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Background The clinical impact of continuing or stopping 5-aminosalicylate (5-ASA) after escalating to treatment with an anti-tumour necrosis factor (TNF) agent in patients with inflammatory bowel disease (IBD) is currently unclear. We aimed to compare the outcomes of IBD patients who stopped or continued 5-ASA after starting anti-TNF therapy. Methods We analysed data obtained from the Korean National Health Insurance claims database between 2007 and 2020. Our analysis included IBD patients already on 5-ASA treatment who started anti-TNF treatment. We compared the prognosis of patients who stopped 5-ASA within 90 days of anti-TNF initiation with those who continued 5-ASA. The primary outcome was any adverse clinical event defined as a composite of intestinal surgery, IBD-related hospitalization, or new corticosteroid use. Kaplan-Meier method and Cox proportional hazards models at landmark time were used to calculate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs). Results Among 62,262 patients diagnosed with IBD during the study period, 7,442 patients were included for analysis. A total of 1,037 (13.9%) patients discontinued 5-ASA within 90 days of starting anti-TNF therapy (Figure 1). Among the included patients, 4,479 (60.2%) had Crohn’s disease, while 2,963 (39.8%) had ulcerative colitis (Table 1). Discontinuation of 5-ASA was not associated with an increased risk of any adverse clinical events, as well as its component outcomes of intestinal surgery, IBD-related hospitalization, and corticosteroid use, with aHRs of 1.011 (95% CI, 0.934 to 1.095), 0.954 (95% CI 0.760 to 1.198), 0.995 (95% CI 0.894 to 1.107), and 0.969 (95% CI, 0.890 to 1.056), respectively (Table 2). In addition, the cumulative incidence of each adverse clinical event, as well as the composite outcome, were not significantly different between the two groups (all, p > 0.05) (Figure 2). Subgroup analysis by sex, IBD type, the timeframe of anti-TNF use, pre-anti-TNF 5-ASA use duration, pre-anti-TNF corticosteroid use, pre-anti-TNF hospitalizations, pre-anti-TNF emergency department visits, and anti-TNF agent type also showed no significant difference in the development of adverse clinical events between the two groups. Conclusion In this nationwide population-based study, we observed that discontinuing 5-ASA after starting anti-TNF therapy was not associated with an increased risk of adverse clinical events.

Background For patients living with inflammatory bowel diseases (IBD), the ultimate treatment goal is “normal life”. However, no patient-reported outcome measurement (PROM) exists to measure the level of life normality in IBD. We previously asked patients across the world (5 continents) to identify and rank-order items important to their “normal life”. The top-25 ranked items are being used for subsequent PROM development. In this study, we aimed to compare the perception of healthcare professionals (HCP) and patients with IBD on normal life. Methods IBD patients without an ostomy, pouch or significant comorbidities were interviewed in their mother tongue in 5 continents about “normal life” using a semi-structured interview guide. All items indicated as important were extracted from translated transcripts using directed content analysis (1) until saturation of items occurred. Categorisation was guided by the Wilson’s & Cleary’s Quality of Life model. (2) Second, in an online Delphi procedure, interviewed patients and HCP from each participating centre scored importance of each item on a 0-10 scale. Items scored 7 or higher by >75% were considered important to the respective group. Patient-ranked items were then presented to a patient focus group to clarify wording and merge similar items. Items merged in the patient focus group were merged similarly in HCP rankings. Third, HCP- and patient-rankings were compared. We compared top-25 items selected for PROM development and top-3 items per category. Results 45 CD and 40 UC patients spread over 6 countries were interviewed (median age 36, 56% male, 68% employed, median disease duration 7 years [IQR 4-15]) (table 1). Saturation occurred after 33 CD and 36 UC interviews, yielding 156 unique items. In the Delphi procedure, 54 patients considered 31 items important for normal life with IBD of which 25 remained after focus group discussion. 34 HCP (12 IBD nurses, 16 IBD gastroenterologists, 6 colorectal surgeons) considered 72 items important. Top-25 rankings overlapped in 15 items between patients and HCP, being 5 of 12 physical, 1 of 4 activities, 2 of 3 social, 4 of 11 psychological items and 3 of 5 circumstances (table 2). Top-3 rankings per category overlapped in 2 physical, 1 activities, 2 social, 1 psychological items and 2 circumstances (table 3). Conclusion We identified discrepancies in the perception of normal life with IBD between patients living with IBD and healthcare professionals (HCP). Of top-25 selected items for PROM development, 15 items overlapped between patients and HCP. Of top-3 items per category, the least overlap was seen in activities and psychological items. PROM development and international validation is ongoing.

Background Infliximab (IFX), a monoclonal antibody approved for treating Crohn’s disease (CD), is known to show differing drug clearances in patients according to several clinical factors. However, information on the population pharmacokinetics (PKs) of intravenous (IV) IFX is lacking for Korean patients with CD. Therefore, in this study, we aimed to establish a PK model of IV IFX for this population. Methods We retrospectively analyzed data of CD patients treated with IV IFX at Asan Medical Center, a tertiary university hospital, from April 2019 to March 2022. Serum trough IFX concentration, clinical laboratory values, Crohn’s disease activity index, and demographic data were collected. NONMEM® version 7.5 was used for nonlinear mixed effects modeling. Results Of the one hundred patients included for analysis in this study, 72 were male (72.0%) (Table 1). No patient had detectable antibodies to IFX. [SJ1] A total of 823 serum IFX concentration data were collected and analyzed for fitting according to the minimization of objective function value and weighted residuals. As a result, a one-compartment population PK model with first-order elimination best described the serum trough IFX concentration measurements. Population PK estimates were 0.012 L/h for clearance (CL) (95% confidence interval: 0.012–0.013) and 6.301 L for the volume of distribution (V) (95% confidence interval: 5.932–6.671) (Table 2). Covariate analysis showed that CL and V increased as body weight increased. CL was higher in patients with low serum albumin, high serum C-reactive protein, and older age, with differing coefficients for each covariate (Figure 1). The final covariate model predicted the observed concentration-time profiles of IFX reasonably well (Figure 2). Conclusion We established a population PK model of IV IFX for CD patients in Korea. The final covariate model showed that the CL of IFX was affected by serum albumin and C-reactive protein levels, in addition to body weight and age.

Background We aimed to assess the gene expression profiles of uninflamed small bowels in patients with Crohn’s disease (CD) to identify its accompanying molecular alterations. Methods We performed RNA sequencing of the uninflamed small bowel tissues obtained from 70 patients with ileal CD, and 9 patients with colon cancer (non-CD controls) during bowel resection. Differentially expressed gene (DEG) analyses were performed using DESeq2. Gene set enrichment, correlation, and cell deconvolution analyses were applied to identify modules and functionally enriched transcriptional signatures of CD. Results A comparison of CD patients and non-CD controls revealed that of the 372 DEGs, 49 protein-coding genes and 5 lncRNAs overlapped with the IBD susceptibility loci. The pathways related to immune and inflammatory reactions were upregulated in CD, while metabolic pathways were downregulated in CD. Compared with non-CD controls, CD patients had significantly higher proportions of immune cells, including plasma cells (P=1.15×10-4), and a lower proportion of epithelial cells (P=1.12×10-4). Co-upregulated genes (M14 module) and co-downregulated genes (M9 module) were identified in CD patients. The M14 module was enriched in immune-related genes and significantly associated with the responses to anti-TNF therapy. Intestinal tissue transcriptomic analysis of 3 independent cohorts, identified M14 module upregulation in non-responders at baseline, which was predictive of response with acceptable discrimination ability (area under the curve of 77~83%). Conclusion The differences in gene expression and cellular composition between CD patients and non-CD controls imply significant molecular alterations, which are associated with the response to anti-TNF treatment.

Background Upadacitinib (UPA) demonstrated efficacy and safety as induction and maintenance therapy for ulcerative colitis (UC) in Phase 3 trials U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026). This post-hoc analysis aims to characterise the benefit-risk profile of UPA induction and maintenance therapy vs placebo (PBO) in patients (pts) with moderately to severely active UC based on a number needed to treat/harm (NNT/NNH) analysis. Methods Efficacy and safety data from the pooled intention-to-treat population of U-ACHIEVE and U-ACCOMPLISH trials were included. Pts received UPA 45 mg (UPA45) once daily (QD) or PBO for 8 weeks (induction trials). Clinical responders (per Adapted Mayo score) at Week 8 of induction were re-randomised to receive UPA 15 mg (UPA15) or 30 mg (UPA30) QD, or PBO in the 52-week maintenance study. The primary efficacy endpoint was clinical remission per Adapted Mayo score. Secondary outcomes are listed in Table 1 and safety outcomes are listed in Table 2. N, percentages, and outcome differences compared by Z test were reported. NNT/NNH was calculated as the inverse of the difference in proportions achieving efficacy/safety outcomes for UPA vs PBO. Positive NNT values indicate greater efficacy and negative NNH values imply lower safety risk for UPA vs PBO. Results A significantly greater proportion of pts achieved clinical remission at induction (UPA45 29.9% vs PBO 4.4%) and maintenance (UPA15 40.4%, UPA30 53.6% vs PBO 10.8%) with UPA vs PBO, as well as all secondary endpoints (all p Conclusion This post-hoc Phase 3 analysis demonstrates greater efficacy and generally comparable safety of UPA vs PBO, indicating a favourable benefit-risk profile for UPA in pts with moderately to severely active UC.

Background CT-P13 SC is the only subcutaneous (SC) formulation of infliximab (IFX) approved to treat Crohn’s disease (CD) or ulcerative colitis (UC). The primary CT-P13 SC study reported no increased risk of immunogenicity (anti-drug antibody [ADA]/neutralising antibody [NAb] positivity) with CT-P13 SC vs. intravenous (IV) in CD or UC patients (pts) despite a numerical trend for lower ADA/NAb positivity with SC dosing.1 It is unclear whether high trough levels (Ctrough) during IFX dosing may account for these observations. Methods This post hoc analysis of part 2 of the randomised, parallel-group CT-P13 SC study (NCT02883452) evaluated predictors of immunogenicity in CD or UC pts treated with CT-P13. The relationship of Week (W) 22 and 30 ADA and NAb positivity rates with W22 CT-P13 Ctrough, under stable dosing, was examined. The optimal threshold of Ctrough for predicting ADA positivity was estimated by receiver operating characteristic (ROC) methodology using W22 data. A generalised linear regression model identified predictive factors for ADA and NAb positivity at W22 and W30. The proportion of pts with Ctrough levels equal to or above the calculated predictive threshold, and ADA/NAb positivity rates, were determined by treatment arm. Results The analysis included 131 pts randomised at W6 to receive CT-P13 SC (n=66) or CT-P13 IV (n=65) as maintenance treatment. Of 113 pts with both Ctrough and immunogenicity data available at W22, 60 were ADA negative, and 53 were ADA positive. At W22, median Ctrough levels were significantly higher in the ADA-negative vs. ADA-positive group (16.95 vs. 3.44 μg/mL, p ROC analysis showed that a Ctrough threshold of 4.695 μg/mL optimally predicted ADA positivity with 66.2% sensitivity and 77.3% specificity (area under the ROC curve, 0.766 [95% confidence interval, 0.664–0.869]; Fig. 2). Concomitant medication use and W22 Ctrough ≥4.695 μg/mL were significantly associated with lower rates of ADA and NAb positivity at W22 and were significant predictors of lower rates of ADA and NAb positivity at W30 (Fig. 3). At W22, a higher proportion of pts had Ctrough ≥4.695 μg/mL in the SC vs. IV arm (96.5% vs. 25.0%, p Conclusion Ctrough level predicted ADA and NAb positivity in CD or UC pts, with levels ≥4.695 μg/mL significantly associated with lower rates of positivity, providing initial evidence on high zone tolerance of IFX. Reference: 1. Schreiber S et al. Gastroenterology 2021;160:2340–2353.

Background Total proctocolectomy has been recommended for patients with ulcerative colitis (UC)-associated dysplasia due to the risk of its progression to colorectal cancer or metachronous recurrence. Recently, endoscopic resection has been considered as a therapeutic option for dysplasia in UC, and endoscopic submucosal dissection (ESD) has been recommended for lesions where endoscopic mucosal resection is unsuitable. We aimed to investigate the long-term outcomes of UC patients who underwent ESD for dysplasia or early colorectal cancer Methods We retrospectively reviewed 47 patients with UC-associated dysplasia/cancer referred for potential ESD to treat non-polypoid or sessile dysplasia between August 2009 and August 2022 at Asan Medical Center, a tertiary hospital in Seoul. Indications for ESD were determined according to the criteria applied for sporadic colorectal neoplasms based on magnifying endoscopy. Results The median age at UC diagnosis was 45 years, and 24 patients (51%) were male. The median duration of UC was 13 years. Colectomy was recommended for 11 patients, and the remaining 36 patients underwent ESD. The en bloc resection rate was 88.9% (32/36), and the histologic complete resection rate was 77.8% (28/36). Five patients underwent colectomy after ESD due to missed adenocarcinoma, deep submucosal cancer, and multiple dysplasia. A total of 31 patients were followed-up after ESD. Their mean (standard deviation) follow-up period was 45.9 (±30.6) months, and the mean number of post-ESD surveillance endoscopies was 3 (±2). Local recurrence of dysplasia occurred in 3 (3/31, 9.6%) patients; metachronous recurrence occurred in 7 patients (7/31, 22.6%). There were no cases of metachronous colorectal cancer. Conclusion ESD for discrete dysplastic lesions in UC patients is feasible and shows favorable outcomes in terms of colorectal cancer prevention. However, surveillance colonoscopy with short intervals is warranted due to the high metachronous recurrence rate.

Background Gut microbial dysbiosis has been suggested to contribute to pathogenesis of inflammatory bowel disease (IBD). Vedolizumab (VDZ), an α4β7 integrin blocker, has been used as an effective agent for patients with IBD. However, effect of VDZ on gut microbiome and its relationship with efficacy outcomes are still unclear. We investigated gut microbial change in patients with ulcerative colitis (UC) during VDZ treatment. Methods Patients with UC were prospectively enrolled and were given a 300 mg infusion of VDZ at weeks 0, 2, and 6 as an induction therapy and then every 8 weeks as a maintenance therapy. In cases of insufficient response, the interval of maintenance therapy was shortened to every 4 week infusion. Faecal samples were collected at weeks 0, 14, and 54 and 16S rRNA gene microbiome profiling analysis was performed. Clinical remission (CREM), clinical response (CRES), endoscopic mucosal healing (MH) and biochemical response (BioRES) were evaluated. Compositional differences in microbiome were analysed according to CREM, CRES, MH, and BioRES at weeks 0, 14, and 54. Results Faecal samples were collected from 27 patients and patients were classified according to their outcomes (Table 1). In the analyses regarding species richness (ACE, Chao1, Jackknife, The number of OTUs) and diversity indices (NPShannon, Shannon, Simpson, Phylogenetic Diversity), no significant difference was observed among groups at weeks 0, 14, and 54. There were no significant changes in microbial composition at week 14 and 54, respectively compared to basal level. However, compared to baseline, relative abundance of genus Prevotella showed significant differences between groups which achieved normalsation of C-reactive protein or not (p=0.0394) (Figure 1). In the linear discriminant analysis effect size (LEfSe) analysis, the genus Actinomyces and the species Actinomyces odontolyticus group increased in patients who had no response at efficacy outcomes (achievement of clinical remission, achievement of clinical response, achievement of endoscopic mucosal healing, normalisation of C-reactive protein, and normalisation of faecal calprotectin) at week 14, compared to week 0 (Fig 2A). The genus Clostridium_g24, the species Paraprevotella_uc and PAC001224_s were also significantly increased in the same patient group at week 54 (Fig 2B). Conclusion In UC patients treated with VDZ, microbial composition showed differences depending on the achievement of efficacy outcomes. Further studies regarding the causal relationship between microbial composition and outcomes are warranted with a larger number of patients.

Background A clinical decision support tool (CDST) has been developed and validated for predicting outcomes of vedolizumab (VDZ) therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC), respectively. We aimed to validate each CDST for predicting outcomes and need for drug optimisation in patients with inflammatory bowel disease (IBD). Methods We retrospectively analysed 166 patients with IBD (71 with CD, and 95 with UC) treated with VDZ from January 2017 through November 2021 at 6 tertiary referral centres in Korea. We assessed clinical remission (CREM) and response (CRES), corticosteroid-free clinical remission (CfCREM) and response (CfCRES), biochemical response (BioRES), endoscopic healing (EH), and need for drug optimisation by CDST-defined response groups (low vs. intermediate to high probability group with a cut-off of 13 points in CD, Table 1A, and 26 points in UC, Table 2A, respectively). CDST was evaluated by area under the receiver operating characteristics curve (AUC) and test performance. Results Patients were classified as low (27 with CD, and 28 with UC) and intermediate to high probability group (44 with CD, and 67 with UC). Among CD patients, there showed no significant difference in the response rate of any outcomes between CDST-defined groups. Among UC patients, the rates of CREM (41.0 vs. 18.5%, p=0.040) and EH (56.5 vs. 33.3%, p=0.045) at week 14 were higher among intermediate to high probability group. The rate of drug optimisation during maintenance therapy was also higher in low probability group (54.2 vs. 30.2%, p=0.038). At week 26, CDST for CD discriminated CfCREM with an AUC of 0.656 (sensitivity 87.5%, specificity 43.8%) (Table 1B). Meanwhile, CDST for UC identified CREM with an AUC of 0.606 (sensitivity 83.3%, specificity 37.9%) at week 14 (Table 2B). BioRES of FC was identified with an AUC of 0.649 (sensitivity 84.6%, specificity 45.2%) at week 26. BioRES of CRP was identified with an AUC of 0.660 (sensitivity 68.8%, specificity 63.2%) at week 26, and with an AUC of 0.642 (sensitivity 70.0%, specificity 58.3%) at week 54. Drug optimisation during maintenance therapy was identified with an AUC of 0.620 (sensitivity 54.2%, specificity 69.8%). Conclusion Both CDST for CD and UC can be used to help guide VDZ therapy for Korean patients to predict BioRES with a fair discriminant function and moderate sensitivity.

Background In comparison with the general population, patients with Crohn’s disease (CD) are at higher risk of developing small bowel adenocarcinoma (SBA). However, with low prevalence of SBA, data regarding the impact of CD on survival are lacking. We investigated the impact of CD on survival in patients with SBA. Methods From January 1998 through July 2021, patients with histologically confirmed SBA were retrospectively collected and classified into binary, namely, sporadic SBA and CD-associated SBA groups. Patients with duodenal SBA were excluded. The overall survival (OS) and factors associated with survival were analysed. Results Of 127 patients with SBA, 115 patients were sporadic SBA and 12 were CD-associated SBA (Table 1). Compared to patients with sporadic SBA, poorly differentiated tumour was more common among patients with CD-associated SBA (41.7 vs. 14.8%, p=0.030). Other baseline demographic characteristics including age at the diagnosis of SBA, sex, Charlson morbidity score more than 2 points, smoking history, family history of cancer, location of SBA, initial stage based on American Joint Committee on Cancer (AJCC) staging system, and treatment showed no significant difference. In survival analyses, the 1-year (yr), 2-yr, and 5-yr OS were lower in patients with CD-associated SBA, without statistical significance (1-yr OS; 81.8 vs. 90.5%, 2-yr OS; 61.4 vs. 81.7, 5-yr OS; 61.4 vs. 69.1%, p=0.590) (Fig 1). Factors associated with decreased survival were disease stage (AJCC stage IV) (hazard ratio [HR] 5.485; 95% confidence interval [CI], 2.442–12.279, p Conclusion The OS of patients with CD-associated SBA was not significantly lower than that of patients with sporadic SBA. The independent risk factors for survival were the stage of SBA and type of treatment, not Crohn’s disease.

Background The characteristics and incidence of esophago-gastroduodenal involvement of Crohn’s disease (CD) are unclear in Korea. We aim to investigate the prevalence and clinicopathological characteristics of CD with esophago-gastroduodenal involvement. Methods A total of 115 patients with CD who underwent esophagogastroduodenoscopy (EGD) including esophageal, gastric and duodenal biopsies were enrolled prospectively between 2020 and 2021 at a tertiary care center. Total of five specimens obtained from the esophagus, gastric body and antrum, and duodenal bulb and second portion respectively during endoscopy were histologically reviewed. The presence of Helicobater pylori was evaluated by immunohistochemical analysis. Results The median age was 30.0 (interquartile range [IQR] 25.0–37.0) years and 74.8% were male. Of total, 32.2% had were symptoms including epigastric pain (29.7%), bloating (27.0%) and dyspepsia (13.5%). Based on histological features, 56 patients (48.7%) were identified as having UGI involvement (15 esophageal, 44 gastric, and 36 duodenal). Of 115 included patients, bamboo- joint-like appearance in the stomach was founded in 81 (70.4%) and their histologic findings were mostly revealed as non-specific feature. Notable histopathological findings included non-caseating granulomas in 8 cases (7.0%), focally enhanced gastritis in 38 cases (33.0%), and lymphocytic esophagitis in 13 cases (10.7%). Among 115 cases, 6 cases (5.2%) were H. pylori positive and 109 cases (94.8%) were H. pylori negative. Conclusion The prevalence of esophago-gastroduodenal involvement of CD was relatively high among CD patients who underwent EGD in Korea. A high suspicion of CD with esophago-gastroduodenal involvement with endoscopic biopsy is warranted when patients have abnormal endoscopic findings.

Background We aimed to investigate the efficacy of oral beclomethasone dipropionate (BDP) as an add-on therapy to concomitant drugs and to clarify the predictive factors for response to oral BDP in Korean patients with ulcerative colitis (UC). Methods Patients with a stable concomitant drug regimen with exposure to oral BDP (5 mg/day) within 30 days before initiation were included. The partial Mayo score (pMS) was used to evaluate response to oral BDP. Clinical remission (CREM) was defined as a posttreatment pMS ≤1 point. Clinical response (CRES) was defined as an at least 2-points decrease in the posttreatment pMS and an at least 30% decrease from the baseline pMS. Patients without CREM or CRES were considered nonresponders (NRs). Results Of total 100 patients, 37 showed CREM, 19 showed CRES, and 44 were NRs (Table 1). The CREM group included more patients with mild disease activity (75.7% vs. 43.2%, P=0.011) than the NR group. In contrast to NR group, responders including CREM and CRES showed significant improvement of posttreatment ESR and CRP (ESR with P=0.001, CRP with P=0.004, respectively). Moreover, initial rectal bleeding subscore (RBS) was significantly different between CREM and CRES, or NR (both with P Conclusion Oral BDP is efficacious as an add-on therapy in Korean UC patients. In case of acute aggravation, patients with mild disease activity, especially low RBS, may be good candidates for oral BDP.

Background Data on the protective immune status against measles, mumps, rubella, varicella zoster virus (VZV), hepatitis A virus (HAV) and Epstein–Barr virus (EBV) infection among inflammatory bowel disease (IBD) patients is still lacking. Therefore, we investigated seropositivity to viral infectious diseases and associated factors in Korean IBD patients. Methods In this retrospective cohort study, serum immunoglobulin G (IgG) antibody positivity against measles virus, mumps virus, rubella virus, VZV, HAV and EBV viral capsid antigen (VCA) were measured in consecutive patients with Crohn’s disease (CD) or ulcerative colitis (UC) who first visited the IBD clinic of Asan Medical Centre, Seoul, Korea. Seropositivities and their associated factors were analysed. Results Of 263 study subjects, one hundred sixty seven (67.3%) were males. Median age at diagnosis of IBD and median age at serologic tests were 28 years (interquartile range [IQR], 20–41) and 30 years (IQR, 22–46), respectively. UC patients were 50.9% (n = 134) and median disease duration at serologic tests were 6 months (IQR, 0–59). One hundred eighty two patients (69.2%) were not under any immunosuppressive therapy. Seropositivity rates were 84.0% for measles, 85.2% for mumps and 66.5% for rubella. IgG anti-VZV positivity rates were 87.4%, but only half (50.0%) were positive for IgG anti-HAV. IgG against EBV VCA was positive in 93.6%. Younger age at IBD diagnosis ( Conclusion Seroprotection rates for common vaccine-preventable diseases and EBV among Korean IBD patients with or without immunosuppressive therapy were similar to those of the general Korean population. In the young age group under 40 years old, immunity to measles, rubella and HAV is needed to be checked together with proper vaccination as needed.

Background As the treatment paradigm of inflammatory bowel disease changes towards patient-centred treatment, it is becoming increasingly important to measure patient-reported outcomes (PROs). We aimed to identify the changes of emotional health and work- or activity-related outcomes one year after the diagnosis of ulcerative colitis (UC) and its predictors in patients enrolled in the moderate-to-severe UC in Korea (MOSAIK) cohort (ClinicalTrials.gov: NCT02229344). Methods The MOSAIK cohort is the first nationwide, prospective, inception cohort on moderate-to-severe UC in Korea. Between August 2014 and March 2017, consecutive patients from 30 tertiary hospitals were enrolled. PRO data including hospital anxiety and depression scale (HADS) for emotional health, and work productivity and activity impairment (WPAI) questionnaire for work- or activity-related outcomes, were collected within the first 4 weeks of diagnosis via patient surveys. Wilcoxon-signed rank tests and linear mixed-effects regression models were used for paired comparisons between baseline and 1 year and assessing the predictors of HADS and WPAI. Results Of the 368 enrolled patients, 333 eligible patients were analyzed. The mean age at diagnosis was 39 years and 57.7% (192/333) were male. A considerable number of patients had moderate to high (≥11 by HADS) levels of anxiety and depression (16.0% and 20.5%, respectively), and about half of patients had work and activity impairment (45.5% and 45.8%%, respectively) at baseline. After 1 year follow-up, significant reduction of anxiety and depression (mean difference [MD] in HADS score -1.3 for both anxiety and depression, P Conclusion Newly diagnosed moderate-to-severe UC patients had considerable anxiety, depression, and work and activity impairment at baseline, but significant improvement was noted after 1 year. Controlling symptoms and disease activity was the most important factor to improve PROs after 1 year.