Journal article
The effects of ALV003 pre-digestion of gluten on immune response and symptoms in celiac disease in vivo
JA Tye-Din, RP Anderson, RA Ffrench, GJ Brown, P Hodsman, M Siegel, W Botwick, R Shreeniwas
Clinical Immunology | Published : 2010
Abstract
Effective treatment of celiac disease is an unmet medical need. A glutenase that destroys immunogenic gluten peptides may be clinically valuable. Twenty patients with celiac disease were randomly assigned to ingest a large gluten meal (16 g daily for 3 days) pre-treated with ALV003, a mixture of highly specific glutenases (n = 10), or pre-treated with placebo (n = 10). Peripheral blood T-cell IFN-γ ELISpot responses to gliadin and an immunogenic 33mer and symptoms were assessed. While baseline IFN-γ ELISpot responses to gliadin and the 33mer were negative in all patients, a significant ELISpot response to gliadin or the 33mer was observed in 6 of 10 patients consuming placebo-treated gluten ..
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Funding Acknowledgements
The authors thank all the volunteers who participated in this study. The authors acknowledge Ms. Bianca Scott and Ms Neelma Narayan from Nucleus Network, and the support of the Coeliac Society of Victoria in the recruitment of volunteers. The authors also acknowledge the technical assistance of Ms. Kylie Goy and the research staff at the Burnet Institute.