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Bevezetés: A végbéldaganatok kezelési protokolljában az elmúlt évtizedekben jelentős változások történtek, melyek nagymértékben csökkentették a helyi kiújulások és a távoli áttétek számát, ezzel növelve a teljes túlélést. Az egyik jelentős előrelépést a kombinált neoadjuváns kezelés bevezetése jelentette. Módszer: A Debreceni Egyetem Sebészeti Klinikáján 2010. január 1. és 2017. december 31. között lokális neoadjuváns kemoradioterápiában részesített, majd műtéten átesett 362, rectumtumoros beteg adatainak retrospektív feldolgozását végeztük statisztikai elemzéssel. A lokális neoadjuváns kezelésre adott válasz mértékét és késői túlélési eredményeinket összehasonlítottuk az időközben megjelent nagy nemzetközi tanulmányokban közölt teljes neoadjuváns kezeléssel elért eredményekkel. Eredmények: Betegeink között 8,6%-ban tapasztaltunk teljes patológiai regressziót. A műtét időpontjára, valamint az azt követő 3 hónapon belül betegeink 10,7%-ában tapasztaltuk távoli áttét kialakulását. Vizsgálataink során a neoadjuváns kezelésre adott válasz mértéke a felismerési stádiumtól független prognosztikai faktornak bizonyult. A jobb választ adó csoportok szignifikánsan jobb túlélési eredményeket produkáltak. Következtetés: A legújabb nemzetközi tanulmányokban teljes neoadjuváns kezelés hatására a teljes patológiai választ adó betegek száma megduplázódott, a távoli áttét pedig 7%-kal kevesebb volt a lokális neoadjuváns csoporthoz képest. Betegeink 85%-a a felismerés pillanatában T3–4N+ stádiumú volt. Tekintettel a műtét pillanatában vagy 3 hónapon belül felismert távoli áttétek 10,7%-os arányára megállapítható, hogy betegeink mintegy felében eredményesebb lett volna a teljes neoadjuváns kezelés alkalmazása. Ennek megfelelően a jövőben intézetünkben is a teljes neoadjuváns protokoll szerint kívánunk eljárni. Orv Hetil. 2022; 163(30): 1196–1205.

Background: Intestinal symptoms are common in patients with hidradenitis suppurativa (HS). HS patients may experience a broad spectrum of chronic inflammatory intestinal disorders (CIID), not exclusive to inflammatory bowel diseases, which are diagnosed by colonoscopy and intestinal biopsies. The frequency of CIID in patients with HS has not been investigated. Objective: The objectives of this study were to determine the occurrence of CIID in HS and characterise this clinical population. Furthermore, the feasibility of using fecal calprotectin (FC) test or anti-Saccharomyces cerevisiae antibody (ASCA) levels to assess the colonic inflammation of CIID in HS patients was investigated. Methods: All newly diagnosed and untreated HS patients (n=74) were referred to a gastroenterologist for FC followed by colonoscopy after informed consent. C-reactive protein (CRP), white blood cell count, nucleotide-binding-oligomerisation-domain-containing-protein-2 (NOD2) polymorphism, and ASCA levels were measured. Patients were divided into HS-only and HS with CIID (HS+CIID) groups, based on the absence or presence of CIID. Laboratory and clinical parameters (age, gender, HS onset, clinical stage, family history, body mass index (BMI), smoking) were compared between the groups. Results: Thirteen patients complained gastrointestinal symptoms prior to any examination, including 11 in the HS+CIID group. The CIID frequency in HS was 28.4% (n=21/74), based on colonoscopy and histology. Significantly more patients had severe disease state in the HS+CIID group compared with the HS-only group, and BMI was significantly lower in the HS+CIID group (28.20±5.58 vs. 32.74±6.45, p=0.006). FC positivity occurred significantly more in HS+CIID patients compared with HS-only patients (90.48% vs. 3.77%, p

A krónikus, nem specifikus gyulladásos bélbetegségekben (IBD) az extraintesztinális tünetek a különböző szervek és szervrendszerek érintettségének jeleként az esetek kb. 30%-ában jelennek meg. Az IBD diagnózisa előtt vagy után, az aktivitással párhuzamosan, vagy attól függetlenül zajló extraintesztinális manifesztációk alapvetően meghatározzák a beteg életminőségét. Tulajdonképpen bármely szerv érintett lehet, de a leggyakrabbak az ízületi, a bőr-, a hepatobiliaris és a szemészeti manifesztációk. A tünetek szisztematikus keresése és a multidiszciplináris közelítés a sikeres kezelés záloga.

In this cross-sectional, real-life study we have investigated the potential association between 6-thioguanine nucleotide (6-TGN) and anti-TNF [infliximab (IFX), adalimumab (ADA)], anti-drug antibody levels and body composition parameters. Based on our results thiopurine and anti-TNF combination therapy resulted in decreased antibody formation in IFX-treated patients. AZA-ADA-treated patients showed increased anti-TNF drug concentrations, regardless of antibody formation. Drug metabolites did not correlate with body composition parameters.

AIM The aim was to explore the subjective health expectations (sHE) of patients with Crohn's disease (CD) for both the near future and the elderly. METHOD A cross-sectional survey was performed in four gastroenterology centres in Hungary. Consecutive outpatients with CD with age ≥ 18 were recruited. Socio-demographic and disease characteristics were recorded and the Crohn's Disease Activity Index (CDAI), Perianal Disease Activity Index, Patients' Global Assessment (PGA) and current pain visual analogue scale (VAS) were assessed. Subjective life expectancy (sLE) was explored and compared to statistical life expectancy. Current health and sHE for 1 year ahead and for ages 60/70/80/90 were assessed using the descriptive system of the EQ-5D-3L. RESULTS In all, 206 patients (54.9% men) with a mean age of 34.7 (SD 10.5 years) and disease duration of 10.5 (SD 6.3) years were studied. The CDAI score was 110.5 (SD 77.0) and 66% were treated by biologic drugs. Mean current EQ-5D-3L score was 0.80 (SD 0.17) and patients expected a 0.05 (SD 0.15) improvement within a year (P

Introduction: There have been significant changes in the treatment protocol for rectal tumors in recent decades, greatly reducing the rate of local recurrence and distant metastasis, thereby increasing overall survival. Method: We performed a retrospective processing and statistical analysis of the data of 362 patients with rectal cancer who underwent local neoadjuvant chemoradiotherapy and then underwent surgical treatment between 1 January 2010 and 31 December 2017 at the Institute of Surgery of the University of Debrecen. We compared the response rate and overall survival results of our patients with local neoadjuvant treatment to the outcomes of total neoadjuvant treatment reported by the recent large international studies. Results: We experienced complete pathological regression in 8.6% of our patients. After neoadjuvant therapy, 10.7% of our patients experienced distant metastasis at the time of the operation or within 3 months period thereafter. In our study, the rate of response to the neoadjuvant treatment was a prognostic factor independent of the stage at di-agnosis and recognition. The groups with better response produced significantly better survival results. Conclusion: The total neoadjuvant treatment doubled the number of patients with complete pathological response, and the incidence of distant metastasis was by 7% lower in both recent international studies compared to the local neoadjuvant group. 85% of our patients were T3-4N+ stage at the time of recognition. Given the 10.7% rate of dis- tant metastases detected at the time of surgery or within 3 months in our patient population, we can state that ap- proximately half of our patients would have benefited from the administration of total neoadjuvant therapy which produced better outcomes. Based on this conclusion, we decided to introduce the total neoadjuvant therapy protocol in our department for treatment of patients with advanced rectal tumors.Bevezetés: A végbéldaganatok kezelési protokolljában az elmúlt évtizedekben jelentős változások történtek, melyek nagymértékben csökkentették a helyi kiújulások és a távoli áttétek számát, ezzel növelve a teljes túlélést. Az egyik jelentős előrelépést a kombinált neoadjuváns kezelés bevezetése jelentette. Módszer: A Debreceni Egyetem Sebészeti Klinikáján 2010. január 1. és 2017. december 31. között lokális neoadjuváns kemoradioterápiában részesített, majd műtéten átesett 362, rectumtumoros beteg adatainak retrospektív feldolgozását végeztük statisztikai elemzéssel. A lokális neoadjuváns kezelésre adott válasz mértékét és késői túlélési eredményeinket összehasonlítottuk az időközben megjelent nagy nemzetközi tanulmányokban közölt teljes neoadjuváns kezeléssel elért eredményekkel. Eredmények: Betegeink között 8,6%-ban tapasztaltunk teljes patológiai regressziót. A műtét időpontjára, valamint az azt követő 3 hónapon belül betegeink 10,7%-ában tapasztaltuk távoli áttét kialakulását. Vizsgálataink során a neoadjuváns kezelésre adott válasz mértéke a felismerési stádiumtól független prognosztikai faktornak bizonyult. A jobb választ adó csoportok szignifikánsan jobb túlélési eredményeket produkáltak. Következtetés: A legújabb nemzetközi tanulmányokban teljes neoadjuváns kezelés hatására a teljes patológiai választ adó betegek száma megduplázódott, a távoli áttét pedig 7%-kal kevesebb volt a lokális neoadjuváns csoporthoz képest. Betegeink 85%-a a felismerés pillanatában T3–4N+ stádiumú volt. Tekintettel a műtét pillanatában vagy 3 hónapon belül felismert távoli áttétek 10,7%-os arányára megállapítható, hogy betegeink mintegy felében eredményesebb lett volna a teljes neoadjuváns kezelés alkalmazása. Ennek megfelelően a jövőben intézetünkben is a teljes neoadjuváns protokoll szerint kívánunk eljárni. Orv Hetil. 2022; 163(30): 1196–1205.

BACKGROUND AND AIMS: There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators.METHODS: I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn's disease, ulcerative colitis, or IBD unclassified established at least 3 months prior to enrollment.RESULTS: A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn's disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathioprine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizumab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia.CONCLUSIONS: I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

Absztrakt: Bevezetés: Akut pancreatitis miatti necrectomiát ideálisan a betegség kezdetétől számított 4–6. héten javasolt elvégezni, amikor az ún. demarkált necrosis (walled-off pancreatic necrosis –WOPN) már kialakult. A szerzők ismertetik a kiterjedt WOPN miatt végzett sebészi transgastricus necrectomiák során nyert tapasztalataikat. Betegek és módszer: Kiterjedt WOPN miatt 2012. január 1-től 2017. december 31-ig terjedő időszakban 17 (12 férfi, 5 nő, átlag életkor 64,00 ± 15,14 év) betegnél végeztek sebészi transgastricus necrectomiát. Valamennyi betegnél a műtétet megelőzően konzervatív és szemikonzervatív kezelés történt átlagosan 61,00 ± 33,47 napig. A WOPN mérete átlagosan 14,00 ± 5,23 cm volt és valamennyi esetben a retrocolicus, retroduodenalis terekbe is beterjedt. A necrosis minden esetben bakteriálisan kontaminált volt. Eredmények: A műtétekkel kapcsolatos szövődmény nem volt. Az ápolási napok száma a műtétet követően 10,00 ± 3,08 nap volt. A mortalitás 5,9% volt. Késői műtét vagy egyéb beavatkozás pseudocystaképződés, vagy pancreas fistula miatt nem volt. Két betegnél a WOPN és a gyomor közötti anastomosis-endoszkópos tágítása és öblítése történt lázas állapot miatt. Frissen kialakult diabetest nem, a meglévő súlyosbodását 6,3%-ban észleltük. Következtetés: A kiterjedt, fertőzött demarkált necrosis kezelésében a sebészi transgastricus necrectomia jó eredménnyel alkalmazható. A műtét előnye, hogy a necrectomia után nem alakulhat ki külső pancreas sipoly és pseudocysta.

The EuroQol five-dimension questionnaire (EQ-5D) is the most commonly used instrument to obtain utility values for cost-effectiveness analyses of treatments for Crohn’s disease (CD). We aimed to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with CD. Between 2016 and 2017, a multicentre cross-sectional survey was carried out. Consecutive outpatients with CD completed the 3L, 5L and EQ visual analogue scale (VAS). Disease severity was graded by the Crohn’s Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI). The 3L and 5L were compared in terms of feasibility, agreement, ceiling effect, redistribution properties, discriminatory power, convergent and known-groups validity. Two-hundred and six patients (54.9% male, mean age 35 ± 11 years) participated in the survey. For 3L, 25 unique health states were observed versus 59 for the 5L. The overall ceiling effect decreased from 29.6% (3L) to 25.5% (5L). Absolute discriminatory power improved (mean Shannon index 0.84 vs. 1.18). The 3L correlated stronger with EQ VAS and CDAI scores, whereas the 5L with PDAI. The 5L demonstrated a better known-groups validity on the basis of age, perianal fistulas, extraintestinal manifestations and disability. This is the first study to report the impact of CD on quality of life using the EQ-5D-5L questionnaire. The 5L seems to perform better than 3L in terms of feasibility, ceiling effect, discriminatory power and known-groups validity. Understanding the differences in psychometrics between the 3L and 5L is essential as they have substantial implications for financial decision-making about CD treatments.

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.

Abstract: Introduction: Hereditary nonpolyposis colorectal carcinoma (HNPCC) is an autosomal dominant disease, which shows familial clustering. Aim: We would like to emphasize the importance of monitoring the HNPCC syndrome patients by presenting a case of a proven MMR gene mutation carrier and her family tree encompassing 10 years. Materials and method: To screen a suspected HNPCC Hungarian family member we are taking thorough family histories. If the diagnosis of HNPCC was further supported by immunohistology and the microsatellite status, sequencing of the MMR genes was carried out. Results: A novel mutation in exon 6 of the hMSH2 gene leading to the deletion of two nucleotide pairs [c.969-970delTC] was detected in our patient. During the 10-year follow-up period of our patient new HNPCC-associated tumors have developed in several family members. Conslusion: Close surveillance of the patient and its family members at risk was effective, although it requires compliance from the subjects. Orv Hetil. 2017; 158(30): 1182–1187.

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

AIM: To evaluate and compare the patients opinion on the two types of anti- TNF-α therapies in a Hungarian cohort of IBD patients. METHODS: This was a prospective, multicentre, questionnaire-based observational study carried out in three Hungarian tertiary centres. From April to September 2014, an anonymous questionnaire was distributed to patients diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD), who have received infliximab (IFX) and/or adalimumab (ADA). The survey focused on the preferences of the two anti-TNF-α therapies on the basis of the efficacy, the administration routes and the side effects. RESULTS: 292 IBD patients, 216 CD, 75 UC and 1 indeterminate colitis patient completed the questionnaire. The mean duration of biological therapy was 1.7 (1 - 7) years. IFX treated patients noticed improvement of symptoms at 4 - 5 weeks while ADA treated patients noticed at 5 - 6 weeks. There was no difference between the patients’ satisfaction regarding the types of anti-TNF-α therapy if they received both. However, subcutaneous administration was preferred by ADA-treated patients previously receiving IFX (p = 0.007) compared to intravenous route and they did not intend to change the mode of therapy (p = 0.040). 90% of the patients, receiving only IFX or ADA were satisfied with their present therapy. The majority of patients (186/292, 63.7%) would not switch therapy. 63 of 291, 22% of the patients reported to have some concern with biological therapy—the majority (32/63, 50.8%) due to fear from side effects. CONCLUSION: Generally, patients preferred and would not change the present anti-TNF-α therapy, however, subcutaneous administration was preferred among those patients who had have experience with both.

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...

A significant percentage of patients receiving anti-tumor necrosis factor alpha (anti-TNFα) agents lose clinical response over time. This study aims to provide representative real-world data on anti-TNFα drug sustainability, prevalence and predictors of anti-TNFα dose escalation.In this nationwide, retrospective study, patients receiving infliximab or adalimumab therapy between 2013 and 2016 were included using the administrative claims database of the Hungarian National Health Insurance Fund. Demographic characteristics, drug sustainability, dose escalation, use of parallel medications were analyzed.476 infliximab and 397 adalimumab patients were included. Dose escalation was observed in 7%, 9% and 22% of patients receiving originator/biosimilar infliximab and adalimumab during the complete follow-up, respectively. Dose escalation was associated with shorter disease duration (OR = 1.75, p = 0.026) and corticosteroid use. Drug retention rates were 62.7%, 72.3%, 75.4% after 1 year follow-up for Remicade®, Inflectra® and Humira®, which decreased to 38.3% and 52.1% for Remicade® and Humira® at 3 years. Drug sustainability was affected by steroid use prior biologic initiation in adalimumab treated patients (HR = 2.04, p 0.001), while in infliximab treated patients dose escalation (HR = 0.51, p = 0.02) and gender (HR = 1.39, p = 0.033) were predictors of treatment discontinuation.Dose escalation rates were lower in this real-world administrative database study for both adalimumab and infliximab compared to published data. Drug retention rates were overall satisfactory, with no apparent difference between the legacy and biosimilar infliximab.

In severe acute pancreatitis the timing of necrosectomy is ideally should be postponed 4-6 weeks after the onset of the disease when the walled-of pancreatic necrosis (WOPN) has developed. The authors present their experience with open transgastric necrosectomy for extended WOPN.The authors performed 17 (12 male, 5 female with a mean age of 61.6 ± 15.1 years) open transgastric necrosectomies for extended WOPN in a period of 1, January 2012 and 31, December 2017. Before the operations conservative and semiconservative therapy was used for an average of 74.6 ± 83.1 days. The mean size of the WOPNs was 13.8 ± 5.2 cm with localisation of the retrocolic and retroduodenal regions. All necroses were septic.Complications related to the operation were not observed. The mean time of hospitalization after the surgery was 11.6 ± 12.8 days. The mortality rate was 5.9%. Late operation or other interventions for pseudocyst or pancreas fistula formation was not performed. Two patients needed endoscopic dilatation with lavage in the early postoperative period because of fever. New diabetes mellitus was not observed but worsening of previously existed diabetes developed in 6.3% of the cases.The open transgastric necrosectomy is safe and effective for extended WOPN. The advantage of this type of necrosectomy is the prevention of pancreatic pseudocyst and fistula formation.Absztrakt: Bevezetés: Akut pancreatitis miatti necrectomiát ideálisan a betegség kezdetétől számított 4–6. héten javasolt elvégezni, amikor az ún. demarkált necrosis (walled-off pancreatic necrosis –WOPN) már kialakult. A szerzők ismertetik a kiterjedt WOPN miatt végzett sebészi transgastricus necrectomiák során nyert tapasztalataikat. Betegek és módszer: Kiterjedt WOPN miatt 2012. január 1-től 2017. december 31-ig terjedő időszakban 17 (12 férfi, 5 nő, átlag életkor 64,00 ± 15,14 év) betegnél végeztek sebészi transgastricus necrectomiát. Valamennyi betegnél a műtétet megelőzően konzervatív és szemikonzervatív kezelés történt átlagosan 61,00 ± 33,47 napig. A WOPN mérete átlagosan 14,00 ± 5,23 cm volt és valamennyi esetben a retrocolicus, retroduodenalis terekbe is beterjedt. A necrosis minden esetben bakteriálisan kontaminált volt. Eredmények: A műtétekkel kapcsolatos szövődmény nem volt. Az ápolási napok száma a műtétet követően 10,00 ± 3,08 nap volt. A mortalitás 5,9% volt. Késői műtét vagy egyéb beavatkozás pseudocystaképződés, vagy pancreas fistula miatt nem volt. Két betegnél a WOPN és a gyomor közötti anastomosis-endoszkópos tágítása és öblítése történt lázas állapot miatt. Frissen kialakult diabetest nem, a meglévő súlyosbodását 6,3%-ban észleltük. Következtetés: A kiterjedt, fertőzött demarkált necrosis kezelésében a sebészi transgastricus necrectomia jó eredménnyel alkalmazható. A műtét előnye, hogy a necrectomia után nem alakulhat ki külső pancreas sipoly és pseudocysta.

Background In patients with Crohn’s disease (CD), luminal disease activity paralleled by perianal fistulas may seriously impair health-related quality of life (HRQoL). Health utility values are not available from patients with CD that reflect the health loss associated with both luminal and perianal CD. Objective To generate utilities for luminal and concomitant perianal fistulising CD health states directly from patients and from members of the general public. Methods A cross-sectional survey was undertaken enrolling CD patients and a convenience sample of members of the general population. Respondents were asked to evaluate four common CD heath states [severe luminal disease (sCD), mild luminal disease (mCD), severe luminal disease with active perianal fistulas (sPFCD), and mild luminal disease with active perianal fistulas (mPFCD)] by 10-year time trade-off (TTO). In addition, patients assessed their current HRQoL by the TTO method. Results Responses of 206 patients (40.8% with perianal fistulas) and 221 members of the general population were analysed. Mean ± SD utilities among patients for sPFCD, sCD, mPFCD and mCD states were 0.69 ± 0.33, 0.73 ± 0.31, 0.80 ± 0.29 and 0.87 ± 0.26. Corresponding values in the general public were: 0.59 ± 0.31, 0.65 ± 0.29, 0.80 ± 0.26 and 0.88 ± 0.25. Patients with active perianal fistulas, previous non-resection surgeries, and higher pain intensity scores valued their current health as worse (p

Introduction: Adalimumab was approved for the treatment of ulcerative colitis refractory to conventional therapy several years later than infliximab in Europe. Due to the relatively low remission rate observed in Ultra trials, data on the efficacy of adalimumab in ulcerative colitis are really helpful in the daily practice. Aim: The aim of this study was to prospectively collect data on induction and maintenance adalimumab therapy in patients with ulcerative colitis treated in Hungarian centres. Method: This prospective study collected data of all patients with ulcerative colitis treated with adalimumab in 10 Hungarian centres. The primary endpoints of the study were rates of remission, response and primary failure at week 12, and the rate of continuous clinical response, remission and loss of response at weeks 30, and 52. Secondary endpoints were endoscopic outcome at week 52 and comparison of the efficacy of adalimumab between treatment naive and infliximab-experienced patients. Results: 73 patients with active ulcerative colitis were enrolled in the study. 75.3% of the patients exhibited clinical response after the induction at week 12. The probability of maintaining adalimumab treatment was 48.6% at week 52 with a continuous clinical response in 92% of these patients. Mucosal healing was achieved in 48.1% of the patients at week 52. Dose intensification was performed in 17.6% of the patients. Minor side effects developed in 4% of the patients and 5.4% of the patients underwent colectomy during the 1-year treatment period. Conclusions: These results coming from the real clinical setting demonstrate a favourable efficacy of adalimumab induction and maintenance therapy in patients with ulcerative colitis. Orv. Hetil., 2016, 157(18), 706–711.

Background and Aims: Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary. Methods: Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level \[TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA\] \[LT-005, Theradiag, France\] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6. Results: A total of 291 consecutive IBD patients (184 Crohn’s disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8% , p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715–0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [ p = 0.04–0.05 for Weeks 14 and 30], early clinical response [ p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [ p = 0.005–0.0001] and previous anti-TNF exposure [ p = 0.03–0.0001 for Weeks 14, 30, and 54] were associated with short-and medium-term clinical response and remission. Conclusions: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes.

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.

FDG PET-CT is a global, noninvasive, sensitive method to determine the location and activity of inflammatory lesions. Segmental FDG uptake is proportional with immune cell infiltration of bowel. Our aim was to evaluate prospectively the role of PET in patients with active Crohn's disease (CD) before and after one year's biological therapy, and to compare simple endoscopic score for CD (SES-CD), CD activity index (CDAI) and global PET scores. We also analyzed the prognostic value of initial PET scores.Twelve patients were selected: six male/six female, ages between 18 and 39, average: 24 years, with CDAI values300.We scored the FDG uptake in the small intestine and the four colon segments (on a scale 0-3 for each), and summed them thus forming a global PET score. The scoring was based on the maximal standardized uptake value of the intestinal segment, related to the SUVmax of the liver (as a reference for normal tissue activity). The SES-CD, CDAI and global PET scores before and after treatment were statistically compared.There were significant changes in CDAI and SES-CD after therapy, PET scores improved only in patients' subgroup with high (4) initial PET score, indicating good prognosis of biological treatment. In active disease, PET was more informative than endoscopy to access the extent of the inflammation, and small intestine involvement.FDG PET-CT score is a promising, noninvasive complementary method in the staging, treatment planning and follow-up of CD. Limitation of the study is the small number of patients.

Background and Aim: Adalimumab [ADA] was approved for the treatment of ulcerative colitis [UC] refractory to conventional therapy in 2012 in Europe. Due to the observed discrepancies between clinical trials and practice, data on the outcome of ADA therapy are really needed from the real life. The aim of this study was to estimate the short- and long-term efficacy and safety of ADA in UC patients from each Hungarian biological centre. Patients and Methods: This prospective study consisted of UC patients treated with ADA in 10 Hungarian inflammatory bowel disease centres. The primary endpoints of the study were rates of continuous clinical response, remission, non-response and loss of response at Weeks 12, 30, and 52.The secondary endpoints included mucosal healing at Week 52 and the comparison of the efficacy of ADA between biological naive and infliximab [IFX]-treated groups. Colonoscopy was performed before starting the therapy and at Week 52. Results: In all, 73 active UC patients were enrolled in the study: 67.1% of the patients received previous IFX therapy; 75.3% of the patients showed short-term clinical response at Week 12. The probability of maintaining ADA was 48.6% at Week 52 with a continuous clinical response in 92% of these remaining patients. Mucosal healing was achieved in 48.1% of the patients at Week 52. Escalation of ADA was performed in 17.6%, and minor side effects developed in 4% of the patients; 5.4% of the patients underwent colectomy during the 1-year treatment period. Conclusion: UC is a progressive disease that may need early aggressive therapy to prevent structural and functional complications. The results of our study demonstrated the favourable efficacy of short- and long-term ADA treatment for patients with UC.

Background: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. Methods: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Results: Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Conclusions: Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.

Hereditary nonpolyposis colorectal carcinoma (HNPCC) is an autosomal dominant disease, which shows familial clustering.We would like to emphasize the importance of monitoring the HNPCC syndrome patients by presenting a case of a proven MMR gene mutation carrier and her family tree encompassing 10 years.To screen a suspected HNPCC Hungarian family member we are taking thorough family histories. If the diagnosis of HNPCC was further supported by immunohistology and the microsatellite status, sequencing of the MMR genes was carried out.A novel mutation in exon 6 of the hMSH2 gene leading to the deletion of two nucleotide pairs [c.969-970delTC] was detected in our patient. During the 10-year follow-up period of our patient new HNPCC-associated tumors have developed in several family members. Conslusion: Close surveillance of the patient and its family members at risk was effective, although it requires compliance from the subjects. Orv Hetil. 2017; 158(30): 1182-1187.

Introduction According to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomised, controlled multicentre trial (the PONCHO trial) revealed that in the case of gallstone-induced pancreatitis, early cholecystectomy was safe in patients with mild gallstone pancreatitis and reduced the risk of recurrent gallstone-related complications, as compared with interval cholecystectomy. We hypothesise that carrying out a sphincterotomy (ES) allows us to delay cholecystectomy, thus making it logistically easier to perform and potentially increasing the efficacy and safety of the procedure. Methods/Design EMILY is a prospective, randomised, controlled multicentre trial. All patients with mild ABP, who underwent ES during the index admission or in the medical history will be informed to take part in EMILY study. The patients will be randomised into two groups: (1) early cholecystectomy (within 6 days after discharge) and (2) patients with delayed (interval) cholecystectomy (between 45 and 60 days after discharge). During a 12-month period, 93 patients will be enrolled from participating clinics. The primary endpoint is a composite endpoint of mortality and recurrent acute biliary events (that is, recurrent ABP, acute cholecystitis, uncomplicated biliary colic and cholangitis). The secondary endpoints are organ failure, biliary leakage, technical difficulty of the cholecystectomy, surgical and other complications. Ethics and dissemination The trial has been registered internationallyNCT10667869, and approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (EKU/2018/12176–5). Trial registration number NCT10667869; Pre-results.

BACKGROUND. Some of the most important questions relating to the use of biological therapy in inflammatory bowel diseases concern the duration of maintenance therapy. The RASH study revealed that previous use of biological therapy and dose intensification are associated with restarting of biological therapy in Crohn's disease. The aim of the study was to assess the disease course and frequency of relapse of ulcerative colitis (UC) following discontinuation of infliximab in patients with remission and to determine predictive factors for relapse. PATIENTS AND METHODS. Fifty-one UC patients who had achieved clinical remission following 1 year of infliximab therapy and for whom infliximab was then discontinued participated in this prospective observational study. 15.7% of the patients received infliximab before the 1-year period of biological therapy analyzed in the study. Biological therapy was restarted in case of recurrent clinical activity. Data were collected from four Hungarian IBD centers. RESULTS. Thirty-five percent of the patients needed to be retreated with infliximab within 1 year after treatment cessation. Logistic regression analysis revealed that previous biological therapy (p = 0.021) was associated with the need of restarting infliximab. None of the data relating to patients' demographic and clinical characteristics, concomitant therapy and CRP level showed association with the need for restarting biological therapy. CONCLUSIONS. Biological therapy was restarted at a median of 4 months after discontinuation in more than every third UC patients who had been in clinical remission following 1 year of infliximab therapy. Response to retreatment with infliximab was favorable in the majority of the patients who relapsed.

A 38-year-old alcoholic man with severe iron deficient anaemia, and bloody-mucous stool was found to have haemorrhoidal bleeding. In spite of intravenous iron supplements haemoglobin levels were falling. He was admitted because of deteriorating condition, jaundice, severe anaemia (haemoglobin, 38 g/l) and iron deficiency. Except of toxic (alcohol) agent all other causes of liver disease could be excluded. Sclero-, and medical therapy, and abstinency resulted in a rapid improvement in his condition and subsequently rectal bleeding also disappeared. Bleeding from the upper gastrointestinal tract is a well known and serious complication in liver cirrhosis, however, a voluminous blood loss resulting in a life-threatening anaemia from lower gastrointestinal tract or haemorrhoids, as it was detected in this patient, is quite rare. Sclerotherapy seems to be an effective method with only minor complications when compared with other invasive techniques. However, the patient’s compliance even in liver cirrhosis with haemorrhoidal nodes is essential for a long-time success. Orv. Hetil., 2013, 154, 382–386.

Introduction: Crohn’s disease (CD) is a chronic inflammatory disease which is frequently complicated by obstructive symptoms secondary to development of intestinal strictures. The aim of this “real life” study was to assess the effectiveness, safety and outcome of endoscopic balloon dilatation (EBD) in de novo vs. anastomotic stenoses. Patients and methods: Data of 93 EBDs in 46 CD patients were retrospectively analyzed. Technical success rate was defined as the ability of endoscope to traverse the stenosis after dilatation. Long-term clinical success rate was claimed if a patient remained asymptomatic and did not require surgery or further endoscopic dilatation following the technical success. Results: About 62.4% of strictures were de novo and 37.6% anastomotic. The elapsed time between diagnosis and the first balloon dilatation was 9.5 (0–35) years. About 73.1% of dilatations were successful over a short-term period without serious complications. About 47.8% of patients showed that EBD is effective over a long-term period. EBD of anastomotic strictures showed better outcome than that of de novo strictures, however biological therapy before or after dilatation, immunomodulatory therapy and the time between the diagnosis and the first dilatation had no influence on long-term effectiveness. Nine subjects required surgery due to strictures after balloon dilatation. Conclusion: The results of this study highlight that EBD is an effective therapy of short strictures in CD with low complication rate. Using this endoscopic method we can avoid surgical interventions in most of the cases. EBD of anastomotic stenosis may be more preferable than that of the de novo strictures.

Adalimumab was approved for the treatment of ulcerative colitis refractory to conventional therapy several years later than infliximab in Europe. Due to the relatively low remission rate observed in Ultra trials, data on the efficacy of adalimumab in ulcerative colitis are really helpful in the daily practice.The aim of this study was to prospectively collect data on induction and maintenance adalimumab therapy in patients with ulcerative colitis treated in Hungarian centres.This prospective study collected data of all patients with ulcerative colitis treated with adalimumab in 10 Hungarian centres. The primary endpoints of the study were rates of remission, response and primary failure at week 12, and the rate of continuous clinical response, remission and loss of response at weeks 30, and 52. Secondary endpoints were endoscopic outcome at week 52 and comparison of the efficacy of adalimumab between treatment naive and infliximab-experienced patients.73 patients with active ulcerative colitis were enrolled in the study. 75.3% of the patients exhibited clinical response after the induction at week 12. The probability of maintaining adalimumab treatment was 48.6% at week 52 with a continuous clinical response in 92% of these patients. Mucosal healing was achieved in 48.1% of the patients at week 52. Dose intensification was performed in 17.6% of the patients. Minor side effects developed in 4% of the patients and 5.4% of the patients underwent colectomy during the 1-year treatment period.These results coming from the real clinical setting demonstrate a favourable efficacy of adalimumab induction and maintenance therapy in patients with ulcerative colitis.

Prospective data collection seems to be essential in evidence-based medicine. Because of the new therapeutic options, the need for standard data collection and testing has significantly increased. In Hungary, a registry for patients with inflammatory bowel disease has already been set up, which makes it possible for clinicians to collect prospective data on their patients. Aim: Basic characteristics of the database of patients with ulcerative colitis are presented in this paper. Methods: The inflammatory bowel disease registry uses the programme of Microsoft Access database management system. Data are stored in a central server. Results: The incidence of inflammatory bowel diseases has been permanently increasing in Hungary; however, its overall prevalence is still low among the European countries. The frequent administration of immunosuppressive medications (azathioprine and corticosteroids) and their increased doses worsen the estimation of the activity. Conclusions: 1., It would be very useful to gain prospective data from all national centres. This kind of database would be able to give a complete picture regarding the Hungarian therapeutical practice. 2., Medications of patients may alter the clinical value of the laboratory findings in the process of determining the severity of the disease. Orv. Hetil., 2012, 153, 702–712.

Aliment Pharmacol Ther 2011; 34: 911–922 Summary Background Adalimumab is a fully human monoclonal antibody targeting tumour necrosis factor with proven efficacy in the treatment of Crohn’s disease (CD). Aim To investigate the predictors of medium-term clinical efficacy and mucosal healing during adalimumab therapy, in patients with CD, in specialised centres approved for biological therapy in Hungary. Methods Data capture of the 201 CD patients was standardised and prospective (male/female: 112/89, median age: 33.0 years, duration: 8 years). Previous infliximab therapy had been administered in 48% of patients, concomitant steroids in 41%, azathioprine in 69% and combined therapy in 27% of patients. Results Overall clinical response and remission rates at 24 weeks were 78% and 52%, respectively; at 52 weeks were 69% and 44%, respectively. Endoscopic improvement and healing were achieved in 43% and 24% of patients. In a logistic regression model, clinical efficacy and CRP at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, whereas CRP at week 12, clinical remission at week 24, inflammatory parameters and nonsmoking were associated to endoscopic improvement/healing. Intensification to weekly dosing was needed in 16% of patients. Parallel azathioprine therapy and clinical remission at week 12 were inversely associated with dose escalation. Conclusions Clinical efficacy and normalised CRP at week 12 (early deep clinical remission) are associated with medium-term clinical efficacy and mucosal healing during adalimumab therapy, whereas need for combined immunosuppression at induction and smoking status are predictors for non-response. Parallel azathioprine therapy may decrease the probability for dose escalation.

The α-chain alleles 1 and 2 of haptoglobin (Hp) molecule account for three phenotypes, which have biologically important differences in their antioxidant, scavenging, and immunomodulatory properties and may thereby influence the course of inflammatory diseases. A follow-up observational study was conducted to assess the association between haptoglobin phenotype and the development of clinically significant bacterial infections in patients with liver cirrhosis. Sera of 336 patients with liver cirrhosis of various etiologies and 384 healthy subjects were investigated. Haptoglobin phenotypes were determined by gel electrophoresis and assigned corresponding genotype. Haptoglobin phenotype distributions of patients and controls was similar (Hp1-1: 10.7% vs 11.5%, Hp2-1: 47.9% vs 46.1% and Hp2-2: 41.4% vs 42.4%). The probability of clinically significant bacterial infections was calculated for each haptoglobin phenotype (Hp1-1: 50.0%, Hp2-1: 36.0% and Hp2-2: 26.6%, p = 0.039). In a logistic regression analysis, Hp1-1 phenotype (p = 0.015, OR: 2.74, 95% CI: 1.22-6.13), Child-Pugh stage (p = 0.038, OR: 1.40, 95% CI: 1.02-1.91) and presence of co-morbidities (p < 0.001, OR: 2.64, 95% CI: 1.63-4.27) were independently associated with infections. In a Cox regression analysis, Hp1-1 phenotype (p = 0.014), Child-Pugh stage C (p < 0.001), and presence of co-morbidities (p = 0.004) were associated with time to first infectious episode. Phenotypic haptoglobin polymorphism was independent predictor for risk and time to first clinically significant bacterial infectious episode.

Background and aims Previous studies have suggested an increasing use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). Furthermore, a significant number of IBD patients fail to comply with treatment. The aim of our study was to evaluate the prevalence of non-adherence and the use of CAM in Hungarian patients with IBD. Methods A total of 655 consecutive IBD patients (CD: 344, age: 38.2 [SD 12.9] years; UC: 311, age: 44.9 [15.3] years) were interviewed during the specialist visit by self-administered questionnaire including demographic and disease-related data as well as items analyzing the extent of non-adherence and CAM use. Patients taking more than 80% of each prescribed medication were classified as adherent. Results The overall rate of self-reported non-adherence (CD: 20.9%, UC: 20.6%) and CAM (CD: 31.7%, UC: 30.9%) use did not differ between Crohn's disease (CD) and ulcerative colitis (UC). The most common causes of non-adherence were: forgetfulness (47.8%), too many/unnecessary pills (39.7%), being afraid of side effects (27.9%) and too frequent dosing. Most common forms of CAM were herbal tea (47.3%), homeopathy (14.6%), special diet (12.2%), and acupuncture (5.8%). In CD, disease duration, date of last follow-up visit, educational level and previous surgeries were predicting factors for non-adherence. Alternative medicine use was associated in both diseases with younger age, higher educational level, and immunosuppressant use. In addition, CAM use in UC was more common in females and in patients with supportive psychiatric/psychological therapy. Conclusions Non-adherence and CAM use is common in patients with IBD. Special attention should be paid to explore the identified predictive factors during follow-up visits to improve adherence to therapy and improving patient–doctor relationship.

Mannose-binding lectin (MBL) is a serum lectin synthesized by the liver and involved in innate host defense. MBL deficiency increases the risk of various infectious diseases mostly in immune-deficient conditions. Bacterial infections are a significant cause of morbidity and mortality in liver cirrhosis due to the relative immuncompromised state.Sera of 929 patients with various chronic liver diseases [autoimmune liver diseases (ALD), 406; viral hepatitis C (HCV), 185; and liver cirrhosis (LC) with various etiologies, 338] and 296 healthy controls (HC) were assayed for MBL concentration. Furthermore, a follow-up, observational study was conducted to assess MBL level as a risk factor for clinically significant bacterial infections in cirrhotic patients.MBL level and the prevalence of absolute MBL deficiency (100 ng/ml) was not significantly different between patients and controls (ALD: 14.5%, HCV: 11.9%, LC: 10.7%, HC: 15.6%). In cirrhotic patients, the risk for infection was significantly higher among MBL deficient subjects as compared to non-deficient ones (50.0% vs. 31.8%, p=0.039). In a logistic regression analysis, MBL deficiency was an independent risk factor for infections (OR: 2.14 95% CI: 1.03-4.45, p=0.04) after adjusting for Child-Pugh score, co-morbidities, gender, and age. In a Kaplan-Meier analysis, MBL deficiency was associated with a shorter time to develop the first infectious complication (median days: 579 vs. 944, pBreslow=0.016, pLogRank=0.027) and was identified as an independent predictor in a multivariate Cox-regression analysis (p=0.003, OR: 2.33, 95% CI: 1.34-4.03).MBL deficiency is associated with a higher probability and shorter time of developing infections in liver cirrhosis, further supporting the impact of the MBL molecule on the host defense.

NOD1/CARD4, a member of the pattern-recognition receptor family, is a perfect candidate as a susceptibility gene for Crohn's disease. Since only limited and conflicting data are available on G796A polymorphisms in inflammatory bowel disease patients, we set out to study the effect of this polymorphism on the susceptibility and course of Crohn's disease in the Hungarian population.Four hundred thirty-four unrelated Crohn's disease patients (age at presentation: 28.6+/-9.6 years, female/male: 210/224, duration of Crohn's disease: 8.2+/-6.9 years) and 200 healthy subjects (blood donors) and 136 non-inflammatory bowel disease gastrointestinal controls with chronic gastritis were investigated. NOD1 G796A was detected by using polymerase chain reaction/restriction fragment length polymorphism. Detailed clinical phenotypes were determined by reviewing the medical charts.The frequencies of the variant alleles of NOD1 G796A differed significantly between the Crohn's disease patients and both healthy (GG 49.5% vs. 67%; AG 41.5% vs. 28%; and AA 9.0% vs. 5.2%; p0.0001) and non-inflammatory bowel disease controls with chronic gastritis. Carriage of the single nucleotide polymorphism of NOD1 G796A proved to be a highly significant risk factor for Crohn's disease compared to both healthy (p0.0001, OR: 2.1, 95% CI: 1.5-2.9) and non-inflammatory bowel disease controls with chronic gastritis (p=0.008). Significant associations were not found between the different genotypes and the demographic data on the patients or the clinical characteristics of Crohn's disease. The different polymorphisms of pattern-recognition receptors (e.g. NOD2/CARD15 SNP8, SNP12 and SNP13 mutations, the TLR4 D299G polymorphism and NOD1 G796A) did not reveal a mutual basis.Our results suggest that carriage of the NOD1 G796A mutation increases susceptibility for Crohn's disease in the Hungarian population.

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 naive, 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.