Table 2. Total Nasal Symptom Score Weighted 10 Hour Area Under the Curve.
P-values, 95% CIs, and Mean Differences were calculated using an analysis of covariance model (ANCOVA) model adjusted for pre-treatment baseline total nasal symptom score (TNSS, scale 0 [best] to 12 [worst]) area under the curve (AUC) at the 0.05 level of significance. Mean differences were calculated as follows: Sublingual immunotherapy– Placebo; Subcutaneous immunotherapy – Placebo; Sublingual immunotherapy – Subcutaneous immunotherapy. The weighted 10 hour AUC was calculated as the (early phase response (0–1 hour)/1) + (late phase response (1–10 hours)/9). Participants in the ITT population with missing primary endpoint data had their data imputed. Imputation was performed within treatment group using participants who had available TNSS AUC values. Specifically, a linear regression line and 95% confidence bands were fit where Year 3 values were regressed on TNSS AUC values at time t (t = Baseline, Year 1 or Year 2). Within each treatment arm, a missing Year 3 TNSS AUC value was imputed as the value predicted from the linear regression line. The primary endpoint was also calculated in the modified ITT population.
| Unadjusted | Model Adjusted | ||||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| Sublingual Immunotherapy | Placebo | Subcutaneous Immunotherapy | Sublingual Immunotherapy vs Placebo | Subcutaneous Immunotherapy vsPlacebo | Sublingual Immunotherapy vs Subcutaneous Immunotherapy | ||
| Baseline | |||||||
| n | 36 | 34 | 36 | ||||
| Mean | 6.36 | 6.06 | 6.10 | ||||
| 95% CI | (5.76, 6.96) | (5.23, 6.88) | (5.32, 6.89) | ||||
| Median | 6.39 | 5.95 | 6.38 | ||||
| Min, Max | 2.8, 9.8 | 2.4, 11.5 | 1.9, 10.1 | ||||
|
| |||||||
| Year 1 (Exploratory) | p-value | 0.13 | <0.001 | 0.03 | |||
| n | 33 | 33 | 34 | ||||
| Mean | 3.94 | 4.63 | 3.05 | Mean Difference | −0.75 | −1.60 | 0.84 |
| 95% CI | (3.31, 4.58) | (3.84, 5.42) | (2.50, 3.60) | 95% CI | (−1.71, 0.22) | (−2.49, −0.71) | (0.09, 1.60) |
| Median | 3.47 | 3.97 | 2.70 | ||||
| Min, Max | 0.8, 8.2 | 0.9, 10.4 | 0.9, 6.9 | ||||
|
| |||||||
| Year 2 (Exploratory) | p-value | 0.02 | <0.001 | 0.20 | |||
| n | 31 | 32 | 32 | ||||
| Mean | 3.70 | 5.07 | 2.96 | Mean Difference | −1.42 | −2.11 | 0.68 |
| 95% CI | (2.85, 4.56) | (4.16, 5.97) | (2.21, 3.71) | 95% CI | (−2.61, −0.22) | (−3.22, −1.01) | (−0.36, 1.73) |
| Median | 2.92 | 5.01 | 1.99 | ||||
| Min, Max | 0.7, 8.1 | 0.6, 9.8 | 0.5, 9.2 | ||||
|
| |||||||
| Year 3 (Primary Outcome ITT) | p-value | 0.75 | 0.053 | 0.11 | |||
| n | 36 | 34 | 36 | ||||
| Mean | 4.73 | 4.81 | 3.89 | Mean Difference | −0.18 | −0.94 | 0.73 |
| 95% CI | (3.97, 5.48) | (3.97, 5.65) | (3.25, 4.54) | 95% CI | (−1.25, 0.90) | (−1.88, 0.01) | (−0.17, 1.62) |
| Median | 4.74 | 4.71 | 3.71 | ||||
| Min, Max | 1.1, 11.0 | 0.8, 11.2 | 0.9, 10.6 | ||||
|
| |||||||
| Year 3 (Primary Outcome Modified ITT) | p-value | 0.62 | 0.10 | 0.27 | |||
| n | 30 | 31 | 31 | ||||
| Mean | 4.55 | 4.82 | 3.96 | Mean Difference | −0.30 | −0.90 | 0.58 |
| 95% CI | (3.67, 5.43) | (3.90, 5.74) | (3.21, 4.71) | 95% CI | (−1.52, 0.92) | (−1.96, 0.16) | (−0.46, 1.63) |
| Median | 4.44 | 4.57 | 3.76 | ||||
| Min, Max | 1.1, 11.0 | 0.8, 11.2 | 0.9, 10.6 | ||||