The detection of the cytomegalovirus DNA in the colonic mucosa of patients with ulcerative colitis is associated with increased long-term risk of proctocolectomy: results from an outpatient IBD clinic.

PURPOSE: Cytomegalovirus (CMV) infection has been found to be associated with a reactivation of ulcerative colitis (UC) and with an impaired response to medical therapy. In the past, only limited data were available on the long-term outcome for UC patients with positive tissue CMV-PCR in the colonic mucosa. METHODS: Between January 2010 and April 2015, we performed a qualitative PCR screening for CMV DNA in one biopsy from most actively inflamed rectal mucosa (tCMV-PCR). All tCMV-PCR-positive patients received 900 mg of valganciclovir b.i.d. for at least 15 days. We analyzed the association of the tCMV-PCR status with the time to steroid-free remission (SFR) and with the risk of proctocolectomy during the further course. RESULTS: One hundred eight consecutive patients (50 women, 58 men, median age 41 years, median UC duration 6 years) with active UC not responding to anti-inflammatory medication were analyzed. Eight of the 24 tCMV-PCR-positive patients (33.3%) compared to ten of the 84 tCMV-PCR-negative patients (11.9%) underwent proctocolectomy during a median follow-up of 52 months (p < 0.005). The median time from CMV diagnosis to colectomy was 501 days (median, interquartile range (IQR): 170, 902 days) in tCMV-PCR-positive and 958 days (IQR: 287, 1328 days) in tCMV-PCR-negative patients (p < 0.01). The median time to SFR was 126 days in tCMV-PCR-positive patients vs. 63 days in tCMV-PCR-negative patients (p < 0.01). CONCLUSIONS: The detection of the CMV DNA in the colonic mucosa of patients with active UC is associated with a longer time to steroid-free UC remission and with an increased rate and earlier need of proctocolectomy.

Bowel preparation prior to colonoscopy with a new colonic irrigation device: Results of a prospective observational study.

Background and study aims The success of colonoscopy is mainly dependent on the effectiveness of prior bowel preparation (BP). Patients often consider BP to be the most burdensome part of colonoscopy, which might be a main barrier to the procedure. The aim of this study was to evaluate safety and effectiveness of colonic irrigation with a new colon hydrotherapy (CHT) device as an alternative to traditional oral BP. Patients and methods A prospective, non-randomized observational study was conducted to evaluate the quality of BP. A BP was considered effective if a score of 6 or better through the Boston Bowel Preparation Scale (BBPS) could be reached. Colonoscopy was performed immediately following colonic irrigation. For safety analysis, data on adverse events (AEs) were collected. Among the secondary outcomes, the BBPS assessed in each bowel segment and cecal intubation rate were analyzed. Results Twenty-eight consecutive patients (11 male [39.3%] and 17 [60.7 %] female) undergoing screening/surveillance or diagnostic colonoscopy were enrolled. Mean age was 54 ±â€Š12.4 years (range 19-80). The evaluated mean BBPS was 7.8 ±â€Š1.5. Twenty-five patients (89.3 %) had a BBPS score of 6 or above. Colonic irrigation was performed without any complications and no AEs were reported within 30 days. The cecal intubation rate was 100 %. Conclusions Colonic irrigation with a new CHT device is an effective and low-risk alternative to traditional oral preparation prior to colonoscopy.

Mesalamine once daily is more effective than twice daily in patients with quiescent ulcerative colitis.

BACKGROUND & AIMS: Oral mesalamine (5-aminosalicylate) is the current standard of care for mild-to-moderate ulcerative colitis. We investigated the efficacy and safety of once daily administration of prolonged-release mesalamine granules in maintenance of remission in patients with quiescent ulcerative colitis, compared with the well established twice daily dosing regimen. METHODS: In this multicenter, randomized, single blind, noninferiority trial, 362 patients with quiescent ulcerative colitis were randomly assigned (1:1) to groups that were given oral mesalamine 2 g, once daily, or 1 g, twice daily, for 12 months. The primary objective was to compare remission rates at 1 year, based on the ulcerative colitis disease activity index score, using Kaplan-Meier methodology. RESULTS: At 1 year, 70.9% of the group given 2 g mesalamine once daily remained in remission vs 58.9% of the group given 1 g mesalamine twice daily; this difference was statistically significant (P = .024), indicating the increased efficacy of once daily, compared with twice daily, dosing. Self-reported adherence to therapy, measured by visual analog scale score after 4, 8, and 12 months, was significantly greater in the group given 2 g mesalamine once daily, compared with twice daily, at all but 1 study visit (P < .05). Compliance measured by medication taken was not significantly different between the groups. The difference between the 2 groups in overall incidence of adverse events was not statistically significant (P = .23). CONCLUSIONS: Patients with ulcerative colitis given prolonged-release oral mesalamine 2 g once daily had better remission rates, acceptability, and self-reported adherence to therapy compared with patients given oral mesalamine 1 g twice daily.

[Inflammatory Bowel Diseases - Diagnosis and Therapy in Practice]. / Chronisch-entzündliche Darmerkrankungen: Diagnostik und Therapie in der Praxis.

Significant increases in Crohn's disease incidence have been noticed in recent decades. Therefore it gets more important to increase practical knowledge, present therapy innovations and draw attention to the need for vaccinations of immunosuppressed IBD patients as well as useful supportive therapy options.

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

Background and study aims The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. Patient and methods Patients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 - 18 hours; Dose 2, 4 - 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6 - 8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0 - 14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [≥ 2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated. Results Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (-3.93, 95 % confidence intervals [CI]: - 4.99, - 2.97; P < 0.0001) in the intent-to-treat analysis set. The PICOPREP TD regimen also resulted in a statistically significant increase in the odds of achieving an ascending colon OS score ≤ 1, compared to the PICOPREP DBD regimen (estimated odds ratio 9.18, 95 % CI: 4.36, 19.32; P < 0.0001). There was no statistically significant difference in the overall rate of treatment-emergent adverse events (12 % (TD) and 5.7 % (DBD), respectively, P = 0.2988). The convenience and satisfaction were comparable in the two groups. Conclusion The TD regimen was superior to the DBD regimen for overall and ascending colon cleansing efficacy. ClinicalTrials.gov Identifier: NCT02239692.

Azathioprine-induced Acute Pancreatitis in Patients with Inflammatory Bowel Diseases--A Prospective Study on Incidence and Severity.

BACKGROUND AND AIMS: Azathioprine [AZA] is recommended for maintenance of steroid-free remission in inflammatory bowel disease IBD. The aim of this study has been to establish the incidence and severity of AZA-induced pancreatitis, an idiosyncratic and major side effect, and to identify specific risk factors. METHODS: We studied 510 IBD patients [338 Crohn's disease, 157 ulcerative colitis, 15 indeterminate colitis] with initiation of AZA treatment in a prospective multicentre registry study. Acute pancreatitis was diagnosed in accordance with international guidelines. RESULTS: AZA was continued by 324 [63.5%] and stopped by 186 [36.5%] patients. The most common cause of discontinuation was nausea [12.2%]. AZA-induced pancreatitis occurred in 37 patients [7.3%]. Of these: 43% were hospitalised with a median inpatient time period of 5 days; 10% had peripancreatic fluid collections; 24% had vomiting; and 14% had fever. No patient had to undergo nonsurgical or surgical interventions. Smoking was the strongest risk factor for AZA-induced acute pancreatitis [p < 0.0002] in univariate and multivariate analyses. CONCLUSIONS: AZA-induced acute pancreatitis is a common adverse event in IBD patients, but in this study had a mild course in all patients. Smoking is the most important risk factor.

Vaccination coverage in immunosuppressed patients: results of a regional health services research study.

BACKGROUND: Patients with chronic inflammatory diseases are at elevated risk of infections that can be prevented by vaccination. This elevated risk is due not just to these patients' primary illnesses, but also to the immunosuppressive treatment that they often receive. We studied the vaccination rate in a random sample of patients with two types of inflammatory bowel disease (IBD), namely, Crohn's disease and ulcerative colitis. In particular, we asked unvaccinated patients why they had re-fused the vaccine. METHODS: From April to September 2009, we gave a 38-item questionnaire to 203 consecutive patients with IBD (57% with Crohn's disease, 63% female, median age 36 years) who had not received vaccination counseling for at least one year, and inspected the patients' vaccination cards. We compared the findings to the current recommendations of the German Federal Standing Committee on Vaccination (Ständige Impfkommission). RESULTS: 83% of the patients had a vaccination card. Substantial deficiencies in vaccination were found. Only 67% of the patients had been immunized against tetanus in the previous 10 years, and only 21% against pertussis. Only 28% were vaccinated against seasonal influenza in 2008, and only 9% had ever received anti-pneumococcal vaccine. A subgroup analysis in which we compared 39 patients taking TNF-blockers to 67 patients who never had any type of immunosuppressive treatment revealed no difference in vaccination rates. 80% of all patients said they were willing to receive all of the officially recommended vaccinations. 22% of all patients said they avoided vaccinations for fear of side effects, while 15% said they did so because their immune system was supposedly "not intact", and 9% because they feared vaccination would worsen their IBD. CONCLUSION: In this random sample, the vaccination rate fell far behind the recommendations. In particular, there was a marked discrepancy between patients' willingness to be vaccinated and the actual provision of vaccination. These findings imply that physicians need to be more aware of the possibly inadequate vaccination state of their immunosuppressed patients.