Long-term outcomes after endoscopic removal of malignant colorectal polyps: Results from a 10-year cohort.

BACKGROUND: Choosing an optimal post-polypectomy management strategy of malignant colorectal polyps is challenging, and evidence regarding a surveillance-only strategy is limited. AIM: To evaluate long-term outcomes after endoscopic removal of malignant colorectal polyps. METHODS: A single-center retrospective cohort study was conducted to evaluate outcomes after endoscopic removal of malignant colorectal polyps between 2010 and 2020. Residual disease rate and nodal metastases after secondary surgery and local and distant recurrence rate for those with at least 1 year of follow-up were investigated. Event rates for categorical variables and means for continuous variables with 95% confidence intervals were calculated, and Fisher's exact test and Mann-Whitney test were performed. Potential risk factors of adverse outcomes were determined with univariate and multivariate logistic regression models. RESULTS: In total, 135 lesions (mean size: 22.1 mm; location: 42% rectal) from 129 patients (mean age: 67.7 years; 56% male) were enrolled. The proportion of pedunculated and non-pedunculated lesions was similar, with en bloc resection in 82% and 47% of lesions, respectively. Tumor differentiation, distance from resection margins, depth of submucosal invasion, lymphovascular invasion, and budding were reported at 89.6%, 45.2%, 58.5%, 31.9%, and 25.2%, respectively. Residual tumor was found in 10 patients, and nodal metastasis was found in 4 of 41 patients who underwent secondary surgical resection. Univariate analysis identified piecemeal resection as a risk factor for residual malignancy (odds ratio: 1.74; P = 0.042). At least 1 year of follow-up was available for 117 lesions from 111 patients (mean follow-up period: 5.59 years). Overall, 54%, 30%, 30%, 11%, and 16% of patients presented at the 1-year, 3-year, 5-year, 7-year, and 9-10-year surveillance examinations. Adverse outcomes occurred in 9.0% (local recurrence and dissemination in 4 patients and 9 patients, respectively), with no difference between patients undergoing secondary surgery and surveillance only. CONCLUSION: Reporting of histological features and adherence to surveillance colonoscopy needs improvement. Long-term adverse outcome rates might be higher than previously reported, irrespective of whether secondary surgery was performed.

Accuracy of the Pancolonic Modified Mayo Score in predicting the long-term outcomes of ulcerative colitis: a promising scoring system.

Background: Different endoscopic scoring systems for assessing ulcerative colitis (UC) severity are available. However, most of them are not correlated with disease extent. Objectives: Our study aimed to compare the predictive value of the PanMay score versus the endoscopic Mayo (MES), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and Dublin score in predicting long-term outcomes of UC. Design: This retrospective study enrolled consecutive UC patients who underwent colonoscopy before at least a 3-year follow-up. Methods: The PanMayo, MES, UCEIS, and Dublin scores and the baseline clinical and demographic characteristics of the participants were assessed. Endpoints were disease flare that required novel biological therapy, colectomy, and hospitalization. Patients were stratified using baseline clinical activity. Results: Approximately 62.8% of the 250 enrolled patients were in clinical remission. In these patients, the PanMayo, MES, and Dublin scores were positively associated with the risk of clinical flare. The MES score increased with clinical flare. The PanMayo score (>12 points), but not the MES score, was associated with the need for novel biological initiation and biological escalation. Furthermore, the Dublin and UCEIS scores of patients in remission who need novel biological treatment had a similar trend. Colectomy risk was associated with PanMayo and Dublin scores. Conclusion: The combined endoscopic assessment of disease extent and severity can be more accurate in predicting outcomes among patients with UC. PanMayo score can be utilized in addition to the existing scoring systems, thereby leading to a more accurate examination. Summary: UC endoscopic scores do not assess extension. Our study aimed to analyze the predictive value of the PanMayo score. Based on 250 patients, results showed that the long-term disease outcomes of UC could be predicted with the PanMayo score more accurately.

Effectiveness and safety of a third-line rescue treatment for acute severe ulcerative colitis refractory to infliximab or ciclosporin (REASUC study).

BACKGROUND: The advent of new therapeutic agents and the improvement of supporting care might change the management of acute severe ulcerative colitis (ASUC) and avoid colectomy. AIMS: To evaluate the colectomy-free survival and safety of a third-line treatment in patients with ASUC refractory to intravenous steroids and who failed either infliximab or ciclosporin. METHODS: Multicentre retrospective cohort study of patients with ASUC refractory to intravenous steroids who had failed infliximab or ciclosporin and received a third-line treatment during the same hospitalisation. Patients who stopped second-line treatment due to disease activity or adverse events (AEs) were eligible. We assessed short-term colectomy-free survival by logistic regression analysis. Kaplan-Meier curves and Cox regression models were used for long-term assessment. RESULTS: Among 78 patients, 32 received infliximab and 46 ciclosporin as second-line rescue treatment. Third-line treatment was infliximab in 45 (58%), ciclosporin in 17 (22%), tofacitinib in 13 (17%) and ustekinumab in 3 (3.8%). Colectomy was performed in 29 patients (37%) during follow-up (median 21 weeks). Of the 78 patients, 32 and 18 were in clinical remission at, respectively, 12 and 52 weeks. At the last visit, 25 patients were still on third-line rescue treatment, while 12 had stopped it due to clinical remission. AEs were reported in 26 (33%) patients. Two patients died (2.6%), including one following colectomy. CONCLUSION: Third-line rescue treatment avoided colectomy in over half of the patients with ASUC and may be considered a therapeutic strategy.

Co-Administration of Proton Pump Inhibitors May Negatively Affect the Outcome in Inflammatory Bowel Disease Treated with Vedolizumab.

Concomitant medications may alter the effect of biological therapy in inflammatory bowel disease. The aim was to investigate the effect of proton pump inhibitors on remission rates in patients with inflammatory bowel disease treated with the gut-selective vedolizumab. Patients from the Hungarian nationwide, multicenter vedolizumab cohort were selected for post hoc analysis. Primary outcomes were the assessment of clinical response and endoscopic and clinical remission at weeks 14 and 54. Secondary outcomes were the evaluation of the combined effect of concomitant steroid therapy and other factors, such as smoking, on remission. A total of 108 patients were identified with proton pump inhibitor data from 240 patients in the original cohort. Patients on steroids without proton pump inhibitors were more likely to have a clinical response at week 14 than patients on concomitant PPI (95% vs. 67%, p = 0.005). Non-smokers with IBD treated with VDZ were more likely to develop a clinical response at week 14 than smokers, particularly those not receiving PPI compared with patients on co-administered PPI therapy (81% vs. 53%, p = 0.041, and 92% vs. 74%, p = 0.029, respectively). We found that the use of PPIs in patients treated with VDZ may impair the achievement of response in certain subgroups. Unnecessary PPI prescriptions should be avoided.

Plasminogen Activator Inhibitor 1 Is a Novel Faecal Biomarker for Monitoring Disease Activity and Therapeutic Response in Inflammatory Bowel Diseases.

BACKGROUND AND AIMS: Crohn's disease [CD] and ulcerative colitis [UC] require lifelong treatment and patient monitoring. Current biomarkers have several limitations; therefore, there is an unmet need to identify novel biomarkers in inflammatory bowel disease [IBD]. Previously, the role of plasminogen activator inhibitor 1 [PAI-1] was established in the pathogenesis of IBD and suggested as a potential biomarker. Therefore, we aimed to comprehensively analyse the selectivity of PAI-1 in IBD, its correlation with disease activity, and its potential to predict therapeutic response. METHODS: Blood, colon biopsy, organoid cultures [OC], and faecal samples were used from active and inactive IBD patients and control subjects. Serpin E1 gene expressions and PAI-1 protein levels and localisation in serum, biopsy, and faecal samples were evaluated by qRT-PCR, ELISA, and immunostaining, respectively. RESULTS: The study population comprised 132 IBD patients [56 CD and 76 UC] and 40 non-IBD patients. We demonstrated that the serum, mucosal, and faecal PAI-1 concentrations are elevated in IBD patients, showing clinical and endoscopic activity. In responders [decrease of eMayo ≥3 in UC; or SES-CD  50% in CD], the initial PAI-1 level decreased significantly upon successful therapy. OCs derived from active IBD patients produced higher concentrations of PAI-1 than the controls, suggesting that epithelial cells could be a source of PAI-1. Moreover, faecal PAI-1 selectively increases in active IBD but not in other organic gastrointestinal diseases. CONCLUSIONS: The serum, mucosal, and faecal PAI-1 concentration correlates with disease activity and therapeutic response in IBD, suggesting that PAI-1 could be used as a novel, non-invasive, disease-specific, faecal biomarker in patient follow-up.

Burnout among European IBD specialists: a survey supported by ECCO.

Background: Burnout remains a significant health concern within the healthcare sector. Numerous studies have explored burnout among gastroenterologists. However, as far as we are aware, there is currently no documented research specifically focused on burnout for specialists in the field of inflammatory bowel disease (IBD). Objective: The aim of our study was to assess the extent of burnout, its determinants, and to analyze potential risk factors among European healthcare professionals who provide care to patients with IBD. Methods: We carried out a cross-sectional pilot study involving healthcare professionals responsible for the treatment of patients with IBD. A total of 102 participants (56.9% male, average age 48 ± 10.6) completed the anonymous multiple question open web survey. The survey consisted of four distinct psychological constructs (burnout, depression, somatization, and well-being), along with inquiries associated with sociodemographic, health-related, and work-related factors. Results: In our study, we observed that 47.1% of professionals specializing in IBD experienced burnout. When considering all three factors of burnout simultaneously, 5.9% of participants fell within the moderate range. Among these, depersonalization (DP) was the most prevalent factor, with 48% at a medium level and 47.1% at a high level. Depression, somatization, and well-being correlated with emotional exhaustion (EE) and DP, while only depression correlated with personal accomplishment (PA). Furthermore, age, physical activity, total time spent in healthcare, and time spent as an IBD specialist were correlated with EE. Multiple linear regression analysis revealed that depression was the most dominant predictor of both PA and DP. In terms of work-related factors, we observed that having endoscopic access had a detrimental impact on burnout, while the presence of a dedicated IBD outpatient unit and opportunities to participate in multidisciplinary meetings had a positive effect on mitigating burnout. Conclusions: Our pilot study underscores the importance of burnout among IBD professionals in Europe, with a specific emphasis on DP. Subsequent studies may help to uncover the way underlying factors contribute to burnout, potentially laying the foundation for international support and prevention initiative programs.

Burnout among European IBD specialists Professionals working with IBD patients are at high risk of burnout. The prevalence of depersonalization is the highest and there are several other risk factors. However, we also found protective factors that may help to reduce and prevent burnout.

Psychological characteristics of patients with inflammatory bowel disease during the first wave of COVID-19.

Introduction: Inflammatory bowel diseases (Crohn's disease (CD) and ulcerative colitis (UC)) are chronic, immune-mediated diseases with unclear aetiology, characterized by relapsing inflammation of the gastrointestinal tract. These conditions significantly impair patients' physical and mental condition and quality of life. Aim: To investigate the impact of the current pandemic situation on inflammatory bowel disease (IBD) patients' psychological status and to determine factors that mediate the level of depression, anxiety, and health-related quality of life. Material and methods: This was a multicentre, observational, cross-sectional, questionnaire-based study. A total of 206 participants (male: 34%) were involved. The online survey consisted of 8 different psychological measures (such as depression, anxiety, coronavirus distress, health-related quality of life, etc.) and other therapy-specific and sociodemographic factors. Results: 28.2% of respondents showed depressive symptoms and 11.2% indicated moderate to severe anxiety. Also, 27.7% revealed mild, moderate, or severe distress regarding the coronavirus situation. According to regression analysis, anxiety and coronavirus distress are mostly influenced by psychological factors. In contrast, the changes in quality of life and depression can be explained by disease-specific and psychological factors as well. Conclusions: Patients need more attention during this period to help them cope with psychological factors and prevent their IBD from becoming worse.

Risk Factors and Interpretation of Inconclusive Endoscopic Ultrasound-Guided Fine Needle Aspiration Cytology in the Diagnosis of Solid Pancreatic Lesions.

BACKGROUND: The inconclusive cytological findings of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) remain a major clinical challenge and often lead to treatment delays. METHODS: Patients who had undergone EUS-FNA sampling for solid pancreas lesions between 2014 and 2021 were retrospectively enrolled. The "atypical" and "non-diagnostic" categories of the Papanicolaou Society of Cytopathology System were considered inconclusive and the "negative for malignancy" category of malignancy was suspected clinically. We determined the frequency and predictors of inconclusive cytological finding. RESULTS: A total of 473 first EUS-FNA samples were included, of which 108 cases (22.83%) were inconclusive. Significant increases in the odds of inconclusive cytological findings were observed for lesions with a benign final diagnosis (OR 11.20; 95% CI 6.56-19.54, p < 0.001) as well as with the use of 25 G FNA needles (OR 2.12; 95% CI 1.09-4.01, p = 0.023) compared to 22 G needles. Furthermore, the use of a single EUS-FNA technique compared to the combined use of slow-pull and standard suction techniques (OR 1.70; 95% CI 1.06-2.70, p = 0.027) and less than three punctures per procedure led to an elevation in the risk of inconclusive cytology (OR 2.49; 95% CI 1.49-4.14, p < 0.001). Risk reduction in inconclusive cytology findings was observed in lesions between 2-4 cm (OR 0.40; 95% CI 0.23-0.68, p = 0.001) and >4 cm (OR 0.16; 95% CI 0.08-0.31, p < 0.001) compared to lesions ≤2 cm. CONCLUSIONS: The more than two punctures per EUS-FNA sampling with larger-diameter needle (19 G or 22 G) using the slow-pull and standard suction techniques in combination may decrease the probability of inconclusive cytological findings.

Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study.

BACKGROUND AND AIMS: Tofacitinib (TFB) appears to be effective in the treatment of ulcerative colitis (UC); however, available real-world studies are limited by cohort size. TFB could be an option in the treatment of acute severe ulcerative colitis (ASUC). We aimed to investigate efficacy and safety of TFB in moderate-to-severe colitis and ASUC. METHODS: This retrospective, international cohort study enrolling UC patients with ≥6-week follow-up period was conducted from February 1 to July 31, 2022. Indications were categorized as ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Steroid-free remission (SFR), colectomy, and safety data were analyzed. RESULTS: A total of 391 UC patients (median age 38 [interquartile range, 28-47] years; follow-up period 26 [interquartile range, 14-52] weeks) were included. A total of 27.1% received TFB in ASUC. SFR rates were 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. The baseline partial Mayo score (odds ratio [OR], 0.850; P = .006) was negatively associated with week 12 SFR, while biologic-naïve patients (OR, 2.078; P = .04) more likely achieved week 52 SFR. The colectomy rate at week 52 was higher in ASUC group (17.6% vs 5.7%; P < .001) and decreased with age (OR, 0.94; P = .013). A total of 67 adverse events were reported, and 17.9% resulted in cessation of TFB. One case of thromboembolic event was reported. CONCLUSIONS: TFB is effective in both studied indications. TFB treatment resulted in high rates of SFR in the short and long terms. Higher baseline disease activity and previous biological therapies decreased efficacy. No new adverse event signals were found.

[Endoscopic ultrasound in the lower gastrointestinal tract]. / Az alsó tápcsatornai endoszkópos ultrahangvizsgálat.

Endoscopic ultrasound is a minimally invasive modality that combines endoscopy with ultrasound, providing a possibility to visualize the wall of the gastrointestinal tract and adjacent tissues and organs. Since the development of the modality in the 1980s, advancements in endoscopic ultrasound technology have led to increasingly broadening indications: besides diagnostic indications, therapeutic indications have also expanded greatly. According to recent guidelines regarding rectal cancer staging, rectal ultrasonography is mainly considered to be a secondary imaging modality compared to magnetic resonance imaging. With the use of forward-viewing echoendoscopes and ultrasound miniprobes that can be inserted through the working channel of the endoscope, endoscopic ultrasound technology can be expanded to proximal, colonic areas as well. Rectal ultrasonography can also play an important role in the differential diagnosis of subepithelial lesions, in the detection of rectal varices, in the diagnosis of inflammatory bowel diseases as well as perianal complications. Diagnostic accuracy can further be improved with the addition of ultrasound-guided sampling in certain cases. Currently, therapeutic indications are more like promising possibilities, than part of everyday clinical practice, but this might change in the near future. The purpose of this review is to summarize the current indications of rectal ultrasound in the clinical practice, including diagnostic and therapeutic ones as well. Orv Hetil. 2023; 164(30): 1176-1186.

Nationwide experiences with trough levels, durability, and disease activity among inflammatory bowel disease patients following COVID-19 vaccination.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has complicated the management of inflammatory bowel diseases (IBD). Objectives: This study aimed to assess the efficacy of different anti-SARS-CoV-2 vaccines under different treatments in IBD patients and identify predictive factors associated with lower serological response, including anti-tumor necrosis factor (anti-TNF) drug levels. Design: A prospective, double-center study of IBD patients was conducted following messenger ribonucleotide acid (mRNA) and non-mRNA anti-SARS-CoV-2 vaccination. Methods: Healthy control (HC) patients were enrolled to reduce bias. Baseline and control samples were obtained 14 days after the second dose to assess the impact of conventional and biological treatments. Clinical and biochemical activity, serological response level, and anti-TNF drug levels were measured. Results: This study included 199 IBD (mean age, 40.9 ± 12.72 years) and 77 HC participants (mean age, 50.3 ± 12.36 years). Most patients (76.9%) and all HCs received mRNA vaccines. Half of the IBD patients were on biological treatment (anti-TNF 68.7%). Biological and thiopurine combined immunomodulation and biological treatment were associated with lower serological response (p < 0.001), and mRNA vaccination promoted better antibody levels (p < 0.001). Higher adalimumab levels caused lower serological response (p = 0.006). W8 persistence of anti-SARS-CoV-2 level was equal in IBD and HC groups. Vaccination did not aggravate clinical disease activity (p = 0.65). Conclusion: Anti-SARS-CoV-2 vaccination is considerably efficacious in IBD patients, with mRNA vaccines promoting better antibody levels. The negative impact of combined biological treatment, especially with high adalimumab drug levels, on serological response to vaccination should be considered. Although midterm durability of vaccination is encouraging, more data are needed to expand the existing understanding on this issue.

Adjustment of COVID-19 vaccination to adalimumab trough level is considerable due to the reduced serological response. mRNA vaccination should be preferred in case of IBD patients with an equal durability of anti-SARS-CoV-2 level of subjects and healthy control participants.

Effects of bowel cleansing on the composition of the gut microbiota in inflammatory bowel disease patients and healthy controls.

Background: In patients with inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC), numerous cases of exacerbations could be observed after colonoscopy, raising the possible pathogenetic effect of colonic microbiota alterations in IBD flare. Objectives: We aimed to investigate the changes in the fecal microbiota composition in IBD patients influenced by the bowel preparation with sodium picosulfate. Design: We enrolled patients with IBD undergoing bowel preparation for colonoscopy in the prospective cohort study. The control group (Con) comprised non-IBD patients who underwent colonoscopy. Clinical data, blood, and stool samples were collected before colonoscopy (timepoint A), 3 days later (timepoint B), and 4 weeks later (timepoint C). Methods: Disease activity and gut microbiota changes were assessed at each timepoint. Fecal microbiota structure - at family level - was determined by sequencing the V4 region of the 16S rRNA gene. Statistical analysis included differential abundance analysis and Mann-Whitney tests. Results: Forty-one patients (9 CD, 13 UC, and 19 Con) were included. After bowel preparation, alpha diversity was lower in the CD group than in the UC (p = 0.01) and Con (p = 0.02) groups at timepoint B. Alpha diversity was significantly higher in the UC group than in the CD and Con (p = 0.03) groups at timepoint C. Beta diversity difference differed between the IBD and Con (p = 0.001) groups. Based on the differential abundance analysis, the Clostridiales family was increased, whereas the Bifidobacteriaceae family was decreased in CD patients compared to the Con at timepoint B. Conclusions: Bowel preparation may change the fecal microbial composition in IBD patients, which may have a potential role in disease exacerbation after bowel cleansing.

Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey.

BACKGROUND: Few data are available on subjective disease control and perception of adverse events (AEs) during switching from original anti-TNF agents to biosimilars. RESEARCH DESIGN AND METHODS: Hungarian patients with inflammatory bowel disease were interviewed after a mandatory non-medical switch from an infliximab (IFX) originator to a biosimilar GP1111 or from an adalimumab (ADA) originator to a biosimilar GP2017. Drug choice was based on patient's and physician's decision. Subjective efficacy was measured using a 10-point scale, and AEs were assessed. Difference in efficacy before and after the switch was compared within and between the drugs. RESULTS: Seventy-three ADA and 106 IFX switching patients were interviewed. Subjective efficacy of IFX biosimilar was rated lower compared to IFX originator (8.72 ± 1.68 vs. 7.77 ± 2.34; p = 0.001). The ADA biosimilar was rated higher than its originator (9.02 ± 1.61 vs. 8.42 ± 1.93; p = 0.017). Patients receiving ADA biosimilar were more satisfied with the new treatment compared to IFX (p = 0.032). The incidence of new AEs was 85% in the ADA and 55% in the IFX group (1.79 vs. 0.93 AEs per patient, respectively, p < 0.001). CONCLUSION: Subjective efficacy of switching to a biosimilar was proven in case of ADA, while reduced efficacy was experienced with IFX biosimilar. Perception of AEs was high and varied between biosimilars.

Comparison of therapeutic efficacy and treatment costs of self-expandable metal stents and plastic stents for management of malignant biliary obstruction.

BACKGROUND: According to the European Society of Gastrointestinal Endoscopy guidelines, self-expandable metal stents (SEMSs) are preferable to plastic stents (PSs) in the management of pancreatic cancer, regardless of cancer stage. The aim of this study was to compare the therapeutic efficacy and treatment costs of SEMS and PS in the management of malignant biliary obstruction. METHODS: One hundred and thirty-five patients who underwent endoscopic stent placement were retrospectively enrolled and divided into PS (41 patients), primary SEMS (39 patients) and secondary SEMS (55 patients) groups. We determined the technical and functional success rate, stent patency, and cumulative treatment cost. RESULTS: A total of 111 SEMSs and 153 PSs were placed with similar technical (100% vs. 98.69%) and functional success rate (90.10% vs. 86.27%) but with different stent patency (10.28 vs. 22.16 weeks; p < 0.001). Multiple PS implantations and larger stent diameter increased the length of stent patency compared to 7-Fr PSs (10.88 vs. 10.55 vs. 7.63 weeks, respectively). The cumulative treatment cost of patients with different survival times did not differ significantly between groups, however, among patients surviving 2-4 months it was higher in PS group than primary SEMS and secondary SEMS groups (2888€ vs. 2258€ vs. 2144€, respectively, p = 0.3369) due to increased number of biliary reintervention (2.08 ± 1.04 vs. 1.20 ± 0.42 vs. 1.50 ± 0.53; p < 0.0274) and longer hospital stay (15.77 ± 10.14 vs. 8.70 ± 7.70 vs. 8.50 ± 6.17 days, p = 0.0527). CONCLUSIONS: In view of treatment costs, the consequences of illness, and the processes of the health care system, SEMS implantation is recommended regardless of patients' life expectancy.

Possible genetical predictors of efficacy and safety of budesonide-MMX in patients with mild-to-moderate ulcerative colitis, and safety comparison with methylprednisolone.

BACKGROUND: Budesonide-MMX is a topically active corticosteroid degraded by cytochrome-P450 enzymes, resulting in favorable side-effect profile. We aimed to assess the effect of CYP genotypes on safety and efficacy, and make a direct comparison with systemic corticosteroids. RESEARCH DESIGN AND METHODS: We enrolled UC patients receiving budesonide-MMX and IBD patients on methylprednisolone in our prospective, observational-cohort study. Before and after treatment regimen clinical activity indexes, laboratory parameters (electrolytes, CRP, cholesterol, triglyceride, dehydroepiandrosterone, cortisol, beta-crosslaps, osteocalcin), and body composition measurements were assessed. CYP3A4 and CYP3A5 genotypes were determined in the budesonide-MMX group. RESULTS: 71 participants were enrolled (budesonide-MMX: 52; methylprednisolone: 19). CAI decreased (p<0.05) in both groups. Cortisol decreased (p<0.001), and the level of cholesterol was elevated in both groups (p<0.001). Body composition altered only following methylprednisolone. Bone homeostasis (osteocalcin; p<0.05) and DHEA (p<0.001) changed more prominently after methylprednisolone. Glucocorticoid-related adverse events were more common following methylprednisolone treatment (47.4% compared to 1.9%). CYP3A5(*1/*3) genotype positively influenced efficacy, but not safety. Only one patient's CYP3A4 genotype differed. CONCLUSIONS: CYP genotypes can affect the efficacy of budesonide-MMX; however, further studies would be needed with analyses of gene expression. Although budesonide-MMX is safer than methylprednisolone, due to glucocorticoid-related side effects, admission should require greater precaution.

Conception and reality: Outcome of SARS-CoV-2 infection and vaccination among Hungarian IBD patients on biologic treatments.

Introduction: Inflammatory bowel disease potentially elevates the risk of infections, independently from age, while the disease activity and medical treatment(s) can also increase the risks. Nevertheless, it is necessary to clarify these preconceptions as well during the COVID-19 pandemic. Methods: An observational, questionnaire based study was conducted in Hungary between February and August 2021. 2 questionnaires were completed. The first questionnaire surveyed the impact of the pandemic on patients with biologic treatments and assessed the severity and outcome of the infection, whereas the second one assessed vaccination rate and adverse events. Results: 472 patients participated in the study. 16.9 % of them acquired the infection and 6.3 % needed hospitalization. None of them required ICU care. Male sex elevated the risk of infection (p = 0.008), while glove (p = 0.02) and mask wearing (p = 0.005) was the most effective prevention strategy. Nevertheless, abstaining from community visits or workplace did not have an impact on the infection rate. Smoking, age, and disease type did not elevate the risk. UC patients had poorer condition during the infection (p = 0.003); furthermore, the disease activity could potentially worsen the course of infection (p = 0.072). The different biological treatments were equally safe; no difference was observed in the infection rate, course of COVID-19. Azathioprine and corticosteroids did not elevate the infection rate. 28 patients (35.0 %) suspended the ongoing biologic treatment, but it had no impact on the disease course. However, it resulted in changing the current treatment (p = 0.004). 9.8 % of the respondents were sceptic about being vaccinated, and 90 % got vaccinated. In one case, a serious flare-up occurred. Discussion: Most patients acquired the infection at workplace. Biologic therapies had no effect on the COVID-19 infection, whereas male sex, an active disease, and UC could be larger threat than treatments. Vaccination was proved to be safe, and patient education is important to achieve mass vaccination of the population.