Safety of p28gst, a protein derived from ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
Permalink :
Title :
Safety of p28gst, a protein derived from a schistosome helminth parasite, in patients with crohn''s disease: a pilot study (acrohnem)
Author(s) :
Capron, Monique [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Beghin, Laurent [Auteur]
Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille]
Lille Inflammation Research International Center - U 995 [LIRIC]
Leclercq, Celine [Auteur]
CHU Lille - Direction de la recherche et de l’innovation
Labreuche, Julien [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Dendooven, Arnaud [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Standaert, Annie [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Delbeke, Marie [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Porcherie, Adeline [Auteur]
Nachury, Maria [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Boruchowicz, Arnaud [Auteur]
Centre hospitalier [Valenciennes, Nord]
Dupas, Jean-Louis [Auteur]
CHU Amiens-Picardie
Fumery, Mathurin [Auteur]
CHU Amiens-Picardie
Paupard, Thierry [Auteur]
Catteau, Sylviane [Auteur]
Centre Hospitalier Boulogne-sur-mer
Deplanque, Dominique [Auteur]
Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille]
Colombel, Jean-Frederic [Auteur]
Desreumaux, Pierre [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]

Lille Inflammation Research International Center - U 995 [LIRIC]
Beghin, Laurent [Auteur]
Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille]
Lille Inflammation Research International Center - U 995 [LIRIC]
Leclercq, Celine [Auteur]
CHU Lille - Direction de la recherche et de l’innovation
Labreuche, Julien [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Dendooven, Arnaud [Auteur]

Lille Inflammation Research International Center - U 995 [LIRIC]
Standaert, Annie [Auteur]

Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Delbeke, Marie [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Porcherie, Adeline [Auteur]
Nachury, Maria [Auteur]

Lille Inflammation Research International Center - U 995 [LIRIC]
Boruchowicz, Arnaud [Auteur]
Centre hospitalier [Valenciennes, Nord]
Dupas, Jean-Louis [Auteur]
CHU Amiens-Picardie
Fumery, Mathurin [Auteur]

CHU Amiens-Picardie
Paupard, Thierry [Auteur]
Catteau, Sylviane [Auteur]
Centre Hospitalier Boulogne-sur-mer
Deplanque, Dominique [Auteur]

Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille]
Colombel, Jean-Frederic [Auteur]
Desreumaux, Pierre [Auteur]

Lille Inflammation Research International Center - U 995 [LIRIC]
Journal title :
Journal of Clinical Medicine
Abbreviated title :
J Clin Med
Volume number :
9
Publication date :
2019-12-24
ISSN :
2077-0383
English keyword(s) :
safety
Crohn's disease activity index
calprotectin
P28GST
helminth protein
Crohn's disease
Crohn's disease activity index
calprotectin
P28GST
helminth protein
Crohn's disease
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Despite the development of novel therapies, inflammatory bowel diseases remain an innovative treatment challenge. Helminth therapy is a new promising approach, and a key issue is the identification of helminth-derived ...
Show more >Despite the development of novel therapies, inflammatory bowel diseases remain an innovative treatment challenge. Helminth therapy is a new promising approach, and a key issue is the identification of helminth-derived anti-inflammatory mediators. P28 glutathione-S-transferase (P28GST), a protein derived from schistosomes, a trematode parasitic helminth, was shown to reduce intestinal inflammation in experimental colitis by down-regulating the Th1/Th17 response. In this multicenter, open-label, pilot Phase 2a study, we evaluated the safety of P28GST administered to patients with mild Crohn's disease (CD). We enrolled 10 patients with a baseline Crohn's disease activity index (CDAI) value <220. Eight patients received two to three subcutaneous injections of recombinant P28GST with adjuvant. This three-month treatment was followed by a nine-month monitoring period. The primary endpoints were the monthly rate and seriousness of adverse events (AEs). Secondary endpoints were clinical recurrence, assessed with the CDAI as well as the levels of immunologic and inflammatory blood and tissue markers. The most common AEs were local or regional events at the injection site and gastrointestinal disorders. At three months after the first injection, CDAI scores and blood calprotectin levels decreased in parallel. These results indicate that P28GST showed promise as a safe and new therapeutic option for treating CD.Show less >
Show more >Despite the development of novel therapies, inflammatory bowel diseases remain an innovative treatment challenge. Helminth therapy is a new promising approach, and a key issue is the identification of helminth-derived anti-inflammatory mediators. P28 glutathione-S-transferase (P28GST), a protein derived from schistosomes, a trematode parasitic helminth, was shown to reduce intestinal inflammation in experimental colitis by down-regulating the Th1/Th17 response. In this multicenter, open-label, pilot Phase 2a study, we evaluated the safety of P28GST administered to patients with mild Crohn's disease (CD). We enrolled 10 patients with a baseline Crohn's disease activity index (CDAI) value <220. Eight patients received two to three subcutaneous injections of recombinant P28GST with adjuvant. This three-month treatment was followed by a nine-month monitoring period. The primary endpoints were the monthly rate and seriousness of adverse events (AEs). Secondary endpoints were clinical recurrence, assessed with the CDAI as well as the levels of immunologic and inflammatory blood and tissue markers. The most common AEs were local or regional events at the injection site and gastrointestinal disorders. At three months after the first injection, CDAI scores and blood calprotectin levels decreased in parallel. These results indicate that P28GST showed promise as a safe and new therapeutic option for treating CD.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Inserm
Université de Lille
Inserm
Université de Lille
Collections :
Submission date :
2024-01-30T10:28:18Z
2024-05-03T10:56:20Z
2024-05-03T10:56:20Z
Files
- jcm-09-00041-with-cover.pdf
- Non spécifié
- Open access
- Access the document