Table 1.
Characteristics and results of hen’s egg and cow’s milk OIT RCTs
| Egg | Burks et al. (2012) | Escudero et al. (2015) | Yanagida et al. (2016) | Jones et al. (2016) |
| Study design | RCT double blinded | RCT, not blinded | RCT, not blinded | RCT, follow-up |
| Age range (years) | 5–11 (median age: 7 ys) | 5–17 (median age: 8 ys) | ≥5 | 5–11 (median age: 7 ys) |
| Number of patients (active group) | 40 | 30 | 21 | 40 |
| Number of patients (control group) | 15 | 31 | 12 | 15 |
| Withdrew from therapy (active group) | 5 | 2 | 5 | 5 |
| Withdrew from therapy (control group) | 2 | 0 | 0 | 2 |
| OIT duration | 22 months | 3 months | 10 weeks | 48 months |
| Maximum tolerated dose | 2 g | one undercooked egg every 2 days | 62–194 mg | 2 g |
| DBPCFC after OIT in placebo group | At month 10 (5 g) 100% positive | Not performed | Not performed | Not performed |
| DBPCFC after OIT in active group | At month 10 22 negative (55%) (P < 0.001) At month 22 (10 g) 30 negative (75%) (P < 0.001) | Not performed | Not performed | Not performed |
| Time of elimination diet (weeks) | 4–6 | 4 | 2 | 4–6 |
| DBPCFC after food avoidance (cumulative maximum dose) | At month 24 (10 g) 11 negative |
At month 4 (3,6 g) 1 negative in CG 11 negative in AG |
At week 12 (3 g) 0 negative in CG 7 negative in AG |
At month 36 18 negative At month 48 20 negative |
| Sustained unresponsiveness (%) | 28 (P = 0.03) | 37 | 33,3 (P = 0.032) | 45% at year 3 50% at year 4 |
| Milk | Yanagida et al. (2015) | Wood et al. (2016) | Takahashi et al. (2016) | |
| Study design | RCT, not blinded | RCT, double blinded | RCT, not blinded | |
| Age range (years) | ≥5 | 7–35 AG median 11.7 years CG median 9.5 years |
5–17 AG median 9 years CG median 7 years |
|
| Number of patients (active group) | 12 | 28 (OIT plus omalizumab) | 31 | |
| Number of patients (placebo group) | 25 | 29(OIT plus placebo) | 17 | |
| Withdrew from therapy (active group) | 0 | 2 | 0 at year 1 11 at year 4 |
|
| Withdrew from therapy (placebo group) | 0 | 5 | 0 | |
| OIT duration | 12 months | 30 months | 4 years | |
| Maximum tolerated dose | 3 ml | 3.8 g | 200 ml | |
| DBPCFC after OIT in placebo group | 4 negative (3 ml) | 20 negative (10 g) | 0 negative (80 ml) | |
| DBPCFC after OIT in active group | 9 negative (3 ml) | 24 negative (10 g) | 14 negative (80 ml) | |
| Time of elimination diet (weeks) | 2 | 8 | 2 | |
| DBPCFC after food avoidance (cumulative maximum dose) | At month 12.5 (3 ml) 4 negative in CG 7 negative in AG |
At month 12.5 (25 ml) 0 negative in CG 4 negative in AG |
At month 32 (10 g) 10 negative in CG 13 negative in AG |
At year 1 (80 ml) 7 negative/31 At year 2 (80 ml) 14 negative/30 |
| Sustained unresponsiveness (%) | 58.3% P = 0.018 |
33.3% P = 0.007 |
35.7% in CG 48.1% in AG |
At year 1 21% At year 2 47% P = 0.008 |