Table 1.
Study outcomes
| NEB (n = 11) |
OVB (n = 11) |
p value | |
|---|---|---|---|
| Primary outcomes | |||
| Overall eosinophil counts (eos/hpf ± SD) | |||
| Baseline maximum eosinophil count | 101 ± 85 | 83 ± 89 | 0.62 |
| Baseline mean eosinophil count | 23 ± 20 | 20 ± 24 | 0.80 |
| Post-treatment max eosinophil count* | 89 ± 94 | 11 ± 23 | 0.02 |
| Post-treatment mean eosinophil count* | 31 ± 37 | 3 ± 7 | 0.02 |
| Maximum eosinophil counts by level (eos/hpf) | |||
| Baseline proximal esophagus | 79 ± 73 | 54 ± 74 | 0.43 |
| Post-treatment proximal esophagus† | 57 ± 78 | 5 ± 17 | 0.04 |
| Baseline mid esophagus | 41 ± 47 | 59 ± 98 | 0.62 |
| Post-treatment mid esophagus‡ | 55 ± 57 | 8 ± 22 | 0.02 |
| Baseline distal esophagus | 54 ± 66 | 53 ± 49 | 0.96 |
| Post-treatment distal esophagus# | 69 ± 81 | 11 ± 23 | 0.03 |
| Symptoms (mean score ± SD) | |||
| Baseline MDQ score | 34 ± 21 | 25 ± 18 | 0.30 |
| Post-treatment MDQ score** | 10 ± 12 | 16 ± 17 | 0.31 |
| Secondary outcomes | |||
| Mucosal medication contact time (median) | |||
| Overall esophageal area under the curve | 19200 | 48900 | 0.005 |
| Proximal esophageal AUC | 7300 | 14400 | 0.14 |
| Mid esophageal AUC | 2800 | 7800 | 0.01 |
| Distal esophageal AUC | 3800 | 18100 | 0.001 |
| AUC with a complete histologic response | 61000 | 65000 | 0.76 |
| AUC without a complete response†† | 19200 | 34000 | 0.06 |
| Histologic response (n, %) | |||
| Complete (< 1 eos/hpf) | 3 (27) | 7 (64) | 0.09 |
| Near-complete (< 7 eos/hpf) | 4 (36) | 8 (73) | 0.09 |
| Partial (< 15 eos/hpf) | 5 (45) | 8 (73) | 0.19 |
| Any response (< baseline eos/hpf) | 6 (55) | 10 (91) | 0.06 |
| Post-treatment EGD findings (n, % with finding) | |||
| Rings | 10 (91) | 4 (36) | 0.008 |
| Narrowing | 6 (55) | 2 (18) | 0.08 |
| Stricture | 3 (27) | 2 (18) | 0.61 |
| Linear furrows | 6 (55) | 4 (36) | 0.39 |
| White plaques/exudates | 3 (27) | 3 (27) | 1.0 |
| Pallor/decreased vascularity | 2 (18) | 0 | 0.14 |
| Crêpe-paper mucosa | 0 | 0 | -- |
| Erosive esophagitis | 0 | 0 | -- |
| Dilation performed | 4 (26) | 3 (27) | 0.65/1.0 |
| EGD improved (n, % global assessment) | 5 (45) | 10 (91) | 0.02 |
| Safety outcomes | |||
| Candidal esophagitis (n, %) | 1 (9) | 2 (18) | 0.53 |
| Baseline adrenal insufficiency (n, %) | 0 | 0 | -- |
| Post-treatment adrenal insufficiency (n, %) | 0 | 0 | -- |
| Post-treatment serum budesonide detected (n, %) | 0 | 0 | -- |
| Esophageal perforation (n, %) | 0 | 0 | -- |
*
For max eosinophil count comparing baseline to post-treatment, p=0.79 for NEB and p=0.03 for OVB; For mean eosinophil count comparing baseline to post-treatment, p=0.71 for NEB and p=0.03 for OVB
†
Comparing baseline to post-treatment for the proximal esophagus, p=0.53 for NEB and p=0.03 for OVB
‡
Comparing baseline to post-treatment for the mid esophagus, p=0.39 for NEB and p=0.01 for OVB
#
Comparing baseline to post-treatment for the distal esophagus, p=0.42 for NEB and p=0.03 for OVB
**
For MDQ score comparing baseline to post-treatment, p=0.002 for NEB and p=0.04 for OVB
††
Comparing those with a complete histologic response to those without a complete histologic response, p=0.43 for NEB and p=0.01 for OVB.