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Digestive Disease Week® 2023 - The effect of AN-PEP protease on gluten exposure in the real life of celiac disease patients measured by stool gluten immunogenic peptides
Congress
Authorship:
STEFANOLO, J.P. ; SEGURA, V. ; GRIZZUTI, M. ; COMINO, I. ; COSTA, A.F. ; PUEBLA, R. ; TEMPRANO, M.P. ; NIVELONI, S. ; DE DIEGO, GABRIEL ALEJANDRO ; OREGUI, M.E. ; SMECUOL, E. ; DE MARZI, M.C. ; VERDÚ, E.F. ; SOUZA, C. ; BAI, J.C.Date:
2023Publishing House and Editing Place:
Digestive Disease Week® 2023Summary *
Background/Aim: The gluten-free diet has limitations, and there is intense research in thedevelopment of adjuvant therapies. Our aim was to examine the effects of orallyadministered Aspergillus niger endopeptidase (AN-PEP) on inadvertent gluten exposureand symptom prevention in adult patients with celiac disease (CeD) following their usualgluten-free diet (GFD).Methods: This was an exploratory, double-blind, randomized, placebo-controlled trial thatenrolled patients with CeD on a long-term GFD. After a four-week run-in period, patientswere randomized to 4 weeks of 2 AN-PEP capsules (GliadinX. AVI Research LLC; USA)at each of 3 meals/day or placebo. Outcome endpoints were: 1- the average weekly stoolgluten immunogenic peptides (GIP) between the run-in and end of treatments, andbetween AN-PEP and placebo; 2) the Celiac Symptom Index (CSI); 3- CeD-specificserology; and 4- the quality of life. Stool samples were collected for GIP by ELISA everyTuesday and Friday during run-ins and treatments.Results: 40 patients were randomized to the intention-to-treat analysis, and three wereexcluded from the per-protocol assessment. Overall, 628/640 (98.1%) stool samples werecollected. GIP was undetectable (<0.08 µg/g) in 65.6% of samples, and no differencesbetween arms were detected. Only 0.5% of samples had GIP concentrations sufficientlyhigh (>0.32µg/g) to potentially cause mucosal damage. Median GIP concentration in theAN-PEP arm was 44.7% lower than in the run-in period. One-third of patients exhibitingGIP >0.08 µg/g during run-in had lower or undetectable GIP after AN-PEP treatment.Compared with the run-in period, the proportion of symptomatic patients (CSI >38) in theAN-PEP arm was significantly lower (p<0.03). AN-PEP did not result in changes inspecific serologies.Conclusions: This exploratory study, conducted in a real-life setting, revealed highadherence to the GFD. The AN-PEP treatment did not significantly reduce overall GIPstool concentration. However, given the observation of a significantly lower prevalence ofsevere symptoms in the AN-PEP arm in patients following their usual GFD, furtherclinical research is warranted. Information provided by the agent in SIGEVAKey Words
AN-PEPDIETA LIBRE DE GLUTENCELIAQUÍAGLUTEN