Table 6. Representative peanut oral immunotherapy clinical trials.
| Design & reference | Sample: size & age | Protocol: duration & daily maintenance dose | Outcome (by ITT) and other significant findings | Notable adverse events |
|---|---|---|---|---|
| Peanut OIT open-label | 39 subjects | 36 months | Peanut OIT induced 3.9 g-desensitization in 74% of subjects with acceptable safety | 3.7% of home doses were accompanied by symptoms; 0.8% requiring treatment, with 2 EAI 4 AE-related withdrawals |
| Jones et al. 2009 | 1–16 years | 1.8 g | ||
| Peanut OIT open-label | 23 subjects | Median 9 months, with 7-day rush | Using a shorter protocol, 61% reached target daily dose of 500 mg. At 1-wk SU OFC, median highest tolerated dose was 1 g. Safety concerns persist despite lower target maintenance, primarily among asthmatics | 0.3% of doses accompanied by AE. 4 AE-related withdrawals all due to asthma exacerbations, with one hospitalization |
| Blumchen et al. 2010 | 3–14 years | 0.5 g minimum | ||
| Peanut OIT vs placebo, RCT | 19 OIT 9 placebo |
12 months | Peanut OIT induced 5-g desensitization in 84% of active subjects, vs 0 on placebo (P<0.001), with acceptable safety profile | 2 EAI with initial dose escalation; no EAI after home dose (except in placebo arm) 3 AE-related withdrawals |
| Varshney et al. 2011 | 1–16 years | 5 g | ||
| Peanut OIT open-label | 22 subjects | 9–17 months | Peanut OIT with lower maintenance dose of 800 mg induced 6.6 g-desensitization in 64% of subjects, with acceptable safety profile | No EAI. 0 AE-related withdrawals. 86% experienced some AE with doses. 0.4% of build-up & 0.3% of maintenance doses required SABA |
| Anagnostou et al. 2011 | 4–18 years | 0.8 g | ||
| Peanut OIT vs avoidance, RCT | 49 OIT 46 avoidance |
6 months | In a study inclusive of subjects with life-threatening anaphylaxis to peanut, peanut OIT induced 1.4 g-desensitization in 50% of active subjects, compared to 0 on avoidance, with acceptable safety profile | 2 home EAI in 1 participant Wheeze after 0.41% of doses in 22% of participants; 4 AE-related withdrawals |
| Anagnostou et al. 2014 | 7–16 years | 0.8 g | ||
| Follow up of Jones 2009; Peanut OIT open-label |
39 subjects | 22 months | 4 week SU to 5 g achieved in 31% of enrolled subjects and 50% of subjects completing the protocol. All subjects with SU were consuming peanut 40 months post-OIT | 6 AE-related withdrawals |
| Vickery et al. 2014 | 1–16 years | 4 g max | ||
| Low vs high dose Peanut OIT in young subjects |
20 low dose 17 high dose |
29 months | Among younger subjects, low and high dose OIT had similar outcomes, inducing 5 g-desensitization in 81% of subjects and 1 month-SU in 78%, with good safety profile | No severe AE; no EAI. 95% of subjects had some dose-related AE, mostly mild, 15% moderate. 2 AE-related withdrawals |
| Vickery et al. 2017 | 9–36 months | 0.3 g or 3 g | ||
| Standardized peanut OIT product vs placebo, multicenter RCT | 29 OIT 26 placebo |
5–9 months | With active OIT, 79% and 62% tolerated 0.443 g and 1.043 g with minimal or no symptoms, respectively; compared to 19% and 0% on placebo (P<0.0001), with good safety profile | 93% of active and 46% of placebo groups experienced dose-related AE. Mostly mild, 4–6% moderate, none severe. 6 AE-related withdrawals, 4 due to GI symptoms |
| Bird et al. 2017 | 4–26 years | 0.3 g |
AE, adverse event; EoE, eosinophilic esophagitis; EAI, epinephrine auto-injector; GI, gastrointestinal; ITT, intention to treat; OFC, oral food challenge; OIT, oral immunotherapy; RCT, randomized controlled trial; SU, sustained unresponsiveness.