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 |