Table 1.
Demographic and clinical characteristics at baseline (randomized ITT).
| Baseline characteristic | Total (n = 60) | 1 g (n = 19) | 300 mg (n = 21) | Blinded discontinuation (n = 20) |
|---|---|---|---|---|
| Age in years, mean (SD) | 9.8 (3.4) | 9.1 (2.4) | 10.0 (4.0) | 10.3 (3.6) |
| Sex, n (%) | ||||
| Male | 37 (62%) | 16 (84%) | 11 (52%) | 10 (50%) |
| Female | 23 (38%) | 3 (16%) | 10 (48%) | 10 (50%) |
| Ethnicity, n (%) | ||||
| Hispanic | 4 (7%) | 1 (5%) | 1 (5%) | 2 (10%) |
| Non-Hispanic | 56 (93%) | 18 (95%) | 20 (95%) | 18 (90%) |
| History of comorbid conditions, n (%) | ||||
| Asthma | 42 (70%) | 18 (95%) | 13 (62%) | 11 (55%) |
| Atopic dermatitis | 49 (82%) | 17 (89%) | 16 (76%) | 16 (80%) |
| Allergic rhinitis | 50 (83%) | 18 (95%) | 15 (71%) | 17 (85%) |
| FEV1, mean (SD) | 97.1 (12.3) | 95.0 (9.7) | 99.0 (12.4) | 97.1 (14.4) |
| Number allergens in OIT, median (IQR) | 3 (2) | 3 (2) | 3 (3) | 3 (1) |
| Participants with…, n (%) | ||||
| 2 allergens in OIT | 18 (30%) | 5 (26%) | 9 (43%) | 4 (20%) |
| 3 allergens in OIT | 15 (25%) | 6 (32%) | 2 (10%) | 7 (35%) |
| 4 allergens in OIT | 13 (22%) | 3 (16%) | 4 (19%) | 6 (30%) |
| 5 allergens in OIT | 14 (23%) | 5 (26%) | 6 (29%) | 3 (15%) |
| Participants with…, n (%) | ||||
| Almond in OIT | 4 (7%) | 2 (11%) | 1 (5%) | 1 (5%) |
| Cashew in OIT | 34 (57%) | 10 (53%) | 13 (62%) | 11 (55%) |
| Egg in OIT | 17 (28%) | 5 (26%) | 5 (24%) | 7 (35%) |
| Hazelnut in OIT | 17 (28%) | 7 (37%) | 4 (19%) | 6 (30%) |
| Milk in OIT | 20 (33%) | 7 (37%) | 4 (19%) | 9 (45%) |
| Peanut in OIT | 51 (85%) | 17 (90%) | 20 (95%) | 14 (70%) |
| Pecan in OIT | 13 (22%) | 4 (21%) | 5 (24%) | 4 (20%) |
| Sesame in OIT | 8 (13%) | 1 (5%) | 4 (19%) | 3 (15%) |
| Shrimp in OIT | 3 (5%) | 0 (0%) | 2 (10%) | 1 (5%) |
| Soy in OIT | 1 (2%) | 0 (0%) | 1 (5%) | 0 (0%) |
| Walnut in OIT | 31 (52%) | 11 (58%) | 9 (43%) | 11 (55%) |
| Wheat in OIT | 4 (7%) | 1 (5%) | 2 (10%) | 1 (5%) |
| Median CTD across participant's OIT foods in baseline food challenge (mg), median (IQR) | 25 (45.6) | 25 (108.8) | 25 (45) | 13.8 (22.5) |
| CTD by food (mg), median (IQR) | ||||
| Almond | 90 (221.3) | 87.5 (87.5) | 375 (NA) | 5 (NA) |
| Cashew | 5 (22.5) | 5 (23.8) | 5 (5) | 5 (10) |
| Egg | 5 (25) | 25 (20) | 5 (25) | 0 (15) |
| Hazelnut | 25 (20) | 25 (37.5) | 15 (32.5) | 25 (18.8) |
| Milk | 25 (70) | 25 (112.5) | 150 (280) | 5 (20) |
| Peanut | 25 (70) | 25 (370) | 25 (70) | 15 (23.8) |
| Pecan | 5 (20) | 200 (356.3) | 5 (20) | 5 (6.3) |
| Sesame | 15 (21.3) | 25 (NA) | 25 (18.8) | 5 (2.5) |
| Shrimp | 75 (35) | NA | 40 (35) | 75 (NA) |
| Soy | 500 (NA) | NA | 500 (NA) | NA |
| Walnut | 25 (120) | 25 (122.5) | 25 (70) | 75 (110) |
| Wheat | 37.5 (150) | 0 (NA) | 225 (150) | 0 (NA) |
| Total IgE (kU/L), median (IQR) | 739.5 (776.2) | 993.7 (761.5) | 671 (802) | 870 (673.5) |
| Peanut specific IgE (kU/L), median (IQR) | 49.6 (193.1) | 32.9 (81.6, n = 12) | 72.5 (217.8, n = 16) | 84.4 (187.1, n = 10) |
| Peanut specific IgG4 (mg/L), median (IQR) | 0.9 (2.1) | 1.5 (2.1, n = 12) | 0.8 (2.3, n = 16) | 1.2 (1.5, n = 10) |
| Median SPT across participant's OIT foods (mm), median (IQR) | 10.8 (6.1) | 11.5 (6.5) | 10.3 (5) | 11.3 (7.9) |
| SPT (mm), median (IQR) | ||||
| Almond | 6.5 (2) | 7.8 (0.7) | 3.5 (NA) | 6.0 (NA) |
| Cashew | 11.8 (8.3) | 14.0 (9) | 11.5 (4.5) | 11.5 (9.8) |
| Egg | 10.5 (4.5) | 10.0 (1) | 12.0 (3) | 10.0 (6) |
| Hazelnut | 9.5 (15) | 13.5 (8.8) | 8.8 (11.9) | 6.5 (2.9) |
| Milk | 11.8 (9.5) | 11.0 (6.8) | 10.2 (2.4) | 17.5 (10) |
| Peanut | 13.0 (7) | 13.5 (7) | 10.5 (6.9) | 14.8 (7.4) |
| Pecan | 7.5 (4) | 6.8 (2.8) | 10.0 (2.5) | 5.5 (2.6) |
| Sesame | 14.0 (11.9) | 15.0 (NA) | 9.5 (9.4) | 17.0 (10.8) |
| Shrimp | 10.0 (2) | NA | 9.0 (2) | 9.0 (NA) |
| Soy | 10.0 (NA) | NA | 10.0 (NA) | NA |
| Walnut | 11.5 (9.8) | 13.0 (7) | 10.5 (11) | 9.0 (7) [n = 10, 1 NA] |
| Wheat | 9.0 (2.4) | 9.5 (NA) | 8.2 (3.3) | 8.5 (NA) |
OIT: oral immunotherapy; IQR: inner quartile range; NA: not applicable; FEV1: forced expiratory volume; CTD: cumulative tolerated dose; SPT: skin prick test wheal diameter.
Note: n for IgE and skin prick test data per allergen per group given only when different from the number listed under participants with the food in OIT.