Table 1 Summary of selected studies reviewed

Burks et al,[15]Randomized, double-blind, placebo-controlled clinical trial. Egg OIT

N = 55

5-11 yrs.

No

Dose = 2000 mg

30 (75%) passed 10 g OFC and desensitized at 22 mos. of OIT

8

11 (28%) at 23 mos. – off 4-6 wks.

↑egg white-specific IgG4; ↓egg white-specific IgE and basophil activation

No severe adverse events. 78% of active OIT children had oral or pharyngeal AEs vs. 20% in placebo group

Duration = 22 mos.

Varshney et al,[16]Randomized, placebo-controlled clinical trial. Peanut OIT

N = 28

1-16 yrs.

No

Dose = 4000 mg

16 (84%) passed 5 g OFC

3

Not assessed

No change in IgE; ↑IgG4 and peanut-specific FoxP3 Tregs; ↓IL-5 and IL-13; ↓skin prick tests

Initial escalation: 9 (47%) of 19 OIT subjects had AEs with 2 requiring epinephrine

Duration = 48 wks.

Build-up doses: OIT subjects experienced AEs with 1.2% of 407 doses, no epinephrine required

Vickery et al,[17]Open-label, uncontrolled trial. Peanut OIT

N = 39

1-16 yrs.

No

Initial pilot OIT trial: Dose = 300 mg

Initial pilot OIT trial: 27 (93%) of 29 passed 3.9 g OFC and considered desensitized

15

Continued OIT trial: 12 (50%) of 24 achieved sustained unresponsiveness (treatment successes) – off 4 weeks

↓skin prick tests, ↓peanut, Ara h 1, & Ara h 2 IgE, ↓peanut IgE/total IgE ratio, no change in peanut IgG4 or functional activity

Initial pilot OIT trial: 92% with AE during 1-day dose escalation; 46% of build-up doses elicited symptoms

Duration = 8 mos.

Continued OIT trial: Dose = 4000 mg

Continued OIT trial: 24 (100%) of 24 passed 5 g desensitization OFC

Continued OIT trial: No AEs reported by treatment successes with peanut exposure vs. 3 (14%) of treatment failures reported mild reactions

Duration = 5 yrs.

Fleischer et al,[30]Randomized, double-blind, placebo-controlled clinical trial. Peanut SLIT

N = 40

12-37 yrs.

Yes

Dose = 165-1386 mcg

14 (70%) in active group vs. 3 (15%) in placebo group were responders

10

Not assessed

No change in peanut-specific IgE; ↑IgG4

First phase: AEs with 40.1% of 5825 peanut SLIT doses including 1 treated with epinephrine vs. 0.6% of 6029 placebo doses

Dose for cross-over group = 3696 mcg

Crossover High dose group: 33.3% of 5030 doses had AEs

Duration = 44 wks.

Keet et al,[29]Randomized open-label clinical trial. Combined cow’s milk SLIT/OIT

N = 30

6-17 yrs.

Yes

SLIT dose =7 mg

1 (10%) SLIT

2

1 SLIT and 8 combined OIT subjects deemed tolerant

↑cow’s milk-specific IgG4 in all groups; ↓specific-IgE and basophil response in combined OIT

Symptoms with 1802 (29%) of 6246 SLIT doses and 2402 (23%) of 10,645 OIT doses. OIT had significantly more multisystem, upper respiratory tract, gastro-intestinal, lower respiratory tract symptoms, more need for B-agonist and antihistamines. Epinephrine 2× in SLIT and 4× in OIT.

OITB dose =1000 mg

6 (60%) SLIT/OITB

OITA dose =2000 mg

8 (80%) SLIT/OITA passed 8 g OFC

SLIT duration = 74 wks.

OIT duration = 86 wks.