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

A székletkalprotektin meghatározásának szerepe a bélbetegségek diagnosztikájában és kezelésében

Absztrakt: Az elmúlt évtizedben a gastrointestinalis kórképek diagnosztikája sokat változott. Az endoszkópos és képalkotó módszerek mellett előtérbe kerültek a gyorsan elvégezhető laboratóriumi diagnosztikus vizsgálatok is. Külön előnynek számít, ha a vizsgálat könnyen ismételhető, így a krónikus betegségek követésére, az esetleges fellángolások időben történő felismerésére is alkalmas lehet. A székletkalprotektin meghatározása, mely más országokban már a mindennapi diagnosztika része, hazánkban is egyre több helyen hozzáférhető. Összefoglaló közleményünkben bemutatjuk a székletkalprotektin-vizsgálat szerepét és megbízhatóságát a gasztroenterológiai kórképekben, különös tekintettel a gyulladásos bélbetegségekre, a bélrendszeri fertőzésekre, az irritábilisbél-szindrómára és egyes gyermek gasztroenterológiai kórképekre. A különböző betegségekben és helyzetekben használatos határértékeknek és az ezekhez tartozó specificitásnak és szenzitivitásnak a bemutatásával szeretnénk segíteni a klinikai orvosokat a helyes döntéshozatalban. Orv Hetil. 2019; 160(9): 322–328. | Abstract: The diagnostics of gastrointestinal diseases have evolved significantly in the past few decades. Besides endoscopy and conventional imaging modalities, there is a growing interest for rapid point-of-care laboratory tests to help discriminate between diseases with similar clinical symptoms and/or help the follow-up of chronic conditions, predicting relapses. The fecal calprotectin testing is a routine diagnostic tool in many countries. It is also more and more accessible in Hungary as well. We aim to present a short review on the role and performance of fecal calprotectin test in the diagnosis and follow-up of gastrointestinal diseases, especially inflammatory bowel diseases, gastrointestinal infections, irritable bowel syndrome and pediatric conditions. By presenting the different cut-off values, sensitivity and specificity rates representative for each disease, we hope to further aid clinicians in decision-making regarding these conditions. Orv Hetil. 2019; 160(9): 322–328

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

Prediction of short- and medium-term efficacy of biosimilar infliximab therapy. Do trough levels/antidrug antibody levels or clinical/biochemical markers play a more important role?

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Long term efficacy, safety and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort

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Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

Background: Safety data of the ‘real life’ use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. Methods: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. Results: Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p < 0.001, OR 6.3 (2.7–14.6)) and ADA positivity (32.6% vs. 4.1%, p < 0.001, OR 19(5–73)) during the induction therapy were predictive factors for infusion reactions. Conclusions: Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has been confirmed to be efficacious in inducing remission in inflammatory bowel diseases (IBD). The aim of this study was to evaluate the long-term efficacy and safety of CT-P13 therapy in Crohn’s disease (CD) and ulcerative colitis (UC), and to identify predictors of sustained clinical response during a 54-week CT-P13 treatment period. Patients and methods: Patients with CD and UC, who were administered CT-P13, were prospectively enrolled. Clinical response was assessed at week 14 and week 54. Predictive factors for disease outcome at week 54 were evaluated. Results: 57 CD and 57 UC patients were included; 55 CD and 49 UC patients completed the induction therapy and 50 CD and 46 UC patients completed the 54-week treatment period. Clinical remission was achieved in 65.5% of CD and 75.5% of UC patients at week 14. Rate of continuous clinical response was 51% in both CD and UC at week 54. None of the examined parameters were predictive to the clinical outcome neither in CD, nor in UC. Conclusion: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD. Response rates at week 54 were similar in CD and UC. © 2017 Informa UK Limited, trading as Taylor & Francis Grou

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

INTRODUCTION: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. METHODS: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. RESULTS: Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p<0.001, OR 6.3 (2.7-14.6)) and ADA positivity (32.6% vs. 4.1%,p<0.001,OR 19(5-73)) during the induction therapy were predictive factors for infusion reactions. CONCLUSIONS: Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions