TABLE I.
Baseline characteristics of the mechanistic cohort by adjuvant treatment arm and MOIT outcome at 32 months
| Adjuvant treatment | MOIT outcome* | ||||
|---|---|---|---|---|---|
| Placebo (n = 22) | Omalizumab (n = 25) | DS (n = 21) | SU (n = 23) | P value | |
| Demographics | |||||
| Age | 11.6 (6.2) | 12.5 (4.3) | 12.3 (4.5) | 12.2 (6.0) | .97 |
| Female sex | 6 (27.3%) | 7 (28.0%) | 6 (28.6%) | 6 (26.1%) | .99 |
| Hispanic or Latino | 2 (9.1%) | 0 (0.0%) | 2 (9.5%) | 0 (0.0%) | .22 |
| Height | 139.2 (21.1) | 145.4 (17.7) | 144.5 (21.6) | 142.2 (17.8) | .70 |
| Weight | 35.4 (16.9) | 37.7 (14.0) | 37.9 (17.2) | 36.3 (14.3) | .74 |
| Medical history | |||||
| Asthma | 17 (77.3%) | 18 (72.0%) | 17 (81.0%) | 15 (65.2%) | .32 |
| Rhinitis | 18 (81.8%) | 18 (72.0%) | 17 (81.0%) | 16 (69.6%) | .50 |
| AD | 7 (31.8%) | 9 (36.0%) | 7 (33.3%) | 7 (30.4%) | .99 |
| Additional food allergy | 14 (63.6%) | 18 (72.0%) | 11 (52.4%) | 18 (78.3%) | .14 |
| SCPs | |||||
| Total IgE (kU/L) | 604.5 (348.0-818.8) | 568.0 (233.0-918.0) | 556.0 (215.0-750.0) | 578.0 (343.0-823.5) | .43 |
| Milk IgE (kUA/L) | 35.8 (12.9-99.1) | 39.4 (9.9-80.3) | 55.6 (25.8-137.0) | 23.7 (5.1-38.9) | .01 |
| Casein IgE (kUA/L) | 39.4 (6.5-129.0) | 19.8 (7.5-88.4) | 68.1 (23.0-163.0) | 14.6 (1.9-38.3) | .003 |
| β-Lactoglobulin IgE (kUA/L) | 4.7 (1.7-35.4) | 4.4 (2.1-20.6) | 15.9 (3.0-40.3) | 3.2 (1.4-13.8) | .02 |
| Casein IgG (mg/mL) | 14.9 (7.0-17.8) | 9.5 (5.9-13.8) | 12.5 (7.8-21.5) | 8.3 (4.8-14.9) | .08 |
| β-Lactoglobulin IgG (mg/mL) | 3.8 (2.0-5.7) | 4.0 (2.4-5.4) | 4.6 (2.6-5.8) | 3.3 (2.0-4.8) | .14 |
| Casein IgG4 (mg/mL) | 2.2 (0.8-5.5) | 2.0 (0.4-2.7) | 2.2 (1.2-3.4) | 1.9 (0.6-4.8) | .75 |
| β-Lactoslobulin IgG4 (mg/mL) | 0.8 (0.2-1.1) | 0.6 (0.3-1.4) | 0.7 (0.3-1.4) | 0.5 (0.3-1.2) | .59 |
| Skin prick test | 8.9 (3.5) | 8.8 (3.1) | 10.2 (3.4) | 7.5 (2.4) | .004 |
Continuous variables are presented as either means and SD or medians and first and third quartiles; categorical variables are reported as frequencies and percentages. MOIT outcome comparison was tested by using either the 2-sample t test or Wilcoxon-Mann-Whitney test when the normality assumption was not met; categorical variables were compared by using either the χ2 test or Fisher exact test for variables with low cell frequencies.
DS, Desensitization.
The nonresponder group (n = 3) is not presented. Because patients were randomized to receive either omalizumab or placebo, baseline comparisons between adjuvant treatment arms were presented as descriptive statistics, and no tests of statistical significance were performed.35