Table 2.
Efficacy outcomes for primary endpoint and major secondary endpoints
| Primary Endpoint | ||||
|---|---|---|---|---|
| Peanut-0 (n = 60) |
Placebo (n = 25) |
OR (95% CI) |
P-value1 | |
| Passing the week 117 DBPCFC to peanut | 21/60 (35%) | 1/25 (4%) | 12·7 (1·8, 554·8) | 0·0024 |
| Secondary Endpoints | ||||
| Peanut-0 (n = 60) |
Placebo (n = 25) |
OR (95% CI) |
P-value1 | |
| Passing the DBPCFC to peanut at… | ||||
| Week 104 (Desensitization) | 51/60 (85%) | 1/25 (4%) | 124·2 (16·6, 5473·4) | <0·001 |
| Week 130 | 12/60 (20%) | 1/25 (4%) | 5·9 (0·8, 266·7) | 0·10 |
| Week 143 | 9/60 (15%) | 1/25 (4%) | 4·2 (0·5, 193·1) | 0·27 |
| Week 156 | 8/60 (13%) | 1/25 (4%) | 3·6 (0·4, 170·4) | 0·27 |
| Complete build-up phase to 4000 mg (peanut or oat flour) with only mild symptoms2 | 15/60 (25%) |
13/25 (52%)3 | 0·3 (0·1, 0·8) |
0·023 |
| Complete build-up and maintenance phases (peanut or oat flour) with only mild symptoms2 | 13/60 (22%) |
13/25 (52%)3 | 0·3 (0·1, 0·7) |
0·0092 |
| Inability to tolerate at least 1000 mg (peanut or oat flour) | 9/60 (15%) | 2/25 (8%)3 | 0·5 (0·05, 2·7) | 0·50 |
| Peanut-0 (n = 60) |
Peanut-300 (n = 35) |
OR (95% CI) |
P-value1 | |
| Passing the DBPCFC to peanut at… | ||||
| Week 104 (Desensitization) | 51/60 (85%) | 29/35 (83%) | 1·2 (0·3, 4·1) | 0·78 |
| Week 117 | 21/60 (35%) | 19/35 (54%) | 0·5 (0·2, 1·2) | 0·086 |
| Week 130 | 12/60 (20%) | 15/35 (43%) | 0·3 (0·1, 0·9) | 0·021 |
| Week 143 | 9/60 (15%) | 13/35 (37%) | 0·3 (0·1, 0·9) | 0·022 |
| Week 156 | 8/60 (13%) | 13/35 (37%) | 0·4 (0·1, 0·8) | 0·010 |
| Complete build-up phase to 4000 mg peanut with only mild symptoms2 | 15/60 (25%) | 12/35 (34%) | 0·6 (0·3, 1·6) | 0·35 |
| Complete build-up and maintenance phases (to peanut) with only mild symptoms2 | 13/60 (22%) | 11/35 (31%) | 0·6 (0·2, 1·5) | 0·33 |
| Inability to tolerate at least 1000 mg peanut | 9/60 (15%) | 6/35 (17%) | 1·2 (0·3, 4·1) | 0·78 |
1
Fisher’s exact test. Peanut-0 = oral immunotherapy with peanut discontinuation arm; Peanut-300 = oral immunotherapy with peanut continuation arm (300 mg). DBPCFC = double-blind placebo-controlled food challenge.
2
Mild symptoms are AEs with CTCAE grade = 1.
3
Since placebo received oat flour, these counts correspond to rates to be expected in the untreated peanut population.