A new opportunity for innovative inflammatory bowel disease research: the moderate-to-severe ulcerative colitis in Korea (MOSAIK) cohort study.
Ontology highlight
ABSTRACT:
SUBMITTER: Lee CK
PROVIDER: S-EPMC6361028 | biostudies-literature | 2019 Jan
REPOSITORIES: biostudies-literature
Publications
A new opportunity for innovative inflammatory bowel disease research: the moderate-to-severe ulcerative colitis in Korea (MOSAIK) cohort study.
Lee Chang Kyun CK Lee Kang-Moon KM Park Dong Il DI Jung Sung-Ae SA Jeen Yoon Tae YT Park Young Sook YS Kim Hyo Jong HJ
Intestinal research 20190125 1
Similar Datasets
Project description:BackgroundMany patients with ulcerative colitis (UC) gain weight after treatment. However, the clinical significance of weight gain in these patients remains unclear. This study aimed to evaluate body weight changes after treatment in patients newly diagnosed with moderate-to-severe UC and their effects on patients' prognosis.MethodsThe change in weight between diagnosis and 1 year after treatment in 212 patients enrolled in the MOSAIK cohort (mean age, 40 years; males, 60%) was analyzed. Significant weight gain was defined as a weight increase of ≥ 5% from the baseline at 1 year. Factors associated with significant weight gain and the effect of significant weight gain on the risk of major adverse outcomes (clinical relapse, hospitalization, and new use of steroids or biologics) during a follow-up period of 20 months were evaluated.ResultsMean weight gain at 1 year was 1.7 ± 4.2 kg. The proportion of overweight/obese patients increased by 9.0% from 37.9% to 46.9%. Thirty-two percent had significant weight gain; extensive colitis at diagnosis was the only factor associated with significant weight gain (odds ratio 6.5, 95% confidence interval 1.4-31.0, p = 0.006). In multivariable analysis, significant weight gain was not associated with the risk of major adverse outcomes. Weight loss symptoms at diagnosis were associated with an increased risk for new steroid use after 1 year.ConclusionsApproximately one-third of patients with moderate-to-severe UC had significant weight gain after 1 year of treatment. However, significant weight gain was not associated with the patient's prognosis.
| S-EPMC10664292 | biostudies-literature
Project description:Background/aimsImproving quality of life has been gaining importance in ulcerative colitis (UC) management. The aim of this study was to investigate changes in health-related quality of life (HRQL) and related factors in patients with moderate-to-severe UC.MethodsA multicenter, hospital-based, prospective study was performed using a Moderate-to-Severe Ulcerative Colitis Cohort in Korea (the MOSAIK). Changes in HRQL, evaluated using the 12-Item Short Form Health Survey (SF-12) and Inflammatory Bowel Disease Questionnaire (IBDQ), were analyzed at the time of diagnosis and 1 year later.ResultsIn a sample of 276 patients, the mean age was 38.4 years, and the majority of patients were male (59.8%). HRQL tended to increase in both the IBDQ and SF-12 1 year after diagnosis. A higher partial Mayo score was significantly related to poorer HRQL on the IBDQ and SF-12 in a linear mixed model (p<0.01). Inflammatory markers such as C-reactive protein (CRP) or erythrocyte sedimentation rate also showed a negative correlation on HRQL (p<0.05). Patients whose IBDQ score improved by 16 or more (71.2%) in 1 year were younger, tended to be nonsmokers, and had a lower partial Mayo score and CRP than those whose IBDQ score did not. There was no significant association between HRQL and disease extent, treatments at diagnosis, or the highest treatment step during the 1-year period.ConclusionsOptimally controlled disease status improves HRQL in patients with moderate-to-severe UC. The partial Mayo score and inflammatory markers may be potential indicators reflecting the influence of UC on patient`s daily lives.
| S-EPMC9099394 | biostudies-literature
Project description:Curcumin was shown in placebo-controlled trials to induce remission in mild-moderate ulcerative colitis (UC). QingDai (QD, Indigo), another herbal extract, showed efficacy in two UC trials from Japan, but evidence in the Western population is scant. We report on the use of curcumin-QingDai combination (CurQD) for the treatment of moderate-severe UC. Patient 1 was a 24-year-old male with severe UC refractory to cyclosporine and corticosteroids. He partially responded to infliximab but later lost response to an optimized dose of infliximab in combination with 6-mercaptopurine, presenting with worsening symptoms and severe Mayo 3 mucosal inflammation. Initiation of CurQD 2.5 g/day resulted in rapid cessation of blood per rectum. Complete clinical remission ensued within few weeks. Follow-up endoscopies performed 12 weeks later showed only minimal residual inflammation. Infliximab was later stopped due to reimbursement issues, and the patient was successfully maintained on lower doses of CurQD and 6-mercaptopurine for 31 months. Two flares have responded to a temporary increase in QD component dose. Patient 2 was a 59-year-old female with extensive UC not responding to maximal oral + topical 5-ASA and corticosteroids. Despite severe mucosal ulceration (Mayo 3) found on endoscopy, she refused the recommendation for biologics and opted for a short-term limited trial of CurQD. This was initiated at 2,000 mg/day and induced rapid clinical remission. Lower endoscopies performed after 2 and 5 months on CurQD showed complete mucosal healing, and the patient maintained her clinical remission on low-dose CurQD for 49 months. No adverse events were noted in the 2 patients.
| S-EPMC9941783 | biostudies-literature
Project description:Background/aimsWe previously reported that patients with moderate-to-severe ulcerative colitis (UC) often experience common mental disorders (CMDs) such as anxiety and depression, necessitating immediate psychological interventions within the first 4 weeks of diagnosis. In this 3-year follow-up study of the MOSAIK cohort in Korea, we examined the effects of CMDs at initial diagnosis on clinical outcomes and health-related quality of life (HRQoL).MethodsWe examined differences in clinical outcomes (evaluated based on clinical response, relapse, hospitalization, and medication use) and HRQoL (assessed using the Inflammatory Bowel Disease Questionnaire [IBDQ] and Short Form 12 [SF-12]) according to Hospital Anxiety and Depression Scale (HADS) scores at diagnosis.ResultsIn a study involving 199 UC patients, 47.7% exhibited significant psychological distress (anxiety and/or depression) at diagnosis. Clinical follow-up showed no major differences in outcomes, including remission rates, response rates, or hospitalization rates, between patients with anxiety or depression at diagnosis and patients without anxiety or depression at diagnosis. The HRQoL at the end of follow-up was notably lower in those with baseline CMDs, particularly anxiety, across all domains of the IBDQ and SF-12. Linear mixed-effect models revealed that higher HADS scores, as well as higher Mayo scores, were independently associated with lower IBDQ scores and both summary domains of the SF-12. Additionally, regular attendance at follow-up visits during the study period was also related to improvements in HRQoL (all p<0.05).ConclusionsWhile CMDs present at the time of UC diagnosis did not influence long-term clinical outcomes, they persistently impaired HRQoL. Our findings support the routine incorporation of psychological interventions into the long-term management of moderate-to-severe UC.
| S-EPMC11907251 | biostudies-literature
Project description:Background and aimsFilgotinib is a small molecule that selectively inhibits Janus kinase [JAK] type 1. It is already approved for the treatment of rheumatoid arthritis and is being evaluated for the management of patients with moderate to severe ulcerative colitis [UC]. The purpose of this review is to provide an overview of the currently available data on filgotinib and to define how to position this new drug in the treatment algorithm of patients with UC.MethodsThe Pubmed, Embase and Scopus databases were searched up to June 25, 2021 in order to identify studies reporting efficacy and safety data of filgotinib in patients with UC.ResultsData from a phase III study enrolling UC patients with moderate to severe disease show that filgotinib is effective with a reassuring safety profile. Filgotinib treatment is not associated with a greater risk of thrombosis and herpes zoster infections compared to other JAK inhibitors. However, animal studies reported impaired spermatogenesis and histopathological effects on male reproductive organs, making it necessary to deepen this aspect in dedicated human studies.ConclusionsFilgotinib is an effective and safe drug for treatment of both biologic-naive and biologic-experienced patients with moderate to severe UC and may soon be available.
| S-EPMC9228886 | biostudies-literature
Project description:Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We characterized tofacitinib pharmacokinetics in patients with moderate to severe UC, and the effects of covariates on variability in pharmacokinetic parameter estimates. Data were pooled from 1 8-week phase 2 and 2 8-week phase 3 induction studies, and a 52-week phase 3 maintenance study (N = 1096). Population pharmacokinetic analysis was conducted using nonlinear mixed-effects modeling. Potential predictors of apparent oral clearance (CL/F) and volume of distribution (V/F) were evaluated. The PK was described by a 1-compartment model parameterized in terms of CL/F (26.3 L/hour [h]) and V/F (115.8 L), with first-order absorption (Ka ; 9.85 h-1 ) and lag time (0.236 h). The derived elimination half-life was approximately 3.05 h. In the final model, baseline creatinine clearance, sex, and race (Asian vs non-Asian) were significant covariates for CL/F; significant covariates for V/F were age, sex, and body weight; baseline albumin and baseline Mayo score were not significant covariates. CL/F between-patient variability was estimated at 22%. Tofacitinib exposure did not change significantly over the duration of induction/maintenance treatment in patients with UC. Although statistically significant covariate effects on CL/F and V/F were observed, the magnitude of the effects are not clinically significant. Therefore, dose adjustment/restrictions for age, body weight, sex, race, or baseline disease severity are not required during tofacitinib treatment. ClinicalTrials.gov numbers: NCT00787202, NCT01465763, NCT01458951, NCT01458574.
| S-EPMC7986169 | biostudies-literature
Project description:A subset of patients with ulcerative colitis (UC) present with, or progress to, moderate to severe disease activity. These patients are at high risk for colectomy, hospitalization, corticosteroid dependence, and serious infections. The risk of life-threatening complications and emergency colectomy is particularly high among those patients hospitalized with acute severe ulcerative colitis. Optimal management of outpatients or inpatients with moderate to severe UC often requires the use of immunomodulator and/or biologic therapies, including thiopurines, methotrexate, cyclosporine, tacrolimus, TNF-α antagonists, vedolizumab, tofacitnib, or ustekinumab, either as monotherapy or in combination (with immunomodulators), to mitigate these risks. Decisions about optimal drug therapy in moderate to severe UC are complex, with limited guidance on comparative efficacy and safety of different treatments, leading to considerable practice variability. Therefore, the American Gastroenterological Association prioritized development of clinical guidelines on this topic. To inform the clinical guidelines, this technical review was completed in accordance with the Grading of Recommendations Assessment, Development and Evaluation framework. Focused questions in adult outpatients with moderate to severe UC included: (1) overall and comparative efficacy of different medications for induction and maintenance of remission in patients with or without prior exposure to TNF-α antagonists, (2) comparative efficacy and safety of biologic monotherapy vs combination therapy with immunomodulators, (3) comparative efficacy of top-down (upfront use of biologics and/or immunomodulator therapy) vs step-up therapy (acceleration to biologic and/or immunomodulator therapy only after failure of 5-aminosalicylates, and (4) role of continuing vs stopping 5-aminosalicylates in patients being treated with immunomodulator and/or biologic therapy for moderate to severe UC. Focused questions in adults hospitalized with acute severe ulcerative colitis included: (5) overall and comparative efficacy of pharmacologic interventions for inpatients refractory to corticosteroids, in reducing risk of colectomy, (6) optimal dosing regimens for intravenous corticosteroids and infliximab in these patients, and (7) role of adjunctive antibiotics in the absence of confirmed infections.
| S-EPMC7117094 | biostudies-literature
Project description: Not available
| S-EPMC10523991 | biostudies-literature
Project description:BackgroundSustaining clinical remission is an important treatment goal in moderate-to-severe UC. This post hoc exploratory analysis assessed the long-term efficacy of vedolizumab in the subset of patients with UC in the GEMINI 1 study who were in clinical remission by week 14 after 3 induction doses, administered at weeks 0, 2, and 6.MethodsSustained clinical remission (primary endpoint) was evaluated using 2 definitions: (1) a partial Mayo Score (pMS) of ≤2 with no subscore >1 and (2) a rectal bleeding subscore (RBS) of 0 throughout weeks 14, 26, 38, and 52.ResultsThe proportion of patients in clinical remission at week 14 was significantly higher in patients receiving vedolizumab (n = 620) compared with placebo (n = 149) (pMS: 32.7% vs 20.1% [percentage-point difference (∆) 12.6%; 95% confidence interval [CI], 5.2-20.0]; RBS: 47.3% vs 28.9% [∆18.4%; 95% CI, 10.1-26.7]). Of patients in clinical remission at week 14, a significantly higher proportion of vedolizumab-treated patients achieved sustained clinical remission compared with placebo (pMS: 66.5% vs 26.7%; ∆39.8%; 95% CI, 22.7-56.9; RBS: 56.7% vs 20.9%; ∆35.7%; 95% CI, 22.3-49.1). Findings were consistent in tumor necrosis factor (TNF) antagonist-naive and antagonist-failure patients.ConclusionCompared with placebo, 35%-40% more patients receiving a full induction course of vedolizumab had sustained clinical remission after 52 weeks of therapy. This result was observed irrespective of TNF antagonist treatment history. Clinical remission at week 14 may therefore be a predictor for sustained clinical remission with vedolizumab.
| S-EPMC6499937 | biostudies-literature
Project description:Background and aimThe aim was to assess non-invasive factors among clinical features, laboratory, and bowel ultrasound (BUS) characteristics and to develop a scoring system to predict endoscopic activities for ulcerative colitis (UC) patients.MethodsWe performed a retrospective study collecting UC patients between January 2015 to September 2020. Logistic regression was performed to predict moderate-to-severe endoscopic activities, defined as endoscopic Mayo score ⩾2. Model performance was described with discrimination and calibration ability and validated by internal and external methods.ResultsA total of 103 and 29 patients were enrolled in the modeling and validation groups, respectively. Stool frequency ⩾5 times/day, hematochezia, erythrocyte sedimentation rate (ESR), and colonic wall flow in BUS were included into two predictive models for endoscopic activities, both with good discrimination ability [Area under curve (AUC) 0.879 and 0.882, p < 0.001] and a sensitivity of 76.7% and specificity of 92.3%, which showed an adequate calibration ability by using the Hosmer-Lemeshow test (p = 0.14 and 0.07). The external validation displayed consistent results with the above mentioned. Nomograms were also established for these models.ConclusionWe developed predictive models for endoscopic disease activities by using noninvasive factors based on stool frequency, hematochezia, ESR, and colonic wall blood flow in BUS. These models performed well in the internal and external validation.
| S-EPMC8283041 | biostudies-literature