Table 8.
Summary of RCTs with peanut allergen
| Study (Author, year, country) | Design | Active group vs comparator | Sample size (AG/CG) | Age (yrs) [mean (range)] | Duration desensitization protocol/maintenance dose | Outcomes: desensitization/sustained unresponsiveness | Discontinued due to AEs | SAEs |
|---|---|---|---|---|---|---|---|---|
| Fleischer, 2012, USA [132] | DBPCRT, multicentre crossover trial | SLIT vs placebo | 20/20 | 15 (12–37) | Phase 1, DBPCRT (SLIT vs placebo): 44 weeks/maintenance dose: 1386 μg/day of peanut protein. Phase 2, After an unblinding 5-g DBPCFC, pts in AG continued on maintenance dosing with a 10-g OFC after 1 year of maintenance therapy and placebo pts crossed over to active peanut SLIT (max maintenance dose of 3694 μg). A 5 g crossover OFC was performed after 44 weeks of SLIT. |
Week 44 (Unblinding 5 g-OFC): OD: 70% (n = 14) in AG vs 15% CG (p < 0.001). Median OFC threshold increased from baseline significantly (371 vs 21 mg) only in AG (p < .01). Week 68 All Week 44 responders were still responders with further significant increase in median OFC threshold (996 mg) than at Wk 44 (p = .05) and baseline (p = .009) |
1 | Only one out of 127 AEs required E and oral antihistamine |
| Kim, 2011, USA [133] | DBPCRT | SLIT vs placebo | 11-lug | 5.2 (1–11) | 1 year [build-up phase + maintenance phase (6 months)]/2000 μg of peanut protein | Median cumulative dose safely reached at OFC increased 20-fold (up to 1710 mg, 6–7 peanuts) in AG/In CG, 85 mg (<1 peanut) [OD: AG vs CG, p = 0.011] | None | No E required for whole study. |
| Tang, 2015, Australia [134] | DBPCRT | (OIT + probiotic, Lactobacillus VS placebo | 31/31 | 6 (1–10) | 18 months [build-up phase (8 months) + maintenance phase (10 month) + peanut elimination diet (median 2.3 weeks, range, 2–5.3 weeks)/2 g peanut protein | After OIT, AG: 87% OD/After OIT+ peanut elimination diet, AG: possible sustained unresponsiveness in 82.1%; CG: 3.6% spontaneous tolerance (P < .001) | none | AG: 45.2% CG: 32.3% Number of SAEs per pt did not differ by group (P = .9). |
| Varshney, 2011, USA [135] | DBPCRCT | OIT vs placebo | 19-set | 6 (2–10) | 148 weeks/4 g | 5 g-OFC, AG: 84% complete OD/CG: 100% pts ingested a median cumulative dose of 280 mg at OFC (range, 0–1900 mg) [p < 0.001]. | 3 | At DBPCFC 0/16 in AG required E, 3/9 in CG |
AG active group, CG control group, DBPRT Double blind placebo controlled randomized trial, LRs Local reactions, OD Oral desensitization, OFC oral food challenge, OIT Oral immunotherapy, OT Oral tolerance, Pt participant, RCT randomized controlled trial, SAE severe adverse event