Effect of Aspergillus niger prolyl endopeptidase in patients with celiac disease on a long-term gluten-free diet

Table 1 Patient data collected in the study in the intention-to-treat analysis

Item	Overall population	Placebo treatment	AN-PEP treatment
Number of patients	40	21	19
Age in yr, median (range)	40.5 (29-47)	42.0 (32-48)	39.0 (28-46)
Females, n (%)	33.0 (82.5)	18.0 (85.7)	15.0 (78.9)
CeD serology in U/mL, median (IQR)
IgA DGP at baseline	3.0 (1.3-5.0)	2.0 (1.0-5.0)	4.0 (2.0-5.0)
End of study	3 (2-6)	3 (2-5)	3 (2-6)
IgA tTG at baseline	17 (7-44)	10 (5-30)	17 (8-49)
End of study	12 (6-50)	11 (6-15)	17 (8-70)
SCI global score at randomization median score (IQR)	36 (32-44)	35 (30-44)	40 (33-44)
End of the study median score (IQR)	34 (28-40)	32 (29-39)	35 (28-41)
SCI scores > 38 at randomization, n (%)	19 (47.5)	8 (38.1)	11 (57.9)
End of the study, n (%)	12 (30.0)	6 (28.6)	6 (31.6)a
Stool GIP. Median and CI (IQR) of the average concentration for period (µg/g)
Run-in period	0.37 (0-0.83)d	0.34 (0-0.68)b	0.42 (0-0.93)c
Treatment period	0.21 (0-0.79)d	0.19 (0.11-0.79)b	0.22 (0-0.89)c

^aComparison with run-in (McNemar test): P < 0.03.

^bComparison with run-in values P (Wilcoxon): P = 0.79.

^cComparison with run-in values P (Wilcoxon): P = 0.19.

^dComparison with run-in values P (Wilcoxon): P = 0.29.

CeD: Celiac disease; CI: Confidence interval; CSI: Celiac symptom index; DGP: Deamidated gliadin peptide antibodies; GIP: Gliadin immunogenic peptides; IQR: Interquartile range; tTG: Tissue transgluteminase antibodies.