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The relationship between clinical outcomes and serum anti-TNF levels is controversial. TheConsecutive IBD patients who received maintenance anti-TNF-α therapy were enrolled. The number of TNF-α positive cells in the mucosa was detected using immunofluorescent labeling on biopsy samples. Serum, mucosal and fecal anti-TNF-α, serum anti-drug antibody, and fecal calprotectin levels were determined using ELISA. Each patient underwent body composition analysis as well.Data of 50 patients were analyzed. The number TNF-α positive cells was significantly higher in the inflamed part of the colon than in the un-inflamed part of the colon. Tissue and fecal drug levels did not show any association with serum drug levels; moreover, serum anti-TNF concentration did not correlate with endoscopic activity. Mucosal anti-TNF levels were higher only in IFX-treated patients in remission and IFX-treated patients with detectable fecal anti-TNF had lower tissue drug levels. Presence of the drug in the feces was significantly different according to disease activity.Fecal drug concentration is suggested to be a better predictor of endoscopic activity and loss of response, and fecal drug monitoring may improve the estimation accuracy of tissue drug levels.

Objective The efficacy of argon plasma coagulation (APC) on gastric antral vascular ectasia (GAVE) may be impaired over time and depends greatly on the application settings. Endoscopic band ligation (EBL) may be an alternative, but study on its efficacy is limited. This study aimed to evaluate and compare the clinical efficacy of APC and EBL in treating GAVE. Methods Changes in the need for blood transfusion, number of treatment sessions and hospitalizations were retrospectively assessed in 63 transfusion-dependent patients with GAVE (mean age: 67.1 y, 54.0% female) treated with either APC or EBL (45 and 18 patients, respectively) in four tertiary endoscopic centers. Results Both methods substantially increased hemoglobin levels and decreased patients' need for a transfusion (22.0 ± 4.0 g/L and -5.62 ± 2.30 units of packed red blood cells [RBC] with APC, and 27.4 ± 6.1 g/L and -4.79 ± 2.46 units of packed RBC with EBL), without a significant statistical difference between the methods. However, fewer EBL sessions were required both for the cessation of need for a transfusion compared with those for the resolution of GAVE lesions (0.90 ± 0.10 vs 1.69 ± 0.31, P = 0.028). Conclusions Both APC and EBL are effective in GAVE treatment. EBL may be superior in terms of number of treatment sessions, but not in its influence on hemoglobin level and need for transfusion. Further prospective studies with large, homogeneous sample size and standardized APC settings are needed.

Összefoglaló. Bevezetés: A gyulladásos bélbetegségek kezelésében a tumornekrózisfaktor-alfa-ellenes (anti-TNFα) antitestek elsődleges választási lehetőséget jelentenek a kortikoszteroid- és immunmoduláns kezelésre refrakter páciensek kezelési stratégiájában. Ezek a hatóanyagok hatékonyak, ám hosszú távú hatásosságukkal kapcsolatban sok az ellentmondás. Célkitűzés: Vizsgálatunk célja megvizsgálni az anti-TNFα-terápia (infliximab [IFX], adalimumab [ADA]) hosszú távú hatékonyságát gyulladásos bélbetegek körében. Módszerek: Retrospektív, adatgyűjtéses vizsgálatunkba a Szegedi Tudományegyetem I. Sz. Belgyógyászati Klinikáján gondozott, 18–65 év közötti gyulladásos bélbetegeket vontunk be. Az adatgyűjtést a Klinika informatikai rendszeréből végeztük a betegek ambuláns megjelenéseinek kezelőlapjaiból, illetve a zárójelentésekből. Eredmények: 102 beteg adatait elemeztük (Crohn-beteg: 67 fő, colitis ulcerosás: 35 fő). A Crohn-betegség diagnózisát követően átlagosan 7,84 év, a colitis ulcerosa diagnózisát követően átlagosan 9,86 év telt el az első anti-TNFα-terápia elkezdéséig. Az első kezelési ciklus átlagosan 2,64 évig tartott, a ciklus végén az IFX-t kapó betegek 50%-ánál, az ADA-t kapó betegek 46%-ánál volt remisszióban a betegség. A második kezelési ciklus átlagosan 4,67 évig tartott, a ciklus végén az IFX-t kapó betegek 36%-a, az ADA-t kapó betegek 40%-a volt remisszióban. Az első, illetve a második kezelési ciklus alatt az allergiás reakciók gyakorisága IFX esetében 13% és 18%, ADA esetében 4% és 3% volt. A primer hatástalanság és a másodlagos hatásvesztés az első ciklusban IFX esetében 4% és 10,5%, ADA esetében 11,5% és 19% volt. A második kezelési ciklusban IFX esetében 9%-ban és 18%-ban, ADA esetében 23%-ban és 10%-ban jelentették a ciklus végét. Következtetés: Az anti-TNFα-terápiák eredményeink alapján hosszú távon is hatékonynak és biztonságosnak bizonyultak. Másodlagos hatásvesztés kisebb arányban fordult elő a vizsgált populációban az irodalmi adatokhoz képest. Orv Hetil. 2020; 161(47): 1989–1994. Summary. Introduction: Anti-tumor necrosis factor-alpha (anti-TNFα) treatment is reserved for steroid-dependent or steroid/immunomodulator-refractory inflammatory bowel diseases patients. These agents are effective, however, their long-term safety is still questionable. Objective: We aimed to assess the long-term efficacy and safety of two anti-TNFα therapies. Methods: In our retrospective study, we reviewed medical records via the administration system of the First Department of Medicine, University of Szeged. Female and male patients, aged between 18–65 years who received anti-TNFα therapy between 2010–2019 were enrolled. Results: 102 patients with inflammatory bowel disease were enrolled (Crohn’s disease: 67, ulcerative colitis: 35). The first anti-TNFα therapy was introduced after an average 7.84 and 9.86 years from diagnosis of Crohn’s disease and ulcerative colitis. The first treatment period lasted for 2.64 years; 50% of patients receiving IFX and 46% of patients receiving ADA were in remission at the end of the period. The second treatment period lasted for 4.67 years, 36% of IFX-treated patients and 40% of ADA-treated patients were in remission at the end of the period. 13% and 18% of patients treated by IFX and 4% and 3% of patients treated by ADA experienced infusion reaction during the first and the second treatment period. Primary non-response and loss of response rates were 4% and 10.5% (IFX) and 11.5% and 19% (ADA) during the first treatment period. These rates were 9% and 18% (IFX) and 23% and 10% (ADA) during the second treatment period. Conclusion: Our study confirmed the long-term efficacy and safety of the anti-TNFα therapies. Loss of response rate is lower in our population compared to the literature. Orv Hetil. 2020; 161(47): 1989–1994.

Absztrakt: Bevezetés: A gyulladásos bélbetegség olyan kórkép, mely a diagnózistól kezdve élethosszig hatással van a betegek fizikális és pszichés egészségi állapotára és életminőségére. Célkitűzés: Megvizsgálni gyulladásos bélbetegek körében a depresszív tünetek és az öngyilkossági gondolatok előfordulásának gyakoriságát, valamint az ezekkel összefüggésben lévő betegség- és terápiaspecifikus tényezőket. Módszer: A vizsgálatban 300 fő vett részt (átlagéletkor 38,8 év, férfiak 47%, nők 53%). A depresszív tüneteket (PHQ-9), öngyilkossági gondolatokat (PHQ-9 9. tétele), a reménytelenség mértékét (Beck Reménytelenség Skála) és a betegséggel összefüggő jóllét mértékét (SIBDQ) vizsgáltuk online formában. Eredmények: A vizsgálati személyek 28,6%-a mutatott depresszív tüneteket, és 9,3%-uk a magas rizikójú csoportba tartozik a reménytelenség tekintetében. Öngyilkossági gondolatokat a válaszadók 16%-a jelzett, ebből magas rizikót a minta 5,3%-a mutatott. A lineáris regressziós modell eredménye alapján a depresszív tüneteket magyarázó tényezők közé tartozik a reménytelenség mértéke, a bélen kívüli tünet fennállása, fájdalomcsillapító rendszeres szedése, a női nem, valamint a betegség aktivitása. Következtetés: A vizsgálatunkban szereplő gyulladásos bélbetegek öngyilkossági gondolatainak és depresszív tüneteinek előfordulási aránya a nemzetközi adatokkal egyezően magas, amire kiemelt figyelmet érdemes fordítani a betegek pszichés vezetése során. A pszichológiai tényezők rendszeres vizsgálata és kezelése fontos része kell hogy legyen a betegek gondozásának, mivel javíthat a páciensek szubjektív állapotán, és a betegség lefolyására is pozitív hatással lehet. Orv Hetil. 2020; 161(42): 1797–1805.

Absztrakt: A gyulladásos bélbetegségben szenvedők kezeléstől függetlenül fogékonyabbak a súlyos, hospitalizációt igénylő vírusinfekciókkal szemben. A betegség kezelésére használt immunszuppresszív és/vagy biológiai terápiák sokszorosára növelik az opportunista fertőzések, köztük az alsó légúti infekciók veszélyét, így az új koronavírus (severe acute respiratory syndrome coronavirus-2) okozta járvány miatt – mely elsősorban tüdőgyulladást okoz – érdemes a megszokottól eltérő terápiás megfontolásokat alkalmazni az effektív és biztonságos betegellátás érdekében. A gyulladásos bélbetegek fokozott koronavírus-rizikóját feltételező várakozásokkal ellentétben a járványban legjobban érintett országok közül sem az Észak-Olaszország, sem a Kína területéről származó tanulmány nem közölt fertőzést egyetlen, gyulladásos bélbetegségben szenvedő egyénnél sem. Ennek hátterében számos tényező állhat, mint például a betegek alacsonyabb átlagéletkora, a társbetegségek ritkább előfordulása stb. Ennek ellenére nem szabad megfeledkezni arról, hogy az immunszuppresszív és/vagy biológiai kezelésben részesülő betegek a veszélyeztetett csoportba tartoznak. Bizonyos esetekben szükségessé válhat a terápia módosítása, a gyógyszeres kezelés változtatásakor azonban vegyük figyelembe, hogy a relapsus és az ennek következtében szükségessé váló ambuláns megjelenés, majd esetleges hospitalizáció növeli a koronavírus-infekció veszélyét. Ennek tükrében a fellángolást mindenképp el kell kerülni, aminek záloga a megkezdett, hatékony kezelés folytatása. Mégis, a nem fertőzött, de a prognosztikai tényezők alapján fokozott rizikójú csoportban is már ajánlott lehet a módosítás. Közleményünk célja, hogy – a nemzetközi terápiás irányelvek alapján – hazánkban is alkalmazható gyakorlati ajánlást nyújtson a praktizáló orvosok számára a járvány idejére, megkönnyítve és hatékonyabbá téve ezzel a gyulladásos bélbetegek ellátását. Orv Hetil. 2020; 161(25): 1022–1027.

Background: Treatment with antitumor necrosis factor alpha (anti-TNF-α) is safe and effective as first-line therapy; however, its efficacy is limited due to primary nonresponse (PNR) and secondary loss of response (LOR), resulting in treatment discontinuation in approximately 40%–50% of cases. Vedolizumab (VDZ) and ustekinumab (UST) therapies could be good alternatives in patient with anti-TNF failure; however, no head-to-head randomized comparison of these drugs as second- or third-line treatments has been made. Objectives: This study aimed to assess the treatment persistence and comparative effectiveness of UST and VDZ in patients with refractory Crohn’s disease (CD). Design: In this nationwide retrospective study, patients with CD on UST or VDZ maintenance therapy were enrolled. Clinical data at baseline, after induction, and at week 52 were obtained. Methods: Clinical and biochemical activities as well as corticosteroid-free remission (SFR) rates were assessed, while concomitant medications, comorbidities, hospitalizations, and surgeries were recorded during the follow-up to detect any predictors. Results: A total of 161 UST- and 65 VDZ-treated patients completed the follow-up. No significant difference in clinical or biochemical remission rates was observed after induction between the two treatment groups; however, clinical remission rate at week 52 was higher in UST group. UST showed superior drug persistence than VDZ (86.5%, 57.9%, p Conclusions: VDZ and UST were safe and effective for treating patients with CD in whom anti-TNF therapy failed. UST showed superior drug persistence than VDZ, but dose escalation was more frequent. Biologicals used in lower treatment lines resulted in better drug persistence.

Although efficacy of ustekinumab (UST) has been demonstrated through randomized trials, data from real-life prospective cohorts are still limited. Our aim was to evaluate clinical efficacy, drug sustainability, dose intensification and results from therapeutic drug monitoring in UST treated patients with Crohn's disease (CD) using a prospective, nationwide, multicenter cohort.Patients from 10 Inflammatory Bowel Disease centers were enrolled between 2019 January and 2020 May. Patient demographics, disease phenotype, treatment history, clinical disease activity (Crohn's Disease Activity Index(CDAI), Harvey Bradshaw Index(HBI)), biomarkers, and serum drug levels were obtained. Evaluations were performed at week8 (post-induction), w16-20, w32-36, and w52-56 follow-up visits.A total of 142 patients were included [57.4% female; complex disease behavior (B2/B3):48%, previous anti-TNF exposition:97%]. Clinical response and remission rates after induction(w8) were 78.1% and 57.7% using CDAI, and 82.5% and 51.8% based on HBI scores. The one-year clinical remission rate was 58%/57.3%(CDAI/HBI). Composite clinical and biomarker remission (CDAI150 and C-reactive protein10 mg/L) rates were 35.4%; 33.3%; 38.6% and 36.6% at w8/w16-20/w32-36 and w52-56. Drug sustainability was 81.9%(standard deviation(SD): 3.4) at 1 year(1y). Probability of dose intensification was high and introduced early, 42.2%(SD:4.2) at ~w32 and 51.9%(SD:4.4%) at 1y.Ustekinumab showed favorable drug sustainability and clinical efficacy in a patient population with severe disease phenotype and previous anti-tumor necrosis factor (anti-TNF) failure, however frequent dose intensification was required.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic poses a challenge to healthcare. Staff and patients are at increased risk during an examination or intervention, so certain restrictions ought to be introduced. Hence, we aimed to measure the effect of the pandemic on endoscopy units in real-life settings. Methods: This was an observational, cross-sectional, questionnaire-based study, carried out between 7 April and 15 June 2020. Responds came from many countries, and the participation was voluntary. The survey contained 40 questions, which evaluated the effect of the COVID-19 pandemic on the endoscopy units and assessed the infection control. Results: A total of 312 questionnaires were filled, 120 from Hungary, and 192 internationally, and 54 questionnaires (17.3%) were sent from high-risk countries; 84.9% of the gastroenterologists declared that they read the European Society of Gastrointestinal Endoscopy (ESGE) statement, while only 32.1% participated in any advanced training at their workplace. Overall, 92.1% of gastroenterologists realized risk stratification, and 72.1% claimed to have enough protective equipment. In 52.6% of the endoscopy units, at least one endoscopist had to discontinue the work due to any risk factor, while 40.6% reported that the reduced staff did not affect the workflow. Gastroenterologists considered that the five most important examinations both in low and high-risk patients are the following: lower/upper gastrointestinal (GI) bleeding with hemodynamic instability, endoscopic retrograde cholangiopancreatography (ERCP) in obstructive jaundice, foreign body in the esophagus, ERCP in acute biliary pancreatitis, and iron deficiency anemia with hemodynamic instability, which correlates well with the ESGE recommendation. Significant correlation was found in the usage of the necessary protective equipment in high-risk patients depending on the countries ( p Conclusions: The survey found weak correlation in preliminary training depending on countries; nevertheless, in Hungary during the examined period, endoscopists considered the recommendations more strictly than in other countries. Although many physicians left the endoscopy lab, the workflow was not affected, probably due to the reduced number of examinations.

BACKGROUND: Inpatient management of severe ulcerative colitis is complicated by the use of prior immunosuppressant therapies. Our aim was to determine the rate of 1-year colectomy among individuals receiving inpatient calcineurin inhibitor (CNI)-based therapy stratified by prior biologic therapy. METHODS: A retrospective cohort study was performed between January 1, 2013 and April 1, 2018. Only individuals requiring inpatient administration of intravenous cyclosporine or oral tacrolimus were included in the analysis. Individuals were stratified according to prior biologic therapy exposure. The primary outcome of interest was 1-year risk of colectomy. Kaplan-Meier curves were generated for time-to-event data, and regression models were performed to examine the effects of covariates on the clinical endpoint. RESULTS: Sixty-nine (62.3% male) patients were treated with an inpatient CNI-based therapy and were included in the analysis. Fifteen (21.7%) patients were biologic-naïve, 42 (60.9%) patients had prior exposure to 1 class of biologic therapy, and 12 (17.4%) patients had prior exposure to 2 classes of biologic therapy (third-line CNI therapy). Third-line CNI therapy showed a greater risk of 1-year colectomy risk when compared with the risk for patients who were biologic-naïve (hazard ratio, 3.63; 95% confidence interval, 1.17-13.45; P = 0.025). In a multivariate proportional hazards model, third-line CNI therapy remained significantly associated with 1-year colectomy risk (hazard ratio, 7.94; 95% confidence interval, 1.97-39.76; P = 0.003). CONCLUSIONS: The use of CNI-based therapy in individuals exposed to multiple classes of prior biologic therapies leads to a significantly increased risk of 1-year colectomy. Future studies will be required to compare inpatient management strategies with the expanding novel therapies in UC.

Background: There are contradictory results about the effect of magnesium citrate plus sodium picosulfate bowel cleansing agents on the fluid and electrolyte balance. Therefore, this study aimed to determine the efficacy, tolerability and safety of this medication in colonoscopy preparation. Methods: 233 patients were enrolled in this phase IV prospective observational study. The effectiveness of bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS). Adequate cleansing was defined as BBPS ≥ 6 and excellent cleansing as BBPS > 7. Tolerability was examined using a standardized questionnaire. In the safety analysis, the change of serum electrolytes levels and renal function during bowel cleansing was assessed. Results: Adequate and excellent bowel cleansing were achieved 94.85% and 72.96% of cases, respectively. None or very mild symptoms were reported in 47.21% of cases. Statistically significant changes occurred in serum potassium (4.38±0.43 vs. 4.25±0.43 mmol/L, p

Diagnostic accuracy and quality of smears obtained by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) are influenced by characteristics of suction and examined organ.Efficiency of EUS-FNA and quality of smears obtained by slow-pull (SP) and standard suction (SS) techniques was prospectively compared in the sampling of pancreatic (SS technique resulted in a higher number of smear pairs both in pancreatic (1.74 vs. 3.19;SP technique yields better quality smears independently from tumors characteristics; however, it shows significant examiner-dependency. SS technique reduces the diagnostic accuracy of sampling in extrapancreatic tumors.

Patients with inflammatory bowel disease are more susceptible to severe viral infections requiring hospitalization regardless of treatment. Immunosuppressives and biological treatments multiply the chances of opportunistic and lung infections, especially in combination therapy, so due to the new coronavirus (severe acute respiratory syndrome coronavirus-2) epidemic, which primarily causes respiratory disease, it is advisable to use different therapeutic considerations for effective and safe patient care. Contrary to the expectations, a study from Italy and China each, despite of the large number of infected cases, did not report any SARS-CoV-2 positivity in patients with inflammatory bowel disease, which can be due to a number of favorable factors, such as the lower average age of the patients, lack of comorbidities, etc. However, it should not be forgotten that the patients on immunosuppressive and/or biological therapy belong to the compromised group. Consequently, in some cases there is a need to modify the therapy, but we should keep in mind that the relapse alongside with the need of medical consultation and even hospitalization elevate the chance of being infected. Thus, flare-ups ought to be avoided as far as they can be, so continuing the already started maintenance therapy can be a reasonable solution, but, in the high-risk group, modifying it can be reasonable as well. Our aim with this article is to make the health care more effective, and to give a practical recommendation for physicians during the epidemic, based on international publications. Orv Hetil. 2020; 161(25): 1022-1027.

Background: Anti-TNF therapy is efficacious in the maintenance of remission in ulcerative colitis (UC); however, long-term data on real-life use of these agents are lacking.Methods: This observatio...

Abstract: Introduction: Transfer is a planned movement of patients and their medical records from one provider to another. Only a few data are available from real life in inflammatory bowel disease patients in this topic. Aim: Our aim was to retrospectively evaluate the results of the transfer of our patients without longitudinal transition. Method: Data of the transferred patients at the University of Szeged were analysed. Patients were diagnosed in paediatric care. Transfer strategy at our departments was detailed medical summary. Results: 59 patients were enrolled in this study. 28.8% of the patients had mild to moderate disease activity and 71.2% was in remission at the time of transfer. Steroid therapy was initiated in 58% of the patients within an average of 9.1 months after the transfer. Anti-tumor necrosis factor therapy was given to 24% of the patients during the paediatric care and to an additional 23% in the adult care within an average of 28 months. Almost 70% of the patients received immunosuppressive therapy during paediatric and adult care. Surgery was required in 17% of the patients within an average 10.7 months after the transfer. Conclusion: Our results revealed that one-third of the paediatric patients have been transferred to adult care in active stage of disease. Shortly after the transfer 58% of the patients required corticosteroids and 17% surgery. Every fifth patient needed biological therapy to be initiated after the transfer. Longitudinal transition may have a potential to decrease the need for therapeutic change and the relatively high rate of surgery. Orv Hetil. 2018; 159(44): 1789–1793.

OBJECTIVES: Inflammatory bowel diseases are lifelong illnesses and have a huge impact on the quality of life and workability. Although the fully human anti-tumor necrosis factor-alpha, adalimumab provides great opportunity to use biological therapy at home, application of the prefilled syringe might be difficult for some. The aim of this study was to evaluate patients’ opinion about the newly introduced adalimumab prefilled pen compared to the prefilled syringe. METHODS: Our questionnaire based survey focused on the degree of difficulty of the usage, any inconveniences and the proportion of self-injection for each mode of administration. RESULTS: The questionnaire was filled by 101 patients (female/male: 49/52). Patients applied adalimumab therapy for 33 months on average and changed from the prefilled syringes to the prefilled pen for 4 months on average. Sixty-six % of those who used the prefilled syringe administered adalimumab themselves. Self-administration of injections caused difficulties for 19% of patients, and 15% of patients had serious aversion to self-administration. On the other hand, in case of the prefilled pen, 94% of patients administered adalimumab themselves. Self-administration caused difficulties for only 5% of patients, and just 1% of patients reported aversion to self-administration (p < 0.001). Overall 70% of patients assessed the change positively, and they reported significantly less (23.6% vs 9.3%; p = 0.009) inconvenience with administration. CONCLUSION: Our multicenter study including more than hundred inflammatory bowel diseases patients revealed that switching from the prefilled syringe to pen results in higher self-adminstering rate, significant reduction in pain and in local reaction at the injection site.

Background Budesonide is an oral corticosteroid, which is widely used in moderate-to-severe ulcerative colitis (UC) to obtain and maintain remission in those cases, where 5-aminosalicylic-acid was ineffective. Unlike previous forms of budesonide absorbing from the ileal and ascending colon region, the new-generation budesonide-MMX contains a formula, that allows absorption throughout the whole colon, and therefore in the whole potentially inflamed area in UC. We aimed to evaluate the effects and safety of budesonide-MMX in our UC patients who meet the above mentioned therapeutic demands in a real-life study. Methods We enrolled 22 patients with mild to severe UC in this single-centre prospective study until August of 2019. Patients received 9 mg oral budesonide-MMX once daily until 8 weeks. Laboratory parameters (cholesterol, triglyceride, CRP) and serum hormone levels (parathormone [PTH], dehydroepiandrosterone [DHEA] and cortisol) were monitored before and after the 8-week therapy to follow metabolic and hormonal changes. During these visits, body composition analysis was also performed with InBody 770 machine to observe the adverse steroid effects of budesonide-MMX in respect of body fat mass, body mass index, protein content of the body and bone mineral content. Disease activity was followed by the partial Mayo (pMayo) score. Statistical analysis was performed by paired t-test and Wilcoxon signed-rank test with SigmaPlot 1.25. Results The total of 22 patients (age: 44.4 ± 15.1 years, 6 male and 16 female patients) had received the 2-month budesonide-MMX therapy (2.0 ± 0.3 months). Mean disease duration was 8.3 years. By the end of follow-up, 15 (68.2%) patients experienced remission and 7 patients (31.8%) were primary non-responders. The disease activity decreased significantly from the mean of 3.95 to 1.64 (p < 0.001). No significant changes were observable in case of any body composition analysis parameter. Regarding the laboratory parameters, serum cholesterin level showed a significant increase (p < 0.001), while triglyceride and CRP showed did not show significant changes. Serum cortisol levels were elevated (p < 0.001), while PTH and DHEA showed no significant decrease. Only two patients experienced side effects: one of them hypertonia, headache and acnes, while the other patient experienced mild diarrhoea. One patient had a relapse during the treatment. Conclusion In our study, budesonide-MMX proved to be safe by bringing up a low number of side effects, while more than two-thirds of the patients could reach remission with this short-term therapy. Hormonal changes were not mentionable, although the drug’s effects on serum lipid content have to be examined further.

Background Tofacitinib (TFC) is an oral, small-molecule Janus kinase inhibitor, which was recently approved for moderate to severe ulcerative colitis (UC). The aim of the current real-life study was to determine efficacy of TFC induction therapy regarding the clinical response and remission in patients with active UC. We evaluated short-term efficacy data in a Hungarian cohort with prior exposure to other biological agents such as anti-TNF drugs and vedolizumab. Methods In this single-centre retrospective study, patients with TFC introduction were included. Since January 2019, a total of 16 patients received an oral TFC induction therapy in a dose of 10 mg twice daily for 8 weeks. Endoscopic activity was evaluated by endoscopic Mayo (eMayo) score before the introduction of TFC and in case of an inadequate therapeutic response to the 5-mg-therapy to confirm therapeutic decision-making. Based on the evaluation of clinical symptoms and laboratory parameters, we either kept the dosage or reduced the dose to 5 mg according to local regulations. We also collected data from the 16. and 24. weeks of the therapy. Primary endpoints were a clinical response (as a reduction in partial Mayo Score [pMayo] by minimum 3 points) or remission (as a Mayo score of the maximum of 2 points and without blood in stool) at week 8. Results Sixteen patients had received the induction therapy (mean age: 36 years, 7 males and 9 females) in our centre. After 8 weeks, 12 (75%) patients responded to the TFC induction therapy and 6 (37.5%) of them were in remission. Four patients were primary non-responders (25%). Corticosteroid therapy (18 ± 7 mg) was required during the induction in 4 responder cases, which could be stepped down by week 8. As a continuous maintenance therapy, 4 patients have already reached the 16th week and 8 have completed the 24th week. By the end of the follow-up, 12 patients responded and 10 was in remission. During the observation period, 3 patients had to remain on 10 mg TFC dose, 6 patients required dose escalation from 5 mg to 10 mg and 5 mg was sufficient in case of only 3 patients after the introduction. Endoscopic activity showed a moderate decrease from 2.5 ± 0.5 eMayo score to 2 ± 1 (n = 7) until week 16. In respect the responder patients, CRP levels decreased from the mean of 7.23 to 5.02. No serious side-effects were observed during the follow-up. Conclusion After the 8-week TFC induction therapy, the response rate was high and only every fourth patients were non-responder. A low number of patients had adequate reactions to the 5 mg-therapy after the introduction, but TFC is effective with dose-escalation in respect of clinical response and remission in patients with UC, who have had an inadequate response to previous biological therapy.

Background Faecal drug concentration is not routinely measured as per therapeutic drug monitoring strategies in inflammatory bowel disease (IBD) patients receiving anti-TNF therapy. However, our previous research work suggested the importance of faecal drug monitoring of anti-TNF agents since active disease may be present in spite of normal serum anti-TNF levels. The aim of the present study was to examine the correlation between faecal calprotectin and faecal infliximab (IFX) concentration and to evaluate the cut-off value of faecal drug concentration in the respect of faecal calprotectin in patients treated with maintenance IFX therapy. Methods Consecutive patients with IBD receiving maintenance IFX therapy at 1st Department of Medicine, University of Szeged were enrolled in the present study. Faecal samples were obtained before the subsequent IFX infusion. Faecal calprotectin and IFX concentrations were determined with ELISA. The correlation between faecal calprotectin and faecal IFX concentration was statistically assessed. Results Sixty-seven IBD patients were enrolled. Female/male ratio was 49%–51%. Sixty-five point six% of the patients were diagnosed with Crohn’s disease and 34.3% with ulcerative colitis. Mean disease duration was 14.9 years (SD 9.7) at the time of analysis. Mean duration of IFX therapy was 42.3 month (SD 31.6). Twenty-eight point three% of the patients received escalated IFX therapy. Mean faecal calprotectin concentration was 545.7 µg/g (SD 379.4 µg/g). Mean faecal IFX concentration was 1 ng/ml (SD 1.3). Faecal calprotectin and faecal IFX concentration showed significant correlation (r=0.37, p = 0.002). A cut-off value of faecal IFX level of 0.6 ng/ml was determined at faecal calprotectin concentration of 500 µg/g. Conclusion According to our results IFX is detectable in the faeces at a calprotectin concentration of 500 µg/g. The cut-off value for faecal IFX concentration proved to be 0.6 ng/ml. Simultaneous determination of faecal anti-TNF and faecal calprotectin concentration is supposed to have a higher benefit in the evaluation of response to IFX therapy.

Background: GEMINI trials demonstrated the therapeutic efficacy of vedolizumab (VDZ) in Crohn’s disease (CD) and ulcerative colitis (UC).Research design and methods: Aim of this study was to determ...

Background: There is a lack of data about demographic and treatment characteristics of adolescent patients with inflammatory bowel disease (IBD). The aim of this retrospective, epidemiological study was to evaluate characteristics and therapeutic features of Hungarian adolescents with IBD. Methods: We analysed the social security databases of the National Health Insurance Fund. Adolescent patients with IBD for whom data from 2009 to 2016 were observable in the database were enrolled. Patients aged 14 to 17 years and 18 to 21 years were defined as middle and late adolescent patients. Results: The incidences of IBD were 20.12 per 100,000 middle adolescent patients and 29.72 per 100,000 late adolescent patients. Admission to gastroenterology department was higher in both groups compared with admissions to surgery department. Mesalazine was used by a high proportion of Crohn’s disease and ulcerative colitis patients. Rates of corticosteroid use were similar in both groups, with a tendency to decrease over time. The need for biologic agents was higher in the middle adolescent patients. The proportion of patients in the middle adolescent group who received anti-TNF therapy showed an increasing tendency. Conclusion: Our data suggest differences in the treatment strategies of gastroenterologists for these age groups. The greater need of anti-TNF therapy among the middle adolescent group indicates that adolescent patients before the transition to adult care may have a more severe disease phenotype. We expect that a strategy of early, effective treatment will significantly ameliorate the subsequent disease course, which is manifested in adult care.

The coronavirus disease 2019 (COVID-19) outbreak emerged in December 2019 in China and rapidly spread worldwide. Inflammatory bowel disease (IBD) patients are likely to be more susceptible to viral infections, and this is significantly influenced by the type of therapy they receive. Thus, issues specifically concerning the medical treatment of IBD patients were shortly addressed at the beginning of the pandemic. However, recently available data on the occurrence and outcome of SARS-CoV-2 infection in IBD patients does not address the concerns raised at the beginning of the pandemic. Growing evidence and the rapid changes happening over the past few weeks have helped elucidate the current situation, contribute to our understanding of the disease, and many previously raised questions could now be answered. We hereby summarise available evidence regarding viral infections and IBD, focusing on SARS-CoV infections, and we provide practical recommendations related to patient management during the COVID-19 pandemic era.

Gut microbial composition alters in some special situations, such as in ulcerative colits (UC) after total proctocolectomy and ileal pouch-anal anastomosis (IPAA) surgery. The aim of our study was to determine the composition of the intestinal microbiome in UC patients after IPAA surgery, compared with UC patients, familial adenomatous polyposis (FAP) patients after IPAA surgery and healthy controls. Clinical data of patients, blood and faecal samples were collected. Faecal microbiota structure was determined by sequencing the V4 hypervariable region of the 16S rRNA gene. Overall, 56 patients were enrolled. Compared to the Healthy group, both the Pouch active and UC active groups had higher Enterobacteriaceae, Enterococcaceae and Pasteurellaceae abundance. The Pouch and UC groups showed distinct separation based on their alpha and beta bacterial diversities. The UC group had higher Prevotellaceae, Rikenellaceae, Ruminococcaceae abundance compared to the Pouch active group. Pouch and FAP participants showed similar bacterial community composition. There was no significant difference in the bacterial abundance between the active and inactive subgroups of the Pouch or UC groups. Gut microbiome and anatomical status together construct a functional unit that has influence on diversity, in addition to intestinal inflammation that is a part of the pathomechanism in UC.

Background Inflammatory bowel diseases (IBD) patients are at increased risk for mental health problems. Managing IBD patients requires cooperation between gastroenterologists and psychologists and psychiatrists. We would like to assess the frequency of depression and suicidal thoughts among Hungarian IBD patients. Methods Multicentre, questionnaire-based survey among inflammatory bowel diseases patients. Demographic data and patient’s medical history was obtained with self-filling questionnaires. Patients’ psychic status was measured with Patient’s Health Questionnaire (PHQ-9), Beck Hopelessness Scale (short version). The survey was conducted in 3 IBD centres in Hungary, First Department of Medicine, University of Szeged, First Department of Surgery, University of Semmelweis and First Department of Medicine, University of Pécs. Results Three hundred IBD patients filled the questionnaires from the 3 IBD centres. Female-male ratio was 57% - 47%. Mean age at the time of the study was 38.8 years (SD 12.5) and mean disease duration was 11.5 years (SD 8.2). Sixty-two point three% was diagnosed with Crohn’s disease, 37.7% with ulcerative colitis, one patients reported IBD unclassified and three patients did not know the type of IBD. Sixty-nine point three% of the patients self-reported the remission state of IBD, while 30.7% self-reported to have active IBD. Proportion of patients on each category of PHQ-9 scale were the followings: severe 2%, moderate to severe 5.3%, moderate 21.3%, mild 33.6% and 37.6% had normal score. Nine point three% of the patients had elevated suicidal risk. More severe PHQ-9 category was associated with elevated risk for suicide. Significant difference was shown in the Hopelessness Scale’s results among the two genders, female patients had higher risks for suicidal thoughts. Those IBD patients in remission have lower probability for moderate or severe depression. Conclusion We have to be aware of that every IBD patient has increased risk for depression and suicide. Among our patients the rate of moderate to severe and severe depression was relatively low. Every tenth of our patients had elevated risk of suicide.

Background Anti-tumour necrosis factor (TNF) therapy has dramatically changed the treatment of inflammatory bowel disease (IBD). The relationship between clinical outcomes and serum anti-TNF levels is controversial. This study aimed to perform simultaneous analyses of the serum, mucosal and faecal infliximab and adalimumab levels to determine the mucosal expression of TNF-α and assess the relationship of the anti-TNF-α levels in these biological samples with the endoscopic and clinical activities and body composition in IBD patients. Methods Consecutive IBD patients who received maintenance anti-TNF-α therapy and underwent colonoscopy were enrolled. We assessed the clinical disease activity, collected the blood, faecal and biopsy samples. The number of TNF-α positive cells in the mucosa was detected using immunofluorescent labelling. Serum, mucosal and faecal anti-TNF-α levels, anti-drug antibody level in the serum and faecal calprotectin were determined using ELISA. Each patient underwent body composition analysis. Results Fifty consecutive patients have been analysed in the study. The number TNF-α positive cells was significantly higher in the inflamed than in the un-inflamed part of the colon (p = 0.01); however, such a difference was not detected in case of tissue drug levels. Tissue drug level did not correlate with the serum drug level. Nevertheless, tissue drug levels of the samples obtained from the un-inflamed part of the colon were significantly higher in patients who were in remission (p = 0.03467). The presence of the drug in the faeces was significantly different according to disease activity (p = 0.0022). Drug levels in the biological samples did not show any association with the presence of anti-drug antibodies. Body composition parameters had no significant impact on the serum and tissue drug levels. Faecal calprotectin showed significant correlation with faecal drug concentration (p = 0.0162) and clinical and endoscopic activity (p < 0.001). Conclusion To the best our knowledge, this is the first study to measure drug concentrations in all the relevant biological samples. Our findings highlight the importance of faecal drug monitoring because active disease may be present in spite of normal serum anti-TNF levels. Simultaneous determination of faecal drug concentration and faecal calprotectin may be more accurate for evaluating therapeutic responses in the future.

Background There is a lack of data regarding clinical and therapeutic characteristics in middle and late adolescent inflammatory bowel diseases (IBD) patients in real life. Our aim was to retrospectively evaluate patient’s characteristics and therapeutic features among the Hungarian adolescent inflammatory bowel diseases population. Also our aim was to assess whether these patients before the transition have more serious disease phenotype than those after transition. Methods Retrospective, epidemiological study using the National Health Insurance Fund social security databases. Adolescent Hungarian IBD patients who were observable in the database between 2008 and 2017 were enrolled. Patients were analysed according to two groups: patients between ages of 14–17 years were defined middle adolescent patients, and patients between 18–21 years were defined late adolescent patients. Results The incidence of IBD was 24.82/100 000 in the middle and 38.17/100 000 in the late adolescent patients. Prevalence rates showed an increasing tendency in both groups. Incidence and prevalence rates were higher in the late adolescent patients. Mesalazine was used in high proportion of patients (66.6% vs. 69.3% of the middle and late adolescent patients, respectively), also in UC and CD patients. While, the use of sulphasalazine (13.1% vs. 19.6%, respectively) and azathioprine (20.3% vs. 11%, respectively) was relatively low. The need of biologics was higher in the middle adolescence group (p < 0.001). Use of anti-TNF agents increased during the observational period in both groups (p < 0.001). Corticosteroid use was similar in both groups; a decreasing tendency was observed. Rate of hospital admissions to gastroenterology department was higher than to surgery department in both groups. The number of hospital admissions to gastroenterology (p < 0.001, p = 0.001) and surgery departments (p < 0.001 and p = 0.031) decreased significantly in both groups throughout the observational period. Conclusion We have analysed the data of huge number of adolescent patients diagnosed with IBD to get better overview on the clinical and treatment characteristics of patients in these sensitive age groups. Overall, the increasing use of anti-TNF therapy and decreasing tendency of corticosteroid use reflects significant changes and improvement in treatment paradigm not only in adult but paediatric care. The higher need of anti-TNF agents reflects that these adolescent patients before the transition have more severe disease phenotype.

Transfer is a planned movement of patients and their medical records from one provider to another. Only a few data are available from real life in inflammatory bowel disease patients in this topic.Our aim was to retrospectively evaluate the results of the transfer of our patients without longitudinal transition.Data of the transferred patients at the University of Szeged were analysed. Patients were diagnosed in paediatric care. Transfer strategy at our departments was detailed medical summary.59 patients were enrolled in this study. 28.8% of the patients had mild to moderate disease activity and 71.2% was in remission at the time of transfer. Steroid therapy was initiated in 58% of the patients within an average of 9.1 months after the transfer. Anti-tumor necrosis factor therapy was given to 24% of the patients during the paediatric care and to an additional 23% in the adult care within an average of 28 months. Almost 70% of the patients received immunosuppressive therapy during paediatric and adult care. Surgery was required in 17% of the patients within an average 10.7 months after the transfer.Our results revealed that one-third of the paediatric patients have been transferred to adult care in active stage of disease. Shortly after the transfer 58% of the patients required corticosteroids and 17% surgery. Every fifth patient needed biological therapy to be initiated after the transfer. Longitudinal transition may have a potential to decrease the need for therapeutic change and the relatively high rate of surgery. Orv Hetil. 2018; 159(44): 1789-1793.Absztrakt: Bevezetés: A gyulladásos bélbetegségek gyakran serdülőkorban manifesztálódnak. A transzfer a betegek gyermekgyógyászati szakrendelésről történő átadását kísérő folyamatnak, a tranzíciónak az utolsó lépése, melynek kimenetelével ez idáig kisszámú tanulmány foglalkozott. Célkitűzés: Felmérni az általunk alkalmazott transzfer eredményességét gyermekszakrendelésről felnőttszakrendelésre átkerülő betegeink körében. Módszer: A Szegedi Tudományegyetem, I. Belgyógyászati Klinikára átkerült és gondozott betegek demográfiai és klinikai adatait elemeztük retrospektív módon. Az általunk vizsgált betegeknél a gyulladásos bélbetegség diagnózisa a gyermekgyógyászati ellátásban került felállításra. Klinikánkon a betegek transzferje során részletes egészségügyi dokumentáció elkészítése és átadása történt. Eredmények: 59 gyulladásos bélbeteg adatait elemeztük. Huszonhét esetben (45,7%) történt endoszkópia a transzferhez kötötten. A transzfer idejében a betegek 28,8%-ánál enyhe, illetve közepesen súlyos volt a betegség aktivitása, míg 71,2%-uk remisszióban volt. A betegek 58%-ánál kortikoszteroid indult, átlagosan 9,1 hónap után. Anti-tumornekrózisfaktor-terápia a gyermekgyógyászati ellátás alatt a betegek 24%-ánál lett bevezetve, és a betegek további 23%-ánál történt meg a felnőttellátás során, a transzfert követően átlagosan 28 hónapon belül. A betegek 70%-a részesült immunszuppresszív kezelésben a transzfer körüli időszakban. Sebészeti beavatkozásra 17%-ban volt szükség a transzfer után átlagosan 10,7 hónapon belül. Következtetés: Betegeink egyharmada aktív állapotban került át a felnőttellátásba. Fiatal betegeink 58%-a igényelt kortikoszteroidterápiát és 17%-a sebészeti beavatkozást a transzfert követő kevesebb, mint egy éven belül. Minden ötödik betegnél biológiai terápia indult a felnőttellátásban. A longitudinális tranzíció folyamatát alkalmazva valószínűleg volna esélyünk csökkenteni az átadásközeli terápiaeszkalációk számát és a relatíve magas sebészeti beavatkozási arányt. Orv Hetil. 2018; 159(44): 1789–1793.

CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC.CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study.61 patients had already completed the 54-week treatment period. Mucosal healing was shown in 65.5 % and 62.1 %, complete mucosal healing was present in 31% and 38 % at week 14 and 54, respectively. The median values of CRP, leukocytes, thrombocytes, and albumin showed significant difference between baseline and week 54. Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54, respectively.Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC.

Inflammatory bowel diseases (IBD) [Crohn’s disease (CD) and ulcerative colitis (UC)], are chronic relapsing disorders of unknown etiology. The aim of this study was to determine demographic features, disease phenotypes, medical and surgical therapies in our IBD patients and to identify which parameters are in association with the need of surgery and/or biologic therapy. Data on demographic and clinical characteristics of the patients were analyzed from the IBD registry of the 1st Department of Medicine, University of Szeged. The study period was between January 2007 and March 2015. Data of 911 IBD patients (428 CD, 483 UC) were analyzed. The median lag time between onset of symptoms and diagnosis proved to be significantly longer in UC than in CD (4.6 years vs. 2.1 years, p = 0.01). 40% of the patients received biological therapy, 301 patients underwent surgery required more frequently for CD than UC. Surgery was more common in CD patients with ileal location and penetrating behaviour. In UC, more severe disease onset predicted to unfavourable disease course. Higher proportion of surgery was shown in patient aged above 40 years in both CD and UC. Diagnostic delay of more than 1 year and appendectomy predicted to unfavourable disease outcome of both CD and UC. This analysis revealed that more than 1 year of diagnostic delay, disease activity at diagnosis in UC, CD, ileal location and penetrating behaviour are factors that may influence disease outcome. Use of thiopurines seemed to be protective in UC.