Study | Subjects | Age of subjects | Baseline OFC | Goal maintenance dose & duration of IT | Clinical outcome/Desensitization n (%) | Drop outs | Tolerance n (%) | Immunologic changes | Safety data |
---|---|---|---|---|---|---|---|---|---|
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 =1000Â mg | 6 (60%) SLIT/OITB | ||||||||
OITA dose =2000Â mg | 8 (80%) SLIT/OITA passed 8Â g OFC | ||||||||
SLIT duration = 74 wks. |  | ||||||||
OIT duration = 86 wks. |