Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study.

BACKGROUND AND AIM: A biosimilar of infliximab, CT-P13 (Remsima®) has the potential to reduce treatment costs and enhance access to biological therapy for inflammatory bowel disease (IBD) patients. However, long-term clinical data on its use for IBD treatment are currently sparse. We aimed to investigate the long-term efficacy and safety of CT-P13 therapy in a large, real-life IBD cohort. METHODS: A total of 368 IBD patients (227 with Crohn's disease [CD] and 141 with ulcerative colitis [UC]) treated with CT-P13 at 16 referral hospitals in Korea between July 2012 and December 2017 were retrospectively analyzed. RESULTS: The cumulative retention rates at years 1, 3, and 5 were 86.1%, 68.5%, and 58.7% and 69.7%, 46.0%, and 26.7% in anti-tumor necrosis factor (TNF)-naïve CD and UC patients, respectively. The clinical response and remission rates at week 14 and at years 1, 3, and 5 were 94.3%, 92.7%, 76.8%, and 17.6% and 78.6%, 82.4%, 72.2%, and 17.6% in anti-TNF-naïve CD and 85.6%, 80.0%, 55.2%, and 6.7% and 42.6%, 59.8%, 44.2%, and 6.7% in anti-TNF-naïve UC patients, respectively. Among patients who switched from the biologic originator to CT-P13, the cumulative retention rates at years 1, 3, and 5 were 88.5%, 66.1%, and 44.8% in CD, and 73.9%, 42.5%, and 42.5% in UC patients, respectively. Significant improvements in disease activity scores were accompanied by marked reductions in inflammatory marker levels, and no unexpected adverse events including death or malignancy occurred during the study period. CONCLUSIONS: Long-term treatment with CT-P13 is effective in inducing and maintaining disease improvement and is well-tolerated in patients with IBD. CT-P13 may be a promising treatment option for IBD.

Radix Polygalae Extract Attenuates PTSD-like Symptoms in a Mouse Model of Single Prolonged Stress and Conditioned Fear Possibly by Reversing BAG1.

Radix Polygalae (RP) has been used to relieve psychological stress in traditional oriental medicine. Recently, cell protective, antiamnestic and antidepressant-like effects were disclosed but the possible application of RP to post-traumatic stress disorder, in which exaggerated fear memory persists, has not yet been explored. For this purpose, the effects of RP on fear behavior was examined in a mouse model of single prolonged stress and conditioned fear (SPS-CF), previously shown to mimic key symptoms of post-traumatic stress disorder. Male mice received daily oral dose of RP extract or vehicle during the SPS-CF procedure. Then fear-related memory (cohort 1, n=25), non-fear-related memory (cohort 2, n=38) and concentration-dependent effects of RP on fear memory (cohort 3, n=41) were measured in 3 separate cohort of animals. Also working memory and anxiety-like behaviors were measured in cohort 1. RP-treated SPS-CF mice exhibited attenuated contextual but not cued freezing and no impairments in the working memory and spatial reference memory performances relative to vehicle-treated SPS-CF controls. RP-treated SPS-CF and naive mice also demonstrated no difference in anxiety-like behavior levels relative to vehicle-treated SPS-CF and naive controls, respectively. In the hippocampus of SPS-CF mice, expression of BAG1, which regulates the activity of GR, was decreased, whereas RP increased expression of BAG1 in naïve and SPS-CF mice. These results suggest that RP exerts some symptomatic relief in a mouse with exaggerated fear response. RP and its molecular components may thus constitute valuable research targets in the development of novel therapeutics for stress-related psychological disorders.

Three-year colonoscopy surveillance after polypectomy in Korea: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter prospective study.

BACKGROUND/AIMS: Colonoscopic surveillance is currently recommended after polypectomy owing to the risk of newly developed colonic neoplasia. However, few studies have investigated colonoscopy surveillance in Asia. This multicenter and prospective study was undertaken to assess the incidence of advanced adenoma based on baseline adenoma findings at 3 years after colonoscopic polypectomy. METHODS: A total of 1,323 patients undergoing colonoscopic polypectomy were prospectively assigned to 3-year colonoscopy surveillance at 11 tertiary endoscopic centers. Relative risks for advanced adenoma after 3 years were calculated according to baseline adenoma characteristics. RESULTS: Among 1,323 patients enrolled, 387 patients (29.3%) were followed up, and the mean follow-up interval was 31.0±9.8 months. The percentage of patients with advanced adenoma on baseline colonoscopy was higher in the surveillance group compared to the non-surveillance group (34.4% vs. 25.7%). Advanced adenoma recurrence was observed in 17 patients (4.4%) at follow-up. The risk of advanced adenoma recurrence was 2 times greater in patients with baseline advanced adenoma than in those with baseline non-advanced adenoma, though the difference was not statistically significant (6.8% [9/133] vs. 3.1% [8/254], P=0.09). Advanced adenoma recurrence was observed only in males and in subjects aged ≥50 years. In contrast, adenoma recurrence was observed in 187 patients (48.3%) at follow-up. Male sex, older age (≥50 years), and multiple adenomas (≥3) at baseline were independent risk factors for adenoma recurrence. CONCLUSIONS: A colonoscopy surveillance interval of 3 years in patients with baseline advanced adenoma can be considered appropriate.

Reduced Consolidation, Reinstatement, and Renewal of Conditioned Fear Memory by Repetitive Treatment of Radix Polygalae in Mice.

The therapeutic goal for the treatment of posttraumatic stress disorder (PTSD) is to promote extinction and to prevent the relapse of fearful memories. Research has identified pharmacological treatments that may regulate the formation and extinction of fear memories, but not many reagents that block the relapse of extinguished fear are known. Radix Polygalae (RP) is an Asian herb used for sedation, and its ingredients have anxiolytic and antidepressant properties. As various neurological effects have been identified, we tested whether RP affects the relapse of fear. Freezing in response to a conditioned context and cues was used to measure the effects of RP in mice. In cohort 1 (n = 30), consolidation, extinction, and reinstatement were tested during the course of 18 days of treatment. In cohort 2 (n = 30), consolidation, extinction, and renewal were tested during 10 days of treatment. The consolidation, extinction, reinstatement, and possibly the renewal of context-induced freezing were inhibited due to the administration of RP in animal subjects. However, the effects of RP on the freezing responses of subjects elicited by conditioned auditory cues were less obvious. Because it effectively suppresses the consolidation of fear memories, RP may be used for primary and secondary prevention of symptoms in PTSD patients. Additionally, because it effectively suppresses the reinstatement and renewal of fear memories, RP may be applied for the prevention of fear relapse in PTSD patients who have undergone exposure therapy.

The Breast Tumor Strain Ratio Is a Predictive Parameter for Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer.

OBJECTIVE: The purpose of this study was to evaluate the association between the breast tumor strain ratio and axillary lymph node metastasis in patients with invasive breast cancer. MATERIALS AND METHODS: The records of 284 patients with invasive breast cancer who underwent ultrasound elastography before surgery between March 2013 and May 2014 were reviewed retrospectively. For women with multifocal or bilateral cancer, the largest tumor was included. An experienced radiologist performed ultrasound elastography and measured the strain ratio, which is defined as the fat-to-lesion ratio and is indicative of the relative stiffness of the breast lesion, using dedicated software within the ultrasound equipment. The associations between axillary lymph node metastasis with the tumor strain ratio and clinical and biologic variables were evaluated using univariate and multivariate logistic regression analyses. RESULTS: Among 284 tumors, 85 (29.9%) showed axillary lymph node metastasis by surgical histopathologic analysis. The strain ratio was statistically significantly higher in tumors with axillary lymph node metastasis than in those without axillary lymph node metastasis (mean ± SD, 5.19 ± 1.28 vs 4.17 ± 1.30, respectively; p < 0.001). On univariate analysis, a higher strain ratio (> 3.89), larger tumor size (> 2 cm), higher histologic grade (grade 3), presence of lymphovascular invasion, palpability, and higher expression of Ki-67 (≥ 14%) were statistically significantly associated with axillary lymph node metastasis. On multivariate analysis, a higher strain ratio (> 3.89) (odds ratio [OR], 14.208; p < 0.001), presence of lymphovascular invasion (OR, 17.437; p < 0.001), and higher expression of Ki-67 (≥ 14%) (OR, 3.744; p = 0.002) maintained independent significance for predicting axillary lymph node metastasis. CONCLUSION: The breast tumor strain ratio on ultrasound elastography is associated independently with axillary lymph node metastasis in patients with invasive breast cancer.

Temporomandibular joint disorder from skull-base osteomyelitis: a case report.

Skull-base osteomyelitis is a rare disease affecting the medulla of the temporal, sphenoid, and occipital bones. In general, it occurs due to external ear canal infections caused by malignant external otitis. Skull-base osteomyelitis usually affects elderly diabetic patients. The patient, a 58-year-old man, was referred for evaluation and management of the left jaw. Clinical examination of the patient revealed pain in the left jaw and mouth-opening deflection to the left. The maximum active mouth opening was measured to about 27 mm. Panoramic, CT, and CBCT revealed bone resorption patterns in the left condyle. Through control of diabetes, continued pharmacological treatment, arthrocentesis, and occlusal stabilization appliance therapy were carried out. The extent of active mouth opening was increased to 45 mm, and pain in the left jaw joint was alleviated. This was a case wherein complications caused by failure to control diabetes induced skull-base osteomyelitis. There is a need for continued discussion about the advantages and disadvantages of arthrocentesis with lavage for patients with skull-base osteomyelitis and other treatment options.

Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea.

OBJECTIVE: To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea. METHODS: This post-marketing study included patients with active moderate-to-severe Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission. RESULTS: No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not. CONCLUSION: CT-P13 was well tolerated and efficacious in patients with IBD.

Facial asymmetry: a case report of localized linear scleroderma patient with muscular strain and spasm.

Facial asymmetry is found in patients with or without cosmetic facial alterations. Some patients have facial asymmetry that manifests underlying skeletal problems, while others have only limited soft-tissue facial asymmetry. Orthognathic surgery brings about a dermatic change, as soft tissue covers underlying bones. Limited soft-tissue asymmetry, meanwhile, is difficult to correct. The treatment modalities for the creation or restoration of an esthetically pleasing appearance were autogenous fat grafts, cartilage graft, and silicon injections. A young female patient had right-side facial asymmetry. The clinical assessment involved visual inspection of the face and palpation to differentiate soft tissue and bone. Although the extra-oral examination found facial asymmetry with skin atrophy, the radiographic findings revealed no mandibular atrophy or deviation. She was diagnosed as localized scleroderma with muscle spasm. In conclusion, facial asymmetry patients with skeletal asymmetry can be esthetically satisfied by orthognathic surgery; however, facial atrophy patients with skin or subdermal tissue contraction need treatment by cosmetic dermatological surgery and orthodontic correction.

High-risk metachronous polyps are more frequent in patients with traditional serrated adenomas than in patients with conventional adenomas: a multicenter prospective study.

BACKGROUND AND AIMS: Although the malignant progression of serrated polyps has been clearly documented, the malignant potential of the traditional serrated adenoma (TSA) subtype has not been established. We compared the prevalence of metachronous polyps in surveillance colonoscopies between patients with TSA and those with conventional adenomas (CAs). METHODS: Four hundred twenty patients were diagnosed with TSAs by current diagnostic criteria at 10 tertiary care university hospitals in Korea from January 2003 to December 2005; 186 patients who received surveillance colonoscopy after removal of initial polyps were enrolled. During the same time period, 372 age- and sex-matched patients diagnosed with CAs were used as a control group. RESULTS: TSA patients had a significantly higher recurrence rate of colorectal polyps compared with CA patients (66.1% vs 43.5%, respectively). TSA patients had a greater number (3 vs 2) and larger size (8.6 ± 5.7 vs 6.3 ± 5.2 mm) of recurrent polyps compared with CA patients. TSA patients also had a higher rate of CA (54.8% vs 37.9%), serrated adenoma (14.0% vs. 0.8%), and hyperplastic polyp (33.3% vs. 13.7%) recurrence compared with CA patients. TSA patients had significantly greater odds of having a recurrent high-risk polyp than CA patients (odds ratio, 2.37; 95% confidence interval, 1.55-3.63). CONCLUSIONS: In comparison with patients with CAs, patients with TSAs have a higher metachronous occurrence rate of all polyp subtypes including CAs, serrated adenomas, and hyperplastic polyps. Moreover, the presence of TSAs is an independent predictor of a high-risk polyp occurrence.

Preoperative 18F-FDG PET/CT predicts disease-free survival in patients with primary invasive ductal breast cancer.

BACKGROUND: Previous studies have correlated the maximum standardized uptake value (SUVmax) of breast cancer lesions with histological and biological characteristics such as tumor size, histologic grade, or hormonal receptor expression status. However, controversy remains concerning the prognostic value of SUVmax in breast cancer. PURPOSE: To determine if the SUVmax of a tumor on 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is associated with disease-free survival in patients with primary invasive ductal breast cancer. MATERIAL AND METHODS: The institutional review board of our hospital approved this retrospective study. From 2009 to 2011, 508 women (mean age, 53.6 years; age range, 26-85 years) with newly diagnosed invasive ductal breast cancer who had undergone preoperative 18F-FDG PET/CT followed by surgery were identified. Clinicopathological variables and FDG uptake quantified by SUVmax were analyzed. The Cox proportional hazards model was used to evaluate the association between SUVmax and disease-free survival after controlling for clinicopathological parameters. RESULTS: There were 21 recurrences at a median follow-up of 46 months. The mean SUVmax of the primary tumor was significantly higher in patients with a recurrence than those who remained disease-free (9.5 ± 3.5 vs. 6.6 ± 4.2, P < 0.001). A receiver operating characteristic curve indicated that a SUVmax of 5.95 was the optimal cut-off value to predict disease-free survival. Multivariate analysis identified a high SUVmax (≥5.95) and high T stage as independent significant variables associated with worse disease-free survival. CONCLUSION: A high primary tumor SUVmax on 18F-FDG PET/CT was an independent factor associated with worse disease-free survival in patients with primary invasive ductal breast cancer.

Sodium Picosulfate with Magnesium Citrate (SPMC) Plus Laxative Is a Good Alternative to Conventional Large Volume Polyethylene Glycol in Bowel Preparation: A Multicenter Randomized Single-Blinded Trial.

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.

Tumour 18 F-FDG Uptake on preoperative PET/CT may predict axillary lymph node metastasis in ER-positive/HER2-negative and HER2-positive breast cancer subtypes.

OBJECTIVES: To evaluate the association between tumour FDG uptake on preoperative PET/CT and axillary lymph node metastasis (ALNM) according to breast cancer subtype. METHODS: The records of 671 patients with invasive breast cancer who underwent (18) F-FDG PET/CT and surgery were reviewed. Using immunohistochemistry, tumours were divided into three subtypes: oestrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative, HER2-positive, and triple-negative. Tumour FDG uptake, expressed as maximum standardized uptake value (SUVmax), and clinicopathological variables were analysed. RESULTS: ALNM was present in 187 of 461 ER-positive/HER2-negative, 54 of 97 HER2-positive, and 38 of 113 triple-negative tumours. On multivariate analysis, high tumour SUVmax (≥4.25) (P < 0.001), large tumour size (>2 cm) (P = 0.003) and presence of lymphovascular invasion (P < 0.001) were independent variables associated with ALNM. On subset analyses, tumour SUVmax maintained independent significance for predicting ALNM in ER-positive/HER2-negative (adjusted odds ratio: 3.277, P < 0.001) and HER2-positive tumours (adjusted odds ratio: 14.637, P = 0.004). No association was found for triple-negative tumours (P = 0.161). CONCLUSIONS: Tumour SUVmax may be an independent prognostic factor for ALNM in patients with invasive breast cancer, especially in ER-positive/HER2-negative and HER2-positive subtypes, but not in those with triple-negative subtype. KEY POINTS: • Tumour SUVmax could be an imaging biomarker for predicting ALNM • Tumour SUVmax predicting ALNM is effective in ER-positive/HER2-negative and HER2-positive subtypes • Tumour SUVmax predicting ALNM is inaccurate in triple-negative subtypes • Accurate prognostic prediction based on molecular subtype may facilitate individualized management.

Magnetic resonance imaging characteristics of invasive breast cancer in women aged less than 35 years.

BACKGROUND: With regard to clinicopathological findings and disease prognosis, breast cancer in young women is different from that in older women. However, few studies have investigated magnetic resonance imaging (MRI) characteristics of young age-onset breast cancer. PURPOSE: To retrospectively evaluate and compare the MR images and clinicopathological characteristics of invasive breast cancer in young women (aged <35 years) with those of breast cancers in older premenopausal women (35-45 years). MATERIAL AND METHODS: A total of 270 invasive breast cancers in 266 premenopausal women aged 45 years and younger who underwent preoperative breast MRI and curative surgery were identified between 2009 and 2013. The subjects were divided into a young group (< 35 years, n = 56) and an older group (35-45 years, n = 214). MRI features and clinicopathological data were compared between the two groups. RESULTS: The young group had more positive axillary lymph nodes, higher histologic grade, negative estrogen receptor (ER), negative progesterone receptor (PR), and higher p53 and Ki-67 expression compared to the older group. Using MRI, the young group was more likely to display a round/oval or lobular mass shape, a smooth mass margin, and a high signal intensity on T2-weighted images when compared to the older group. In multivariate analysis, positive axillary nodal status (adjusted odds ratio [OR], 4.070; P = 0.002), higher expression of p53 (adjusted OR, 2.902; P = 0.038), lobular mass shape (adjusted OR, 4.979; P = 0.028), and smooth mass margin (adjusted OR, 5.123; P = 0.048) were independently associated with the young group. CONCLUSION: MR morphologic features, including lobular mass shape and smooth mass margin, were independently associated with breast cancer in young women, in addition to positive axillary nodal status and higher p53 expression status.

Long-term clinical outcomes of korean patient with Crohn's disease following early use of infliximab.

BACKGROUND/AIMS: Several recent studies have reported that the early use of infliximab (IFX) improves the prognosis of Crohn's disease (CD). However, no data are available from Asian populations, as the forementioned studies have all been conducted in Western countries. The aim of the current study was to evaluate the impact of early use of IFX on the prognosis of Korean patients with CD. METHODS: Patients with a diagnosis of CD established between July 1987 and January 2012 were investigated in 12 university hospitals in Korea. Because insurance coverage for IFX treatment began in August 2005, patients were assigned to either of 2 groups based on diagnosis date. The first group included patients diagnosed from July 1987 to December 2005, and the second from January 2006 to January 2012. We compared the cumulative probabilities of operation and reoperation between the two groups using the Kaplan-Meier method and a log-rank test. RESULTS: Of the 721 patients investigated, 443 (61.4%) comprized the second group. Although the cumulative probabilities of immunosuppressant (P<0.001) and IFX use (P<0.001) after diagnosis were significantly higher in the second group, there were no significant differences in cumulative probabilities of operation (P=0.905) or reoperation (P=0.418) between two groups. CONCLUSIONS: The early use of IFX did not reduce CD-related surgery requirements in Korean patients with CD. These study results suggest that the early use of IFX may have little impact on the clinical outcome of CD in Korean patients in the setting of a conventional step-up algorithm.

The effect of infliximab on patients with ulcerative colitis in Korea.

BACKGROUND/AIMS: Infliximab was introduced recently as a rescue therapy for ulcerative colitis (UC) patients refractory to conventional treatments such as therapy with 5-amiono salicylic acids (5-ASA), immune modulators, and corticosteroids. However, there is insufficient data about its efficacy and safety in Korea. METHODS: From 7 tertiary referral hospitals, 33 patients who were treated with infliximab for moderate to severe (Mayo score 6-12) UC refractory to conventional treatment were recruited to this study. Clinical remission was defined as a total Mayo score of 2 or lower and every subscore less than 2. Partial response was defined as a decrease of Mayo score at least 3 points from baseline. RESULTS: Twenty-three patients (69.7%) showed clinical remission and 29 patients (87.8%) showed partial response in the observation period. When the remission and non-remission groups were compared in univariate analysis, only a higher total Mayo score at base line (11.0±0.9 vs. 9.9±1.5; P=0.04) was related to remission. The remission maintenance rate decreased with time in the Kaplan-Meier analysis. Two patients experienced re-remission after the first remission followed by aggravation during infliximab treatment. Three patients stopped infliximab treatment owing to adverse events including rhabdomyolysis, pneumonia, and fever of unknown origin. CONCLUSIONS: If there is no choice except surgery for UC patients refractory to conventional treatment, infliximab is an effective and relatively safe treatment option for these patients in Korea.

Comparison of endoscopic band ligation and endoclip closure of colonic perforation: technical feasibility and efficacy in an ex vivo pig model.

BACKGROUND AND AIM: Recent reports have indicated several instances of successful treatment of bowel perforation by using endoscopic band ligation (EBL) when treatment with endoclipping is unsuccessful, but this salvage method has not been investigated in any prospective model. Herein we aimed to compare the technical feasibility and efficacy of EBL and endoclip use in intraluminal closure of colon perforation, in an ex vivo model. METHODS: Standardized colonic perforations were created using fresh porcine colon and subsequently closed by full-thickness interrupted sutures, endoclip (QuickClip2(TM)), or EBL. Each closure site was tested with compressed air by using a digital pressure monitor for evaluating leak pressure. RESULTS: No significant differences were noted between the endoclip and EBL in leak pressures. Mean (± SD) pressures for air leakage from the perforations closed using the different devices were as follows: normal colon samples, 52.0 ± 13.2 mmHg; perforations closed with hand-sewn sutures, 32.3 ± 8.3 mmHg; perforations closed with endoclipping, 53.5 ± 22.7 mmHg; and perforations closed with EBL, 50.4 ± 12.5 mmHg. Time taken for closure by EBL was significantly less than that for closure by endoclipping (3.2 ± 1.7 min vs 6.8 ± 1.3 min, P < 0.01). Further, the number of devices used to achieve complete closure in the EBL group was lower than that with endoclipping (1.6 ± 0.5 vs 3.7 ± 0.8, P < 0.01). CONCLUSION: Endoluminal closure of a 1.5-cm colon perforation with EBL decreased procedure time and was not inferior in leak pressure compared with endoclipping in this ex vivo porcine model.

[Usefulness of polyp and adenoma detection rate in the proximal and distal colon].

BACKGROUND/AIMS: The polyp detection rate (PDR) has been suggested as a surrogate for adenoma detection rate (ADR). The purpose of this study was to determine the level of agreement between PDR and ADR in the proximal and distal colon. METHODS: A total of 1,937 consecutive, asymptomatic individuals aged 40 years and older who underwent colonoscopies at six academic teaching hospitals in Korea were included in this study. PDR and ADR were calculated for each colonic segment. PDR was compared with ADR in the proximal and distal colon. RESULTS: During 1,937 colonoscopies, 1,862 polyps were removed; 1,421 (76%) were adenomas. The PDR and ADR in the proximal colon was 25.8% and 22.8%, respectively (kappa value=0.917, p=0.26), and that in the distal colon was 28.9% and 22.2%, respectively (p<0.001). There was a strong correlation between PDR and ADR in the proximal colon, but diverged in sigmoid colon and rectum. CONCLUSIONS: PDR and ADR correlate well in the proximal colon, but not in the distal colon, especially sigmoid and rectum. PDR should be measured for each colonic segment when using PDR as a surrogate for ADR. PDR is a valid proxy for ADR in the proximal colon.

Clinical features and predictors of clinical outcomes in Korean patients with Crohn's disease: a Korean association for the study of intestinal diseases multicenter study.

BACKGROUND AND AIM: Although differences in genetic susceptibility and the clinical features of Crohn's disease (CD) have been reported between Asian and Caucasian patients, the disease course and predictors of CD in Asians remains poorly defined. The study therefore aimed to investigate factors predictive of the clinical outcomes of patients with CD in a Korean population. METHODS: This retrospective multicenter cohort study included 728 Korean CD patients from 13 university hospitals. The first CD-related surgery or need for immunosuppressive or biological agents were regarded as the clinical outcomes of interest. RESULTS: A total of 126 (17.3%) CD patients underwent CD-related surgery, while 473 (65.0%) and 196 (26.9%) were prescribed thiopurine drugs and infliximab, respectively. Multivariate Cox regression analysis identified current (hazard ratio [HR] = 1.86; P = 0.018) and former smoking habits (HR = 1.78; P = 0.049), stricturing (HR = 2.24; P < 0.001), and penetrating disease behavior at diagnosis (HR = 3.07; P < 0.001) as independent predictors associated with the first CD-related surgery. With respect to immunosuppressive and biological agents, younger age (< 40 years) (HR = 2.17; P < 0.001 and HR = 2.10; P = 0.006, respectively), ileal involvement (HR = 1.36; P = 0.035 and HR = 2.17; P = 0.006, respectively), and perianal disease (HR = 1.42; P = 0.001 and HR = 1.38; P = 0.038, respectively) at diagnosis were significant predictors for the need of these medications. CONCLUSIONS: In Korean patients with CD, stricturing, penetrating disease behavior, and smoking habits at the time of diagnosis are independent predictors for CD-related surgery. It was also identified that younger age (< 40 years), ileal involvement, and perianal disease at diagnosis are predictive of a need for immunosuppressive or biological agents.

Patients with Crohn's disease on anti-tumor necrosis factor therapy are at significant risk of inadequate response to the 23-valent pneumococcal polysaccharide vaccine.

BACKGROUND/AIMS: The effect of immunosuppressants on the efficacy of a variety of vaccines is a controversial issue in patients with inflammatory bowel disease (IBD). In this study we determined whether specific immunosuppressants impair the serological response to the standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) in a large cohort of patients with Crohn's disease (CD). METHODS: This was a multi-center, prospective observational study of adult patients with CD at 15 academic teaching hospitals in Korea. The study population received one intramuscular injection of PPSV23. Anti-pneumococcal IgG antibody titers were measured by immunoassay prior to and 4weeks after vaccination. All vaccination-related adverse events and the effect of the vaccine on disease activity were also evaluated. RESULTS: The overall serological response rate was 67.5% (133/197). The serological response rate was significantly lower in patients on anti-tumor necrosis factor (anti-TNF) therapy (50.0% on anti-TNF alone; 58.0% on anti-TNF combined with an immunomodulator, IM) than patients on 5-aminosalicylate (78.4%; all P-values vs. 5-aminosalicylate<0.05); 45.6% (41/90) of patients on anti-TNF therapy were not protected against PPSV23. IM did not affect the immunologic response to the vaccine. Female gender and anti-TNF therapy were significant predictors of non-response to the vaccine (odds ratio [OR] 2.316, P=0.015; OR 2.582, P=0.048, respectively). Vaccination was generally safe and tolerated by all patients. CONCLUSIONS: Patients with CD on anti-TNF therapy are at significant risk of an inadequate response to PPSV23. The pneumococcal vaccination strategy should be optimized for patients with CD on anti-TNF therapy.

Pathological Predictors for Defining a Therapeutic Strategy for Early Colon Cancer after Endoscopic Resection: Multicenter Retrospective Analysis from Surgically Resected Specimens.

BACKGROUND/AIMS: For the possibility of regional lymph node metastasis (LNM), early colon cancer (ECC) is a boundary lesion between endoscopic resection and surgery. The aim of study is to clarify risk factors for LNM and to determine therapeutic strategy after endoscopic resection in patients with ECC. METHODOLOGY: The histopathology of patients with ECC underwent surgery with LN dissection in 8 university hospitals were reviewed by experienced pathologist blinded to LN status. RESULTS: In total, 370 patients (107 with mucosal cancer, 263 with submucosal invasive colorectal carcinoma [SICC]) were enrolled. Excluding mucosal cancer, the LNM rate was 11.8% (31/263, including 15.4% [8/52] with pedunculated SICC [P-SICC] and 10.9% [23/211] with non-pedunculated SICC [NP-SICC]). Multivariate analysis showed that tumor sprouting (P < 0.001; odds ratio [OR], 8.83; 95% confidence interval [CI], 3.04-25.69), submucosal invasion depth (SM depth) > 2000 µm (P = 0.024; OR, 3.68; 95% CI, 1.19-11.37), and lymphatic invasion (P = 0.022; OR, 3.48; 95% CI, 1.19-10.13) were related to LNM. All LNMs with SM depth < 2000 µm showed tumor sprouting without lymphatic invasion. CONCLUSIONS: Significant risk factors for predicting LNM in patients with SICC were tumor sprouting, SM depth > 2000 µm, and lymphatic invasion.