Background We investigated the real-life effectiveness and safety of vedolizumab maintenance treatment among Korean patients with Crohn’s disease (CD) or ulcerative colitis (UC) who previously failed anti-tumour necrosis factor (anti-TNF) therapy. Methods Adult patients with CD or UC who have previously failed anti-TNF therapy and received vedolizumab were prospectively enrolled from 16 hospitals in Korea. The primary outcome was clinical remission at week 54. Clinical remission was defined as a Crohn’s disease activity index (CDAI) <150 and a partial Mayo score ≤2 with a combined rectal bleeding and stool frequency subscore ≤1. We also analyzed factors associated with clinical remission at week 54. Results Between August 2017 to July 2020, a total of 165 patients (81 with CD and 84 with UC) received vedolizumab therapy, of whom 154 patients (93.3%) (75 with CD and 79 with UC) received vedolizumab maintenance therapy (Table 1). Clinical remission and response rates at week 54 were 22.2% and 24.1% among patients with CD and 41.4% and 45.7% among patients with UC, respectively (Figure 1A and 1B). Among 70 patients with UC with baseline Mayo endoscopic subscore ≥2, endoscopic remission (Mayo endoscopic subscore ≤1) at week 54 was observed in 19 patients (27.1%). Out of 50 patients with CD with ulcers in baseline endoscopy, 2 patients (4%) showed a disappearance of ulcers at week 54 (Figure 1C). In the multivariable analysis, age at baseline (adjusted odds ration [aOR] 1.065, 95% confidence interval [CI] 1.003–1.131, P=0.041) and Mayo endoscopic subscore at baseline (aOR 0.141, 95% CI 0.026–0.746, P=0.021) were significantly associated with clinical remission at week 54 among patients with UC (Table 2). No factors were found to be associated with clinical remission at week 54 among patients with CD. Among patients who experienced one or more adverse events (n=134, 81.2%), serious adverse events occurred in 82 patients (49.7%) (Table 3). Disease exacerbation was the most common adverse events (n=89, 53.9%). Conclusion The real-life effectiveness of vedolizumab maintenance treatment for Korean patients with UC who failed anti-TNF therapy was generally similar with the outcomes reported from the previous Western studies. A substantial proportion of patients with CD experienced a loss of response during the first year of treatment. Less severe disease at baseline was associated with clinical remission at 1 year of vedolizumab therapy among patients with UC.
Background This study aimed to investigate the adverse events (AEs) after SARS-CoV-2 vaccination in patients with inflammatory bowel disease (IBD) and to compare them with healthcare workers (HCWs). Methods We conducted a web-based survey on the local and systemic AEs experienced within 7 days of SARS-CoV-2 vaccination (BNT162b2, mRNA-1273, or ChAdOx1 nCoV-19) in IBD patients and HCWs between October 2021 and February 2022. The frequency of all AEs was compared between IBD patients and HCWs, and propensity score matching method was used to control confounding factors. Results A total of 336 IBD patients (139 Crohn’s disease [CD] and 197 ulcerative colitis [UC]) and 288 HCWs who completed the questionnaire had received the same type of vaccine for their first and second doses. Common local AEs in patients with IBD were injection site pain (78.9% and 70.8% after receiving first and second vaccine doses, respectively), swelling (35.4% and 31.5%), and induration (35.1% and 26.5%), and systemic AEs were fatigue (44.6% and 42.0%), myalgia (42.6% and 37.2%), and fever or febrile sense (29.5% and 32.1%). All severe AEs were rarely observed (0-3.9%). Hospital visits or hospitalizations associated with AEs were observed in 16 (4.8%) and 18 (5.4%) patients, respectively. A small number of patients reported deterioration of bowel frequency (CD: 10.1% and 12.2%, UC: 8.1% and 11.7%), abdominal pain (CD: 5.0% and 7.9%), and rectal bleeding (UC: 5.1% and 7.6%). About 30% of IBD patients reported a worsening of their sense of well-being. After propensity score matching, there was no significant increase in the frequency of AEs in IBD patients except for diarrhea (14.5% vs 4.8%, P = 0.005) and dyspepsia (15.2% vs 5.5%, P= 0.007) after first vaccination. Conclusion SARS-CoV-2 vaccination in patients with IBD was generally well-tolerated and severe AEs occurred rarely. Compared with HCWs, the frequency of AEs does not seem to increase except for diarrhea and dyspepsia.
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.
Background Ulcerative colitis (UC) is characterized by continuous mucosal inflammation extending from rectum to the proximal lesion. However, there are cases of atypical distribution of inflammation, such as appendiceal orifice inflammation (AOI), skipped lesion, and rectal sparing. This study aimed to evaluate the prevalence and clinical course of atypical distribution of inflammation in newly diagnosed UC. Methods Between 2013 and 2021, 374 patients who underwent a colonoscopy at the time of diagnosis of UC were retrospectively reviewed. Clinical courses including relapse rate within 1-year, 2-year of diagnosis and exposure to immunomodulator or biologics during follow-up were retracted from the prospective IBD registry (ClinicalTrial.gov, NCT02193464). Atypical UC was defined as patients with AOI, skipped lesion or rectal sparing at initial colonoscopy. The clinical courses and changes of endoscopic findings were compared between typical UC group and atypical UC group. Results Of 374 patients, 116 (31.0%) categorized as atypical UC; specifically, 90 (24.1%) showed AOI, 17 (4.5%) showed rectal sparing and 49 (13.1%) showed skipped lesion. When 90 patients with AOI were reclassified according to the extent of inflammation, 62(16.6%) had a localized inflammation at peri-appendiceal area, 13(3.5%) had an inflammation of the entire cecum, 15(4.0%) had an inflammation extends to the proximal A-colon. The clinical courses of atypical UC were not different from typical UC group, however, patients with skipped lesion showed a lower 1-year relapse rate compared to those without skipped lesion (P=0.042). Of 96 patients with atypical UC who underwent follow-up endoscopy, 73 (75.8%) demonstrated a typical distribution of UC at their follow-up colonoscopy. Conclusion Atypical distribution of UC including AOI, skipped lesion, and rectal sparing are not uncommon in patient with newly diagnosed UC. However, most of these features do not appear to correlate significantly with prognosis in the clinical course of UC. In majority of patients with atypical UC, the lesion turned into typical UC on follow-up colonoscopy.
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