The median time on GFD treatment was similar in both groups. Two patients were excluded after the safety phase because of a histological deterioration of two and three Marsh grades, respectively, which for one patient returned to normal (Marsh 0) after four weeks of exclusion. The patient that did not return to normal started the study with high IgA/G-DGP-tTG values. However, Dorsomorphin buy other CD-related antibodies remained undetectable in these two patients. The remaining 14 patients entered and completed the efficacy phase. Table 1 Demographic and baseline characteristics of the safety and efficacy phase When correlating the patients�� baseline characteristics with their response to gluten, highly significant inverse relationships were found between the patients�� time since diagnosis or time spent on a GFD and their response to gluten as measured by IgG-AG, IgA-tTG and IgA/G-DGP-tTG, and Marsh scores (data not shown).
Adverse events No serious adverse events occurred during the trial, patients reported no severe adverse events, and no patients withdrew during the trial. Complaints that were reported during the safety and efficacy phase were of gastrointestinal nature and mostly mild and transient. The number of reported gastrointestinal complaints did not differ between the AN-PEP and placebo group (Table (Table11). Celiac-disease quality of life The mean total scores of the four categories on the CD quality of life were relatively high (145-156 out of a total score of 196) in the total group and throughout both study phases. In the safety phase, the total CD quality of life score significantly (P = 0.
04) increased by 6 points during gluten with AN-PEP treatment. This increase was however lower than the 12-point increase that is considered a clinically relevant quality of life improvement. In the efficacy phase, the individual or total CD quality of life scores of patients consuming gluten with placebo or gluten with AN-PEP did not significantly deteriorate. No differences between the groups were observed. The mean score for the gastrointestinal CD quality of life was relatively high throughout the study, indicating that gluten with AN-PEP was well tolerated. Mucosal biopsy immunohistology In the patients receiving gluten plus AN-PEP treatment in the safety phase, several patients showed variation in Marsh scores but overall no significant change in degree of mucosal damage, as indicated by changes in the Marsh score, Carfilzomib was observed (Table (Table2).2). Two of 16 patients were excluded from entering the efficacy phase as their mucosa showed an increase of two Marsh steps while 14 patients were considered histologically stable on gluten with AN-PEP.