Real-life effectiveness of allogeneic expanded adipose-derived mesenchymal stem cell therapy for perianal fistulizing refractory Crohn's disease: allogeneic MSC therapy in perianal fistulizing CD.
Crohn's disease
Mesenchymal stem cell therapy
anoperineal complex fistula
fistula closure
Journal
Clinics and research in hepatology and gastroenterology
ISSN: 2210-741X
Titre abrégé: Clin Res Hepatol Gastroenterol
Pays: France
ID NLM: 101553659
Informations de publication
Date de publication:
28 Sep 2024
28 Sep 2024
Historique:
received:
09
07
2024
revised:
21
09
2024
accepted:
25
09
2024
medline:
1
10
2024
pubmed:
1
10
2024
entrez:
30
9
2024
Statut:
aheadofprint
Résumé
Real life data about the long-term efficacy of darvadstrocel for treating perianal fistulas in Crohn's disease (CD) remain scarce. To report the effectiveness and safety of darvadstrocel therapy to close perianal fistula in a real-life cohort of CD patients. All patients with CD suffering complex draining perianal fistulas who consecutively underwent administration of a single local injection of darvadstrocel at two centres were followed up and evaluated. The primary endpoint was clinical remission (closure of all external openings with no discharge at pressure) at week 24. Combined remission (defined as clinically plus MRI-assessed fistula closure) were also assessed at week 24 and 52. A total of 36 CD patients (19 Male, mean age 38.5 years) were included with a median follow up of 16 months. Clinical remission was achieved in 17 out of 36 patients (47.2 %) and combined remission in 15 out of 36 patients (41.6 %) at week 24. At week 52, clinical and combined remission was achieved in 17 out of 36 patients (47.2 %) and in 15 out of 33 evaluable patients (45.4 %), respectively. In this real-world setting, a successful response to darvadstrocel therapy based on clinical remission was reported in around half of the patients and combined remission including radiological assessment in more than 4 out of 10 patients.
Sections du résumé
BACKGROUND
BACKGROUND
Real life data about the long-term efficacy of darvadstrocel for treating perianal fistulas in Crohn's disease (CD) remain scarce.
AIM
OBJECTIVE
To report the effectiveness and safety of darvadstrocel therapy to close perianal fistula in a real-life cohort of CD patients.
METHODS
METHODS
All patients with CD suffering complex draining perianal fistulas who consecutively underwent administration of a single local injection of darvadstrocel at two centres were followed up and evaluated. The primary endpoint was clinical remission (closure of all external openings with no discharge at pressure) at week 24. Combined remission (defined as clinically plus MRI-assessed fistula closure) were also assessed at week 24 and 52.
RESULTS
RESULTS
A total of 36 CD patients (19 Male, mean age 38.5 years) were included with a median follow up of 16 months. Clinical remission was achieved in 17 out of 36 patients (47.2 %) and combined remission in 15 out of 36 patients (41.6 %) at week 24. At week 52, clinical and combined remission was achieved in 17 out of 36 patients (47.2 %) and in 15 out of 33 evaluable patients (45.4 %), respectively.
CONCLUSION
CONCLUSIONS
In this real-world setting, a successful response to darvadstrocel therapy based on clinical remission was reported in around half of the patients and combined remission including radiological assessment in more than 4 out of 10 patients.
Identifiants
pubmed: 39349101
pii: S2210-7401(24)00194-3
doi: 10.1016/j.clinre.2024.102473
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
102473Informations de copyright
Copyright © 2024. Published by Elsevier Masson SAS.
Déclaration de conflit d'intérêts
Declaration of competing interest R Altwegg, Maria Alonso-Gomez, declares no conflict of interest related to this work. S Nancey declares counseling, boards, transports or fees from Abbvie, Biogen, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Takeda, Tillots, BMS, Amgen, and Fresenius. E Cotte declares fees from Abbvie, Takeda G Boschetti declares fees from Abbvie, Takeda, Janssen Anne Laure Charlois: None Claire Gay: Takeda, Abbvie, Janssen. Pauline Danion: none Emilie Malezieux: Nonea