Table 2.
Peanut OIT studies.
| Reference, Year | Design | Sample Size (n) | Subject Age (yrs) | Maintenance Dose (mg) | Duration | Conclusions |
|---|---|---|---|---|---|---|
| Jones SM. et al., 2009 [24] | open-label | 29 | 1–16 | 1800 | 36 mo | 93% passed 3.9 g peanut OFC |
| Blumchen K. et al., 2010 [58] | randomized, open-label | 23 | 3–14 | 500 | 7-day rush escalation, 8 wk maintenance |
64% reached their maintenance dose of 500 mg peanut |
| Varshney P. et al., 2011 [25] | randomized, placebo-controlled | 19 | 3–11 | 2000 | 48 wk | 84% passed 5000 mg peanut OFC |
| Anagnostou K. et al., 2011 [59] | open-label | 22 | 4–18 | 800 | 32 wk | 64% tolerated 6.6 g OFC |
| Anagnostou K. et al., 2014 [60] | randomized, placebo-controlled | 39 | 7–16 | 800 | 26 wk | 62% tolerated 1400 mg challenge |
| Vickery BP. et al., 2014 [10] | open-label | 24 | 1–16 | ≤ 4000 | ≤ 5 y | 1 mo after OIT stopped, 50% achieved sustained unresponsiveness to 5000 mg OFC |
| Narisety SD. et al., 2015 [6] | randomized, placebo-controlled | 16 | 7–13 | 2000 | 12 mo | Significantly greater increase in OFC threshold in OIT vs. SLIT, low rate of sustained unresponsiveness |
| Kukkonen K. et al., 2017 [61] | double-blind, placebo-controlled | 39 (60 tot, 39 OIT and 21 controls) | 6–18 | 100-2000 | 8 mo | 85% of patients passed the build-up phase, and 67% tolerated 5 g of peanuts during the post-treatment challenge |
| Vickery B. et al., 2017 [62] | double-blind, placebo-controlled | 40 (40 OIT and 154 controls) | 9–36 mo | 300-3000 | 29 mo | overall 78% of subjects receiving E-OIT demonstrated sustained unresponsiveness to peanut four weeks after stopping E-OIT and reintroduced peanut into the diet |
| Bird JA. et al., 2018 [63] | double-blind, placebo-controlled | 29 (tot 55, 29 OIT and 26 controls) | 4–26 | 300 | 20-34 wk | 79% and 62% AR101 subjects tolerated > 443 mg and 1043 mg respectively, versus 5 of 26 (19%) and 0 of 26 (0%) placebo subjects (both p < 0.0001) |
| PALISADE group, 2018 [4] | double-blind, placebo-controlled | 372 (496 tot, 372 OIT and 124 controls) | 4–17 | 300 | 24 wk | 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge |
| Nachshon L. et al., 2018 [64] | prospective | 139 (145 tot, 139 < 18 y) | 4–18 | 1200 or 3000 | 6 mo | Of the 145 patients treated, 113 (77.9%) were fully desensitized to 3000 mg of peanut protein, 20 (13.8%) patients were partially desensitized to 300-2400 mg, and 12 patients (8.3%) failed. 63/64 patients (98.4%) consuming 1200 mg maintenance dose were successfully re-challenged to 3000 mg. All patients in the high dose group (3000 mg) who continued regular consumption and arrived for follow-up (n = 22) passed a challenge to 3000 mg. |
| Nagakura K. et al., 2018 PAI [65] | prospective, open-label | 24 (24 OIT, 10 controls) | 5–18 | 133 | 12 mo | 16 children (67%) passed the 133-mg OFC, and 14 (58%) passed the 795-mg OFC. Only 1 child (10%) in the historical control group passed the 133-mg OFC (p = 0.006). Ultimately, eight children (33%) in the OIT group achieved sustained unresponsiveness |
| Nagakura K. et al., 2018 [66] | double-blind, placebo-controlled | 22 (22 OIT, 11 controls) | 5–18 | 795 | 2 y | 15/22 patients (68.1%) in the OIT group achieved sustained unresponsiveness, whereas only 2 (18.1%) in the control group passed the second OFC |
| Anvari S. et al., 2018 [67] | double-blind, placebo-controlled | 15 | 5–16 | 3900 | 3 mo | OIT participants who underwent dose variations on the unexpired lots of peanut flour were able to successfully tolerate the 100% dose increase, following a two-week tolerance of a 50% dose reduction on an unexpired lot of peanut flour |
| Zhong Y. et al., 2018 [68] | open-label | 7 (9 total, 7 completed protocol) | 8–14 | 3000 | 12 mo | Of the seven who completed OIT, six tolerated 6000 mg of peanut protein at the first OFC at six months of maintenance phase; the last patient was afraid of consuming more than 3000 mg of peanut protein but passed the challenge with 3000 mg. After 12 months of maintenance therapy, only 3 of the 7 subjects consented to 4 weeks of abstinence. Of these, only 1 passed the challenge with 6000 mg of peanut protein. |
| Fauquert JL. et al., 2018 [69] | double-blind, placebo-controlled | 21 (30 tot, 21 OIT and nine controls) | 12–18 | 400 IN CAPSULES | 24 wk | Unresponsiveness to 400 mg of peanut protein was achieved in 17/21 peanut group patients (two patients withdrew) and 1/9 in the placebo group |
| Blumchen K. et al., 2019 [70] | double-blind, placebo-controlled | 31 (62 tot, 31 OIT and 31 controls) | 3–17 | 125–250 | 16 mo | Twenty-three of 31 (74.2%) children of the active group tolerated at least 300 mg peanut protein at final food challenge compared with 5 of 31 (16.1%) in the placebo group (p < 0.001). Thirteen of 31 (41.9%) children of the active versus 1 of 31 (3.2%) of the placebo group tolerated the highest dose of 4.5 g peanut protein at final OFC (p < 0.001) |
| Wasserman RL. et al., 2019 [71] | retrospective record | 270 | 4–18 | 3000 | 36 mo | All patients who reached the 3000 mg target dose (214/262 81%) were challenged with 6000 mg of peanut protein and all but 1 patient passed the challenge. 14 had demonstrated sustained unresponsiveness with 6000 mg |
Legend: Y: years; mo: months; n: number; OFC: oral food challenge; OIT: oral immunotherapy; tot: total; wk: weeks; SLIT sublingual immunotherapy.