PMID- 31878146
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 9
IP  - 1
DP  - 2019 Dec 24
TI  - Safety of P28GST, a Protein Derived from a Schistosome Helminth Parasite, in 
      Patients with Crohn's Disease: A Pilot Study (ACROHNEM).
LID - 10.3390/jcm9010041 [doi]
LID - 41
AB  - 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.
FAU - Capron, Monique
AU  - Capron M
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
FAU - Beghin, Laurent
AU  - Beghin L
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
AD  - CIC 1403, Centre d'Investigation Clinique, Univ. Lille, Inserm, CHU Lille, 
      F-59000 Lille, France.
FAU - Leclercq, Celine
AU  - Leclercq C
AD  - Direction de la Recherche et de l'Innovation, CHU Lille, F-59000 Lille, France.
FAU - Labreuche, Julien
AU  - Labreuche J
AD  - EA 2694-Sante Publique: epidemiologie et Qualite des Soins, Univ. Lille, CHU 
      Lille, F-59000 Lille, France.
FAU - Dendooven, Arnaud
AU  - Dendooven A
AUID- ORCID: 0000-0003-4918-2223
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
FAU - Standaert, Annie
AU  - Standaert A
AUID- ORCID: 0000-0002-7752-3964
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
FAU - Delbeke, Marie
AU  - Delbeke M
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
FAU - Porcherie, Adeline
AU  - Porcherie A
AD  - Par'Immune, Eurasante, F-59120 Loos lez Lille, France.
FAU - Nachury, Maria
AU  - Nachury M
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
FAU - Boruchowicz, Arnaud
AU  - Boruchowicz A
AD  - Service des Maladies de l'Appareil Digestif, Unite de Recherche Clinique, Centre 
      Hospitalier de Valenciennes, F-59300 Valenciennes, France.
FAU - Dupas, Jean-Louis
AU  - Dupas JL
AD  - Service d'Hepato-Gastro-Enterologie, CHU Amiens Picardie, F-80054 Amiens, France.
FAU - Fumery, Mathurin
AU  - Fumery M
AD  - Service d'Hepato-Gastro-Enterologie, CHU Amiens Picardie, F-80054 Amiens, France.
FAU - Paupard, Thierry
AU  - Paupard T
AD  - Service d'Hepato-Gastro-Enterologie, Unite de Recherche Clinique, Centre 
      Hospitalier de Dunkerque, F-59385 Dunkerque, France.
FAU - Catteau, Sylviane
AU  - Catteau S
AD  - Service d'Hepato-Gastro-Enterologie, Unite de Recherche Clinique, Centre 
      Hospitalier de Boulogne sur Mer, F-62200 Boulogne Sur Mer, France.
FAU - Deplanque, Dominique
AU  - Deplanque D
AD  - CIC 1403, Centre d'Investigation Clinique, Univ. Lille, Inserm, CHU Lille, 
      F-59000 Lille, France.
FAU - Colombel, Jean-Frederic
AU  - Colombel JF
AD  - Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
FAU - Desreumaux, Pierre
AU  - Desreumaux P
AD  - U995-LIRIC, Lille Inflammation Research International Center, Univ. Lille, 
      Inserm, CHU Lille, F-59000 Lille, France.
LA  - eng
GR  - ANR-2011 program (RPIB 021 01),/(Agence Nationale de la Recherche, Paris, France/
PT  - Journal Article
DEP - 20191224
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC7019330
OTO - NOTNLM
OT  - Crohn's disease
OT  - Crohn's disease activity index
OT  - P28GST
OT  - calprotectin
OT  - helminth protein
OT  - safety
COIS- The authors declare no conflict of interest.
EDAT- 2019/12/28 06:00
MHDA- 2019/12/28 06:01
PMCR- 2019/12/24
CRDT- 2019/12/28 06:00
PHST- 2019/11/28 00:00 [received]
PHST- 2019/12/17 00:00 [revised]
PHST- 2019/12/19 00:00 [accepted]
PHST- 2019/12/28 06:00 [entrez]
PHST- 2019/12/28 06:00 [pubmed]
PHST- 2019/12/28 06:01 [medline]
PHST- 2019/12/24 00:00 [pmc-release]
AID - jcm9010041 [pii]
AID - jcm-09-00041 [pii]
AID - 10.3390/jcm9010041 [doi]
PST - epublish
SO  - J Clin Med. 2019 Dec 24;9(1):41. doi: 10.3390/jcm9010041.