Earlier surveillance colonoscopy programme improves survival in patients with ulcerative colitis associated colorectal cancer: results of a 23-year surveillance programme in the Japanese population.
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ABSTRACT:
SUBMITTER: Hata K
PROVIDER: S-EPMC2394323 | biostudies-other | 2003 Oct
REPOSITORIES: biostudies-other
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Project description:We previously performed a randomized controlled trial (RCT) comparing targeted and random biopsy in neoplasia detection in patients with ulcerative colitis (UC), which showed the short-term effectiveness of targeted biopsy with one-time colonoscopy. In this retrospective cohort study, we investigated the long-term effectiveness of targeted biopsy in tertiary care hospitals, using the follow-up data from patients with UC for ? 8 years who had enrolled in the initial RCT. The primary outcome was death from colorectal cancer (CRC). Secondary outcomes were advanced neoplasia (CRC or high-grade dysplasia) and colectomy due to neoplasia after the RCT. We compared these outcomes between target and random groups. Data on 195 of the 221 patients (88.2%) enrolled in the previous RCT were collected from 28 institutions between 2008 and 2019. No patients died of CRC in either group, with a median 8.8-year follow-up demonstrating a robustness for targeted biopsy in terms of CRC death prevention. Advanced neoplasia was detected in four and three patients in the target and random groups, respectively. Colectomy was required due to neoplasia in three patients in each group. The chance of developing CRC in patients with a negative colonoscopy was low, and the targeted biopsy appeared effective in this population. Conversely, patients found with low-grade dysplasia at initial RCT have 10-fold higher risk of progression to high-grade dysplasia and/or CRC. Ten extracolonic malignancies were observed during the follow-up, resulting in four deaths. Panchromoendoscopy was used only in 4.6% and targeted biopsy was only performed in 59.1% of colonoscopies. We recommend targeted biopsy rather than > 33 random biopsies in real-world settings under adequate observation by specialists.
| S-EPMC7408776 | biostudies-literature
Project description:ObjectivesThis study provides an overview of the largest and longest-running colonoscopic surveillance program for colorectal cancer (CRC) in patients with long-standing ulcerative colitis (UC).MethodsData were obtained from medical records, endoscopy, and histology reports. Primary end points were defined as death, colectomy, withdrawal from surveillance, or censor date (1 January 2013).ResultsA total of 1,375 UC patients were followed up for 15,234 patient-years (median, 11 years per patient). CRC was detected in 72 patients (incidence rate (IR), 4.7 per 1,000 patient-years). Time-trend analysis revealed that although there was significant decrease in incidence of colectomy performed for dysplasia (linear regression, R=-0.43; P=0.007), IR of advanced CRC and interval CRC have steadily decreased over past four decades (Pearson's correlation, -0.99; P=0.01 for both trends). The IR of early CRC has increased 2.5-fold in the current decade compared with past decade (χ(2), P=0.045); however, its 10-year survival rate was high (79.6%). The IR of dysplasia has similarly increased (χ(2), P=0.01), potentially attributable to the recent use of chromoendoscopy that was twice more effective at detecting dysplasia compared with white-light endoscopy (χ(2), P<0.001). CRCs were frequently accompanied by synchronous CRC or spatially distinct dysplasia (37.5%). Finally, the risk of CRC was not significantly different between "indefinite" or low-grade dysplasia (log-rank, P=0.78).ConclusionsColonoscopic surveillance may have a significant role in reducing the risk of advanced and interval CRC while allowing more patients to retain their colon for longer. Given the ongoing risk of early CRC, patients with any grade of dysplasia who are managed endoscopically should be monitored closely with advanced techniques.
| S-EPMC4517513 | biostudies-literature
Project description:Background and aimsTofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes.MethodsThree cohorts were analysed: Induction [P2/3 induction studies]; Maintenance [P3 maintenance study]; and Overall [all tofacitinib-treated patients in induction, maintenance, or ongoing, open-label, long-term extension studies; as of May 2019]. Proportions and incidence rates [IRs; unique patients with events/100 patient-years] of serious infections [SIs], herpes zoster [HZ] [non-serious and serious], and opportunistic infections [OIs] are reported [censored at time of event].ResultsIn the Induction Cohort [N = 1220], no patients receiving placebo and eight [0.9%] receiving tofacitinib 10 mg twice daily [BID] developed SIs. Maintenance Cohort [N = 592] SI IRs (95% confidence interval [CI]) were 1.94 [0.23-7.00] for placebo and 1.35 [0.16-4.87] and 0.64 [0.02-3.54] for tofacitinib 5 and 10 mg BID, respectively; HZ IRs were 0.97 [0.02-5.42], 2.05 [0.42-6.00], and 6.64 [3.19-12.22], respectively. In the Overall Cohort [N = 1157; 82.9% predominantly received tofacitinib 10 mg BID], SI, HZ, and non-HZ OI IRs were 1.70 [1.24-2.27], 3.48 [2.79-4.30], and 0.15 [0.04-0.38], respectively. No SIs resulted in death.ConclusionsDuring induction, SIs were more frequent with tofacitinib versus placebo. SIs were generally infrequent in the Maintenance and Overall Cohorts, with rates comparable between treatment groups. Maintenance Cohort HZ IR was numerically higher with tofacitinib 10 mg BID versus 5 mg BID. Overall Cohort HZ IRs remained stable over time. Non-HZ OIs and viral infections were rare.
| S-EPMC8218715 | biostudies-literature
Project description:BackgroundThe 52-week safety and efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis were demonstrated in a placebo-controlled phase 2/3 trial. Data from patients who enrolled in the open-label extension study are presented.MethodsRemission and response per the full Mayo score (FMS) and the partial Mayo score (PMS), remission per the Inflammatory Bowel Disease Questionnaire (IBDQ) score, corticosteroid-free remission, and mucosal healing were assessed up to week 196 (week 208 for remission/response per PMS) of adalimumab treatment in patients who received one or more doses of adalimumab with use of a hybrid nonresponder imputation (hNRI) method. Nonresponder imputation was used for missing data up to the latest possible follow-up date for each patient, followed by observed case. Adalimumab trough concentrations were reported from week 52 to week 196 of treatment. Treatment-emergent adverse events were reported for all adalimumab-treated patients.ResultsTwo hundred sixty-six patients received adalimumab. At week 196 of treatment, remission and response rates per FMS, remission and response rates per PMS, remission rate per IBDQ score, mucosal healing rate, and corticosteroid-free remission rate were 19.2%, 32.2%, 22.5%, 32.5%, 33.1%, 30.5% (hNRI), and 40.5% (17/42; as observed), respectively. Serum adalimumab concentrations remained constant in patients receiving 40 mg every other week but increased in patients who underwent dose escalation. The safety profile was consistent with that in the 52-week study.ConclusionsThe efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis was maintained for up to 4 years of treatment. No new safety signals were observed.
| S-EPMC5569655 | biostudies-literature
Project description:BACKGROUND:Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). AIM:To report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme. METHODS:DVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study and an ongoing, open-label, long-term extension (OLE) study (September 2018 datacut). Data were analysed in induction, maintenance and overall (patients receiving ? 1 dose of tofacitinib 5 or 10 mg b.d. in any phase 2, 3 or OLE study) cohorts. RESULTS:1157 patients (2404 patient-years' exposure; ? 6.1 years' tofacitinib treatment) were evaluated in the overall cohort. In induction, one placebo-treated patient had DVT and one had PE; no tofacitinib-treated patients had DVT/PE. In maintenance, one placebo-treated patient had DVT and one had PE; no tofacitinib-treated patients had DVT/PE. In the overall cohort, one patient had DVT (incidence rate [patients with events/100 patient-years; 95% CI]: 0.04 [0.00-0.23]); four had PE (0.16 [0.04-0.41]); all received predominant dose tofacitinib 10 mg b.d.; all had venous thromboembolism risk factors alongside UC. CONCLUSIONS:In this post hoc analysis of patients with UC, during tofacitinib exposure, one patient had DVT and four had PE, all during the OLE study, on predominant dose 10 mg b.d. (83% of overall cohort patients received predominant dose 10 mg b.d.) with venous thromboembolism risk factors. This analysis is limited by small sample size and limited drug exposure; further studies are needed. ClinicalTrials.gov: NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.
| S-EPMC6899755 | biostudies-literature
Project description:ObjectivesPerforming a sigmoidoscopy or colonoscopy is recommended for assessment of disease activity, excluding infection, and guiding medical treatment during ulcerative colitis (UC)-related hospitalizations. However, it is unknown whether the timing of endoscopy impacts clinical outcomes. The objective of our study was to determine the impact of timing of endoscopy on hospital outcomes in patients with UC-related hospitalizations.MethodsThis is a cross-sectional study using data from the Nationwide Inpatient Sample database (2006-2013). Adult inpatients (≥19 years) with UC-related hospitalizations were identified using appropriate International Classification of Diseases, Ninth revision, Clinical modification codes (ICD-9-CM). Hospital outcomes stratified by disease severity were compared between patients receiving early (<3 days after admission) and delayed endoscopies (between 3 and 7 days after admission). The primary clinical outcomes included mortality, frequency of large intestine surgery, length of stay (LOS), and hospital cost. Results were analyzed using univariate and multivariate analyses.ResultsOf a total of 84,359 patients with UC-related hospitalizations, 67.2% (56,657) underwent an early endoscopy and 32.8% (27,702) underwent a delayed endoscopy. Delayed endoscopy was associated with higher mortality (adjusted odds ratio: 1.76 (95% confidence interval (CI): 1.08, 2.88)), prolonged LOS (adjusted coefficient: 2.69 (95% CI: 2.61, 2.77)), and higher hospital cost (adjusted coefficient: $3,394 (95% CI: 3,234, 3,554)). In UC patients with intermediate disease severity, delayed endoscopy was associated with an increased frequency of large intestine surgery (adjusted odds ratio: 1.60 (95% CI: 1.01, 2.53)).ConclusionsIn UC-related hospitalizations, the timing of endoscopic procedures impacts outcomes. Early endoscopy is associated with decreased mortality and better health-care utilization (LOS and hospital cost) compared with delayed endoscopy. In UC patients with intermediate disease severity, early endoscopy is also associated with a decreased frequency of large intestine surgery.
| S-EPMC5288584 | biostudies-literature
Project description:BackgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Post-marketing surveillance (PMS) is an important part of monitoring adverse events (AEs).AimsTo report an analysis of PMS case safety reports for tofacitinib in patients with UC METHODS: Worldwide tofacitinib PMS reports received in the Pfizer safety database from 30 May 2018 (first regulatory approval) to 25 August 2020 were analysed. The type and estimated reporting rate (RR) of serious AEs of interest, including infection, gastrointestinal, vascular, respiratory, neoplasm and cardiac events, were reviewed. Patient-years of exposure (PY) was estimated based on worldwide sales data and the calculated daily regimens of tofacitinib 5 or 10 mg twice daily, immediate- or extended-release formulations.ResultsDuring the 27-month reporting period, worldwide post-marketing exposure to tofacitinib was 8916 PY. Overall, 4226 case reports were received and included 12 103 AEs, of which 1839 were serious AEs (SAEs). Among the cases reported, 1141 (27.0%) included an SAE and 18 (0.4%) were fatal. The RR (per 100 PY) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 3.28 for infections, 1.26 for vascular disorders, 0.74 for respiratory disorders, 0.55 for neoplasms and 0.50 for cardiac disorders.ConclusionsThe types of AEs were consistent with those reported in tofacitinib clinical trials. Most reported AEs were non-serious. Limitations of PMS reports and reliance on estimated RRs due to lack of precise values for exposure, required for incidence rate calculation, should be considered when interpreting these results.
| S-EPMC9293472 | biostudies-literature
Project description:To determine the 3 year mortality of patients admitted to hospital for the treatment of ulcerative colitis (UC).Retrospective case note review of all patients admitted to hospital for treatment of active UC over a 6 year period from 1 January 2000.Teaching hospital with a tertiary referral practice for the management of infiammatory bowel disease.106 patients (134 admissions) met the inclusion criteria.Elective and emergency colectomy was undertaken in 16 and 26 patients, respectively.Mortality at 3 years.There were six deaths after 3 years. Case fatality at 30 days, 1, 2 and 3 years was 1.0% (95% CI 0.2 to 5.1), 1.9% (95% CI 0.2 to 6.6), 2.9% (95% CI 5.9 to 8.0) and 5.7% (95% CI 2.1 to 11.9), respectively. There were no deaths in either surgical group. One patient (89 years, female) died while awaiting emergency colectomy. Patients who died were significantly older at the time of admission (79 years (95% CI 71 to 88 years) vs 41.2 years (95% CI 38 to 45 years)) and were more likely to have comorbid illness (p<0.001). Severity of disease, prior immunosuppressive use, first presentation and smoking status were not associated with increased mortality.Three year mortality following admission for treatment of UC was 5.7% (95% CI 2.1 to 11.9), significantly lower than that reported previously. Mortality was significantly associated with increasing age and the presence of comorbid disease. Disease specific factors such as severity, extent and first presentation were associated with emergency colectomy but not mortality.
| S-EPMC5517156 | biostudies-other
Project description:IntroductionThis ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab.MethodsPatients were enrolled via a web-based electronic data capture system from approximately 250 institutions. Incidence of adverse events and treatment responses were assessed by the physicians after the patient had received three doses of vedolizumab or when the drug was discontinued, whichever occurred first. Therapeutic response was defined as any treatment response, including remission or improvement of complete or partial Mayo score, and was assessed in the total and stratified patient populations according to prior tumor necrosis factor alpha (TNFα) inhibitor treatments and/or baseline partial Mayo score.ResultsThe total incidence of adverse drug reactions (ADRs) was 4.10% (11/268). Common ADRs were dizziness, nausea, and arthralgia, each reported in 0.75% of patients (2/268). Serious ADRs were herpes zoster oticus and UC, each reported in 0.37% of patients (1/268). Therapeutic response was reported in 84.5% (218/258) of all patients, 85.8% (127/148) of TNFα inhibitor-naïve patients, and 82.7% (91/110) of TNFα inhibitor-experienced patients. Among patients with partial Mayo score of ≥ 4 at baseline, partial Mayo score remission in patients without or with prior TNFα inhibitor treatment was 62.5% (60/96) and 45.6% (36/79), respectively.ConclusionThe results confirm a safety and effectiveness profile of vedolizumab consistent with that observed in previous trials.Clinical trial registrationJapicCTI-194603, NCT03824561.
| S-EPMC10220148 | biostudies-literature
Project description:BackgroundStool DNA testing in patients with inflammatory bowel disease (IBD) may detect colorectal cancer and advanced precancers with high sensitivity; less is known about the presence of DNA markers in small IBD lesions, their association with metachronous neoplasia, or contribution to stool test positivity.MethodsAt a single center in 2 blinded phases, we assayed methylated bone morphogenic protein 3, methylated N-Myc downstream-regulated gene 4, and mutant KRAS in DNA extracted from paraffin-embedded benign lesions, and matched control tissues of patients with IBD, who were followed for subsequent colorectal dysplasia. Stool samples from independent cases and controls with lesions <1 cm or advanced neoplasms were assayed for the same markers.ResultsAmong IBD lesions (29 low-grade dysplasia, 19 serrated epithelial change, and 10 sessile serrated adenoma/polyps), the prevalence of methylation was significantly higher than in mucosae from 44 matched IBD controls (P < 0.0001 for methylated bone morphogenic protein 3 or methylated N-Myc downstream-regulated gene 4). KRAS mutations were more abundant in serrated epithelial change than all other groups (P < 0.001). Subsequent dysplasia was not associated with DNA marker levels. In stools, the sensitivity of methylated bone morphogenic protein 3 as a single marker was 60% for all lesions <1 cm, 63% for low-grade dysplasia ≥1 cm and 81% for high-grade dysplasia/colorectal cancer, all at 91% specificity (P < 0.0001).ConclusionsSelected DNA markers known to be present in advanced IBD neoplasia can also be detected in both tissues and stools from IBD patients with small adenomas and serrated lesions. Mutant KRAS exfoliated from serrated epithelial change lesions might raise false-positive rates. These findings have relevance to potential future applications of stool DNA testing for IBD surveillance.
| S-EPMC4911339 | biostudies-literature