Safety, Efficacy and Persistence of Advanced Therapies in Inflammatory Bowel Disease: Results from ORIGINS. A Retrospective Observational Study.

BACKGROUND AND 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.

ERCP in Romania in 2006; a National Programme seems mandatory.

BACKGROUND: Endoscopic retrograde cholangio-pancreato-graphy (ERCP) is a procedure used in the diagnosis and treatment of biliary and pancreatic diseases, more preferable to open surgery in terms of a lower risk of morbidity and mortality and costing much less. METHODS: This was a retrospective, multicenter study, in which we tried to involve the largest medical centers in Romania. They were asked to complete a questionnaire detailing the number of ERCPs performed in 2006, the type of and accessibility to radiology equipment, indications for ERCP, the availability of skilled endoscopists for ERCP and if there were any training pro-grammes. RESULTS: The number of ERCP procedures performed in 2006 by the participating centers was 2647. There was a strong correlation between the availability of radiology equipment, the number of days allocated by the radiology department for the procedure, and the number of ERCPs performed. Gallstone removal accounted for most (50%) of the therapeutic ERCP indications. CONCLUSIONS: For a large country such as Romania, a total number of 2647 ERCPs for 2006 is too low. Various important factors such as lack of access to equipment and few skilled ERCP endosco-pists were identified as possible causes. The number of ERCPs performed in Romania should be reorganized to perform 20000 per year in 5 years from now (2012) and give our population access to proper intervention endoscopy. The National Gastroenterology Society should actively encou-rage training in interventional endoscopy, and collaborate with Ministry of Health to have a National Task-force for Endoscop.