Risk Of Colectomy Research Articles

Cartographie du risque d’être transfusé en chirurgie au CHU de Lyon : un outil de rationalisation de la prescription des examens immunohématologiques (Hospices civils de Lyon – HCL)

IntroductionImmunohaematology examinations are usually prescribed preoperatively according to more or less standardized protocols. We wanted to assess the relevance of these protocols on the basis of factual data: an overview of the rate of transfusions carried out as part of surgery within the HCL in 2009. Study designThe list of patients operated in 2009 in the HCL (IPOP by Cristalnet) has been combined with the list of patients transfused in the same time period (CTS server, Inlog). The percentage of patients transfused during the stay, and the percentage of patients transfused on the day of the intervention itself were determined for each type of surgery. The study focused on 13 571 patients affected by 44 surgeries. Patients and methodsSix hundred and thirty-three patients were transfused, 45% of them the day of the intervention. The risk of needing to carry out a transfusion depends on the risk to the patient and surgery. For example, the total hip arthroplasty transfusion risk is 11.9% when it's programmed against 37.8% in emergency surgery. The transfusion risk of knee arthroscopies, osteosynthesis of wrist fracture, carpal canal surgeries and of appendectomies, thyroidectomies, herna repair surgeries are below 0.5%. The transfusion risk of colectomy is 18.1%. Thus, new recommendations for good clinical practices on the relevance of settled surgery-preoperative immunohematologic exams can be established. ConclusionThe emergency degree of the transfusion must be taken into account for such recommendation. Each hospital should perform its own cartography to justify its own protocols.

Cyclosporine or infliximab as rescue therapy in severe refractory ulcerative colitis: Early and long-term data from a retrospective observational study

IntroductionAbout 30-40% of patients with acute severe ulcerative colitis (UC) fail to respond to intensive intravenous (iv) corticosteroid treatment. Iv cyclosporine and infliximab are an effective rescue therapy in steroid-refractory UC patients but up to now it is still unclear which is the best therapeutic choice. MethodsWe reviewed our series of severe steroid-refractory colitis admitted consecutively since 1994 comparing two historical cohort treated with iv cyclosporine (2mg/kg) or iv infliximab (5mg/kg). The main outcome was the colectomy rate at 3 months, 12 months and at the end of the follow-up. ResultsA total of 65 patients were included: 35 in the cyclosporine group and 30 in the infliximab one. At 3 months the colectomy rate was 28.5% in the cyclosporine group and 17% in the infliximab group (p=0.25), while 48% versus 17% at 12 months (p=0.007, OR 4.7; 95% CI: 1.47-15.16). The 1-2-3 year cumulative colectomy rates were 48%, 54%, 57% in the cyclosporine group, and 17%, 23%, 27% in the infliximab group. At the end of the follow-up the colectomy rate was 60% versus 30% (p=0.04, HR 2.2; 95% CI: 1.11-4.86). High level of C reactive protein (p=0.04), extensive disease (p=0.01) and no azathioprine treatment (p<0.001) were related to the risk of colectomy. ConclusionThis study, despite being retrospective, indicates that both cyclosporine and infliximab are effective in avoiding a colectomy in steroid-refractory UC patients. During the follow-up the risk of a colectomy is higher in patients treated with cyclosporine than with infliximab.

Progressive Primary Sclerosing Cholangitis Requiring Liver Transplantation Is Associated With Reduced Need for Colectomy in Patients With Ulcerative Colitis

We investigated the association between the severity of primary sclerosing cholangitis (PSC) and clinical outcomes of patients with ulcerative colitis (UC) on the basis of need for colectomy. We analyzed data from 167 patients with PSC and UC who were followed from 1985 to 2011. Patients with PSC and UC were divided into groups that received orthotopic liver transplantation (OLT) (n = 86) or did not (non-OLT, n = 81). Clinical and demographic variables were obtained, and patients were followed until they received OLT or the date of their last clinical visit. The OLT group had significantly more subjects with less severe symptoms of UC (59, 68.6%) than the non-OLT group (12, 14.8%; P < .001). The subjects in the OLT group had a median of 0 UC flares compared with 3 in the non-OLT group (P < .001); fewer subjects in the OLT group required use of azathioprine or mercaptopurine (1, 1.2%), compared with the non-OLT group (14, 17.3%; P = .006). More subjects in the non-OLT group required colectomies (61, 75.3%) than in the OLT group (23, 26.7%; P < .001). On the basis of Cox regression analysis, OLT for PSC independently reduces the need for colectomy (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.25-0.75; P = .003), as does a high Mayo risk score at diagnosis (HR, 0.52; 95% CI, 0.37-0.72; P < .001). Development of colon neoplasia increased the risk for colectomy (HR, 2.47; 95% CI, 1.63-3.75; P < .001). Severe progressive PSC that requires liver transplantation appears to reduce the disease activity of UC and the need for colectomy.

Severity of primary sclerosing cholangitis and its impact on the clinical outcome of Crohn's disease

Background and aimCrohn’s disease (CD) is associated with primary sclerosing cholangitis (PSC). The aim of the study was to study the association between the severity of PSC and clinical outcome of CD, comparing the course of CD in patients with PSC not needing orthotopic liver transplantation (OLT) and those requiring OLT. MethodsA total of 41 patients with PSC and CD seen at the Cleveland Clinic between 1985 and 2011 were included in this study. Clinical and demographic variables were obtained regarding the outcome of CD in patients with and without OLT. ResultsPatients with PSC–CD were divided into two groups: 20 without OLT (non-OLT) and 21 with OLT. 18 (85.7%) of patients in the OLT group had pancolitis in contrast to 14 (70%) in the non-OLT group. (p=0.22). There were no significant differences regarding duration of CD, but the duration of PSC was longer in the OLT group [16.0±7.8 vs. 10.3±6.4, p=0.01]. The OLT and non-OLT groups did not differ in the number of CD flares [0 (0, 0) vs. 0 (0, 5), p=0.28) and need for surgery for CD [(6 (28.6%) vs. 9 (45%), p=0.27]. Colon carcinoma and dysplasia were similar in the non-OLT and OLT groups [(4 (20%) vs. 3 (13.2%), p=0.52]. On Cox regression analysis, OLT for PSC [Hazards ratio (HR) 1.2 (95% confidence interval (C.I.): 0.38–3.7, p=0.79] did not impact the risk of colectomy. ConclusionsIn contrast to UC, severe PSC requiring OLT does not appear to impact the clinical outcome of CD.

Surgical and nonsurgical hospitalization rates and charges for patients with ulcerative colitis in Italy: A 10-year cohort study

BackgroundToday we are observing an increasing incidence of ulcerative colitis associated with an improved survival of patients. AimTo analyse current rates, outcomes, and costs of inpatient care for ulcerative colitis patients of central Italy. MethodsThe cohort included 644 ulcerative colitis patients, living in the Lazio region, with diagnosis made or confirmed by the staff of a single tertiary referral centre in Rome (1997–2006). Follow-up data on hospitalization rates, costs, and colectomy rates were collected from the Regional Hospital Information System. ResultsOverall hospitalization rates were 3 times higher than those of the region's general population, reflecting excess admissions for digestive or infectious diseases (standardized hospitalizations rates for digestive-tract: 15.9; for infectious diseases: 3.5). The overall cumulative risk for colectomy was 7.5%. On the average, hospitalizations for ulcerative colitis lasted 10 days. The mean reimbursement for a ulcerative colitis-related hospitalization was EUR 5120 (€4609 for nonsurgical admissions, €8655 for surgical hospitalizations). ConclusionUlcerative colitis patients are 3 times more likely to be hospitalized than the general population. Colectomy rates in Italian ulcerative colitis patients resemble those of northern Europe, but most hospital admissions are for diagnostic procedures or medical therapy. Hospitalizations are almost twice as long as those reported in the United States although their mean cost is considerably lower.

The impact of severity of primary sclerosing cholangitis and clinical outcome in patients with Ulcerative Colitis

Ulcerative colitis (UC) associated with primary sclerosing cholangitis (PSC) is associated with pancolitis and clinically mild disease. The aim of the study was to study the association between the severity of PSC and clinical outcome of UC, comparing the course of UC in patients with PSC not needing orthotopic liver transplantation (OLT) and those requiring LT. A total of 167 patients with PSC and UC seen at the Cleveland Clinic between 1985 and 2011 were included in this study. Clinical and demographic variables were obtained regarding the outcome of UC in patients with and without OLT for underlying UC. Patients were followed-up until OLT or the date of the last clinical visit. Logistic regression model was constructed by including variables known at UC or PSC diagnosis for the risk of colectomy. Patients with PSC/UC were divided into two groups: 81 did not need OLT (no-OLT) and 86 were transplanted (OLT). 81 (94.2%) of patients in the OLT group had pancolitis in contrast to 72 (88.9%) in the no-OLT group. (p=0.005) There were no significant differences concerning duration of UC between the two groups, while the duration of PSC was longer in the OLT group [median of 13.5 (interquartile range 10, 20) vs. 11(7.5, 17), p=0.01] than the no-OLT group. The median follow-up was a little higher for the OLT group (13.5 vs. 11 years, p=0.009). The OLT group had significantly more clinically quiescent UC compared with the no-OLT group. (59 (68.6%) vs. 12 (14.8%), p<0.001) The OLT group had fewer UC flare-ups [3 (2, 6) vs. 0 (0, 1), p<0.001) and required less use of azathioprine [(1 (1.2%) vs. 14 (17.3%), p=0.006]. There was an increased need for surgery in the no-OLT group [(61 (75.3%) vs. 23 (26.7%), p<0.001]. Colon carcinoma and dysplasia were also more frequent in the no-OLT group [(33 (40.7%) vs. 22 (25.6%), p=0.04]. On Cox regression analysis, OLT for PSC [Odds ratio (OR) 0.15 (95% confidence interval (C.I): 0.06 - 0.37, p<0.001] and higher Mayo risk score at diagnosis [OR 0.26, 95% CI: (0.13 - 0.52), p<0.001] independently protected against the risk of colectomy. Table 1 shows Cox regression analysis for the risk of colectomy. Cox regression analysis for the risk of colectomy Cox regression analysis for the risk of colectomy Severe PSC requiring OLT is associated with a milder course of UC (reduced disease activity and less use of azathioprine and surgery). Decreased disease activity is also associated with reduced incidence of dysplasia and colon carcinoma. The requirement for OLT and a higher Mayo PSC risk score at diagnosis appears to independently protect against colectomy.

Clostridium difficile infection is associated with worse long term outcome in patients with ulcerative colitis

BackgroundClostridium difficile infection (CDI) is becoming prevalent in general population as well as in patients with inflammatory bowel disease (IBD). AimThe aim of the study was to investigate the long-term impact of CDI in patients with ulcerative colitis (UC). MethodsUC inpatients or outpatients who had positive results for stool C. difficile toxins A and B between 2002 and 2007 were identified (N=45). The 45 patients were matched for age and gender to UC patients who were negative for C. difficile and had never been diagnosed with CDI (N=101). The primary Colectomy within 12months of C. difficile testing was the primary outcome patients with CDI and no-CDI. ResultsForty-five patients were CDI positive and 101 were negative. Patients who were CDI positive had significantly more UC-related emergency room visits in the year following initial infection (37.8% vs. 4%, p<0.001) than those without CDI. One year following the index infection admission, CDI patients also had a significantly higher rate of colectomy than controls (35.6% vs. 9.9%, p<0.001). Among patients with CDI, 55.8% of patients had an escalation in medical treatment in the year after CDI as compared to the prior year of 12.9%, p<0.0001. CDI (odds ratio (OR) 10.0, 95% confidence interval CI: 2.7, 36.3, p<0.001) and severe disease on endoscopy (OR 16.7, 95% (CI): 4.1, 67.9, p<0.001) were found to be independently associated with colectomy within 1year on logistic regression analyses. ConclusionsCDI appears to be associated with escalation of medical therapy in the year following infection. CDI and severe disease on endoscopy appear to be associated with an increased risk for subsequent colectomy on long-term follow up.

Validating Acute Kidney Injury as a Marker of Severity in Clostridium difficile Infection in Hospitalized Adults: Results from a Nation-wide survey: 2011 ACG Presidential Poster

Purpose:Clostridium difficile infection (CDI) is known to cause adverse outcomes in hospitalized adults. Practice guidelines recommend that acute kidney injury (AKI), defined by an increase in serum creatinine ≥ 1.5 times baseline, is a marker of severe CDI based on consensus opinion. We examined clinical outcomes of hospitalized patients with CDI and AKI using the National Hospital Discharge Survey (NHDS) database. Methods: We analyzed NHDS data for 2005-2009; the database contains demographic information, ICD-9 diagnosis and procedure codes and discharge information for patients admitted to non-Federal United States hospitals with mean length of stay (LOS) < 30 days. CDI and AKI patients were identified using ICD-9 codes. 29 Comorbid conditions (hypertension, diabetes mellitus, heart failure, valvular disease, pulmonary circulation disorders, peripheral vascular disease, neurological disorders, malignancies, amongst others) were abstracted from the database using the Healthcare Cost and Utilization Project guidelines. Outcomes in patients with AKI and CDI were compared to patients with CDI without AKI using SAS version 9.2 and JMP version 9.0.1. Results: There were 9,911 hospitalized patients with CDI identified with median age 71 years and 59.9% were female. AKI developed during the hospitalization in 16.54%. On univariate analyses, CDI patients with AKI were significantly older (mean age 74.4 vs. 70.4 years, p<0.0001), had a higher risk of colectomy (2.2% vs. 1.2%, OR 1.87, 95% CI 1.27-2.75), and a higher all cause in-hospital mortality rate (17.4% vs. 5.7%, OR 3.52, 95% CI 3.0-4.1, p<0.001). CDI patients with AKI required longer length of stay (12.8 versus 10.2 days) and were more likely to be dismissed to a care facility (57.7% vs. 43.6%, OR 1.76, 95% CI 1.55-2.0) as compared to CDI patients without AKI (all p<0.001). After adjusting for age, gender and all comorbidities (except renal failure), AKI was an independent predictor of increased risk of colectomy (OR 1.66, p=0.01), higher all-cause in-hospital mortality (OR 2.78, p<0.0001), increased LOS (adjusted mean difference 1.2 days, p<0.0001), and dismissal to a care facility (OR 1.56, p<0.0001). Conclusion: AKI was associated with prolonged hospitalization, an increased likelihood of colectomy, and higher in-hospital mortality in hospitalized CDI patients. These findings support prior consensus opinion that AKI should be considered a marker of severe CDI and these patients should be managed more aggressively to prevent further adverse outcomes.

Clostridium difficile Infection in Ulcerative Colitis: Increased Risk of Colectomy and Postoperative Infectious Complications

Purpose: Ulcerative colitis (UC) patients diagnosed with Clostridium difficile (C. difficile) in hospital have worse outcomes; however, the majority of studies have only evaluated the influence of in-hospital diagnosis of C. difficile. The aims of this study were to determine whether: 1) UC patients diagnosed with C. difficile infections in-hospital and up to 90 days prior to admission were more likely to have an emergent colectomy; and 2) whether C. difficile increased the risk of postoperative complications following colectomy. Methods: Population-based surveillance was conducted in the Calgary Health Zone between January 1, 2000 and December 31, 2009 to identify all adults (≥ 18 years) admitted to hospital for an UC flare (n=481). In addition, the Calgary Laboratory Services (CLS) laboratory provided all C. difficile toxin tests ordered within 90 days of hospital admission (n=123). UC patients admitted to hospital for flare who responded to medical management (n=295) and were discharged from hospital were compared to UC patients who failed medical management and required an in-hospital emergent colectomy (n=186). Secondly, the records of patients undergoing emergency colectomy were reviewed to assess for the occurrence of various postoperative complications stratified as any complication and infectious. Multivariate logistic regression analysis was performed to examine the association between C. difficile infection and: 1) emergent colectomy versus medically responsive UC flare; and 2) postoperative complications (any and infectious). Results: Patients diagnosed with C. difficile 90 days before or during hospitalization (n=18) were at higher risk for having a colectomy when compared to patients who were C. difficile negative (OR= 2.87; 95% CI: 1.03-8.03) after adjusting for age, sex, corticosteroid use in hospital and disease extent. UC patients who underwent emergent colectomy and were diagnosed with C. difficile prior to surgery were not at a statistically higher risk of developing postoperative complications in general (OR=3.48; 95% CI: 0.93-13). However, preoperative C. difficile infection increased the risk of specified infectious complications (OR=4.56; 95% CI: 1.07-18.34) in the postoperative period. Conclusion: UC patients were significantly less likely to be medically responsive and hence, required a colectomy when they were diagnosed with a C. difficile infections in-hospital or within 90 days of admission. Moreover, UC patients who had concomitant C. difficile, preoperatively were at a higher risk of infectious complications following colectomy.

Early Mucosal Healing With Infliximab Is Associated With Improved Long-term Clinical Outcomes in Ulcerative Colitis

In the Active Ulcerative Colitis Trial (ACT)-1 and ACT-2, patients with ulcerative colitis treated with infliximab were more likely than those given placebo to have a clinical response, undergo remission, and have mucosal healing. We investigated the association between early improvement (based on endoscopy) and subsequent clinical outcome. Patients underwent endoscopic evaluations at weeks 0, 8, 30, and 54 (ACT-1 only), and were categorized into 4 subgroups by week 8 (Mayo endoscopy subscore, 0-3). The association of week 8 endoscopy subscores, subsequent colectomy risk, symptoms and corticosteroid use outcomes were analyzed. Mucosal healing was defined as a Mayo endoscopy subscore of 0 (normal) or 1 (mild). Infliximab-treated patients with lower week 8 endoscopy subscores were less likely to progress to colectomy through 54 weeks of follow-up evaluation (P=.0004). This trend was not observed among patients given placebo (P=.47). Patients with lower endoscopy subscores achieved better symptomatic and corticosteroid use outcomes at weeks 30 and 54 (P<.0001, infliximab; P<.01, placebo). Among patients who achieved clinical response at week 8, trends in subsequent clinical outcomes by week 8 endoscopy subscores were generally consistent with that for the overall patient population; no trends were observed among patients who achieved clinical remission. The degree of mucosal healing after 8 weeks of infliximab was correlated with improved clinical outcomes including colectomy. Similar trends were observed for all outcomes except colectomy among the subgroup with clinical response at week 8. The degree of mucosal healing at week 8 among those in clinical remission did not predict subsequent disease course.

The Risk of Early and Late Colectomy in Patients With Ulcerative Colitis: Results From a Population-Based Cohort

The Risk of Early and Late Colectomy in Patients With Ulcerative Colitis: Results From a Population-Based Cohort

Decision tree for early introduction of rescue therapy in active ulcerative colitis treated with steroids

Corticosteroids are the treatment of choice for moderate-to-severe active ulcerative colitis (UC) but up to 30%-40% of patients fail to respond. It has been reported that early clinical-biological parameters may identify those patients at high risk of colectomy. The aim was to identify predictors of rapid response to systemic steroids in moderate-to-severe attacks of UC. Consecutive patients treated with prednisone 1 mg/kg/day for moderate-to-severe attacks of UC were prospectively included. Clinical and biological parameters at 3 and 7 days after starting steroids were recorded. Response was defined as mild or inactive UC activity at day 7 (as assessed by the Montreal Classification of severity) together with no need for rescue therapies (cyclosporin, infliximab, or colectomy). A logistic regression analysis was performed to identify those independent predictors of response. In addition, a decision-tree analysis was also performed. Sixty-eight percent of patients (64 out of 94) responded to steroids. In the univariate analysis the number of bowel movements, rectal bleeding, platelet count, and C-reactive protein (CRP) levels at day 3 were associated with response at day 7, but only rectal bleeding was found to be an independent predictor in the logistic regression analysis. Conversely, the classification and regression tree (CART) model included these four variables. The decision-tree model showed a higher sensitivity in predicting a rapid response to steroids than the logistic regression one. Rapid response to steroids in active UC attacks can be predicted after 3 days of treatment by simple clinical and biological parameters. A decision-tree model for early introduction of rescue therapies is provided.

Infliximab or Cyclosporine as Rescue Therapy in Hospitalized Patients with Steroid-Refractory Ulcerative Colitis: A Retrospective Observational Study

Cyclosporine (CsA) or infliximab (IFX) are used as rescue therapies in steroid-refractory, severe attacks of ulcerative colitis (UC). There are no data comparing the efficacy of these two alternatives. Outcome of rescue therapy was retrospectively studied in two cohorts of patients hospitalized due to steroid-refractory moderate to severe UC: 1) a Swedish-Danish cohort (n = 49) treated with a single infusion of IFX; 2) an Austrian cohort (n = 43) treated with intravenous CsA. After successful rescue therapy, maintenance immunomodulator treatment was given to 27/33 (82%) of IFX patients and to 31/40 (78%) of CsA patients. Endpoints were colectomy-free survival at 3 and 12 months. Kaplan-Meier and Cox regression models were used to evaluate the association between treatment groups and colectomy. At 15 days, colectomy-free survival in the IFX cohort was 36/49 (73%) versus 41/43 (95%) in the CsA cohort (P = 0.005), at 3 months 33/49 (67%) versus 40/43 (93%) (P = 0.002), and at 12 months 28/49 (57%) versus 33/43 (77%) (P = 0.034). After adjusting for potential confounding factors, Cox regression analysis yielded adjusted hazard ratios for risk of colectomy in IFX-treated patients of 11.2 (95% confidence interval [CI] 2.4-53.1, P = 0.002) at 3 months and of 3.0 (95% CI 1.1-8.2, P = 0.030) at 12 months in comparison with CsA-treated patients. There were no opportunistic infections or mortality. Colectomy frequencies were significantly lower after rescue therapy with CsA than with a single infusion of IFX both at 3 and 12 months' follow-up. The superiority of CsA was seen principally during the first 15 days.

Hyperplastic Polyposis and the smoking paradox in females

Background Smoking has consistently been associated with the development of polyps in the colorectum. However the association between smoking and cancer of the colorectum is less than consistent, a phenomenon known as “the smoking paradox”. Recently, it has been demonstrated that the link between smoking and polyps is strongest in hyperplastic polyps, and in the subset of cancers which develop from hyperplastic polyps. Therefore, given that hyperplastic polyposis is associated with an increased risk for developing colorectal cancer (CRC), the aim of this work was to investigate the association between smoking and the risk of CRC in these high-risk patients. Methods One hundred and fifty-one Caucasian individuals with multiple hyperplastic polyps including at least 5 polyps outside the rectum, were classified into non-smokers, current or former smokers at the time of initial diagnosis of polyposis. Cases were individuals with multiple serrated polyps who presented with CRC. Controls were individuals with multiple serrated polyps and no CRC. Multivariate logistic regression was performed to estimate associations between smoking and CRC with adjustment for age at first presentation, sex, and co-existing traditional adenomas, a feature which has been consistently linked with CRC risk in patients with hyperplastic polyposis. Results CRC was diagnosed in 56 (37%) individuals at initial presentation. Patients with at least one adenoma were 4 times more likely to present with CRC compared with patients without adenomas (OR=4.09; 95%CI 1.27 to 13.14; P=0.02). For females, the odds of CRC decreased by 90% in current smokers as compared to never smokers (OR=0.10; 95%CI 0.02 to 0.47; P=0.004) after adjusting for age and adenomas. The 2 currently smoking females who presented with CRC both had their polyps concentrated in the recto-sigmoid and had >100 hyperplastic polyps in total. For males, there was no relationship between current smoking and CRC. There was no statistical evidence of an association between former smoking and CRC for both sexes. A decreased odds for CRC was identified in females with multiple serrated polyps who currently smoke, independent of age and the presence of a traditional adenoma. This observation could be seen as a parallel to the observations regarding current smoking and disease in ulcerative colitis, and perhaps suggests that females with hyperplastic polyposis favoring the proximal colon may have an inflammatory basis for their disease. Conclusion Investigations into the biological basis of these observations could lead to non-smoking-related therapies being developed to decrease the risk of CRC and colectomy in patients with hyperplastic polyposis.

Cyclosporine is Safe and Effective in Patients With Severe Ulcerative Colitis

Cyclosporine (CSA) is effective in the short-term for severe, steroid refractory ulcerative colitis; but its use has been limited by concerns about safety and colectomy-sparing rates. The aim of this study was to assess the long-term colectomy-sparing effects and safety of CSA in patients hospitalized for ulcerative colitis. Review of the patients who underwent intravenous CSA for ulcerative colitis between 1989 and 2003. A total of 71 patients with severe ulcerative colitis were treated with IV CSA. The median length of follow-up was 1.5 years (mean=3 y) (range 1 mo to 14 y) (IQR 0.6 to 4.6). Eighty-five percent (60/71) of patients responded to IV CSA and were discharged on oral CSA. Of these 60 patients, 26 were transitioned from CSA to 6MP. Of the 26 patients who were transitioned from CSA to 6MP, only 1 patient (4%) ultimately required colectomy; whereas colectomy was carried out in 76% (26/34) of the patients who were not transitioned from CSA to 6MP. Only concomitant 6MP therapy was associated with a reduced risk of colectomy (OR 0.01, 95% CI 0.001, 0.09, P<0.0001) on long-term follow-up in this group. Cumulative colectomy rates for the entire cohort were 39% (28/71) at 1 year, 42% (30/71) at 2 years, and 46% (33/71) at 5 years. Side effects were noted in two-thirds of the patients, the majority of which were mild. CSA is an effective therapy for severe ulcerative colitis. Long-term efficacy is improved with transition to 6MP. Adverse events with CSA are frequent, but most are mild.

Short-and Long-Term Clinical Outcomes of Infliximab in Fulminant Ulcerative Colitis

The aim was to characterize short- and long-term clinical outcomes of infliximab in fulminant ulcerative colitis. Patients with severe ulcerative colitis meeting the criteria of fulminant colitis after 3 days of glucocorticosteroid treatment were randomized to control or additional induction therapy of infliximab followed by an on demand/maintenance therapy of infliximab. Twenty six patients with fulminant colitis were equally randomized. At Day 7, ten patients in the control group and none in the infliximab group were in the need of colectomy (). Due to superior effect of infliximab, patients in the control group were of ethical reasons transformed to infliximab treatment instead of performing colectomy. The probability to avoid colectomy was 0.66 with a median observation time of 52 months and a maximal of 91 months. The addition of azathioprine reduced the risk of late colectomy. We conclude that infliximab is effective in preventing early and late colectomy in fulminant colitis.

Clinical variables as prognostic tools in pediatric-onset ulcerative colitis: A retrospective cohort study

Clinical variables may identify a subset of patients with pediatric-onset ulcerative colitis (UC) (≤18 years at diagnosis) at risk for adverse outcomes. We postulated that routinely measured clinical variables measured at diagnosis would predict colectomy in patients with pediatric-onset UC. We conducted a chart review of patients with pediatric-onset UC at a single center over a 10-year period. We compared patients with and without colectomy across several variables, used proportional hazards regression to adjust for potential confounders, and assessed the ability of a UC risk score to predict colectomy. Among 470 patients with inflammatory bowel disease ICD9-coded encounters, 155 patients had UC and 135 were eligible for analysis. The 1- and 3-year colectomy rates were 16.7% (95% confidence interval [CI]: 11.0%-24.8%) and 35.6% (26.7%-45.4%). White blood cell (WBC) count and hematocrit measured at diagnosis were associated with colectomy at 3 years, even after correcting for potential confounding variables. A UC Risk Score derived from the WBC count and hematocrit was strongly associated with colectomy risk, with a high negative predictive value (NPV) for colectomy at 1 and 3 years (NPV = 0.95 and 0.89, respectively), but low positive predictive value (PPV = 0.22 and 0.38, respectively). A risk score calculated from WBC and hematocrit measured at diagnosis was associated with, but incompletely predictive of, colectomy in pediatric-onset UC. These data suggest 1) routinely measured clinical variables may have a prognostic role in risk stratification, and 2) multicenter prospective studies are needed to optimize risk stratification in pediatric UC. Our findings have impact on the design of such studies.

Individual health discount rate in patients with ulcerative colitis

In cost-effectiveness analysis, discount rates are used in calculating the value of future costs and benefits. However, standard discount rates may not accurately describe the decision-making of patients with ulcerative colitis (UC). These patients often choose the long-term risks of immunosuppressive therapy over the short-term risks of colectomy, demonstrating very high discount rates for future health. In this study we aimed to measure the discount rate in UC patients and identify variables associated with the discount rate. We surveyed patients with UC and patients who were postcolectomy for UC to measure their valuations of UC and colectomy health states. We used Standard Gamble (SG) and Time-Trade-Off (TTO) methods to assess current and future health state valuations and calculated the discount rate. Participants included 150 subjects with UC and 150 subjects who were postcolectomy for UC. Adjusted discount rates varied widely (0%-100%), with an overall median rate of 55.0% (interquartile range [IQR] 20.6-100), which was significantly higher than the standard rate of 5%. Within the normal range of discount rates, patients' expected discount rate increased by 0.80% for each additional year of age, and female patients had discount rates that averaged ≈ 8% less than their age-matched counterparts and approached statistical significance. The accepted discount rate of 5% grossly underestimates UC patients' preference for long-term over short-term risk. This might explain UC patients' frequent choice of the long-term risks of immunosuppressive medical therapy over the short-term risks of colectomy.

Mucosal Healing in Patients with Ulcerative Colitis Associates with a Reduced Colectomy Risk, High Incidence of Symptomatic Remission, and Corticosteroid-Free State

Purpose: To assess whether there is an association between degree of mucosal healing (MH) at wk 8 and clinical outcomes in patients with moderate-to-severe ulcerative colitis (UC) in ACT1 and ACT2. Methods: MH at wk 8 was assessed using the Mayo endoscopic subscore classification (0-normal, 1-mild, 2-moderate, 3-severe disease). A post-hoc logrank test was used to examine the distribution of time to colectomy through wk 54 across the 4 endoscopy subgroups for IFX and PBO-treated patients, respectively (ACT 1 and ACT 2 combined). The proportion of patients with symptomatic remission (stool frequency score of 0/1 and a rectal bleeding score of 0) and corticosteroid-free status were assessed at wk 30 (ACT 1 and ACT 2 combined) and at wk 54 (ACT 1). Results: IFX patients who had endoscopy subscores of 0 or 1 at wk 8 were less likely to progress to colectomy through wk 54 (Table; p=0.0004). Small event numbers in PBO patients precluded a clear conclusion for PBO. IFX patients with lower endoscopy scores at wk 8 were more likely to be in symptomatic remission at wk 30 (71% (0); 51% (1); 23% (2); 10% (3), p<0.0001). Among those receiving corticosteroids prior to starting IFX-treatment, patients were more likely to be corticosteroid-free at wk 30 as their degree of MH improved at wk 8 (62% (0); 46% (1); 20% (2); 10% (3), p<0.0001). Similar trends in symptomatic remission and the attainment of a corticosteroid-free status were observed at wk 54 for IFX patients in ACT 1. Although a lower proportion of PBO patients achieved symptomatic remission or became corticosteroid-free vs. IFX patients, similar trends of improved outcomes at wks 30 and 54 were associated with the degree of MH attained by PBO patients at wk 8.[1200] Table. Kaplan-Meier estimates of time to colectomyConclusion: Patients with moderate-to-severe UC, who achieve early mucosal healing, are less likely to go on to colectomy through 1 year of follow-up. Improved endoscopic outcomes were associated with a greater likelihood of achieving symptomatic remission and eliminating corticosteroids. Disclosure: Dr Sandborn-Investigator, Centocor R&D, Inc Dr Rutgeerts-Investigator, Centocor R&D, Inc Dr Reinisch-Investigator, Centocor R&D, Inc Dr Esser-Employee-Centocor BV Drs Wang and Oddens-Employees-Schering Corp Drs Lang, Marano, Strauss-Employees-Centocor R&D, Inc Dr Feagan-Investigator, Centocor R&D, Inc Dr Hanauer-Investigator, Centocor R&D, Inc Dr Lichtenstein-Investigator, Centocor R&D, Inc Dr Present-Investigator, Centocor R&D, Inc Dr Sands-Investigator, Centocor R&D, Inc Dr Colombel-Investigator, Centocor R&D, Inc. This research was supported by an industry grant from Centocor R&D, Inc.

A fulminant colitis index greater or equal to 8 is not predictive of colectomy risk in infliximab-treated moderate-to-severe ulcerative colitis attacks

In severe attacks of ulcerative colitis (UC) treated with intravenous corticosteroids, a fulminant colitis index (FCI) greater or equal to 8 has been associated with a greater likelihood of colectomy (72 vs 16% with an FCI<8). This retrospective study aimed to assess the accuracy of such an association in infliximab-treated patients with moderate-to-severe bouts of UC. The study was based on the medical files of 43 patients who had received at least one infusion of infliximab to treat moderate-to-severe UC (partial Mayo Clinic score). Remission and clinical response were also assessed using the partial Mayo score. The accuracy of an FCI greater or equal to 8 to predict the likelihood of colectomy was assessed by calculating the sensitivity, specificity, positive and negative predictive values, Yule's Q coefficient, Youden's index and statistical significance (Chi(2) test). After treatment with infliximab, 10 patients were in remission (23.3%), 21 (48.8%) had a clinical response, four (9.3%) had treatment failure (without, however, requiring colectomy) and eight (18.6%) had a colectomy. Calculation of the above-mentioned indicators revealed that an FCI greater or equal to 8 was not an indicator of the risk of colectomy in this patient population, and found that only an FCI greater or equal to 16 was statistically significant. However, low values for sensitivity, positive predictive value and Youden's index preclude the clinical application of this latter result. In patients treated with infliximab for moderate-to-severe UC attacks, the FCI is not a predictor of colectomy. In such patients, the factors predictive of a response to treatment or likelihood of colectomy, currently acknowledged with corticosteroid treatment, need to be further assessed for infliximab treatment.