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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 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]