Table 2 Summary of the epicutaneous immunotherapy (EPIT) for food allergy clinical trials
From: Epicutaneous immunotherapy in rhino-conjunctivitis and food allergies: a review of the literature
References | Study population | Allergen | Single-patch allergen dose | Patch application time (h) | Safety | Efficacy | |
|---|---|---|---|---|---|---|---|
Primary outcomes | Results with statistical/clinical significance | ||||||
Proof of concept trial: Dupont et al. [21] | 19 children | Cow’s milk | 1 mg | 48 | Local AE: TG: 4 subjects     PG: 2 subjects Systemic AE: TG: 24 times      PG: 8 times | OFC: increase in cumulative tolerate dose from baseline (< 10 ml) after 3 months | None |
Safety and tolerability trial: Jones et al. [22] | 100 mixed populationa | Peanuts | 20 μg 100 μg 250 μg 500 μg | 24 48 | TEAE: TG: 52.5%     PG: 45% L-TEAEs: TG: 84%     PG: 64% |  |  |
Efficacy, safety and dose-ranging trial: Sampson et al. [23] | 221 mixed populationa | Peanuts | 50 μg 100 μg 250 μg | 24 | TEAE: 50 μg: 96.2%     100 μg: 94.6%     250 μg: 96.4%     PG: 48.2% 1 moderate anaphylaxis | OFC after 12 months (1000 mg or tenfold increase)b | Overall response rate     250 μg-placebo: 50–25% (p = 0.01) 6–11 year stratum      250 μg placebo: 53.6–19.4% (p = 0.008) |
171 mixed population | Peanuts | 50 μg 100 μg 250 μg | 24 | TEAEs: 93% in year 1 of extension 62% in year 2 of extension | OFC after 12 and 24 months | Overall response rate 12 months: 59.7% 24 months: 64.5% | |
Efficacy, safety and immune-response trial: Jones et al. [24] | 74 mixed populationc | Peanuts | 100 μg 250 μg | 24 | Patch site AE: 100 μg: 79.8%      250 μg: 79.8%     PG: 14.4% Non-patch site AE: 100 μg: 0.2%     250 μg: 0.1%     PG: 0.2% 1 systemic hives | OFC after 52 weeks (5044 mg or tenfold increase)d | 100 μg-placebo: 45.8% (p = 0.005) 250 μg-placebo: 48% (p = 0.003) |