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Background and aims Inflammatory bowel disease [IBD] can impair patients' functional capacity with significant negative effects on their quality of life. Our aim was to determine the impact of IBD diagnosis on fitness levels and to assess the levels of engagement in physical activity and fatigue in IBD patient before and after diagnosis. Methods A prospective multi-centre cross-sectional study was performed. Patients diagnosed with IBD in the previous 18 months were recruited. Inclusion criteria included clinical remission and/or no treatment changes within the previous 6 months. Physical exercise levels were assessed by the Godin score and fatigue levels was assessed by the functional assessment of chronic illness therapy [FACIT] score. Results In total, 158 patients (100 Crohn's disease [CD]) were recruited. Mean age was 35.1 years (95% confidence interval [CI] ± 2.0). Gender distribution was approximately equal [51.3% male]. The Mean Harvey Bradshaw and Simple Clinical Colitis Activity indices were 2.25 [95% CI ± 0.40] and 1.64 [95% CI ± 0.49], respectively. The mean Godin score difference before and after IBD diagnosis was 6.94 [p = 0.002]. Patients with ulcerative colitis [UC] [41.8%] were more likely than patients with CD [23.0%] to reduce their exercise levels [p = 0.04]. FACIT scores were lower in patients who had experienced relapses [p = 0.012] and had severe disease [p = 0.011]. Approximately one-third of patients reduced their activity level following IBD diagnosis. Conclusions Patients were significantly less physically active after a diagnosis of IBD and this was more apparent in UC. Identification of the risk factors associated with loss of fitness levels would help to address the reduced patient quality of life.

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 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.