% CI | Adjusted p value | ||
| OMA 300 (n = 167) versus placebo (n = 83) | −11.68 (0.49) | −5.76 (0.69) | −5.92 (0.85) | (−7.59, −4.24) | <0.001 | |
| OMA 150 (n = 166) versus placebo (n = 83) | −11.11 (0.49) | −5.76 (0.69) | −5.35 (0.84) | (−7.00, −3.69) | <0.001 | |
| Logistic regression analysis of proportion of patients with UAS7 ≤ 6 at week 12 | ||||||
| n/M (%) | Comparison | OR | 95% CI | Adjusted p value | ||
| OMA 300 | 81/167 (48.5) | Versus placebo | 7.02 | (3.27, 15.06) | <0.001 | |
| OMA 150 | 79/167 (47.3) | Versus placebo | 7.03 | (3.29, 15.06) | <0.001 | |
| Placebo | 9/83 (10.8) | – | – | – | – | |
| Logistic regression analysis of proportion of patients with UAS7 = 0 at week 12 | ||||||
| n/M (%) | Comparison | OR | 95% CI | Adjusted p value | ||
| OMA 300 | 62/167 (37.1) | Versus placebo | 11.21 | (3.88, 32.37) | <0.001 | |
| OMA 150 | 39/167 (23.4) | Versus placebo | 5.88 | (2.01, 17.17) | 0.002 | |
| Placebo | 4/83 (4.8) | – | – | – | – | |
| Logistic regression analysis of proportion of patients with ISS7 MID at week 12 | ||||||
| n/M (%) | Comparison | OR | 95% CI | Adjusted p value | ||
| OMA 300 | 125/167 (74.9) | Versus placebo | 2.73 | (1.51, 4.95) | 0.002 | |
| OMA 150 | 125/167 (74.9) | Versus placebo | 2.53 | (1.41, 4.56) | 0.002 | |
| Placebo | 49/83 (59.0) | – | – | – | – | |
| MMRM analysis of change from baseline in overall DLQI at week 12 | ||||||
| Test | Reference | Difference (SE) | 95% CI | Adjusted p value | ||
| OMA 300 (n = 165) versus placebo (n = 83) | −10.4 (0.50) | −6.5 (0.69) | −4.0 (0.85) | (−5.7, −2.3) | 0.002 | |
| OMA 150 (n = 166) versus placebo (n = 83) | −9.9 (0.49) | −6.5 (0.69) | −3.5 (0.85) | (−5.1, −1.8) | 0.002 | |
| Cox regression analysis of time to first ISS7 MID response by week 12 | ||||||
| n/M (%) | Comparison | HR | 95% CI | Adjusted p value | ||
| OMA 300 | 142/167 (85.0) | Versus placebo | 1.71 | (1.25, 2.33) | 0.002 | |
| OMA 150 | 144/167 (86.2) | Versus placebo | 1.66 | (1.22, 2.25) | 0.002 | |
| Placebo | 59/83 (71.1) | – | – | – | – | |
Abbreviations: CI, confidence interval; DLQI, Dermatology Life Quality Index; HR, hazard ratio; ISS7, weekly Itch Severity Score; LS mean, least squares mean; M, total number of patients in the analysis; MID, minimally important difference; MMRM, mixed model with repeated measures; n (in the MMRM model results), total number of patients in the analysis; n (in the Logistic regression results), number of patients who achieved the investigated response at week 12 (after imputation); n (in the Cox regression results), total number of events included in the analysis; NHS7, weekly Number of Hives Score; OMA, omalizumab; OR, odds ratio; SE, standard error; UAS7, weekly Urticaria Activity Score.