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Interobserver agreement analysis of a National Inflammatory Bowel Disease Information System (IBDIS)

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... According to the Montreal classification, age at diagnosis was A2 (17-40 years of age) in 76.6% of our patients (95% CI: 72.5-80), A1 (≤16 years of age) in 16.8% (95% CI: [13][14][15][16][17][18][19][20], and A3 (>40 years of age) in 6.6% (95% CI: 4-9) patients [ Figure 2]. ...
... had ileocolonic involvement, 43.5% (95% CI: 38.6-48.4) had limited disease to the terminal ileum, and 7.7% (95% CI: 5-10) had involvement of the colon only; in addition, 15.6% (95% CI: [12][13][14][15][16][17][18][19] had upper GI involvement [ Figure 3]. There was no significant difference in the disease behavior or location in relation to age at diagnosis. ...
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Background/aim: Tumor necrosis factor inhibitors (TNFi) have become the mainstay of treatment in moderate-to-severe cases of inflammatory bowel disease (IBD). Neutropenia has been reported in patients receiving TNFi for IBD and other diseases. In this study, we aimed to ascertain the relationship between the use of TNFi and the development of neutropenia in patients with IBD. Patients and methods: This is a retrospective cohort study including all adult patients with IBD receiving TNFi at a tertiary care center over an 11-year period. The primary outcome was the development of any neutropenic episode after starting a TNFi. For our secondary outcomes, we evaluated the impact of concomitant use of 5-aminosalicylic acid (5-ASA) or an immunomodulator on the risk of developing neutropenia. Results: The final analysis included 281 patients. Of those included, 34.2% developed at least one episode of neutropenia while on a TNFi. The majority of these episodes (67.7%) were mild with ANC between 1000 and 1500/mm3. No significant difference was observed in the age, gender, agent used or type of IBD between those who developed neutropenia and those who did not. Concomitant use of azathioprine (OR = 2.32, 95% CI: 1.26-4.28; P = 0.007) or 5-ASA (OR = 3.15, 95% CI: 1.55-6.39; P = 0.001) were significant independent predictors of developing neutropenia. Conclusions: In this study, mild neutropenia was common among patients with IBD on TNFi. Future prospective studies are required to further clarify the significance of neutropenia in patients with IBD receiving TNFi.
... According to the Montreal classification, age at diagnosis was A2 (17-40 years of age) in 76.6% of our patients (95% CI: 72.5-80), A1 (≤16 years of age) in 16.8% (95% CI: [13][14][15][16][17][18][19][20], and A3 (>40 years of age) in 6.6% (95% CI: 4-9) patients [ Figure 2]. ...
... had ileocolonic involvement, 43.5% (95% CI: 38.6-48.4) had limited disease to the terminal ileum, and 7.7% (95% CI: 5-10) had involvement of the colon only; in addition, 15.6% (95% CI: [12][13][14][15][16][17][18][19] had upper GI involvement [ Figure 3]. There was no significant difference in the disease behavior or location in relation to age at diagnosis. ...
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Background/aims: Inflammatory bowel disease (IBD) is a chronic inflammatory condition that requires early diagnosis and proper management. Patients with early symptoms of IBD are typically evaluated first by primary healthcare (PHC) physicians, who in turn refer patients with suspected IBD to specialists. Therefore, we aimed to assess the knowledge and attitude of PHC physicians toward IBD. Materials and methods: We conducted a comparative cross-sectional survey of PHC physicians practicing at the Ministry of Health PHC centers in Jeddah, KSA. Demographics and data on the knowledge and practices of physicians were collected through a predefined and tested questionnaire that included three domains (Eaden, Leong, and Sign/Symptom Awareness). A subgroup of the cohort was educated about IBD referral criteria (group A, n = 65) prior to study initiation and their responses were compared with those from the remaining group (group B, n = 135). Regression analysis was used to test associations with the significance threshold set at 5%. Results: A total of 211 PHC physicians were surveyed with a response rate of 95%. Female physicians comprised 66.5% of the cohort and the mean age was 32.26 ± 6.6 years. About 91% of physicians were Saudi nationals, and 75.5% were MBBS degree holders. The majority of the respondents (93%) reported seeing zero to five patients with IBD per month, and almost half of the physicians preferred to always refer patients to specialists (49.5%). Most of the respondents were uncomfortable (3.27 ± 1.4 to 4.35 ± 1.2) with initiating or managing specific medical therapies (maintenance therapy, therapy for acute flare, corticosteroids, immunomodulators, and biologics) for patients with IBD. With regard to knowledge, group A had higher scores in all three domains especially in the Sign/Symptom Awareness domain (mean score 6.17 ± 1.1 vs. 3.5 ± 1.01, P < 0.001). According to multivariate analyses, both groups' knowledge showed no significant relationship with any of the medical therapies, except for the Sign/Symptom Awareness domain which was shown to be significantly affecting the comfort of doctors in managing maintenance therapy among patients with IBD [odds ratio (OR) =1.61, P = 0.008]. Gender, nationality, and qualifications were found to have a significant influence on the comfort in initiating specific medical therapies. Group A was identified as a significant factor in predicting comfort with managing corticosteroids (OR = 8.25, P = 0.006) and immunomodulators (OR = 6.03, P = 0.02) on patients with IBD. Conclusion: The knowledge and comfort of PHC physicians with IBD medication prescription appears to be higher when education is provided. This observation is important, since PHC physicians are responsible for early identification and referral of patients suspected of having IBD, to specialists.
... According to the Montreal classification, age at diagnosis was A2 (17-40 years of age) in 76.6% of our patients (95% CI: 72.5-80), A1 (≤16 years of age) in 16.8% (95% CI: [13][14][15][16][17][18][19][20], and A3 (>40 years of age) in 6.6% (95% CI: 4-9) patients [ Figure 2]. ...
... had ileocolonic involvement, 43.5% (95% CI: 38.6-48.4) had limited disease to the terminal ileum, and 7.7% (95% CI: 5-10) had involvement of the colon only; in addition, 15.6% (95% CI: [12][13][14][15][16][17][18][19] had upper GI involvement [ Figure 3]. There was no significant difference in the disease behavior or location in relation to age at diagnosis. ...
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Background/Aims: Despite the remarkable increase in the incidence of Crohn's disease among Saudis in recent years, data about Crohn's disease in Saudi Arabia are scarce. The aim of this study was to determine the clinical epidemiology and phenotypic characteristics of Crohn's disease in the central region of Saudi Arabia. Patients and Methods: A data registry, Inflammatory Bowel Disease Information System (IBDIS), was used to register Crohn's disease patients who presented to the gastroenterology clinics in four tertiary care centers in Riyadh, Saudi Arabia between September 2009 and February 2013. Patients’ characteristics, disease location, behavior, age at diagnosis according to the Montreal classification, course of the disease, and extraintestinal manifestation were recorded. Results: Among 497 patients with Crohn's disease, 59% were males with a mean age at diagnosis of 25 years [95% Confidence Interval (CI): 24-26, range 5-75 years]. The mean duration from the time of complaint to the day of the diagnosis was 11 months, and the mean duration of the disease from diagnosis to the day of entry to the registry was 40 months. Seventy-seven percent of our patients were aged 17-40 years at diagnosis, 16.8% were ≤16 years of age, and 6.6% were >40 years of age. According to the Montreal classification of disease location, 48.8% of patients had ileocolonic involvement, 43.5% had limited disease to the terminal ileum or cecum, 7.7% had isolated colonic involvement, and 16% had an upper gastrointestinal involvement. Forty-two percent of our patients had a non-stricturing, non-penetrating behavior, while 32.8% had stricturing disease and 25.4% had penetrating disease. Conclusion: Crohn's disease is frequently encountered in Saudi Arabia. The majority of patients are young people with a predilection for males, while its behavior resembled that of western societies in terms of age of onset, location, and behavior.
... For each patient, a detailed chart review was performed, and disease specific data were collected according to the definitions of the Montreal Classification 25 and a validated documentation standard for IBD (IBDIS, Inflammatory Bowel Disease Information System). 26 Variables of interest included, among others, age at diagnosis, disease location and behavior, number(s) and type(s) of intestinal surgery, and use and duration of medication. To assess smoking habits, all study subjects were required to complete a questionnaire consisting of 15 questions concerning the exposure to passive smoking during childhood and adulthood and active smoking habits. ...
Article
Background Despite substantial evidence on the negative effect of active smoking, the impact of passive smoking on the course of Crohn’s disease (CD) remains largely unclear. Our aim was to assess passive smoking as a risk factor for intestinal surgeries in CD. Methods The study was conducted in a university-based, monocentric cohort of 563 patients with CD. Patients underwent a structured interview on exposure to passive and active smoking. For clinical data, chart review was performed. Response rate was 84%, leaving 471 cases available for analysis. For evaluation of the primary objective, which was the impact of exposure to passive smoking on the risk for intestinal surgery, only never actively smoking patients were included. Results Of 169 patients who never smoked actively, 91 patients (54%) were exposed to passive smoking. Exposed patients were more likely to undergo intestinal surgery than nonexposed patients (67% vs 30%; P < 0.001). Multivariate Cox regression analysis revealed that passive smoking was an independent risk factor for intestinal surgeries (hazard ratio, 1.7; 95% CI, 1.04–2.9; P = 0.034) after adjustment for ileal disease at diagnosis (hazard ratio, 2.9; 95% CI, 1.9–4.5; P < 0.001) and stricturing or penetrating behavior at diagnosis (hazard ratio, 1.9; 95% CI, 1.2–3.1; P = 0.01). Passive smoking during childhood was a risk factor for becoming an active smoker in later life (odds ratio, 2.2; 95% CI, 1.5–3.2; P < 0.001). Conclusion Passive smoking increases the risk for intestinal surgeries in patients with CD.
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To determine the clinical, epidemiological and phenotypic characteristics of ulcerative colitis (UC) in Saudi Arabia by studying the largest cohort of Arab UC patients. Data from UC patients attending gastroenterology clinics in four tertiary care centers in three cities between September 2009 and September 2013 were entered into a validated web-based registry, inflammatory bowel disease information system (IBDIS). The IBDIS database covers numerous aspects of inflammatory bowel disease. Patient characteristics, disease phenotype and behavior, age at diagnosis, course of the disease, and extraintestinal manifestations were recorded. Among 394 UC patients, males comprised 51.0% and females 49.0%. According to the Montréal classification of age, the major chunk of our patients belonged to the A2 category for age of diagnosis at 17-40 years (68.4%), while 24.2% belonged to the A3 category for age of diagnosis at > 40 years. According to the same classification, a majority of patients had extensive UC (42.7%), 35.3% had left-sided colitis and 29.2% had only proctitis. Moreover, 51.3% were in remission, 16.6% had mild UC, 23.4% had moderate UC and 8.6% had severe UC. Frequent relapse occurred in 17.4% patients, infrequent relapse in 77% and 4.8% had chronic disease. A majority (85.2%) of patients was steroid responsive. With regard to extraintestinal manifestations, arthritis was present in 16.4%, osteopenia in 31.4%, osteoporosis in 17.1% and cutaneous involvement in 7.0%. The majority of UC cases were young people (17-40 years), with a male preponderance. While the disease course was found to be similar to that reported in Western countries, more similarities were found with Asian countries with regards to the extent of the disease and response to steroid therapy.
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IFN-γ release assays (IGRA), widely used for latent tuberculosis screening prior to anti-TNF-α treatment, are limited by indeterminate results in patients under immunomodulatory (IM) therapy. The aim of our observational study was to delineate factors associated with indeterminate IGRA results. A total of 190 patients with inflammatory bowel disease were included. IGRA was indeterminate if the result of IFN-γ concentration was < 0·35 IU mL(-1) for tuberculosis-specific antigens and < 0·5 IU mL(-1) for the positive control. Predictors for indeterminate results were delineated from multivariate logistic regression. IFN-γ release assays was indeterminate in 26/190 (13·7%) patients. Indeterminate IGRA were associated with lower serum albumin levels (odds ratio [OR] 0·88, 95% confidence interval [CI] 0·79-0·96), lower absolute lymphocyte count (OR 0·39, 95% CI 0·18-0·75) and double IM therapy (OR 2·98, 95% CI 0·95-8·90). Sub-analysis of IM therapy revealed an association of steroid therapy with indeterminate IGRA (OR 3·19, 95% CI 1·35-7·70). Hypoalbuminaemia increased the risk of indeterminate IGRA by (OR 2·97, 95% CI 1·03-8·61) and lymphopaenia by (OR 3·28, 95% CI 1·41-7·65). After a mean of 18·5 ± 14·4 days, retesting of IGRA in 18 patients with indeterminate results yielded 9 negative vs. 9 indeterminate results. Our results reveal associations of indeterminate IGRA with low serum albumin levels and absolute lymphocyte count and double IM therapy. IGRA testing appears best to be performed prior to initiation of IM therapy in patients with inflammatory bowel disease.
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Fibrostenotic lesions are common complications in Crohn's disease (CD) often requiring surgery. Inherited thrombotic risk factors are associated with fibrosis in other chronic inflammatory diseases. The aim of the study was to assess whether inherited thrombotic risk factors are associated with fibrostenosis in CD. Clinical data on 529 CD patients were collected retrospectively. Subjects were tested for and grouped according to the presence of factor V Leiden (FVL), the prothrombin G20210A, and the methylenetetrahydrofolate reductase C677T mutation (MTHFR). Patients who underwent CD-related intestinal surgery were assessed for the presence of fibrostenosis, which was the primary endpoint. The diagnosis of fibrostenosis was based on surgical, pathological, and histopathological reports. A Cox proportional hazards model was used for statistical analysis. Thirty-two (6.1%, heterozygous 30, homozygous 2) patients were carriers of FVL, 19 (3.6%, all heterozygous) carried the prothrombin variant, and 318 (60.1%) the MTHFR variant (243 heterozygous, 75 homozygous). In all, 303 (57.3%) patients underwent intestinal surgery. Fibrostenosis was identified in 219 (72.3%) surgical specimens. The rate of first intestinal surgeries with fibrostenosis tended to be more frequent in patients with the homozygous 677TT MTHFR mutation (hazard ratio, HR 1.39; 95% confidence interval [CI]: 0.98-1.97; P = 0.067). After adjustment for potential confounders homozygous 677TT MTHFR mutation did not remain a risk factor for intestinal surgery with fibrostenosis (HR 1.23; 95% CI: 0.77-1.98; P = 0.387). FVL and the prothrombin variant had no influence on the primary endpoint. The MTHFR 677TT mutation, factor V Leiden, and the prothrombin G20210A mutation are not associated with fibrostenosis in CD.
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Screening for latent tuberculosis (LTB) including chest x-ray, tuberculin skin test (TST), and facultative whole blood interferon-γ assay (IGRA) is part of routine management in inflammatory bowel disease (IBD) patients before starting therapy with tumor necrosis factor (TNF)-α inhibitors. However, in patients with immunomodulators (IM) TST and IGRA might show limitations. We aimed to evaluate the results from an IGRA (QuantiFERON-TB Gold in Tube) and TST as well as their concordance in 208 consecutive IBD patients with indications for anti-TNF-α therapy. Associations of both tests with risk factors for LTB were determined by logistic regression. During screening, 149 patients (71.6%) were under IM therapy. In 26 (12.5%) patients TST was positive, whereas 15 (7.2%) patients showed a positive result from IGRA. IGRA failed on samples from 16/208 (7.7%) patients, resulting in 192/208 (92.3%) patients in whom results from both screening tests were available. Correlation between IGRA and TST results was fair (84.9%, κ = 0.21). The presence of risk factors for LTB showed association with positive results of TST (odds ratio [OR] 3.7, 1.5-9.6) and IGRA (OR 3.5, 1.2-11.3). TST was associated furthermore with age (OR 1.06, 1.02-1.10) and signs indicative of LTB in chest x-ray (OR 4.9, 1.1-19.9). The IGRA was negatively influenced by IM therapy (OR 0.3, 0.1-0.9). Our study reveals that results of IGRA are negatively affected by IM therapy. Thus, current guidelines for TB screening prior anti-TNF-α therapy appear inaccurate in patients under IM. Therefore, LTB screening might be best performed prior to initiation of IM treatment.
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Smoking and a lack of immunosuppressive (IS) therapy are considered risk factors for intestinal surgery in Crohn's disease (CD). Good evidence for the latter is lacking. The objective of this study was to evaluate the impact of thiopurine treatment on surgical recurrence in patients after first intestinal resection for CD and its possible interaction with smoking. Data on 326 patients after first intestinal resection were retrieved retrospectively, and subjects were grouped according to their postoperative exposure to thiopurines. Treatment with either azathioprine (AZA) or 6-mercaptopurine (6-MP) was recorded on 161 patients (49%). Smoking status was assessed by directly contacting the patients. Surgical recurrence occurred in 151/326 (46.3%) patients after a median time of 71 (range 3-265) months. Cox regression revealed a significant reduction of re-operation rate in patients treated with AZA/6-MP for > or = 36 months as compared with patients treated for 3-35 months, for less than 3 months, and to those without postoperative treatment with AZA/6-MP (P=0.004). Cox regression analysis revealed treatment with thiopurines for > or = 36 months (hazard ratio (HR) 0.41; 95% confidence interval (CI) 0.23-0.76, P=0.004) and smoking (HR 1.6; 95% CI 1.14-2.4, P=0.008) as independent predictors for surgical recurrence. Furthermore, longer duration of disease tended to be protective (HR 0.99; 95% CI 0.99-1.0, P=0.067). Long-term maintenance treatment with AZA/6-MP reduces the risk of surgical recurrence in patients with CD. We also identified smoking as a risk factor for surgical recurrence.
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