Insights into treatment of complex Crohn's perianal fistulas
Status PubMed-not-MEDLINE Jazyk angličtina Země Velká Británie, Anglie Médium electronic
Typ dokumentu časopisecké články
PubMed
38658942
PubMed Central
PMC11044286
DOI
10.1186/s12919-024-00291-4
PII: 10.1186/s12919-024-00291-4
Knihovny.cz E-zdroje
- Klíčová slova
- Crohn's Disease, Darvadstrocel Therapy, Long-term Safety Evaluation, Multidisciplinary Management, Perianal Fistulas, Surgical Procedures, Treatment Challenges,
- Publikační typ
- časopisecké články MeSH
Complex perianal fistula is a common complication of Crohn's disease (CD) which leads to negative impact on patient's quality of life. Successful management of the disease requires a multidisciplinary approach, including a gastroenterologist and a colorectal surgeon, applying combined surgical and medical therapy. One of frequently practiced surgical procedures is seton placement in the fistula tract, which is used to control perianal sepsis and drain the fistula, while preventing recurrent abscess formation.Darvadstrocel, a suspension of expanded, allogeneic, adipose-derived, mesenchymal stem cells, is safe and effective for treatment-refractory complex perianal fistulas in patients with Crohn's disease. Following approval of darvadstrocel, the INSPIRE registry is being conducted in order to evaluate long-term safety and effectiveness of the drug on a large, heterogenous population.An online expert meeting was held from March 20 to March 30, 2023, which provided relevant insights into the decision-making process regarding seton use and obtained feedback on the first experiences with darvadstrocel. The aim of this article is to present the perspectives from gastroenterologists and colorectal surgeons practicing in Czechia, Hungary, Israel, Lithuania, Serbia, and Slovenia in topics such as diagnosis and treatment options for patients with complex Crohn's perianal fistulas (CPF), specifically focusing on the use of setons and darvadstrocel.During this virtual session, unavailability of comprehensive data on safety and efficacy of available treatment procedures was emphasized as an important obstacle towards development of standardized recommendations and improvement of outcomes in treatment of (CPF). Furthermore, achieving consensus in seton use, duration of its placement, and frequency of change is recognized as one of CPF treatments major challenges. Despite these issues, it is important to promote better understanding and treatment of complex perianal fistulas in order to improve the quality of life of those affected by this condition.
Beilinson Hospital Rabin Medical Center Ze'ev Jabotinsky Street 39 Petah Tikva Israel
Clinical Hospital Centre Zvezdara Preševska 31 Belgrade Serbia
Lithuanian University of Health Sciences Kaunas Clinics Eivenių G 2 Kaunas Lithuania
Military University Hospital U Vojenské Nemocnice 1200 Prague Czechia
Semmelweis University Üllői Út 26 Budapest Hungary
Takeda Pharmaceuticals d o o Bleiweisova Cesta 30 Ljubljana Slovenia
Tel Aviv University Ramat Aviv Tel Aviv Israel
University Clinical Centre of Serbia Pasterova 2 Belgrade Serbia
University Medical Centre Ljubljana Zaloška Cesta 2 Ljubljana Slovenia
Zobrazit více v PubMed
Lee JL, et al. Treatment Strategy for Perianal Fistulas in Crohn Disease Patients: The Surgeon's Point of View. Annals of coloproctology. 2021;37(1):5–15. doi: 10.3393/ac.2021.02.08. PubMed DOI PMC
Wasmann KA, et al. Treatment of Perianal Fistulas in Crohn's Disease, Seton Versus Anti-TNF Versus Surgical Closure Following Anti-TNF [PISA]: A Randomised Controlled Trial. J Crohns Colitis. 2020;14(8):1049–1056. doi: 10.1093/ecco-jcc/jjaa004. PubMed DOI PMC
European Medicine Agency. Press release: New medicine to treat perianal fistulas in patients with Crohn’s disease. 2017. https://www.ema.europa.eu/en/news/new-medicine-treat-perianal-fistulas-patients-crohns-disease.
Adegbola SO, et al. Medical and surgical management of perianal Crohn's disease. Ann Gastroenterol. 2018;31(2):129–139. doi: 10.20524/aog.2018.0236. PubMed DOI PMC
Gold SL, et al. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018;14(9):521–528. PubMed PMC
Bubbers EJ, Cologne KG. Management of Complex Anal Fistulas. Clin Colon Rectal Surg. 2016;29(1):43–49. doi: 10.1055/s-0035-1570392. PubMed DOI PMC
Alofisel Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/alofisel-epar-product-information_en.pdf. Last accessed June 2023.
Garcia-Olmo D, et al. Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial. Dis Colon Rectum. 2022;65(5):713–720. doi: 10.1097/DCR.0000000000002325. PubMed DOI PMC
Zmora O, et al. P603 INSPIRE: 6-month interim analysis from an observational post-marketing registry on the effectiveness and safety of darvadstrocel in patients with Crohn’s disease and complex perianal fistulas. J Crohns Colitis. 2022;16:i536–i537. doi: 10.1093/ecco-jcc/jjab232.729. DOI
Takeda Pharmaceutical Company Ltd. Alofisel▼ (darvadstrocel) Shows Clinical Remission Rate at Six-Months in the Real-World INSPIRE Study Interim Analysis Consistent with the Pivotal Clinical ADMIRE-CD Study. Available at: https://www.takeda.com/newsroom/newsreleases/2022/alofisel-darvadstrocel-shows-clinical-remission-rate--at-six-months-in-the-real-world-inspire-study-interim-analysis-consistent-with-the-pivotal-clinical-admire-cd-study/ . Last accessed June 2023.
Gionchetti P, et al. ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 2: Surgical Management and Special Situations. J Crohns Colitis. 2017;11(2):135–149. 10.1093/ecco-jcc/jjw169. PubMed
Present DH, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999;340(18):1398–1405. doi: 10.1056/NEJM199905063401804. PubMed DOI
Sostegni R, et al. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003;17(Suppl 2):11–17. doi: 10.1046/j.1365-2036.17.s2.17.x. PubMed DOI
Panés J, et al. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016;388(10051):1281–1290. doi: 10.1016/S0140-6736(16)31203-X. PubMed DOI
Ruiz-Fernández MD, et al. Quality of Life in Nursing Professionals: Burnout, Fatigue, and Compassion Satisfaction. Int J Environ Res Public Health. 2020;17(4):1253. doi: 10.3390/ijerph17041253. PubMed DOI PMC
Geldof J, et al. Classifying perianal fistulising Crohn's disease: an expert consensus to guide decision-making in daily practice and clinical trials. Lancet Gastroenterol Hepatol. 2022;7(6):576–584. doi: 10.1016/S2468-1253(22)00007-3. PubMed DOI
Guadalajara H, et al. Mesenchymal stem cells in perianal Crohn's disease. Tech Coloproctol. 2020;24(8):883–889. doi: 10.1007/s10151-020-02250-5. PubMed DOI