Table 2.
Per-protocol data and analysis
|
Item
|
Overall population
|
Placebo treatment
|
AN-PEP treatment
|
| Number of patients | 37 | 20 | 17 |
| Age in yr, median (range) | 40 (29-46) | 41 (31-48) | 39 (28-45) |
| Females, n (%) | 31 (83.8) | 17 (85.0) | 14 (82.3) |
| CeD serology in AU/mL, median (IQR) | |||
| IgA DGP at baseline | 3 (1-5) | 2 (1-5) | 3 (1-5) |
| At end of study | 3 (2-6) | 3 (2-5) | 3 (2-6) |
| IgA tTG at baseline | 17 (7-43) | 13 (6-36) | 17 (11-48) |
| End of study | 12 (6-48) | 11 (5-20) | 17 (7-62) |
| SCI global score at randomization median score (IQR) | 36.0 (31.0-44.0) | 35.0 (30.0-45.5) | 40.0 (33.0-44.0) |
| End of the study median score (IQR) | 33.0 (28.0-39.0) | 32.0 (28.5-37.5) | 35.0 (28.0-41.0) |
| SCI scores > 38 at randomization, n (%) | 17 (45.9) | 7 (35.0) | 10 (58.8) |
| End of study, n (%) | 10 (27.0) | 5 (25.0) | 5 (29.4)a |
| Stool GIP median and CI (IQR) of the average concentration for period, µg/g | |||
| Run-in period | 0.40 (0-0.86) | 0.37 (0-0.73) | 0.55 (0-0.93) |
| Treatment period | 0.30 (0.10-0.80)b | 0.25 (0.11-0.79)c | 0.32 (0-0.89)d |
a
Comparison with run-in (McNemar test): P < 0.03.
b
Comparison with run-in values P (Wilcoxon): P = 0.43.
c
Comparison with run-in values P (Wilcoxon): P = 0.79.
d
Comparison with run-in values P (Wilcoxon): P = 0.33.
CeD: Celiac disease; CSI: Celiac symptom index; DGP: Deamidated gliadin peptide antibodies; GIP: Gliadin immunogenic peptides; IQR: Interquartile range; tTG: Tissue transgluteminase antibodies.