BACKGROUND: Perianal fistulas of Crohn's disease (CD) create a significant burden on patients' lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. AIMS: To examine the usability of darvadstrocel therapy in managing perianal CD. METHODS: We enrolled patients with CD and perianal fistulas in this retrospective multicenter study. The primary outcome was perianal clinical remission (defined as all treated fistulas closed) at weeks 26 and 52. Secondary outcomes were clinical response rates (≥ 1 fistulas closed), perianal activity (PDAI), patient satisfaction, and adverse events. Data were recorded at baseline and weeks 12, 26 and 52. Prediction of primary outcomes was performed by logistic regression. RESULTS: Overall, among 223 patients (male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until weeks 26 and 52. Baseline PDAI score (OR 0.75), number of fistulas (OR 0.28) and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at weeks 26 and 52. Improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of patients, respectively. Adverse events occurred in 13.5% of patients; perianal abscesses and proctalgia were the most frequently reported. CONCLUSION: Effectiveness data were higher than in clinical trials. The safety profile was reassuring, and patients' satisfaction was high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success.
- Klíčová slova
- Crohn's disease, darvadstrocel, mesenchymal stem cell treatment, perianal disease,
- MeSH
- Crohnova nemoc * terapie komplikace MeSH
- dospělí MeSH
- indukce remise MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- rektální píštěl * terapie etiologie MeSH
- retrospektivní studie MeSH
- spokojenost pacientů MeSH
- transplantace mezenchymálních kmenových buněk * metody škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
Fossil bioinclusions in amber are invaluable source of information on the past evolution and diversity of various organisms, as well as on the paleoecosystems in general. The click-beetles, Elateridae, which originated and greatly diversified during the Mesozoic, are mostly known from the adpression-like fossils, and their diversity in the Cretaceous ambers is only poorly documented. In this study, we describe a new click-beetle based on an incomplete inclusion in ajkaite, an Upper Cretaceous (Santonian) amber from the Ajka Coal Formation from Hungary. We used X-ray micro-computed tomography scanning to reconstruct its morphology because it is deposited in an opaque piece of amber. Our results suggest that the newly described Ajkaelater merkli gen. et sp. nov. belongs to subfamily Elaterinae. It represents the first Mesozoic beetle reported from Hungary, and the first Mesozoic Elateridae formally described from mainland Europe. Our discovery supports an Eurasian distribution and diversification of Elaterinae already in the Cretaceous. The paleoenvironment of the Ajka Coal Formation agrees well with the presumed habitat preference of the new fossil taxon. The discovery of a presumably saproxylic click-beetle shed further light on the yet poorly known paleoecosystem of the Santonian present-day western Hungary.
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH