scholarly journals P600 Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S546-S547
Author(s):  
J S Lasa ◽  
A Sambuelli ◽  
I Zubiaurre ◽  
G J Correa ◽  
P Lubrano ◽  
...  

Abstract Background Evidence on the adoption of different pharmacologic strategies in inflammatory bowel disease (IBD) in the real-world setting in Latin America is scarce. Herein, we describe the clinical characteristics and therapeutic strategies of IBD patients (pts) in Argentina. Methods RISE AR (NCT03488030) was a multicentre, non-interventional study with a cross-sectional evaluation and a 3-year retrospective data collection period conducted in Argentina (12/2018-05/2019) to assess the use of IBD treatments. Adult pts (≥18 years old) with a previous diagnosis of moderate-to-severe ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria at least 6 months prior to enrolment, were included. Results Overall, 101 CD and 145 UC pts were included. Median (range) age (years) at enrolment was 39.5 (18.2–74.0) for CD (51.2% female) and 41.9 (18.0–80.4) for UC (55.2% female); median (range) disease duration (years) was 7.4 (0.6–36.9) for CD and 5 (0.7–33.8) for UC. At enrolment, 51.5% of CD pts had colonic involvement, 32.7% ileocolonic, 8.9% ileal, 1% isolated upper tract and 5.9% had combined L4/other. In UC, 46.2% had extensive colitis, 44.7% left-sided colitis and proctitis 9.1%. 51.6% of CD pts had non-inflammatory behaviour (37.7% stricturing; 13.9% penetrating), and 34% had perianal disease (13.9% as B1p), resulting in a total of 65.5% pts with complicated disease. Only 9.3% of CD (Harvey Bradshaw Index ≥8) and 7.7% of UC (partial Mayo Score ≥5) pts showed moderate-to-severe disease activity at enrolment. In CD, 70.3% of pts were receiving a biologic agent vs. 29.7% of UC pts. Immunosuppressant (IMM) use was similar between groups (CD 39.6%, UC 40.0%); nearly one-third of the pts on a biologic were receiving concomitant IMM (CD 33.8%, UC 34.9%). Aminosalicylates (5-ASA) were used for most UC pts (89.0%) vs. 47.5% of CD pts, mainly in those with L2 disease. 5-ASA monotherapy was prescribed in 32.1% of UC vs. 5.3% of CD pts, but were also used with IMM (UC 25%, CD 11%), biologics (UC 15%, CD 11.6%) or all three therapies combined (UC 6.4%, CD 17.9%). Corticosteroids (CS) were the least prescribed therapy (CD 7.9%, UC 13.8%). IBD treatments ever prescribed during the retrospective period were (CD, UC): biologics: 79.2%, 33.8%; IMM: 65.3%, 58.6%; 5-ASA: 62.4%, 97.9%; CS: 55.4%, 69.7%. Conclusion In this cohort of IBD patients, biologics use was high, especially among CD patients, in line with disease behaviour, and possibly by their increased availability in these reference centres. This study also highlights country-specific clinical features such as the low proportion of CD pts and the high prevalence of colonic involvement in CD.

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S313-S313
Author(s):  
I V Gubonina ◽  
V Grinevich ◽  
M Poluektov ◽  
T Kolodin ◽  
S Lapteva ◽  
...  

Abstract Background Currently the incidence of patients with Metabolic Syndrome (MS) tends to increase among patients with inflammatory bowel disease (IBD). The purpose of the study is to investigate the course of IBD depending on the presence of MS. Methods This cross-sectional analysis was performed on the database of patients with IBD to estimate the frequency of MS presence and study the clinical course (extension of pathologic process, severity and phenotype) of Crohn’s disease (CD) and ulcerative colitis (UC). Results 347 patients with IBD were included in the investigation: 259 patients with UC and 88 patients with CD. MS was revealed with the same frequency among patients with UC (26 patients, 10.04%) and CD (9 patients, 10.23%). Proctitis (48 patients, 20.6%) and left-sided colitis (121 patients, 51.93%) are usually found among patients with UC without MS while total colitis is significantly more frequent among patients with underlying MS (12, 46.15%, p < 0,05). It was found that patients without MS more often suffered from mild UC (116 patients, 49.79%, p < 0,01) while among patients with MS severe UC occurred more frequently (6 patients, 23.08%, p < 0.05). Among patients with CD and MS, there was no significant correlation between underlying MS and localisation, severity and course of CD. Conclusion Patients with UC and MS suffer from a more severe course of UC (as to both the extension of pathologic process and severity) in comparison with the patients with UC without MS. Due to the small quantity of patient with CD and MS insufficient evidence for the influence of MS on the course of CD has been obtained.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S643-S643
Author(s):  
I A da Luz Rosa ◽  
P Silva ◽  
S Mata ◽  
F Magro ◽  
F Carneiro ◽  
...  

Abstract Background Inflammatory Bowel Disease (IBD) with colonic involvement increases colorectal cancer risk. However, the distinction between IBD related and sporadic dysplasia in IBD patients is difficult. Some data favours the importance of abnormal DNA methylation in IBD-related carcinogenesis. Our study aimed to define methylation patterns in patients with a colonic cancer or dysplasia diagnosis following an IBD diagnosis. Methods Multicentric cross-sectional study- 91 samples from colonic mucosa with/without dysplasia from 9 patients with IBD-related dysplasia/cancer and 26 patients with IBD and sporadic dysplasia/cancer were included. Methylation patterns of CpG islands in the promoter regions of 67 genes were studied by Methylation-specific Multiplex Ligation-dependent Probe Amplification. Results Mean age at IBD diagnosis: 42±16 years; at dysplasia diagnosis: 56± ± 14 years. Twenty-nine patients had ulcerative colitis. Twenty-five patients had at least 1 lesion endoscopically described as adenoma-like, 4 at least 1 non-adenoma like, 3 had cancer and 3 had dysplasia in flat mucosa. No patient had both adenoma-like and non-adenoma-like lesions. Patients with an IBD-related lesion were significantly younger at IBD diagnosis (p = 0.003) and at dysplasia/cancer diagnosis (p = 0.039). Promoter methylation of IGF2, RARB, ESR1, CHFR, CDH13, WT1, GATA5, WIF1 genes was significantly associated to dysplasia/cancer; methylation of MSH6, TIMP3 was significantly associated to IBD-related dysplasia/cancer. Promoter methylation of MSH6, MSH3, RUNX3, CRABP1, TP73, RARB, CDH13, PAX5, WT1, THBS1, TP53, SFRP1, WIF1, APAF1, BCL2 genes was significantly associated to active IBD. Conclusion Methylation analysis, namely of MSH6, may contribute to the classification of dysplastic lesions in IBD– to be further tested in prospective studies.


Author(s):  
Jing Liu ◽  
Xiaolong Ge ◽  
Chunhui Ouyang ◽  
Dongxu Wang ◽  
Xiaoqi Zhang ◽  
...  

Abstract Background Malnutrition is prevalent among patients with inflammatory bowel disease (IBD). Nutritional profiles among Asian patients with IBD have seldom been investigated. We assessed the prevalence of and risk factors for malnutrition, use of nutrition support, and sociopsychological status associated with malnutrition among patients with IBD in China. Methods Patients with ulcerative colitis (UC) and Crohn’s disease (CD) recruited from 43 tertiary referral hospitals were screened for malnutrition and nutrient deficiencies in this cross-sectional study. The use of nutrition support was recorded. The sociopsychological status was assessed by subjective questionnaires. Factors associated with malnutrition were analyzed, and multivariate regression was used to determine independent predictors for malnutrition. Results We recruited 1013 patients with a median age of 35.0 years, 58.5% of them had CD, and 61.4% of all patients were male. Overall, 49.5% (501) of patients were diagnosed with malnutrition, including 57.0% of patients with CD, 38.8% of patients with UC, and 44.1% of patients with quiescent or mildly active disease. Nutrient deficiencies were prevalent despite the absence of malnutrition. Malnutrition was associated with adverse sociopsychological status, including decreased social support, higher perceived stress, and impaired quality of life. Moderate to severe disease activity and extensive disease were two independent risk factors for malnutrition. In total, 41.6% of patients received nutrition support, and patients with risk factors were more likely to receive nutrition support. Conclusions Malnutrition was highly prevalent and associated with adverse consequences in Chinese patients with IBD. Malnutrition screening and early initiation of nutrition support are essential components in IBD care.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S266-S266
Author(s):  
A Hassine ◽  
A Hammami ◽  
W Ben Ameur ◽  
W Dahmani ◽  
N Elleuch ◽  
...  

Abstract Background Sexual dysfunction is often associated with impaired body image and quality of life in patients. However, little data exists on sexual dysfunction (SD) in patients with Chronic Inflammatory Bowel Disease (IBD). The aim of this study was to assess the prevalence and risk factors for sexual dysfunction in patients with IBD. Methods This is a cross-sectional study of all patients followed for IBD. Sexual function was assessed by the Female Sexual Index Function (FSIF) for women and the International Index of Erectile Function (IIEF) for men. Sexual dysfunction was confirmed when the total FSIF score was less than 26, or the IIEF score less than 26. Crohn’s disease (CD) activity was assessed by the Harvey-Bradshaw index (HBI), and that of ulcerative colitis (UC), by the clinical Mayo scores. Results We collected 100 patients, with a mean age of 42.18 ± 15.71 and a sex ratio (M / F) = 1.5. Sixty eight patients had CD and 32 patients had UC. Ano-perineal manifestations were present in 38.2% of cases. Severe disease activity was noted in 14 patients (20.6%) with CD and 10 patients (31.3%) with UC. Twelve patients had proctitis. 38% of patients had surgical treatment: 18.75% for patients with UC and 47.05% for those with CD. Total colectomy was performed in 12% of cases. At the time of the study, 20% of patients were on systemic corticosteroid therapy, 22% on Azathioprine, 4% on Salazopyrine, 8% on 5-ASA and 46% on Anti-TNFα. Sexual dysfunction was reported by 42.9% of women: 57.14% (UC) vs 38.46% (CD) (p = 0.042). On the other hand, sexual dysfunction was reported by 27.6% of men: 22.2% of men with UC and 28.57% with CD, with no statistically significant difference (p = 0.78). A significant association was found between sexual dysfunction and the degree of disease activity (p <0.001 for CD, p = 0.003 for UC), as well as pancolitic involvement in women with UC (p = 0.002). However, the presence of anoperineal manifestations, rectal involvement and history of surgery were not significantly associated with the frequency of sexual disturbances. Conclusion Our study showed a high prevalence of sexual dysfunction in patients with IBD. Training gastroenterologists in the management of sexual dysfunction would make it possible to satisfy patient expectations.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S204-S205
Author(s):  
L Martins Figueiredo ◽  
F Correia ◽  
M A Rafael ◽  
L Lourenço ◽  
A M Oliveira ◽  
...  

Abstract Background The real impact of COVID-19 infection on patients with Inflammatory Bowel Disease (IBD) is unknown. It was speculated that this population could be a risk group. The aim of this study is to evaluate the incidence of SARS-CoV2 infection, the impact of initiation/change of IBD therapy and its morbidity and mortality, during the COVID-19 pandemic in Portugal. Methods Prospective cross-sectional study. Patients with IBD followed at a Gastroenterology Department in an area with a high incidence rate of SARS-CoV2 were included, from 01/03/2020 to 31/08/2020. Data was obtained through telephonic appointments, hospital inpatients admissions, Emergency Department Service and Day Hospital episodes. Results 335 patients were included, 194 female, with a mean age of 47.4 years (18–88). 200 had Crohn’s disease (CD), 132 Ulcerative Colitis, 3 unclassified colitis. 320 were on therapy (95.5%): salicylates n=230 (71.9%), systemic corticosteroids n=34 (10.6%) (18 started during the pandemic), thiopurines/methotrexate n=117 (36.6%) (8 started in this period), biological n=148 (46.3%) (14 started in this period). 7 patients (2.2%) triple immunosuppressed. 75 patients had disease in remission, 232 mild/moderate, 28 severe disease (requiring hospitalization). SARS-CoV2 infection was observed in 3 patients (incidence rate: 0.89%), treated as an outpatient basis. 2 male, mean age 58 years, 2 with CD. Comorbidities: 0: n = 1; 2: n = 1; 4: n = 1. 2 patients were on salicylates and one on adalimumab (monotherapy, before the pandemic). There were no deaths. Conclusion All patients started or maintained their IBD therapy according to current international guidelines. A significantly higher incidence of COVID-19 infection than that of the local and Portuguese population in general has not been documented. According to our preliminary results, the population with IBD does not appear to be a risk group for acquiring infection or having a severe course of the disease.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S228-S229
Author(s):  
T Stevens ◽  
M Wildenberg ◽  
M Koželj ◽  
G Novak ◽  
K Gecse ◽  
...  

Abstract Background To facilitate personalised treatment of inflammatory bowel disease (IBD), biomarkers for disease entity and disease severity in easily accessible samples are required. Therefore, we aimed to (i) identify proteins that discriminate Crohn’s disease (CD) from ulcerative colitis (UC), (ii) assess the association of proteomic profiles with disease severity and (iii) assess the potential to use serum samples as a proxy for intestinal biopsies. Methods In this prospective cross-sectional study, IBD patients with active endoscopic disease (presence of ≥1 ulcer (CD) or Mayo score ≥1 (UC)) and age matched non IBD controls (normal endoscopy) were included. In IBD, biopsies were taken from inflamed tissue; in CD from the edge of an ulcer and in UC and controls between 20 and 25 cm from the anal verge. Disease severity was dichotomised in mild vs. severe defined as SES CD <10 vs. ≥11 in CD and Mayo endoscopy score 1/2 vs. 3 in UC. Ninety-two inflammatory proteins were measured in biopsies and serum using a proximity extension assay (OLINK). The elastic net algorithm was used to select proteins associated with disease severity. Multiplicity adjustments were done using the Benjamini–Hochberg approach. Results Forty-one CD, 39 UC and 10 controls were included. Median SES-CD score [IQR] was 9 [7–16] in CD. In UC, 20 (51.3%), 15 (38.5%) and 4 (10.3%) patients had an endoscopic Mayo score of 3, 2 and 1, respectively. Three proteins differed significantly between UC and CD in tissue (IL-17A, IL13 and CCL4). However, this was not reflected in serum levels of these molecules. For prediction of disease severity in CD, elastic net regression identified a set of 11 serum proteins that discriminated mild from severe disease (accuracy 0.667). Top five proteins were IFNγ (OR 3.03), CCL23 (OR 1.28), Cystatin D (OR 0.61), TNF (OR 1.28) and HGF (OR 1.17) (Figure 1). In tissue, no discriminatory profile was identified. Conversely, in serum of UC, no proteins were selected, while a set of three tissue proteins was associated with disease severity (accuracy 0.725). These proteins were osteoprotegerin (OPG) (OR 1.66), IL8 (OR 1.09) and CCL25 (OR 0.97). The discrepancy between serum and tissue was further supported by correlation analyses. Of all 92 proteins, only three showed significant correlation between tissue and serum: IL17A (r = 0.44), TGF-α (r = 0.42) and IL6 (r = 0.39). Conclusion Proteomic profiles between tissue and serum in active IBD correlated poorly. Only in CD, serum markers differentiated mild from severe disease. In UC, no proteins in serum were selected whereas in tissue, expression of OPG, IL-8 and CCL25 was associated with disease severity. These data again emphasise the difference between CD and UC on a molecular level.


2021 ◽  
Vol 6 (1) ◽  
pp. 1363-1368
Author(s):  
Mohan Khadka

Introduction: Inflammatory bowel disease (IBD), once considered disease of west is also increasingly diagnosed in Asia in recent years. As there are already studies about IBD in Southeast Asia like India, Srilanka, it would be more informative to study the disease in Maldives as being closer to India and Srilanka. This is probably the first study about the disease from Maldives conducted in a single tertiary hospital center. The objectives of the study were to determine the prevalence, clinical characteristics and treatment of IBD in Maldives. Methodology: A preliminary hospital-based retrospective observational study was performed in ADK multispecialty hospital, a referral tertiary center located in the capital city of Maldives. Patients visiting gastroenterology OPD, who were diagnosed as IBD either Crohn's disease (CD) or Ulcerative colitis (UC) on basis of internationally established standard practice, were recruited in the study after informed oral consents for the duration of three years from January, 2017 to December, 2020. We collected clinical data including gender, age at diagnosis, symptomatology, severity, smoking habits, family history, disease phenotype, and behavior at diagnosis from each involved patients as per clinical proforma prepared for UC and Crohn's disease in separate forms. Result: Total 41 patients of IBD with 15 CD and 26 UC were recruited during study period. The prevalence of IBD in the country was estimated to be at least 20 per 100000 persons. Ileocolonic phenotype in CD and Extended colitis in UC were more common. Clinically, majority IBD patients presented with moderate to severe form. Biologic agents were frequently used in IBD. Conclusion: The prevalence of IBD in Maldives is also more or less similar to other Asian countries where as some aspects of clinical characteristics are similar to Western countries. There needs to be nationwide epidemiological study or multi center hospital based prospective or at least cross sectional study for detail and optimal information about various aspects of IBD. 


2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Cole Johnson ◽  
Edward L Barnes ◽  
Xian Zhang ◽  
Millie D Long

Abstract Background and Aims There are currently several recruitment challenges in randomized controlled trials (RCTs) for inflammatory bowel disease (IBD), which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors that could influence future recruitment strategies. Methods We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an RCT of medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated in an RCT during each calendar year from 2011 to 2018 and accessed Clinicaltrials.gov to determine the number of active RCTs for IBD therapies per year during that same period. Results A total of 14,747 patients with IBD were included in the analysis and 1116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation included following at an academic institution [odds ratio (OR) = 1.8; 95% confidence interval (CI) 1.51–2.04) and age 36–75 (OR = 1.7; 95% CI 1.46–1.92). Patients with Crohn’s disease were more likely to participate than those with ulcerative colitis (OR = 1.5; 95% CI 1.35–1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR = 2.6; 95% CI 2.19–2.99), IBD-related surgery (OR = 2.5; 95% CI 2.24–2.87), biologic exposure (OR = 3.2; 95% CI 2.76–3.65), and “Poor” or worse quality of life (OR = 1.7; 95% CI 1.45–1.93). Steroid-free remission was associated with a lower likelihood of RCT participation (OR = 0.6; 95% CI 0.53–0.70). Although the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort. Conclusions RCT participation declined within this cohort. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean disease activity scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-tumor necrosis factor (TNF) exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.


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