Therapeutic preferences and outcomes in newly diagnosed patients with Crohn’s diseases in the biological era in Hungary: a nationwide study based on the National Health Insurance Fund database

Abstract Background Accelerated treatment strategy, including tight disease control and early aggressive therapy with immunosuppressives (IS) and biological agents have become increasingly common in inflammatory bowel disease (IBD). The aim of the present study was to estimate the early treatment strategy and outcomes in newly diagnosed patients with Crohn’s disease (CD) between 2004 and 2008 and 2009–2015 in the whole IBD population in Hungary based on the administrative database of the National Health Insurance Fund (OEP). Methods We used the administrative database of the OEP, the only nationwide state-owned health insurance provider in Hungary. Patients were identified through previously reported algorithms using the ICD-10 codes for CD in the out-, inpatient (medical, surgical) non-primary care records and drug prescription databases between 2004 and 2015. Patients were stratified according to the year of diagnosis and maximum treatment steps during the first 3 years after diagnosis. Results A total of 6173 (male/female: 46.12%/53.87%) newly diagnosed CD patients with physician-diagnosed IBD were found in the period of 2004–2015. The use of 5-ASA and steroids remained common in the biological era, while immunosuppressives and biologicals were started earlier and became more frequent among patients diagnosed after 2009. The probability of biological therapy was 2.9%/6.4% and 8.4%/13.7% after 1 and 3 years in patients diagnosed in 2004–2008/2009–2015. The probability of hospitalization in the first 3 years after diagnosis was different before and after 2009, according to the maximal treatment step (overall 55.7%vs. 47.4% (p = 0.001), anti-TNF: 73%vs. 66.7% (p = 0.103), IS: 64.6% vs. 56.1% (p = 0.001), steroid: 44.2%vs. 36.8% (p < 0.007), 5-ASA: 32.6% vs. 26.7% p = 0.157)). In contrast, surgery rates were not significantly different in patients diagnosed before and after 2009 according to the maximum treatment step (overall 16.0%vs.15.3%(p = 0.672) anti-TNF 26.7%vs.27.2% (p = 0.993), IS: 24.1%vs22.2% (p = 0.565), steroid 8.1%vs.7.9% (p = 0.896), 5-ASA 10%vs. 11% (p = 0.816)). Conclusions IS and biological exposure became more frequent, while hospitalization decreased and surgery remained low but constant during the observation period. Use of steroids and 5-ASA remained high after 2009. The association between the maximal treatment step and hospitalization/surgery rates suggests that maximal treatment step can be regarded as proxy severity marker in patients with IBD

The burden of Clostridium difficile infection between 2010 and 2013: trends and outcomes from an academic center in Eastern Europe

Modeling is now an essential ingredient in business process management and information systems development. The general usefulness of models in these areas is therefore generally accepted. It is also undisputed that the quality of the models has a significant impact on their usefulness. In the literature we can find any number of quality metrics, but hardly any study that investigates their relation with (perceived) usefulness and none that considers their relative impact on usefulness. We take a look at some of the most frequent quality dimensions and their relative impact on the perceived usefulness of models

Is early limited surgery associated with a more benign disease course in Crohn’s disease?

AIM: To analyze the difference in disease course and need for surgery in patients with Crohn's disease (CD). METHODS: Data of 506 patients with incident CD were analyzed (age at diagnosis: 31.5 ± 13.8 years). Both hospital and outpatient records were collected prospectively with a complete clinical follow-up and comprehensively reviewed in the population-based Veszprem province database, which includes incident CD patients diagnosed between January 1, 1977 and December 31, 2008. Follow-up data were collected until December 31, 2009. All patients included had at least 1 year of follow-up available. Patients with indeterminate colitis at diagnosis were excluded from the analysis. RESULTS: Overall, 73 patients (14.4%) required resective surgery within 1 year of diagnosis. Steroid exposure and need for biological therapy were lower in patients with early limited surgery (P < 0.001 and P = 0.09). In addition, surgery rates during follow-up in patients with and without early surgery differed significantly after matching on propensity scores (P < 0.001, HR = 0.23). The need for reoperation was also lower in patients with early limited resective surgery (P = 0.038, HR = 0.42) in a Kaplan-Meier and multivariate Cox regression (P = 0.04) analysis. However, this advantage was not observed after matching on propensity scores (P(Logrank) = 0.656, P(Breslow) = 0.498). CONCLUSION: Long-term surgery rates and overall exposure to steroids and biological agents were lower in patients with early limited resective surgery, but reoperation rates did not differ

A felső és alsó endoszkópiák indikációja, a diagnózisok megoszlása és minőségi mutatók 2010–2011-ben a Semmelweis Egyetem I. Belgyógyászati Klinikáján

Absztrakt: Bevezetés és célkitűzés: A Semmelweis Egyetem I. Belgyógyászati Klinikájának endoszkópos laboratóriumában vizsgálták a felső és alsó endoszkópiák indikációit, a diagnózisok megoszlását indikációk szerint, valamint a kolonoszkópiák minőségi mutatóit. Módszer: 2010. január 1. és 2011. december 31. között 2987 beteg felső és alsó endoszkópos vizsgálatának adatait elemezték (férfi/nő: 1361/1626, átlagéletkor: 60,7 év, SD: 16,7 év) a fekvő- és járóbeteg-megjelenések riportjaiból. Eredmények: A felső endoszkópiák során a jóindulatú fekélybetegség, nyelőcső-varicositas, gyomorpolip és gyomorrák előfordulási gyakorisága 10,8%, 4,5%, 6,1% és 2,9% volt. Az alsó endoszkópos vizsgálatok vastagbélpolipot, diverticulosist, daganatot és gyulladásos bélbetegséget 29,9%, 22,4%, 6,9% és 9,7%-ban írtak le. A betegek 26,3%-át vizsgálták okkult/manifeszt GI-vérzés indikációjával. A vérzés indikációjával vizsgált betegek idősebbek voltak (p<0,01), több volt a férfi (p<0,001, OR: 1,64), gyakrabban szedtek acenocoumarol- vagy heparinkészítményeket (p<0,001), gyakoribb volt a jóindulatú fekélybetegség (p<0,001, OR: 2,83) és nyelőcső-varicositas (p<0,001, OR: 2,79), a gasztroszkópiák, valamint a kolonoszkópiák során a colorectalis daganat (p<0,001, OR: 3,27). A kolonoszkópiák 81%-a volt komplett. Az inkomplett vizsgálat hátterében elégtelen előkészítés (38,2%), technikai nehézség (25,1%) és daganat miatti szűkület (20,5%) állt. Következtetés: A diagnózisok megoszlása és a minőségi mutatók (adenomatalálat, komplettálási arány) megfeleltek az adott populációban várhatónak. Orv. Hetil., 2016, 157(52), 2074–2081. | Abstract: Introduction and aim: The aim was to assess the incidence of endoscopic findings based on the indication of the procedures in upper/lower endoscopies, and measuring quality indicators of colonoscopies at the 1st Department of Medicine, Semmelweis University, Budapest. Method: Data of 2987 patients (male/female:1361/1626, mean age: 60.7 years(y), SD: 16.7y) between 01.01.2010 and 31.12.2011 were analyzed. Both inpatient and outpatient records were collected. Results: Incidence of peptic ulcer disease, esophageal varices, gastric polyps and gastric cancer were 10.8%, 4.5%, 6.1%, 2.9% in upper endoscopies, respectively. In colonoscopies colorectal polyps, diverticulosis, colorectal cancer and IBD were found in 29.9%, 22.4%, 6.9%, 9.7%, respectively. In patients having upper endoscopy with GI bleeding indication, older age (p<0.001), male gender (p<0.001, OR: 1.64), acenocoumarol/heparin use (p<0,001, peptic ulcers and esophageal varices were more frequent (p<0.001, OR: 2.83 and p<0.001, OR: 2.79), while in colonoscopies colorectal cancer had higher incidence (p<0.001, OR:3.27). 81% of colonoscopies were complete. Causes of incomplete procedures were ineffective bowel preparation (38.2%), technical difficulties (25.1%) and strictures (20.5%). Conclusion: The endoscopic findings and quality indicators (adenoma detection rate, coecal intubation rate) were in line with that reported in published series. Orv. Hetil., 2016, 157(52), 2074–2081

„A Crohn-betegség epidemiológiájának változásai a Veszprém megyei populációs adatbázis feldolgozása alapján”

A multifaktoriális eredetű Crohn-betegség genetikailag hajlamos egyénekben különböző környezeti tényezők hatására jön létre. A nem megfelelően kontrollált immunszabályozás hatására folyamatosan aktivált gyulladásos válaszreakció és a normál bélflórával szembeni túlérzékenység alakul ki. A betegség kialakulásában mindezek alapján genetikai, immunológiai, mikrobiológiai és környezeti tényezők is egyaránt fontos szerepet játszanak. A betegség etiológiájának kutatásában folyamatosan zajló vizsgálatok már 200 génpolimorfizmust és számos mikrobiotát összefüggésbe hoztak a betegség kialakulásával. A betegség leggyakrabban fiatalkorban indul, élethosszig tartó visszatérő aktivitásával jelentősen befolyásolja a betegek szociális helyzetét, munkavégző képességét, összességében a betegek életminőségére is negatív hatással bír. A nemzetközi eredményekkel összhangban, tanulmányainkban igazoltan jelenleg is magas a betegség incidenciája és különösen a gyermekkorban észlelhető, egyre növekvő incidencia miatt a betegség jelentősége igen nagy, amely az egészségügyi ellátórendszerre is nagy terhet ró. A gyermekkorban induló IBD-re a kiterjedtebb lokalizáció és agresszívabb viselkedésforma jellemző és a gyermekek között magasabb az immunszuppresszív kezelés szükségének aránya is. A betegek követése során azonban a felnőttkorihoz hasonló lefolyást mutat, a kialakuló szövődmények aránya is a felnőttkorival megegyező mértékű. Az évtizedekig is fennálló intestinalis gyulladás összefüggésbe hozható rosszindulatú daganatok kialakulásával. Eredményeink alapján van azonban egy fenotípus (vastagbél-lokalizációjú, szűkületes betegségforma), amely már rövid betegségtartam mellett is kifejezett rizikót jelent a colorectalis rák kialakulására, így a betegek ezirányú szűrése is kiemelt jelentőségű. A lymphoma előfordulási aránya igen alacsony volt és kialakulásában nem találtunk összefüggést az alkalmazott gyógyszeres kezeléssel. A betegség komplex volta miatt csak a multidiszciplináris terápiás megközelítés hozhat eredményt a szövődmények megelőzésében és kezelésében, a betegek életminőségének javításában

Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort

Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn’s disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. Results: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [ p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. Conclusions: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions