Brief Article
Copyright ©2013 Baishideng Publishing Group Co.
World J Gastroenterol. Sep 21, 2013; 19(35): 5837-5847
Published online Sep 21, 2013. doi: 10.3748/wjg.v19.i35.5837
Table 1 Demographic and baseline characteristics of the safety and efficacy phase
Safety phaseEfficacy phase
Gluten + AN-PEPGluten + placeboGluten + AN-PEP
(n = 16)(n = 7)(n = 7)
Patients (n)1677
Gender (female:male)12:45:26:1
Median age at inclusion, yr (range)55 (20-68)44 (20-68)57 (30-64)
Median age at diagnosis, yr (range)44.5 (0-62)29 (0-62)49 (26-53)
Median time on a GFD, yr (range)7.5 (2-40)9 (2-40)8 (4-12)
HLA class (n)
DQ2/X1255
DQ2/DQ2211
DQ2/DQ8101
Unknown110
Marsh at inclusion (n)
Marsh 01043
Marsh I634
Gastrointestinal symptoms
Abnormal bowel sounds402
Abdominal pain532
Bowel distension531
Change of defecation426
Constipation320
Diarrhoea311
Dysgeusia110
Flatulence612
Nausea420
Reflux201
Vomiting110
Weight loss010
Total number of symptoms381715
Table 2 Serum antibodies, duodenal immunohistology and tTGA-A antibody deposits in the safety and efficacy phase for all patients
Baseline
Safety phase
Efficacy phase
2 wk gluten + AN-PEP
2 wk gluten + AN-PEP or placebo
Serum
Biopsy
TxSerum
Biopsy
TxSerum
Biopsy
IgA-tTGIgA-AGIgG-AGIgA/G-DGP-tTGMarshIgA-tTG depositsIgA-tTGIgA-AGIgG-AGIgA/G-DGP-tTGMarshIgA-tTGIgA-AGIgG-AGIgA/G-DGP-tTGMarshIgA-tTG deposits
1----INDA----0P----I0
2-+/---00A-+--IP-+++-IIIA1-2
3----I0A----IP----IIIA1-2
4+/---+I1A---+0P+--++I2-3
5----0NDA----0P----00
6----00A----0P----01
7----00A----0P----I1-2
8----INDA----IIA----I0
9----03A----IA-+/--+I1
10----0NDA-+/---IA-+/-++I0
11----I0A-+--IIA-+/---IIIA1
12----INDA----IA----I0
13----0NDA----0A----00
14----0NDA----0A----00
15---++0NDA---++IIE---++IIIAND
16----0NDA----IIIAE----0ND