Background We aimed to compare trough infliximab levels and the development of anti-drug antibody (ADA) for 1 year between Crohn’s disease (CD) and ulcerative colitis (UC) patients who were biologic-naïve and to evaluate their impact on clinical outcomes. Methods This was a prospective, multi-center, observational study. Biologic-naïve patients with moderate to severe CD and UC who started CT-P13 therapy were eligible for the study. The trough drug and ADA levels were measured serially for 1-year after CT-P13 initiation. Clinical outcomes were assessed with intention-to-treat purpose. Results 267 patients who received CT-P13 treatment were enrolled in the study (CD 168, UC 99). The rates of clinical remission (72% vs. 32.3%, p<0.001) and clinical response (75.6% vs. 47.5%, p<0.001) at 54-week were significantly higher in CD than in UC. The median trough drug level (μg/mL) was significantly higher in CD than in UC up to 14-week (2-week, 19 vs. 15, p<0.001; 6-week, 13 vs. 9, p<0.001; 14-week, 3 vs. 2, p=0.001, Fig 1). The median ADA level (AU/mL) was significantly lower in CD than in UC at 2-week (6 vs. 7, p=0.046), 30-week (8 vs. 12, p=0.007) and 54-week (9 vs. 12, p=0.032, Fig 1). The difference in drug and ADA levels between CD and UC remained significant after adjustment for confounders in repeated measures analysis. Cox proportional hazard analysis showed that CD over UC (adjusted hazard ratio (aHR) 0.78, 95% confidence interval (CI) 0.62–0.95, p=0.016, Fig 2) and no immunomodulator (aHR 1.55, 95% CI 1.07–2.25, p=0.02) were independent risk factors for the development of ADA. The development of ADA at 2-week (adjusted odds ratio (aOR) 0.12, 95% CI 0.03–0.6, p=0.009) and CD over UC (aOR 1.85, 95% CI 1.33–2.56, p=0.0002) were independent predictors of clinical remission at 54-week. Conclusion CD shows favorable pharmacokinetics of infliximab including high trough drug and low ADA level compared with UC which might be related with better clinical outcomes for 1-year of infliximab.
Background Intravenous steroid therapy is the main initial treatment for acute severe ulcerative colitis (ASUC). However, steroid dependence in patients who were treated with intravenous steroid therapy for ASUC is not fully evaluated. We aimed to determine the prevalence and risk factors of corticosteroid dependence after treatment of ASUC. Methods Adult patients who were admitted for the treatment of ASUC satisfying Truelove-Witts criteria from January 2015 to December 2020 were included in the study. Steroid dependence was defined as a failure to taper steroids below 10 mg within 3 months from initiating intravenous therapy or relapse within 3 months after steroid discontinuation. Results Among a total of 140 patients who received intravenous steroids as initial treatment for ASUC, 105 (75.0%) showed a response while 35 (25.0%) were refractory to steroids. Of 105 patients who responded to intravenous steroid therapy, 21 (20.0%) showed steroid dependence during the follow-period. Demographic and clinical variables were not significantly different between steroid-dependent and steroid response groups. However, initial C-reactive protein (CRP) levels in steroid-dependent groups were numerically lower compared with those in the steroid response group with statistical significance (4.4 ± 4.6 mg/dL versus 7.0 ± 6.4 mg/dL, p = 0.04). Conclusion A total of 20.0% of responders to intravenous steroid treatment for ASUC had a steroid dependency during follow-up. The demographic and clinical features of ASUC according to the presence or absence of steroid dependency were similar. Initial CRP levels were low in patients with steroid dependence.
Background Many patients with inflammatory bowel disease experience extra-intestinal manifestations (EIM)s. The presence of EIMs is related to disease activity. Acute severe ulcerative colitis (ASUC) is associated with a high inflammatory burden. However, there are insufficient studies on the relation between the presence of EIMs and the prognosis of exacerbation of ulcerative colitis. This study was conducted to elucidate the correlation between EIMs and ASUC. Methods We retrospectively included patients who were hospitalized at four tertiary medical centers for ASUC management between January 2015 to December 2020, and data on the underlying disease, disease activity, EIMs, colectomy, treatment method, and readmission due to ulcerative colitis aggravation were checked. Results A total of 145 patients (mean age 44.4 years, 68 women) were investigated. The initial partial Mayo score, the Mayo endoscopy sub-score, and the ulcerative colitis endoscopic severity index were 7.6±0.8%, 2.7±0.5, and 6.0±1.4%, respectively. EIMs were expressed in a total of 10.3% (15/145) of patients. The most common type of EIMs was the peripheral articular type (46.7%) followed by skin lesions (20%) and axial articular disease (13.3%). The group with EIMs was younger and had a higher proportion of women than the group without EIMs (39.4 versus 45 years, p=0.03), and had a longer duration of disease (5.8 versus 3.5 years, p=0.02). The Mayo endoscopic sub-score (2.9 vs. 2.7, p<0.01) and partial endoscopic score (7.9 vs. 7.6, p<0.01) were also higher in the EIMs group. The length of hospital stay was also longer in the EIMs group (25.5 days vs. 13.8 days, p<0.01). The response rate to initial treatment was lower in the EIMs group (71.4% vs. 95.5%, p<0.01), and more rescue therapy (28.6% vs. 4.5%, p<0.01) was performed. The rate of colectomy on admission was also higher in the group with EIMs (13.3% vs. 0.8%, p<0.01). Patients with EIMs showed a high tendency to visit the hospital for re-exacerbation of ulcerative colitis after discharge (p=0.07, HR 2.10 CI: 0.93 – 4.76). Conclusion EIMs were expressed in a total of 10.3% of patients with ASUC. The presence of EIMs suggested a poor prognosis in ASUC.
Background Disease monitoring through objective measures including fecal calprotectin and endoscopy is crucial for the management of ulcerative colitis (UC). The role of stool pictures taken by smart phones in the disease monitoring of UC is not known. We aimed to develop artificial intelligence (AI) model using stool pictures for predicting endoscopic mucosal inflammation in patients with UC. Methods This was a prospective multicenter study conducted in 6 tertiary referral hospitals. Patients scheduled to undergo endoscopy for monitoring of mucosal inflammation were included in the study. They were asked to send their stool photos taken at the toilet using smartphones within ± 5 days from the day of endoscopy. Endoscopic activity was assessed with Ulcerative Colitis Endoscopic Index of Severity (UCEIS). 80% and 20% of total data were randomly selected as training and validation set, respectively and this process repeated 4 times on different iterations for cross-validation. Accuracy of AI model for predicting endoscopic healing was compared with that of fecal calprotectin (Fcal). Results A total of 2463 stool pictures from 293 patients with UC were collected (mean age, year, 44±15.2; female, 108 (36.9%)). Endoscopic healing was found in 165 patients (56.3%). In validation set, the mean area under the receiver operating characteristic (AUROC) for predicting endoscopic activity using AI model was 0.78±0.02 (p=0.001) which was not statistically different from the AUROC of Fcal (0.81±0.08, p=0.01; AI model vs. Fcal p>0.05). When we excluded rectal sparing cases (20, 6.8%), the mean AUROC of AI model increased to 0.85±0.05 (p=0.0007). Accuracy, sensitivity and specificity of AI model for predicting endoscopic activity in all patients and without rectal sparing cases were 0.739, 0.643, and 0.826, and 0.798, 0.711, and 0.872, respectively. Conclusion Stool photos of UC patients with deep learning technology demonstrated similar accuracy to Fcal in speculating endoscopic activity with better accuracy in patients without rectal sparing. The potential of simple stool pictures as a possible monitoring tool for UC activity is hopefully presented in this study.
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