Background: Crohn's Disease (CD) is a chronic inflammatory disease characterized by a relapsing and remitting transmural inflammation of the gastrointestinal tract. Surgical resection of the involved bowel is not curative and postoperative recurrence (POR) is common. Therefore, prevention of recurrence is an important part of post-surgical management of patients with this disease. Although Vedolizumab (VDZ) and Ustekinumab (UST) were approved for CD a few years ago, efficacy data in the postoperative setting are scarce. Aim of the study: The aim of the study was to evaluate the efficacy and safety of VDZ and UST in preventing POR in patients with CD by collecting the endoscopic, clinical, biochemical data at 1, 2, and 3 years after surgery. The secondary purpose of the study was to compare the data obtained for these patients with those of patients who received anti-TNFα. Materials and Methods: The single-center retrospective study evaluated patients undergoing surgery for CD followed by the Gastroenterology Unit of the University of Padua Hospital. Data about endoscopic, biochemical, clinical, and surgical recurrence were collected. Results: For the prevention of POR, among a total of 94 patients, 18 (19,1%) were treated with UST, 13 (13,8%) with VDZ and 40 (42,6%) with anti-TNF. In UST treated group, median age at diagnosis was 22 (10,5-62,8) years and 10/18 (55,6%) patients were male. In group receiving VDZ, median age at diagnosis was 21 (16,5-35,0) years and 12/13 (92,3%) patients were male. At diagnosis, median age of patients treated with anti-TNF was 25 (19,0-35,0) years and 30/40 (75,0%) patients were male. UST and VDZ treated patients at the time of surgery had significantly higher anti-TNF prior exposure compared with anti-TNF treated patients (p=0,001 and p=0,028, respectively). No significant difference was observed in the three groups both in terms of overall rate of endoscopic POR at 12-36 months and in terms of change in endoscopic findings compared with baseline (6-12 months). Regarding biochemical recurrence, fecal calprotectin (FC) was significantly higher at 6-12 months after surgery in the VDZ group than in the UST (p=0,012) and anti-TNF (p<0,001) groups, while no difference was found between UST and anti-TNF groups (p=0,56). Considering C-reactive protein (CRP), this was significantly higher at 6-12 months in the VDZ group than in the anti-TNF group (p=0,025), but no significance was obtained between UST and VDZ (p=0,386). The results also showed no significant difference for biochemical POR at 12-24 and 24-36 months in the three groups. The rate of clinical POR was significantly higher in the anti-TNF group than VDZ at 6-12 months (p=0,017), although no differences were found for surgical POR in the three groups. Treatment persistence was significantly higher for UST than VDZ (p=0,042) and, although not significantly, also higher for UST than anti-TNF (p=0,405). Finally, there were no drug treatment discontinuations due to adverse events or deaths during follow-up in the UST and VDZ groups. In the anti-TNF group, adverse events and/or intolerance were recorded in 9/40 patients (22,5%), following which treatment was discontinued in all cases. Conclusions: Our data suggest that VDZ and UST are effective drugs for the prevention of POR in CD patients undergoing surgery for severe disease activity; the results obtained from this study need further investigation in order to evaluate the true efficacy and safety of both drugs, in the second or third line, in the post-operative setting. The numerous confounding factors underscore the need for an individualized approach after surgical resection, also based on the different conditions and variables of each patient.
Background: La Malattia di Crohn è una malattia infiammatoria cronica caratterizzata da un'infiammazione transmurale recidivante-remittente del tratto gastrointestinale. La resezione chirurgica dell'intestino coinvolto non è curativa e la recidiva post-operatoria (POR) è comune. La prevenzione delle recidive è pertanto una parte importante della gestione post-chirurgica dei pazienti affetti da tale patologia. Sebbene i farmaci biologici Vedolizumab (VDZ) e Ustekinumab (UST) siano stati autorizzati per la MC alcuni anni fa, dati di efficacia nel setting post-operatorio sono scarsi. Scopo dello studio: Lo scopo dello studio è stato quello di valutare l’efficacia e la sicurezza di VDZ e UST nel prevenire la POR in pazienti con MC, analizzando i dati endoscopici, clinici, bioumorali a distanza di 1, 2 e 3 anni dall’intervento. Scopo secondario dello studio è stato quello di confrontare i dati ottenuti con quelli dei pazienti che hanno ricevuto un farmaco anti-TNFα. Materiali e metodi: Lo studio retrospettivo monocentrico ha valutato pazienti sottoposti ad intervento per MC che hanno intrapreso un percorso di follow-up presso l’U.O.C. di Gastroenterologia di Padova. Di questi pazienti sono stati valutati la recidiva endoscopica, biochimica, clinica e chirurgica. Risultati: Tra i 94 pazienti totali, 18 (19,1%) sono stati trattati con UST, 13 (13,8%) con VDZ e 40 (42,6%) con anti-TNF. Nel gruppo in trattamento con UST l’età mediana alla diagnosi era di 22 (10,5-62,8) anni e 10/18 (55,6%) pazienti erano di sesso maschile. Nel gruppo ricevente VDZ, l’età mediana alla diagnosi era di 21 (16,5-35,0) anni e 12/13 (92,3%) pazienti erano di sesso maschile. Alla diagnosi, l’età mediana dei pazienti trattati con anti-TNF era di 25 (19,0-35,0) anni e 30/40 (75,0%) pazienti erano di sesso maschile. I pazienti trattati con UST e VDZ al momento dell’intervento avevano avuto una pregressa esposizione agli anti-TNF significativamente maggiore rispetto al gruppo dei pazienti trattati con anti-TNF (p=0,001, p=0,028, rispettivamente). Non è stata osservata alcuna differenza significativa nei tre gruppi sia in termini di tasso complessivo di POR endoscopica a 12-36 mesi, sia in termini di variazione del quadro endoscopico rispetto al baseline (6-12 mesi). Per quanto riguarda la recidiva biochimica, la calprotectina fecale (CF) è risultata significativamente più elevata a 6-12 mesi dall’intervento nel gruppo VDZ rispetto ai gruppi UST (p=0,012) e anti-TNF (p<0,001), mentre nessuna differenza è stata riscontrata tra il gruppo UST e quello anti-TNF (p=0,56). La PCR era significativamente più elevata a 6-12 mesi nel gruppo VDZ rispetto al gruppo anti-TNF (p=0,025), ma nessuna significatività è stata ottenuta tra UST e VDZ (p=0,386). I risultati non hanno inoltre evidenziato nessuna differenza significativa per le POR biochimiche a 12-24 e 24-36 mesi nei tre gruppi. Il tasso di POR clinica è risultato significativamente più elevato nel gruppo anti-TNF rispetto a VDZ a 6-12 mesi (p=0,017), anche se non sono state riscontrate differenze per la POR chirurgica nei tre gruppi. La persistenza al trattamento è risultata significativamente maggiore per UST rispetto a VDZ (p=0,042) e, seppur in maniera non significativa, maggiore anche per UST rispetto agli anti-TNF (p=0,405). Infine, non sono state registrate interruzioni del trattamento farmacologico a causa di eventi avversi né decessi durante il follow-up nei gruppi UST e VDZ. Nel gruppo anti-TNF sono stati registrati eventi avversi e/o intolleranza in 9/40 pazienti (22,5%), in seguito ai quali il trattamento è stato interrotto. Conclusioni: I nostri dati suggeriscono che VDZ e UST sono farmaci efficaci per la prevenzione della POR in pazienti con MC operata; i risultati ottenuti da questo studio necessitano di ulteriori indagini al fine di valutare la reale efficacia e sicurezza di entrambi i farmaci nel contesto post-operatorio.
Efficacia e sicurezza di Vedolizumab versus Ustekinumab nel prevenire la recidiva post-operatoria nella malattia di Crohn
FERRARO, LAURA
2022/2023
Abstract
Background: Crohn's Disease (CD) is a chronic inflammatory disease characterized by a relapsing and remitting transmural inflammation of the gastrointestinal tract. Surgical resection of the involved bowel is not curative and postoperative recurrence (POR) is common. Therefore, prevention of recurrence is an important part of post-surgical management of patients with this disease. Although Vedolizumab (VDZ) and Ustekinumab (UST) were approved for CD a few years ago, efficacy data in the postoperative setting are scarce. Aim of the study: The aim of the study was to evaluate the efficacy and safety of VDZ and UST in preventing POR in patients with CD by collecting the endoscopic, clinical, biochemical data at 1, 2, and 3 years after surgery. The secondary purpose of the study was to compare the data obtained for these patients with those of patients who received anti-TNFα. Materials and Methods: The single-center retrospective study evaluated patients undergoing surgery for CD followed by the Gastroenterology Unit of the University of Padua Hospital. Data about endoscopic, biochemical, clinical, and surgical recurrence were collected. Results: For the prevention of POR, among a total of 94 patients, 18 (19,1%) were treated with UST, 13 (13,8%) with VDZ and 40 (42,6%) with anti-TNF. In UST treated group, median age at diagnosis was 22 (10,5-62,8) years and 10/18 (55,6%) patients were male. In group receiving VDZ, median age at diagnosis was 21 (16,5-35,0) years and 12/13 (92,3%) patients were male. At diagnosis, median age of patients treated with anti-TNF was 25 (19,0-35,0) years and 30/40 (75,0%) patients were male. UST and VDZ treated patients at the time of surgery had significantly higher anti-TNF prior exposure compared with anti-TNF treated patients (p=0,001 and p=0,028, respectively). No significant difference was observed in the three groups both in terms of overall rate of endoscopic POR at 12-36 months and in terms of change in endoscopic findings compared with baseline (6-12 months). Regarding biochemical recurrence, fecal calprotectin (FC) was significantly higher at 6-12 months after surgery in the VDZ group than in the UST (p=0,012) and anti-TNF (p<0,001) groups, while no difference was found between UST and anti-TNF groups (p=0,56). Considering C-reactive protein (CRP), this was significantly higher at 6-12 months in the VDZ group than in the anti-TNF group (p=0,025), but no significance was obtained between UST and VDZ (p=0,386). The results also showed no significant difference for biochemical POR at 12-24 and 24-36 months in the three groups. The rate of clinical POR was significantly higher in the anti-TNF group than VDZ at 6-12 months (p=0,017), although no differences were found for surgical POR in the three groups. Treatment persistence was significantly higher for UST than VDZ (p=0,042) and, although not significantly, also higher for UST than anti-TNF (p=0,405). Finally, there were no drug treatment discontinuations due to adverse events or deaths during follow-up in the UST and VDZ groups. In the anti-TNF group, adverse events and/or intolerance were recorded in 9/40 patients (22,5%), following which treatment was discontinued in all cases. Conclusions: Our data suggest that VDZ and UST are effective drugs for the prevention of POR in CD patients undergoing surgery for severe disease activity; the results obtained from this study need further investigation in order to evaluate the true efficacy and safety of both drugs, in the second or third line, in the post-operative setting. The numerous confounding factors underscore the need for an individualized approach after surgical resection, also based on the different conditions and variables of each patient.File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/47054