The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety ...of these drugs in this context.
Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians’ assessment.
Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab.
Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.
Background and Aims: The perianal fistula is a pathological tract between two epithelial surfaces of the anorectal canal and perianal skin. The most common treatment method is fistulotomy which leads ...to complications, such as incontinency. The present is study aimeds to compare the results of fistulotomy surgery and sclerotherapy in the management of managing the perianal fistula. Materials and Methods: This Randomized controlled clinical study was performed on 24 patients with anorectal fistula. The procedure performed for group 1 was surgical fistulotomy, and group 2 underwent sclerosant agent injection. Recovery time, recurrence rate, post-operative pain, and degree of incontinency were evaluated. The statistical analysis was performed in SPSS software (Version 18), and a p-value less than 0.05 was considered statistically significant. Results: There were 5 (41.7%) men and 7 (58.3%) women in the sclerosing group, as well as 7 (58.3%) men and 5 (41.7%) women in the fistulotomy group. There was no significant relationship between the two groups (P=0.68). The recurrence rate was 3 cases (42.9%) in sclerosing group and 4 cases (57.1%) in the fistulotomy group, which was not statistically significant (P=0.65). The fecal continency score after sclerotherapy was greater than that in the fistulotomy group (P<0.05), and the length of hospitalization, post-surgery discomfort, and the time it took for the fistula to heal were all considerably shorter in the sclerosing group. Conclusion: We concluded that injectable sclerotherapy is effective, safe, simple, acceptable and affordable in the treatment of perianal fistula.
Higher anti-tumor necrosis factor-α (TNF) drug levels are associated with improved clinical healing of Crohn's perianal fistulas. It is unclear whether this leads to improved healing on radiologic ...assessment. We aimed to evaluate the association between anti-TNF drug levels and radiologic outcomes in perianal fistulising Crohn's disease.
A cross-sectional retrospective multicenter study was undertaken. Patients with perianal fistulising Crohn's disease on maintenance infliximab or adalimumab, with drug levels within 6 months of perianal magnetic resonance imaging were included. Patients receiving dose changes or fistula surgery between drug level and imaging were excluded. Radiologic disease activity was scored using the Van Assche Index, with an inflammatory subscore calculated using indices: T2-weighted imaging hyperintensity, collections >3 mm diameter, rectal wall involvement. Primary endpoint was radiologic healing (inflammatory subscore ≤6). Secondary endpoint was radiologic remission (inflammatory subscore = 0).
Of 193 patients (infliximab, n = 117; adalimumab, n = 76), patients with radiologic healing had higher median drug levels compared with those with active disease (infliximab 6.0 vs 3.9 μg/mL; adalimumab 9.1 vs 6.2 μg/mL; both P < .05). Patients with radiologic remission also had higher median drug levels compared with those with active disease (infliximab 7.4 vs 3.9 μg/mL; P < .05; adalimumab 9.8 vs 6.2 μg/mL; P = .07). There was a significant incremental reduction in median inflammatory subscores with higher anti-TNF drug level tertiles.
Higher anti-TNF drug levels were associated with improved radiologic outcomes on magnetic resonance imaging in perianal fistulising Crohn's disease, with an incremental improvement at higher drug level tertiles for both infliximab and adalimumab.
BACKGROUND:There has been a surge in clinical trials studying the safety and efficacy of mesenchymal stem cells for the treatment of perianal Crohn’s disease.
OBJECTIVE:The purpose of this work was ...to systematically review the literature to determine safety and efficacy of mesenchymal stem cells for the treatment of refractory perianal Crohn’s disease.
DATA SOURCES:Sources included PubMed, Cochrane Library Central Register of Controlled Trials, and Embase.
STUDY SELECTION:Studies that reported safety and/or efficacy of mesenchymal stem cells for the treatment of perianal Crohn’s disease were included. Two independent assessors reviewed eligible articles.
INTERVENTION:The study intervention was delivery of mesenchymal stem cells to treat perianal Crohn’s disease.
MAIN OUTCOMES MEASURES:Safety and efficacy of mesenchymal stem cells used to treat perianal Crohn’s disease were measured.
RESULTS:Eleven studies met the inclusion criteria and were included in the systematic review. Three trials with a comparison arm were included in the meta-analysis. There were no significant increases in adverse events (OR = 1.07 (95% CI, 0.61–1.89); p = 0.81) or serious adverse events (OR = 0.53 (95% CI, 0.28–0.98); p = 0.04) in patients treated with mesenchymal stem cells. Mesenchymal stem cells were associated with improved healing as compared with control subjects at primary end points of 6 to 24 weeks (OR = 3.06 (95% CI, 1.05–8.90); p = 0.04) and 24 to 52 weeks (OR = 2.37 (95% CI, 0.90–6.25); p = 0.08).
LIMITATIONS:The study was limited by its multiple centers and heterogeneity in the study inclusion criteria, mesenchymal stem cell origin, dose and frequency of delivery, use of scaffolding, and definition and time point of fistula healing.
CONCLUSIONS:Although there have been only 3 trials conducted with control arms, existing data demonstrate improved efficacy and no increase in adverse or serious adverse events with mesenchymal stem cells as compared with control subjects for the treatment of perianal Crohn’s disease.
OBJECTIVEPerianal disease is a debilitating condition that frequently occurs in Crohn’s disease (CD) patients. It is currently unknown whether its incidence has changed in the era of frequent ...immunomodulator use and biological availability. We studied the incidence and outcome of perianal and rectovaginal fistulas over the past two decades in our population-based Inflammatory Bowel Disease South-Limburg cohort.
PATIENTS AND METHODSAll 1162 CD patients registered in the Inflammatory Bowel Disease South-Limburg registry were included. The cumulative probabilities of developing a perianal and rectovaginal fistula were compared between three eras distinguished by the year of CD diagnosis1991–1998, 1999–2005 and 2006–2011. Second, clinical risk factors and the risk of fistula recurrence were determined.
RESULTSThe cumulative 5-year perianal fistula rate was 14.1% in the 1991–1998 era, 10.4% in the 1999–2005 era and 10.3% in the 2006–2011 era, P=0.70. Colonic disease was associated with an increased risk of developing perianal disease, whereas older age was associated with a decreased risk (both P<0.01). Over time, more patients were exposed to immunomodulators or biologicals before fistula diagnosis (18.5 vs. 32.1 vs. 52.1%, respectively, P=0.02) and started biological therapy thereafter (18.6 vs. 34.1 vs. 54.0%, respectively, P<0.01). The cumulative 5-year perianal fistula recurrence rate was not significantly different between eras (19.5 vs. 25.5 vs. 33.1%, P=0.28). In contrast, the cumulative 5-year rectovaginal rate attenuated from 5.7% (the 1991–2005 era) to 1.7% (the 2006–2011 era), P=0.01.
CONCLUSIONOver the past two decades, the risk of developing a perianal fistula was stable, as well as its recurrence rate, underlining the lasting need for improving treatment strategies for this invalidating condition.
OBJECTIVES:
To determine outcome of fistula in ano after incision drainage of acute peri anal abscess.
METHODOLOGY:
This descriptive case series study was conducted after approval of the Ethical ...committee. A total of 154 patients were observed for a six-month duration. Pre-design proforma was used to collect data. An inclusive criterion was age between 18-50 years of both genders with acute perianal abscess with low-level fistula (submucosal and mucocutaneous) and high-level fistula (ischiorectal and pelvirectal). Exclusive criterion was observed in all admitted patients who include secondary abscess formation for example diabetes mellitus, tuberculosis, and carcinoma with any previous history of fistula in ano. The result was analyzed through the SPSS-24 version.
RESULTS:
Ratio 35 (22.72%) was obtained for age group 18-30, 49 (31.81%) for age group 31-40 and 70 (45.44%) were in age group 41-50. The mean age was 38.25 years with SD ±9.70. The ratio of Males 143 (92.85%) leads high to females 11 (7.15%). The fistula was found in 64 (41.55%) patients postoperative after incision drainage for perianal abscess. Among 64 patients, 54 (37.01%) were male and 7 (4.54%) females. 90 (58.44%) patients had no fistula postoperatively. Low-level 45 (29.22%) and 19 (12.33%) high-level fistula was found in patients. Among the low-level ratio, 40 were male and 5 were female. Similarly, in high-level fistula 17 were male and 2 were female.
CONCLUSION:
Fistula is more common in males than females. Low lying fistula leads the chart more than a high lying fistula. The incidence of anal fistula in our observed patient’s abscess was 41.55%.
Mesenchymal stem cells have been used for the treatment of perianal Crohn's fistulizing disease by direction injection. However, no studies to date have included patients with proctitis, anal canal ...involvement, and multiple branching tracts.
To determine safety and efficacy of mesenchymal stem cells for refractory perianal Crohn's disease.
Phase IB/IIA randomized control trial.
Tertiary inflammatory bowel disease referral center.
Adult Crohn's patients with perianal fistulizing disease.
75 million mesenchymal stem cells were administered with a 22G needle by direct injection after curettage and primary closure of the fistula tract. A repeat injection of 75 million mesenchymal stem cells at 3 months was given if complete clinical and radiographic healing were not achieved.
Adverse and serious adverse events at post procedure day 1, week 2, week 6, month 3, month 6 and month 12. Clinical healing, radiographic healing per magnetic resonance imaging, and patient reported outcomes at the same time points.
A total of 23 patients were enrolled and treated; 18 were treatment and 5 were control. There were no adverse or serious adverse events reported related to mesenchymal stem cells therapy. At six months, 83% of the treatment group and 40% of the control had complete clinical and radiographic healing. The perianal Crohn's disease activity index, Wexner incontinence score, and VanAssche score had all significantly decreased in treatment patients at six months; none significantly decreased in the control group.
Single institution and single blinded.
Bone marrow derived mesenchymal stem cells offer a safe and effective alternative treatment approach for severe perianal fistulizing Crohn's disease. See Video Abstract at http://links.lww.com/DCR/C128.
Perianal fistula is a common disease affecting the general population but development of mucinous adenocarcinoma (MA) in a chronic perianal fistula is a rare entity. Due to the rare nature of the ...disease, there are no established guidelines regarding the diagnosis and management of the condition. The aim of this article is to report a case of MA perianal region that we managed surgically with an extra levator abdominoperineal resection and flap reconstruction.
Abstract
Background and Aims
Most patients with perianal Crohn’s fistula receive medical treatment with anti-tumour necrosis factor TNF, but the results of anti-TNF treatment have not been directly ...compared with chronic seton drainage or surgical closure. The aim of this study was to assess if chronic seton drainage for patients with perianal Crohn’s disease fistulas would result in less re-interventions, compared with anti-TNF and compared with surgical closure.
Methods
This randomised trial was performed in 19 European centres. Patients with high perianal Crohn’s fistulas with a single internal opening were randomly assigned to: i chronic seton drainage for 1 year; ii anti-TNF therapy for 1 year; and iii surgical closure after 2 months under a short course anti-TNF. The primary outcome was the cumulative number of patients with fistula-related re-interventions at 1.5 years. Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort.
Results
Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate 10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, p = 0.02. No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry, inferiority of chronic seton treatment was not observed for any outcome measure.
Conclusions
The results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn’s fistulas.
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