Efficacy and Safety of Infliximab in Intestinal Behçet’s Disease:A Multicenter, Phase 3 Study (BEGIN)

Background/Aims@#To date, there is no prospective study that specifically investigated the efficacy of infliximab in intestinal Behçet’s disease (BD). This study evaluated the efficacy of infliximab in patients with moderate-to-severe active intestinal BD that are refractory to conventional therapies. @*Methods@#This phase 3, interventional, open-label, single-arm study evaluated clinical outcomes of infliximab treatment in patients with moderate-to-severe intestinal BD. The coprimary endpoints were clinical response, decrease in disease activity index for intestinal BD (DAIBD) score ≥20 from weeks 0 to 8 for the induction therapy and week 32 for the maintenance therapy. @*Results@#A total of 33 patients entered the induction therapy and were treated with infliximab 5 mg/kg intravenously at weeks 0, 2, and 6. The mean DAIBD score changed from 90.8±40.1 at week 0 to 40.3±36.4 at week 8, with a significant mean change of 50.5±36.4 (95% confidence interval, 37.5 to 63.4; p<0.001). Thirty-one (93.9%) continued to receive 5 mg/kg infliximab every 8 weeks during the maintenance therapy. The mean change in the DAIBD score after the maintenance therapy was statistically significant (61.5±38.5; 95% confidence interval, 46.0 to 77.1; p<0.001, from weeks 0 to 32). The proportion of patients who maintained a clinical response was 92.3% at week 32. No severe adverse reactions occurred during the induction and maintenance therapies. @*Conclusions@#This study provided evidence that infliximab 5 mg/kg induction and maintenance therapies are efficacious and well-tolerated in patients with moderate-to-severe active intestinal BD. (ClinicalTrials.gov identifier: NCT02505568)

Association between soy products, fruits, vegetables, and dairy products and gastric cancer risk in Helicobacter pylori-infected subjects: a case-control study in Korea

BACKGROUND/OBJECTIVES@#Consumption of certain protective foods may help inhibit Helicobacter pylori (H. pylori) associated gastric pathologies. However, studies conducted to assess the efficacy of protective foods in H. pylori-infected subjects are either limited or inconsistent. This study evaluated the association of individual or a combination of protective foods on the incidence of gastric cancer (GC) in H. pylori-positive subjects through a casecontrol study.MATERIALS/METHODS: Subjects aged 20–79 years were selected from 2 hospitals between December 2002 and September 2006. In total, 134 patients and 212 controls tested positive for H. pylori infection. Among these, we included 82 pairs of cases and controls matched by sex, age (± 5 years), enrollment period (± 1 years), and hospital. @*RESULTS@#A higher intake of soy products was associated with a significantly lower risk of GC than a lower intake of soy products (odds ratio [OR] = 0.37, 95% confidence interval [CI] = 0.14–0.96). Additionally, a higher fruit intake resulted in a significantly lower risk of GC than a lower fruit intake (OR = 0.35, 95% CI = 0.13–0.94). A combination of food groups was evaluated, and a lower risk of GC was observed with a high intake of both soy products and fruits (OR = 0.20, 95% CI = 0.06–0.67), high intake of soy and dairy products (OR = 0.28, 95% CI = 0.10–0.78) and high intake of fruits and dairy products (OR = 0.28, 95% CI = 0.09–0.83). @*CONCLUSIONS@#A high intake of soy products or fruits was associated with a lower risk of GC.A combination of soy products or fruits with dairy products was associated with a lower risk of GC. A balanced intake of soy products, fruits, and dairy products may help reduce GC risk.

Dietary Intake of Soy Products, Vegetables, and Dairy Products and Gastric Cancer Survival according to Histological Subtype: a Long-term Prospective Cohort Study

Purpose@#Owing to differences in the general characteristics of gastric cancer (GC) according to histological type, the association of GC risk factors, such as diet, may also differ depending on the histological type. We investigated the associations between individual and combined intake of soy products, vegetables, and dairy products and GC mortality by following up cases of death among Korean GC cases and whether these associations differ according to the histological type. @*Materials and Methods@#A total of 508 GC cases were enrolled from two hospitals between 2002 and 2006. Their survival or death was prospectively followed up until December 31, 2016, through a review of medical records and telephonic surveys. Finally, 300 GC cases classified as intestinal- or diffuse-type GC cases were included. The median follow-up period was 7.1 years. @*Results@#In the fully adjusted model, a high intake of soy products (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.19–0.96) and the combination of soy products and vegetables (HR, 0.34; 95% CI, 0.12–0.96) or soy products and dairy products (HR, 0.37; 95% CI, 0.14–0.98) decreased the mortality from intestinal-type GC. In particular, patients consuming various potentially protective foods (HR, 0.23; 95% CI, 0.06–0.83) showed a highly significant association with a lower mortality from intestinal-type GC. However, no significant association was found with diffuse-type GC. @*Conclusions@#High intake of potentially protective foods, including soy products, vegetables, and dairy products, may help increase survival in intestinal-type GC.

The Pathologic Confirmation in Subepithelial Tumors

Background/Aims@#Subepithelial tumors (SETs) are small, mostly asymptomatic lesions with normal overlying mucosa, usually identified incidentally on endoscopy. The aim of this study was to evaluate the pathologic diagnosis of SETs, and to assess the diagnostic yield and impact of endoscopic submucosal dissection (ESD) biopsy on the management of patients with SETs. @*Materials and Methods@#We included 52 subepithelial lesions in this study during the study period. Inclusion criteria included size of the SET >2 cm, and a gastrointestinal stromal tumor (GIST) that cannot be excluded using EUS. We performed an endoscopic biopsy of each SET using the ESD technique. @*Results@#The mean diameter of the lesions was 24.15±6.0 mm. The diagnostic yield of this method was 96.15%. Among the 52 participants, 45 were located in the stomach, four in the esophagus, and three in the duodenum. The pathologic diagnoses included: 17 leiomyomas, 13 GISTs, 11 ectopic pancreases, two carcinomas, two inflammatory fibroid polyps, two Brunner’s gland hyperplasia, two lipomas, one glomus tumor, and two remained undiagnosed. The mean duration of the procedure was 13.44±2.41 minutes. Three complications were associated with the procedure. @*Conclusions@#Deep biopsy via ESD is useful in determining the histopathologic nature of SETs. This method minimizes the need for unnecessary surgery in benign SETs.

Long-term outcomes of infliximab in a real-world multicenter cohort of patients with acute severe ulcerative colitis

Background/Aims@#Infliximab (IFX) has proven effective as rescue therapy in steroid-refractory acute severe ulcerative colitis (ASUC), however, the long-term real-world data are scarce. Our study aimed to assess the long-term treatment outcomes of IFX in a real-life cohort. @*Methods@#We established a multicenter retrospective cohort of hospitalized patients with ASUC, who met Truelove and Witt’s criteria and received intravenous corticosteroid (IVCS) or IFX during index hospitalization between 2006 and 2016 in 5 university hospitals in Korea. The cohort was systematically followed up until colectomy, death or last follow-up visit. @*Results@#A total of 296 patients were followed up for a mean of 68.9 ± 44.0 months. During index hospitalization, 49 patients were treated with IFX; as rescue therapy for IVCS failure in 37 and as first-line medical therapy for ASUC in 12. All patients treated with IFX avoided colectomy during index hospitalization. The cumulative rates of rehospitalization and colectomy were 20.4% and 6.1% at 3 months and 39.6% and 18.8% at the end of follow-up, respectively. Patients treated with IFX presented with significantly shorter colectomy-free survival than IVCS responders (P= 0.04, log-rank test). Both cytomegalovirus colitis and Clostridioides difficile infection (CDI) were the significant predictors of colectomy in the overall study cohort (hazard ratios of 6.57 and 4.61, respectively). There were no fatalities. @*Conclusions@#Our real-world cohort study demonstrated that IFX is an effective therapeutic option in Korean patients with ASUC, irrespective of IFX indication. Aggressive vigilance for cytomegalovirus colitis and CDI is warranted for hospitalized patients with ASUC.

The Pathologic Confirmation in Subepithelial Tumors

Background/Aims@#Subepithelial tumors (SETs) are small, mostly asymptomatic lesions with normal overlying mucosa, usually identified incidentally on endoscopy. The aim of this study was to evaluate the pathologic diagnosis of SETs, and to assess the diagnostic yield and impact of endoscopic submucosal dissection (ESD) biopsy on the management of patients with SETs. @*Materials and Methods@#We included 52 subepithelial lesions in this study during the study period. Inclusion criteria included size of the SET >2 cm, and a gastrointestinal stromal tumor (GIST) that cannot be excluded using EUS. We performed an endoscopic biopsy of each SET using the ESD technique. @*Results@#The mean diameter of the lesions was 24.15±6.0 mm. The diagnostic yield of this method was 96.15%. Among the 52 participants, 45 were located in the stomach, four in the esophagus, and three in the duodenum. The pathologic diagnoses included: 17 leiomyomas, 13 GISTs, 11 ectopic pancreases, two carcinomas, two inflammatory fibroid polyps, two Brunner’s gland hyperplasia, two lipomas, one glomus tumor, and two remained undiagnosed. The mean duration of the procedure was 13.44±2.41 minutes. Three complications were associated with the procedure. @*Conclusions@#Deep biopsy via ESD is useful in determining the histopathologic nature of SETs. This method minimizes the need for unnecessary surgery in benign SETs.

Long-term outcomes of infliximab in a real-world multicenter cohort of patients with acute severe ulcerative colitis

Background/Aims@#Infliximab (IFX) has proven effective as rescue therapy in steroid-refractory acute severe ulcerative colitis (ASUC), however, the long-term real-world data are scarce. Our study aimed to assess the long-term treatment outcomes of IFX in a real-life cohort. @*Methods@#We established a multicenter retrospective cohort of hospitalized patients with ASUC, who met Truelove and Witt’s criteria and received intravenous corticosteroid (IVCS) or IFX during index hospitalization between 2006 and 2016 in 5 university hospitals in Korea. The cohort was systematically followed up until colectomy, death or last follow-up visit. @*Results@#A total of 296 patients were followed up for a mean of 68.9 ± 44.0 months. During index hospitalization, 49 patients were treated with IFX; as rescue therapy for IVCS failure in 37 and as first-line medical therapy for ASUC in 12. All patients treated with IFX avoided colectomy during index hospitalization. The cumulative rates of rehospitalization and colectomy were 20.4% and 6.1% at 3 months and 39.6% and 18.8% at the end of follow-up, respectively. Patients treated with IFX presented with significantly shorter colectomy-free survival than IVCS responders (P= 0.04, log-rank test). Both cytomegalovirus colitis and Clostridioides difficile infection (CDI) were the significant predictors of colectomy in the overall study cohort (hazard ratios of 6.57 and 4.61, respectively). There were no fatalities. @*Conclusions@#Our real-world cohort study demonstrated that IFX is an effective therapeutic option in Korean patients with ASUC, irrespective of IFX indication. Aggressive vigilance for cytomegalovirus colitis and CDI is warranted for hospitalized patients with ASUC.

Colonoscopy quality in community hospitals and nonhospital facilities in Korea

Background/Aims@#High-quality colonoscopy is essential to reduce colorectal cancer-related deaths. Little is known about colonoscopy quality in non-academic practice settings. We aimed to evaluate the quality of colonoscopies performed in community hospitals and nonhospital facilities. @*Methods@#Colonoscopy data were collected from patients referred to six tertiary care centers after receiving colonoscopies at community hospitals and nonhospital facilities. Based on their photographs, we measured quality indicators including cecal intubation rate, withdrawal time, adequacy of bowel preparation, and number of polyps. @*Results@#Data from a total of 1,064 colonoscopies were analyzed. The overall cecal intubation rate was 93.1%. The median withdrawal time was 8.3 minutes, but 31.3% of colonoscopies were withdrawn within 6 minutes. Community hospitals had longer withdrawal time and more polyps than nonhospital facilities (median withdrawal time: 9.9 minutes vs. 7.5 minutes, p < 0.001; mean number of polyps: 3.1 vs. 2.3, p = 0.001). Board-certified endoscopists had a higher rate of cecal intubation than non-board-certified endoscopists (93.2% vs. 85.2%, p = 0.006). A total of 819 follow-up colonoscopies were performed at referral centers with a median interval of 28 days. In total, 2,546 polyps were detected at baseline, and 1,088 were newly identified (polyp miss rate, 29.9%). Multivariable analysis revealed that older age (odds ratio [OR], 1.032; 95% confidence interval [CI], 1.020 to 1.044) and male sex (OR, 1.719; 95% CI, 1.281 to 2.308) were associated with increased risk of missed polyps. @*Conclusions@#The quality of colonoscopies performed in community hospitals and nonhospital facilities was suboptimal. Systematic reporting, auditing, and feedback are needed for quality improvement.

Alcohol consumption and gastric cancer risk in Korea: a case-control study

BACKGROUND/OBJECTIVES: The International Agency for Research on Cancer defined alcohol beverages and acetaldehyde derived from alcoholic beverages as a Group 1 carcinogen to humans. However, the association between alcohol consumption and gastric cancer risk has been controversial in Korean. We assessed the relationship between alcohol consumption and gastric cancer risk in Korea through a case-control study. SUBJECTS/METHODS: From 2 hospitals, a total of 316 cases with gastric cancer (208 men, 108 women) were selected and matched to 316 controls by sex and age (± 5 years) during the same duration. The current status, frequency, and amount of alcohol consumption for a year three years ago were assessed by trained interviewers. RESULTS: Alcohol consumption status and frequency did not show any significant association with gastric cancer risk. However, high alcohol consumption (≥ 20 g/day for women or ≥ 40 g/day for men) significantly increased the risk of gastric cancer (odds ratio (OR) 1.73; 95% confidence interval (CI) 1.05–2.85). Gastric cancer risk was strongly positively associated with alcohol consumption of ≥ 20 g/day, especially in women (OR 5.62; 95% CI 1.32–23.81). CONCLUSION: The results from this study suggest that excessive alcohol consumption rather than the current status or frequency of alcohol consumption contributes to the increased risk of gastric cancer, especially in women.

Prediagnostic Smoking and Alcohol Drinking and Gastric Cancer Survival: A Korean Prospective Cohort Study / 대한소화기학회지

BACKGROUND/AIMS: Behavioral factors, such as smoking and heavy alcohol consumption, increase the risk of gastric cancer (GC), but their effects on survival are not clear. We examined associations between prediagnostic smoking and alcohol drinking behavior and GC death by long-term follow-up. METHODS: The participants were 508 GC patients enrolled at Chungnam University Hospital and Hanyang University Guri Hospital from 2001 to 2006. Information on clinicopathologic and behavioral risk factors was collected, and patient survival was prospectively followed until 2016 by medical chart review and telephone survey. RESULTS: During above 10 years follow-up period, overall death was 46.2% (n=226) and GC deaths was 38.2% (n=187) among the 489 GC patients included in the analysis. No significant association was found between smoking habits and overall or GC survival. However, after stratification by histological type, the hazard ratio (HR) of GC death for current smokers tended to be higher for the diffuse type (HR 1.61, 95% CI 0.57–4.59 for current vs. never) rather than for the intestinal type (HR 0.78, 95% CI 0.28–2.19 for current vs. never). Light alcohol consumption was found to be associated with a significantly lower risk of GC death (HR 0.52, 95% CI 0.36–0.75 for <20 g/day for women or <40 g/day for men vs. never and past), and the effects of alcohol drinking habits had similar effects on GC death for the intestinal and diffuse types. CONCLUSIONS: These results suggest smoking and alcohol drinking behaviors before a diagnosis of GC are weakly associated with GC survival. Nevertheless, the effect of smoking behavior on prognosis appears to depend on the histological type of GC.

Intestinal microbiota, chronic inflammation, and colorectal cancer

In addition to genetic and epigenetic factors, various environmental factors, including diet, play important roles in the development of colorectal cancer (CRC). Recently, there is increasing interest in the intestinal microbiota as an environmental risk factor for CRC, because diet also influences the composition of the intestinal microbiota. The human intestinal microbiota comprises about 100 trillion microbes. This microbiome thrives on undigested dietary residues in the intestinal lumen and produces various metabolites. It is well known that the dietary risk factors for CRC are mediated by dysbiosis of the intestinal microbiota and their metabolites. In this review, we describe the bacterial taxa associated with CRC, including Fusobacterium nucleatum, enterotoxigenic Bacteroides fragilis, Escherichia coli, and butyrate-producing bacteria. We also discuss the host-diet interaction in colorectal carcinogenesis.

Corrigendum: Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies

The authors regret an error in the reporting of Inflammatory Bowel Disease Questionnaire (IBDQ) patient-reported outcome data in the manuscript. A data extraction error resulted in incorrect IBDQ data being presented in the publication. The error does not affect the overall conclusions regarding IBDQ as the difference between the corrected and erroneous numbers is, in general, small. The error was specific to IBDQ data; all other data have been reviewed and are correct as originally reported.

Guideline Adherence to Colonoscopic Surveillance Intervals after Polypectomy in Korea: Results from a Nationwide Survey

BACKGROUND/AIMS: People around the world are increasingly choosing to undergo colorectal cancer screening via colonoscopy. As a result, guideline adherence to postpolypectomy colonoscopy surveillance has drawn increasing attention. The present study was performed to assess recognition and adherence to guidelines among primary care physicians and gastroenterologists and to identify characteristics associated with compliance. METHODS: A nationwide sample of primary care physicians employed at cancer screening facilities and registered members of the Korean Society of Gastrointestinal Endoscopy were recruited. Participants were asked to complete a survey of six hypothetical clinical scenarios designed to assess their potential course of action in response to screening or follow-up colonoscopy results. Frequencies and odds ratios and 95% confidence intervals for guideline adherence were estimated. RESULTS: The proportions of doctors recommending shortened colonoscopy surveillance intervals for low- and high-risk adenomas were greater than 90% among primary physicians and were much lower among gastroenterologists. Guideline adherence was relatively good among groups of doctors who were young, had a specialty in gastroenterology, worked at tertiary hospitals, and cared for an appropriate number of patients. CONCLUSIONS: The present study reveals a remaining discrepancy between practitioner recommendations and current guidelines for postpolypectomy surveillance. Several factors were shown to be related to guideline adherence, suggesting a need for appropriate control and continuing education or training programs among particular groups of practitioners.

Three-year colonoscopy surveillance after polypectomy in Korea: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter prospective study

BACKGROUND/AIMS: Colonoscopic surveillance is currently recommended after polypectomy owing to the risk of newly developed colonic neoplasia. However, few studies have investigated colonoscopy surveillance in Asia. This multicenter and prospective study was undertaken to assess the incidence of advanced adenoma based on baseline adenoma findings at 3 years after colonoscopic polypectomy. METHODS: A total of 1,323 patients undergoing colonoscopic polypectomy were prospectively assigned to 3-year colonoscopy surveillance at 11 tertiary endoscopic centers. Relative risks for advanced adenoma after 3 years were calculated according to baseline adenoma characteristics. RESULTS: Among 1,323 patients enrolled, 387 patients (29.3%) were followed up, and the mean follow-up interval was 31.0±9.8 months. The percentage of patients with advanced adenoma on baseline colonoscopy was higher in the surveillance group compared to the non-surveillance group (34.4% vs. 25.7%). Advanced adenoma recurrence was observed in 17 patients (4.4%) at follow-up. The risk of advanced adenoma recurrence was 2 times greater in patients with baseline advanced adenoma than in those with baseline non-advanced adenoma, though the difference was not statistically significant (6.8% [9/133] vs. 3.1% [8/254], P=0.09). Advanced adenoma recurrence was observed only in males and in subjects aged ≥50 years. In contrast, adenoma recurrence was observed in 187 patients (48.3%) at follow-up. Male sex, older age (≥50 years), and multiple adenomas (≥3) at baseline were independent risk factors for adenoma recurrence. CONCLUSIONS: A colonoscopy surveillance interval of 3 years in patients with baseline advanced adenoma can be considered appropriate.

The Clinical Characteristics and Prognosis of Crohn's Disease in Korean Patients Showing Proximal Small Bowel Involvement: Results from the CONNECT Study

BACKGROUND/AIMS: We aimed to evaluate the clinical characteristics and prognosis of Crohn's disease (CD) in patients who showed proximal small bowel involvement using a nationwide Korean CD cohort. METHODS: We reviewed the data from a cohort of patients diagnosed with CD. The clinical outcomes of patients were evaluated according to the presence of proximal small bowel involvement. RESULTS: Among 1,329 patients with CD for whom complete disease location data were available, 222 patients (16.7%) showed involvement of the proximal small bowel. Compared to patients without proximal small bowel involvement, those with small bowel involvement were more likely to display stricturing behavior (19.8% vs 12.7%, p=0.020). The surgery-free survival of patients who showed proximal small bowel involvement was inferior to that of patients without proximal small bowel involvement (10-year surgery-free survival: 58.4% vs 67.7%, respectively, p < 0.001). Additionally, upper gastrointestinal involvement was more common in patients with proximal small bowel involvement than in those without involvement (odds ratio, 1.643; 95% confidence interval, 1.008 to 2.677). CONCLUSIONS: Proximal small bowel involvement is a poor prognostic factor for the surgery-free survival of Korean patients with CD. Proximal small bowel involvement should be evaluated in patients with CD for predicting long-term clinical outcomes.

Association of Perianal Fistulas with Clinical Features and Prognosis of Crohn’s Disease in Korea: Results from the CONNECT Study

BACKGROUND/AIMS: The disease course and factors associated with poor prognosis in Korean patients with Crohn’s disease (CD) have not been fully determined. The aim of this study was to explore potential associations between the clinical characteristics and long-term outcomes of CD and perianal fistulas in a Korean population. METHODS: The retrospective Crohn’s Disease Clinical Network and Cohort (CONNECT) study enrolled patients diagnosed with CD between July 1982 and December 2008 from 32 hospitals. Those followed for < 12 months were excluded. Clinical outcomes were CD-related surgery and complications, including nonperianal fistulas, strictures, and intra-abdominal abscesses. RESULTS: The mean follow-up period was 8.77 years (range, 1.0 to 25.8 years). A total of 1,193 CD patients were enrolled, of whom 465 (39.0%) experienced perianal fistulas. Perianal fistulizing CD was significantly associated with younger age, male gender, CD diagnosed at primary care clinics, and ileocolonic involvement. Both nonperianal fistulas (p=0.034) and intra-abdominal abscesses (p=0.020) were significantly more common in CD patients with perianal fistulas than in those without perianal fistulas. The rates of complicated strictures and CD-related surgery were similar between the groups. Independently associated factors of nonperianal fistulas were perianal fistulas (p=0.015), female gender (p=0.048), CD diagnosed at referral hospital (p=0.003), and upper gastrointestinal (UGI) involvement (p=0.001). Furthermore, perianal fistulas (p=0.048) and UGI involvement (p=0.012) were independently associated with the risk of intra-abdominal abscesses. CONCLUSIONS: Perianal fistulas predicted the development of nonperianal fistulas and intra-abdominal abscesses in Korean CD patients. Therefore, patients with perianal fistulizing CD should be carefully monitored for complicated fistulas or abscesses.

Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies

BACKGROUND/AIMS: Tofacitinib is an oral, small-molecule Janus kinase inhibitor being investigated for ulcerative colitis (UC). In OCTAVE Induction 1 and 2, patients with moderately to severely active UC received placebo or tofacitinib 10 mg twice daily (BID) for 8 weeks. Clinical responders in OCTAVE Induction were re-randomized to 52 weeks' therapy with placebo, tofacitinib 5 mg BID, or tofacitinib 10 mg BID. METHODS: We conducted post-hoc efficacy and safety analyses of East Asian patients in OCTAVE Induction 1 and 2 and OCTAVE Sustain. RESULTS: A total of 121 East Asian (Japan, Korea, and Taiwan) patients were randomized in OCTAVE Induction 1 and 2 (placebo, n=26; tofacitinib 10 mg BID, n=95), and 63 in OCTAVE Sustain (placebo, n=20; tofacitinib 5 mg BID, n=22; tofacitinib 10 mg BID, n=21). At week 8 of OCTAVE Induction 1 and 2, 18.9% of patients (18/95) achieved remission with tofacitinib 10 mg BID versus 3.8% (1/26) with placebo. In OCTAVE Sustain, the week 52 remission rates were 45.5% (10/22), 47.6% (10/21), and 15.0% (3/20) with 5 mg BID, 10 mg BID, and placebo, respectively. Adverse event rates were similar between groups in OCTAVE Induction and numerically higher with tofacitinib in OCTAVE Sustain. Serious adverse event rates were similar across groups in all studies. Infections were numerically more frequent with tofacitinib than placebo. Increases in serum lipid levels were observed with tofacitinib. CONCLUSIONS: In East Asian patients with UC, tofacitinib demonstrated numerically greater efficacy versus placebo as induction and maintenance therapy, with a safety profile consistent with the global study population. ClinicalTrials.gov: NCT01465763; NCT01458951; NCT01458574.

Comparing the clinical outcomes of young-onset and adult-onset ulcerative colitis: a multi-center Korean Association for the Study for Intestinal Diseases study

BACKGROUND/AIMS: The aim of this study was to compare the clinical features and outcomes of ulcerative colitis (UC) according to the age of onset in Korea. METHODS: A total of 1,141 patients who were diagnosed with UC between July 1987 and November 2013 at 11 tertiary hospitals were enrolled. The baseline disease characteristic and disease state at onset, treatment during the disease course were retrospectively reviewed among patients with young-onset (YO, < 20 years) and adult-onset (AO, ≥ 20 years). Severe outcome was defined as use of intravenous (IV) steroids, infliximab, immunosuppressant, or UC-related operation. RESULTS: There were 55 YO patients (mean age, 17.8 ± 2.4) and 1,086 AO patients (mean age, 43.0 ± 13.6). High Mayo scores (7.7 ± 3.0 vs. 5.6 ± 2.7, p = 0.000), extensive UC (52.7% vs. 25.8%, p = 0.000) and IV steroid (41.8% vs. 18.0%, p = 0.000), immunosuppressant (47.3% vs. 26.9%, p = 0.002), and infliximab (20.0% vs. 7.2%, p = 0.001) use were more frequent in the YO than in the AO group. According to multivariate analysis, severe outcomes were related to YO disease (hazard ratio [HR], 2.18; 95% confidence interval [CI], 1.27 to 3.71), body mass index < 23 kg/m² (HR, 1.46; 95% CI, 1.07 to 2.00), severe (HR, 2.29; 95% CI, 1.36 to 3.38), and moderate (HR, 2.48; 95% CI, 1.67 to 3.67) disease, extensive UC (HR, 2.90; 95% CI, 1.79 to 4.69), UC-related admission (HR, 63.89; 95% CI, 20.41 to 200.02), and oral steroid use (HR, 0.51; 95% CI, 0.39 to 0.67). CONCLUSIONS: UC with YO presented with more advanced clinical features at onset and more severe outcomes than the AO. YO cases require careful management and intense treatment strategies.

Second Korean guidelines for the management of ulcerative colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by a relapsing and remitting course. The direct and indirect costs of the treatment of UC are high, and the quality of life of patients is reduced, especially during exacerbation of the disease. The incidence and prevalence of UC in Korea are still lower than those of Western countries, but have been rapidly increasing during the past decades. Various medical and surgical therapies, including biologics, are currently used for the management of UC. However, many challenging issues exist, which sometimes lead to differences in practice between clinicians. Therefore, the IBD study group of the Korean Association for the Study of Intestinal Diseases established the first Korean guidelines for the management of UC in 2012. This is an update of the first guidelines. It was generally made by the adaptation of several foreign guidelines as was the first edition, and encompasses treatment of active colitis, maintenance of remission, and indication of surgery for UC. The specific recommendations are presented with the quality of evidence and classification of recommendations.

Second Korean Guideline for the Management of Ulcerative Colitis / 대한소화기학회지

Ulcerative colitis (UC) is a chronic inflammatory bowel disorder characterized by a relapsing and remitting course. The direct and indirect costs of the treatment of UC are high, and the quality of life of patients is reduced, especially during exacerbation of the disease. The incidence and prevalence of UC in Korea are still lower than those of Western countries, but have been rapidly increasing during the past decades. Various medical and surgical therapies, including biologics, are currently used for the management of UC. However, many challenging issues exist, which sometimes lead to differences in practice between clinicians. Therefore, the Inflammatory Bowel Disease Study Group of the Korean Association for the Study of Intestinal Diseases established the first Korean guideline for the management of UC in 2012. This is an update of the first guideline. It was generally made by the adaptation of several foreign guidelines as was the first edition, and encompasses treatment of active colitis, maintenance of remission, and indication of surgery for UC. The specific recommendations are presented with the quality of evidence and classification of recommendations.