Search

Background & Aims: Real-world assessments of efficacy and safety of advanced therapies used for inflammatory bowel disease (IBD) patients are limited. We aimed to report safety, efficacy and treatment persistence of new molecules (infliximab, adalimumab, vedolizumab, tofacitinib, ustekinumab) in a retrospective multicentric national Romanian analysis. Methods: We conducted a nationwide, retrospective observational multicentric study. Data were collected retrospectively from electronic and paper files. Patients who started on one of the five investigated molecules during December 2019-December 2021 were included. The main outcome measures were clinical remission, endoscopic healing, persistence on treatment and safety data. Results: A total of 678 adult patients from 24 Romanian IBD centers with a diagnosis of ulcerative colitis or Crohn's disease were included. Participants had previously failure to one (268, 39.5%), two (108, 15%) or more treatment lines and only 38% (259) were biologic naïve. In the 24 months study period, most patients were started on vedolizumab (192, 28%), followed by adalimumab, infliximab, ustekinumab and tofacitinib. In biologic-naïve patients, most physicians (72%) preferred anti-TNF treatment as first line biologic (93 patients started on infliximab, 92 on adalimumab), followed by vedolizumab, ustekinumab and tofacitinib. During follow-up, 71% (470, p=0.05) of patients achieved clinical remission and 36% (134, p=0.03) achieved mucosal healing. The 6 months milestone for persistence was reached in 78% (530) of cases. Almost half of patients (47%, 316 patients) persisted on their current treatment for over 12 months. Overall, an adverse reaction was reported for 67 (10.4%) patients, with no lethal events. Conclusions: Population of biologic-experienced IBD patients in Romania is increasing and is becoming more difficult to achieve long-term disease control. Discontinuation rates for advanced therapies are high. [ABSTRACT FROM AUTHOR]

Background & Aims: Identifying the risk factors for extraintestinal manifestations (EIMs) in inflammatory bowel diseases (IBD) may optimize the therapeutic decision. We aimed to assess the prevalence of EIMs in IBD patients in Romania and to determine the risk factors. Methods: We analyzed 2,626 patients registered in the Romanian IBD Prospect National Registry. We performed a descriptive cross-sectional study to assess the point prevalence of EIMs, calculating global prevalence and analyzing the different types of EIMs and their respective frequencies were carried out. Demographic and clinical risk factors were researched as possible predictors for EIMs development, based on the results of the univariate and multivariate logistic regression analysis. Results: The overall point prevalence of EIMs was 16.3%. A significantly higher frequency of EIMs in Crohn's disease (CD) was noted in comparison to ulcerative colitis (UC) and IBD unclassified (IBDU) (23.2% vs 11.3% and 16.3%, respectively, p<0.001). The most frequent type of EIM was peripheral arthropathy (8.3%), significantly associated with CD (p<0.001). Univariate analysis highlighted the significant independent common predictive risk factors for EIMs, in both CD and UC patients: female gender, patient's urban area of origin, anemia, hypoalbuminemia, and high level of C-reactive protein (CRP), while significant independent IBD phenotype-related risk factors were ileocolonic location and concomitant involvement of upper gastrointestinal tract for CD, non-smoker status and both moderate and severe disease activity for UC (p<0.05). Multivariate analysis determined that female CD patients with moderate or severe disease activity, with other than isolated ileal disease, and female UC patients with moderate or severe extensive colitis are the most likely to develop EIMs. Conclusions: IBD patients are experiencing EIMs in a large proportion, with higher rates for CD. As EIMs negatively affect patient outcomes, foreseeing the risk by identifying independent and associated predictive factors could be a first step to optimal work-up and treatment [ABSTRACT FROM AUTHOR]

Background and aim. The management of patients with inflammatory bowel diseases (IBD) has been changed during the COVID-19 pandemic, when many hospitals have been designated COVID-19 support. We performed a comparative retrospective analysis of the management of IBD patients treated in Gastroenterology Clinic in two distinct periods: before the pandemic (between 2016 and 2019) and during the pandemic (between 2020 and 2022). Methods: We collected data regarding IBD extension and severity, therapy, and type of medical visits over a period of seven years. Results. A total number of 146 patients were included, 101 with ulcerative colitis (UC), and 45 with Crohn disease (CD). 27 patients with UC had proctitis, 38 left sided colitis, and 36 pancolitis. Among CD patients 14 had colonic involvement, 13 ileal involvement, and 18 ileo-colonic disease. 99 patients with UC were on aminosalicylates, 18 on immunomodulators (Azathioprine), and 19 on biologic therapy. Biologics were used in 17 patients with CD, Azathioprine in 15 patients, aminosalicylates in 42 patients. We registered a total of 1755 hospital visits, from which 958 (54.6%) were in the pre-pandemic period. Patients with UC had the highest number of hospital visits (1159, 66%). We noticed a progressive increase in the number of visits in pre-pandemic years until 2019 (23.42%), followed by a decrease in 2020 (16%), then a further increase in 2021 (25.98%). The majority of visits (850, 48.4%) consisted in one-day hospitalizations, 637 (36.3%) were outpatient visits, and 268 (15.3%) ward hospitalizations. In pre-pandemic years a significant higher admission rate was for patients with UC, while during the pandemic for CD patients (p< 0.05). Before 2020 patients were more frequently referred for mild (225, 23.5%) to moderate IBD flares (270, 28.2%); 36 (3.75%) ward hospitalizations for severe flare were registered. During the pandemic, IBD remission was noted in most hospital visits (396, 49.6%, p<0.05). Ward hospitalizations were indicated only for severe IBD flare (57, 7.2%). There was a significantly higher rate of ward hospitalizations (173, 65%) and oneday hospitalizations (470, 55.3%) before 2020, and a significant increase in the number of outpatient visits (322, 50.5%, p<0.05) during the pandemic. Presentation at the hospital for the purpose of administering biological therapy was prevalent in the pandemic (460, 57.7%). Conclusions. Although hospital referrals have declined during the pandemic years, we optimized therapy and maintained IBD remission at a significant rate. There was a significant shift to outpatient visits, enforced by the pandemic restrictions. [ABSTRACT FROM AUTHOR]

Background & Aims: Prevalence of malnutrition in inflammatory bowel diseases (IBD) varies between 16% and 75%. Data on the nutritional status at initial diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) are scarce. It is believed that more than 50% of IBD patients suffer significant weight loss prior to diagnosis. The aims of our study were to assess malnutrition in patients recently diagnosed with IBD and to determine its predictive factors. Methods: We retrospectively included 625 IBD patients registered in the Romanian "IBD Prospect" database between January 2006 and July 2017. All patients were diagnosed within 6 months prior to registration. We defined malnutrition as weight loss of more than 5% of the initial weight during the 3 months prior to registration. Results: There were 361 new cases of UC, 241 CD and 23 cases of unclassified IBD. There was a slight male predominance (M/F=1.2). Prevalence of overall malnutrition was 36.3%. It was significantly more frequent in CD than in UC patients (41.1% vs. 32.4%, p=0.031). In multivariate analysis, malnutrition in UC patients was associated with male gender (p=0.001), more severe disease (p<0.0001) and more extensive disease (p=0.027), while in CD it was associated with younger age (p=0.013) and more severe disease (p<0.0001). Conclusions: About 1 in 3 newly diagnosed IBD patients presents with malnutrition at the time of diagnosis. [ABSTRACT FROM AUTHOR]