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Background/Aims: Our study aimed to evaluate the long-term outcomes and risk factors for relapse after anti-tumor necrosis factor (TNF)-α cessation in inflammatory bowel disease (IBD) patients because they are not well established. Methods: A retrospective multicenter cohort study was conducted involving patients with Crohn’s disease (CD) or ulcerative colitis (UC) from 10 referral hospitals in Korea who discontinued firstline anti-TNF therapy after achieving clinical remission. Results: A total of 109 IBD patients (71 CD and 38 UC) with a median follow-up duration of 56 months were analyzed. The cumulative relapse rates at 1, 3, and 5 years were 11.3%, 46.7%, and 62.5% for CD patients and 28.9%, 45.3%, and 60.9% for UC patients. Multivariable Cox analysis revealed that discontinuation owing to the clinician’s decision was associated with lower risk of relapse (vs patient’s preference: hazard ratio [HR], 0.13; 95% confidence interval [CI], 0.04 to 0.48; p=0.002) and adalimumab use was associated with higher risk of relapse (vs infliximab: HR, 4.42; 95% CI, 1.24 to 17.74; p=0.022) in CD patients. Mucosal healing was associated with lower risk of relapse (vs nonmucosal healing: HR, 0.12; 95% CI, 0.02 to 0.83; p=0.031) in UC patients. Anti-TNF re-induction was provided to 52 patients, and a response was obtained in 50 patients. However, 25 of them discontinued retreatment owing to a loss of response (n=15), the patient’s preference (n=6), and other factors (n=4). Conclusions: More than 60% of IBD patients in remission under anti-TNF therapy relapsed within 5 years of treatment cessation. Anti-TNF re-induction was effective. However, half of the patients discontinued anti-TNF therapy, and 50% of these patients discontinued treatment owing to loss of response. [ABSTRACT FROM AUTHOR]

Background/Aims Poor adherent to bowel cleansing solution is major risk factor for incomplete colonoscopy. The ideal bowel cleansing solution should be effective, safe and acceptable to patients. This study was aimed to investigate the efficacy, safety and patient acceptability of D-sorbitol and picosulfate plus ascorbic acid (Asc), as a new bowel cleansing solution. Methods This was a prospective, multicenter and randomized phase III clinical trial which was involved five tertiary hospitals in Korea. All participants scheduled to undergo colonoscopy were randomized to receive either 0.46-L D-sorbitol and picosulfate plus Asc or 2-L polyethylene glycol (PEG) + Asc. The same day bowel preparation performed 4 to 5 hours before colonoscopy was administered for D-sorbitol and picosulfate plus Asc group. Bowel cleansing was assessed by independent blinded raters via videotapes. Safety was assessed by clinical and laboratory parameters, and patient acceptability was assessed by questionnaire. All parameters were compared between two groups. Results A total of 243 patients were enrolled (mean age 50.6 ±12.14 years, 39.9% male), of which 122 (50.2%) took D-sorbitol and picosulfate plus Asc solution. Successful bowel cleansing defined as grade A or B according to the Harefield Cleansing Scale was similar between two groups (98.36% in D-sorbitol and picosulfate plus Asc group and 96.69% in PEG+Asc group, p=0.45). Clinical and laboratory safety parameters also showed no significant difference between two groups. The proportion of patients experience difficulty in taking cleansing solution was significantly lower in D-sorbitol and picosulfate plus Asc group than in PEG+Asc group (22.13% vs 80.99%, p<0.01). Patients rating score of overall satisfaction for the solution was better for D-sorbitol and picosulfate plus Asc group than PEG + Asc group (8.71 vs 6.22, p<0.001). Conclusions The D-sorbitol and picosulfate plus Asc solution-based bowel cleansing reduces the volume of cleansing solution to drink without compromising efficacy or safety. This solution is more acceptable to patients and can improve patients adherence to bowel cleansing solution resulting in successful colonoscopy. [ABSTRACT FROM AUTHOR]

Background/Aims Postoperative ileus (POI) is an impaired gastrointestinal (GI) motility caused by surgery. The aim of this study was to investigate the altered composition of gut microbiota, organic acids, and the effect of probiotics in guinea pig model of POI. Methods A laparotomy with cecal manipulation was performed to induce POI in guinea pigs. Fecal pellets were collected before (control) and 1, 3, and 5 days after the operation. Extracted fecal DNA was amplified and sequenced using Illumina MiSeq sequencing system. Same procedures were performed before and after pretreatment of probiotics (a mixture of Enterococcus faecalis, Bacillus mesentericus, and Clostridium butyricum) or placebo via oral route for 7 days. Fecal samples were analyzed by species specific PCR, and enzyme-linked immunosorbent assay to evaluate the effect of probiotics on specific species, and fecal acetate and butyrate. GI transit was assessed via measurement of fecal pellet output. Results Community alpha-diversity of fecal microbiota was not significantly different between control and POI model. However, beta-diversity measured by Bray-Curtis dissimilarity in POI model was significantly different from that of control, and lactic-acid producing bacteria was more abundant in control. The relative abundances of C. butyricum, Lactobacillus plantarum, Bifidobacterium longum, and Bifidobacterium bifidum were significantly decreased at 1 or 3 days after operation. In probiotics pretreatment group, the abundances of B. longum and B. bifidum were significantly increased compared with those of placebo group after operation. Fecal butyrate level was decreased in POI model, and significantly increased at the level of control in probiotics pretreatment group. GI transit was significantly improved in probiotics pretreatment group. Conclusions POI induces gut bacterial dysbiosis, and reduces fecal organic acids. Pretreatment of probiotics before operation restores the abundance of several beneficial bacterial species, butyrate production, and bowel movement. The modulation of gut microbiota may help for the treatment and prevention of POI. [ABSTRACT FROM AUTHOR]

Background/Aims To assess the efficacy and safety of adalimumab, a recombinant human monoclonal antibody against tumor necrosis factor α (TNF-α), and to explore predictors of response in Korean patients with ulcerative colitis (UC). Methods We conducted a prospective observational multicenter study over 56 weeks in adult patients with moderately to severely active UC. The primary outcomes were rates of clinical response at week 8 and 56. Secondary outcomes were rates of clinical remission, steroid-free remission, and mucosal healing at week 8 and 56. Adalimumab drug levels were checked at week 8 and at loss of response. Results A total of 146 patients were enrolled and included in the analysis. Clinical response rates were 52.1% (76/146) and 37.7% (55/146) at week 8 and 56, respectively. Clinical remission were achieved in 24.0% (35/146) and 21.9% (32/146) of patients at week 8 and 56. Steroid-free remission rates was 21.2% (31/146) at week 56. Mucosal healing rates were 39.0% (57/146) and 30.1% (44/146) at week 8 and 56. Prior use of anti-TNF-α did not affect the primary and secondary outcomes. Adalimumab drug level was significantly higher in patients with clinical response, clinical remission, and mucosal healing at week 8. Clinical response (74.5% vs 38.5%, p<0.001) and mucosal healing (52.7% vs 30.8%, p=0.008) at week 8 were associated with clinical response at week 56. Serious adverse drug reactions were identified in 2.7% (4/146) of patients including one case of pulmonary tuberculosis. Conclusions Adalimumab is safe and effective for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF therapy. A better response to induction therapy can predict a better long-term response. [ABSTRACT FROM AUTHOR]

Background/Aims Despite of proven efficacy of anti-tumor necrosis factor-α (anti-TNF) for inflammatory bowel disease (IBD), some patients have to discontinue it for various reasons in a real-world. This study aimed to evaluate long-term outcomes and risk factors of relapse after discontinuation of anti-TNF in IBD patients with clinical remission. Methods A retrospective cohort study was conducted at 10 referral hospitals, affiliated in IBD Study Group of Korean Association for the Study of Intestinal Diseases. The study population comprised Crohn's disease (CD) or ulcerative colitis (UC) patients, treated with anti- TNF (infliximab [IFX] or adalimumab [ADA]) to induce remission and in whom anti-TNF had been discontinued after clinical remission. The patients were excluded for follow-up of <12 months after discontinuation. Results The 125 IBD patients were eligible, and then 109 patients (71 CD and 38 UC) were analyzed and median follow-up period was 56 months. The reasons of discontinuation of anti-TNF was physician's decision (29.4%), patient's own preference (27.5%), adverse events/opportunistic infection (16.5%), and other reasons (26.6%). Relapse rate at 1 and 5 years in CD was 11.3%, and 62.5% and that in UC was 28.9% and 60.9%. Multivariate Cox regression analysis identified risk of relapse was associated with ADA use (vs IFX: hazard ratio [HR], 3.65; 95% confidence interval [CI], 1.03 to 13.02) and discontinuation due to physician's decision (vs patient's preference: HR, 0.14; 95% CI, 0.04 to 0.48) in CD, whereas that was decreased in UC with mucosal healing (vs non-mucosal healing: HR, 0.07; 95% CI, 0.01 to 0.55). Retreatment with anti-TNF was done in 52 patients and effective in 44 patients. Conclusions Discontinuation of anti-TNF was associated with increased risk of relapse. Although retreatment of anti-TNF seems to be effective and safe, discontinuation should be carefully considered based on anti-TNF type, reason of discontinuation, and mucosal healing status. [ABSTRACT FROM AUTHOR]