Table 1.
Patient Demographics and Disease Characteristics
| Larazotide Acetate (n=258) | |||||
|---|---|---|---|---|---|
|
| |||||
| Placebo (n=84) | 0·5 mg TID (n=86) | 1·0 mg TID (n=85) | 2·0 mg TID (n=87) | Total (N=342) | |
|
| |||||
| General characteristics | |||||
| Age (years), mean [SD] | 45·5 [14·6] | 44·2 [14·4] | 46·2 [15·0] | 44·7 [16·0] | 45·2 [15·0] |
| Female, n (%) | 69 (82·1) | 73 (84·9) | 71 (83·5) | 72 (82·8) | 285 (83·3) |
| White, n (%) | 83 (98·8) | 84 (97·7) | 85 (100) | 86 (98·9) | 338 (98·8) |
| Weight (kg), mean [SD] | 74·3 [16·8] | 75·5 [16·0] | 72·2 [15·4] | 73·4 [15·3] | 73·9 [15·8] |
| Height (cm), mean [SD] | 167·3 [9·6] | 165·4 [8·9] | 166·2 [8·6] | 167·4 [8·5] | 166·5 [8·9] |
| Body Mass Index (kg/m2), mean [SD] | 26·6 [5·4] | 27·6 [5·3] | 26·0 [4·6] | 26·1 [4·6] | 26·6 [5·0] |
|
| |||||
| Clinical characteristics | |||||
| Time since CeD symptom onset (months), mean [SD] | 145·5 [141·1] | 149·2 [144·8]a | 162·9 [150·6]a | 174·6 [174·7] | 158·1 [158·3]a |
| Time since CeD diagnosis* (months), mean [SD] | 60·3 [51·3] | 58·0 [50·1]b | 66·7 [68·2]b | 71·5 [65·07]b | 64·1 [59·2]b |
| Time on most recent GFD* (months), mean [SD] | 62·1 [58·7] | 60·3 [60·1] | 71·4 [86·2] | 70·9 [63·7] | 66·2 [68·0] |
|
| |||||
| Symptoms at diagnosis, n (%) | |||||
| Diarrhea | 67 (79·8) | 68 (79·1) | 69 (81·2) | 64 (73·6) | 268 (78·4) |
| Bloating | 75 (89·3) | 77 (89·5) | 78 (91·8) | 78 (89·7) | 308 (90·1) |
| Abdominal distention/ Stomach swelling | 64 (76·2) | 62 (72·1) | 68 (80·0) | 68 (78·2) | 262 (76·6) |
| Recurrent abdominal pain | 72 (85·7) | 78 (90·7) | 76 (89·4) | 75 (86·2) | 301 (88·0) |
|
| |||||
| Scores at baseline, mean [SD] | |||||
| CeD-GSRS | 3·26 [0·92] | 3·05 [0·84] | 3·21 [0·77] | 3·25 [0·96] | Not Calculated |
| Total GSRS | 3·03 [0·82] | 2·89 [0·80] | 3·03 [0·75] | 3·09 [0·89] | |
| CeD PRO Abdominal Domain | 2·56 [1·71] | 2·19 [1·34] | 2·63 [1·59] | 2·90 [1·58] | |
| CeD PRO GI Domain | 2·27 [1·46] | 1·86 [1·10] | 2·23 [1·29] | 2·35 [1·29] | |
| Average weekly number of bowel movements† | 9·00 [7·11] | 7·59 [4·62] | 7·25 [4·78] | 7·95 [5·45] | |
*
Assessed at screening visit
†
As recorded in the Bristol Stool Form Scale (BSFS) daily diary
a
Data missing for one patient each in the 0·5 mg and 1·0 mg TID group
b
Data missing for one patient in each of the three larazotide acetate treatment groups
CeD = Celiac Disease; GFD = gluten-free diet; GSRS = Gastrointestinal Symptom Rating Scale; CeD-GSRS = Celiac Disease focused domains of the Gastrointestinal Symptom Rating Scale; CeD PRO = Celiac Disease Patient Reported Outcome; BSFS = Bristol Stool Form Scale
There were no significant differences between cohorts in any measure