Effectiveness and safety of darvadstrocel in patients with complex perianal fistulizing Crohn's disease: a systematic review.

Autor:	Fousekis FS; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Ioannina, Greece (Fotios S. Fousekis, Konstantinos Mpakogiannis, Anastasios Koukoudis, Dimitrios K. Christodoulou, Konstantinos H. Katsanos)., Mpakogiannis K; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Ioannina, Greece (Fotios S. Fousekis, Konstantinos Mpakogiannis, Anastasios Koukoudis, Dimitrios K. Christodoulou, Konstantinos H. Katsanos)., Lianos GD; Department of Surgery, School of Health Sciences, University Hospital of Ioannina and Faculty of Medicine, University of Ioannina, Greece (Georgios D. Lianos)., Koukoudis A; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Ioannina, Greece (Fotios S. Fousekis, Konstantinos Mpakogiannis, Anastasios Koukoudis, Dimitrios K. Christodoulou, Konstantinos H. Katsanos)., Christodoulou DK; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Ioannina, Greece (Fotios S. Fousekis, Konstantinos Mpakogiannis, Anastasios Koukoudis, Dimitrios K. Christodoulou, Konstantinos H. Katsanos)., Papaconstantinou I; Second Department of Surgery, Aretaieion University Hospital, Medical School, National and Kapodistrian University of Athens, Greece (Ioannis Papaconstantinou)., Katsanos KH; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Ioannina, Greece (Fotios S. Fousekis, Konstantinos Mpakogiannis, Anastasios Koukoudis, Dimitrios K. Christodoulou, Konstantinos H. Katsanos).
Jazyk:	angličtina
Zdroj:	Annals of gastroenterology [Ann Gastroenterol] 2024 Jan-Feb; Vol. 37 (1), pp. 46-53. Date of Electronic Publication: 2023 Dec 23.
DOI:	10.20524/aog.2023.0850
Abstrakt:	Background: Managing complex perianal fistulizing Crohn's disease (CD) remains challenging, despite current medical and surgical treatment approaches. Darvadstrocel, a therapy utilizing adipose-derived stem cells, shows promise in promoting tissue regeneration and healing, offering a novel and effective treatment for fistula management. Method: A systematic literature search was conducted on PubMed and Scopus to identify studies involving patients with complex perianal fistulizing CD treated with darvadstrocel. Results: In total, 2 randomized controlled trials (RCT), 5 observational studies with retrospective data collection and 2 observational studies with prospective design were included in the final review. Data from the European ADMIRE-CD RCT demonstrated that darvadstrocel is superior to placebo in terms of clinical and imaging improvement over both the short and long term. These findings align with the prospective studies analyzed in this systematic review. The rate of treatment-emergent adverse events in the ADMIRE-CD trial's RCTs was similar in both the darvadstrocel and control groups, with perianal abscess being the most common adverse event up to 52 weeks after drug administration. Retrospective studies indicated no side-effects beyond 52 weeks. Conclusions: Darvadstrocel appears to be a new, potentially effective and safe treatment option for the management of complex perianal fistulas. However, more randomized clinical trials are needed to evaluate the efficacy and safety profile of the drug. Competing Interests: Conflict of Interest: None (Copyright: © Hellenic Society of Gastroenterology.)
Databáze:	MEDLINE
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