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Background: The therapeutic goal of clinical remission in patients with moderate to severe ulcerative colitis (UC) is achieved after biological therapy only in 16–39%. Individualization of therapeutic intervention would benefit from prediction of early response. Study Objective: The primary objective of our study was to assess golimumab (GLM) trough serum level of ≥2.5 μg/mL in combination with a reduction of faecal calprotectin (FC) of ≥50% at week 6 compared to baseline to predict clinical response at week 26 after regular GLM intake. Methods: Patients with moderate to severe active UC and planned GLM treatment were recruited for a prospective, multicentre, observational study in Germany. Prediction of clinical response was assessed by FC and GLM trough level. Missing data were imputed as therapy failure according to the last observation carried forward method. Results: Fifty nine patients have been enrolled. 54% of patients were anti-TNF naïve. Clinical response at week 6 was a significant predictor for achieving clinical response at week 26 (odds ratio [OR] 10.97, confidence interval [CI], 2.96–40.68; p < 0.001). Moreover, patients with a GLM trough level of ≥2.5 μg/mL and a ≥50% reduction of FC at week 6 had an OR of 5.33 (95% CI, 0.59–47.84) to achieve clinical response at week 26. Conclusion: Clinical response at week 6 is the best predictive marker for achieving clinical response at week 26. Consideration of significant reduction of FC and trough GLM serum levels could improve prediction of response.

ZusammenfassungDie COVID-19-Pandemie beeinflusst das Leben von Patient*innen mit chronisch-entzündlichen Darmerkrankungen (CED) in erheblicher Weise. Betroffene und Angehörige haben zahlreiche Fragen zum Erkrankungsrisiko, zum Verlauf einer möglichen SARS-CoV-2-Infektion oder auch zum Einfluss der CED-spezifischen Therapie. Auch bestehen bei vielen CED-Patient*innen zusätzliche Fragen zu Sicherheit und Wirksamkeit einer Impfung gegen SARS-CoV-2. Ziel dieser Übersicht ist die Zusammenfassung der neusten Erkenntnisse zu COVID-19 und CED, aber auch die Diskussion zum Impfansprechen (humoral/zellulär), zum Einfluss laufender Therapie auf die Impfantwort sowie zur Häufigkeit von Nebenwirkungen und zur Bedeutung der Booster-Immunisierungen zu führen und für das Gespräch mit Patient*innen eine Evidenz-basierte Grundlage zu schaffen.

Purpose The clinical course of ulcerative colitis (UC) is highly heterogeneous, with 20 to 30% of patients experiencing chronic disease activity requiring immunosuppressive or biologic therapies. The aim of this study was to identify predictors for a complicated disease course in an inception cohort of patients with UC. Methods EPICOL was a prospective, observational, inception cohort (UC diagnosis, ≤ 6 months) study in 311 patients with UC who were naive to immunosuppressants (IS)/biologics. A complicated course of disease was defined as the need for IS and/or biologic treatment (here therapy with a TNF-α antagonist) and/or UC-related hospitalisation. Patients were followed up for 24 months. Results Of the 307 out of 311 participants (4 patients did not meet the inclusion criteria “confirmed diagnosis of active UC within the last 6 months” (n = 2) and “immunosuppressive-naïve” (n = 2), analysis population), 209 (68.1%) versus 98 (31.9%) had an uncomplicated versus a complicated disease course, respectively. In a multivariate regression analysis, prior use of corticosteroids and prior anaemia were associated with a significantly increased risk for a complicated disease course (2.3- and 1.9-fold increase, respectively; p p = 0.002). Based on these parameters, a risk model for patient stratification was developed. Conclusion Our study identifies anaemia and an early need for corticosteroids as predictors for a complicated course of disease in an inception cohort of patients with UC. By determining these parameters in routine clinical practice, our results may support the identification of patients who might benefit from early escalation of therapy.

Vaccination against SARS-CoV-2 is a promising strategy to protect immunocompromised IBD patients from a severe course of COVID-19. As these patients were excluded from initial clinical vaccination trials, patients frequently express concerns regarding the safety of these vaccines, especially whether vaccination might trigger IBD flares ("hit-and-run-hypothesis").In order to assess the risk of an IBD flare after vaccination against SARS-CoV-2, an anonymous survey was performed at five German IBD centers and one patient organization (Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e.V.) in August and October 2021.The questionnaire was answered by 914 patients, 781 of whom reported a previous vaccination against SARS-CoV-2 (85.4%). Vaccination against SARS-CoV-2 was not associated with an increased risk of IBD flares (p=0.319) or unscheduled visits to the IBD physician (p=0.848). Furthermore, typical symptoms of an IBD flare including abdominal pain, increases in stool frequency, or rectal bleeding were not influenced by the vaccination.Vaccination against SARS-CoV-2 is safe in IBD patients. These results may help to reduce fears regarding the vaccination in IBD patients. Our results can help to reduce fears in IBD patients regarding the SARS-CoV-2 vaccine. A close communication between patients and physicians before and after the vaccination may be beneficial.Die Impfung gegen SARS-CoV-2 kann immunkompromittierte Patienten mit einer chronisch-entzündlichen Darmerkrankung (CED) vor einem schweren Verlauf einer COVID-19-Erkrankung schützen. Da diese Patientengruppe in den Zulassungsstudien nicht eingeschlossen wurde, werden vielfach von Patienten Sorgen im Hinblick auf die Sicherheit geäußert, insbesondere bestehen Ängste vor der Auslösung eines akuten CED-Schubs.Zwischen August und Oktober 2021 wurde eine retrospektive Umfrage an 5 deutschen CED-Zentren und unter den Mitgliedern der „Deutschen Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e.V.“ durchgeführt, um das Auftreten eines Schubs nach SARS-CoV-2-Impfung zu erfassen.Der Fragebogen wurde von 914 Patienten beantwortet. Von diesen haben 781 (85,4%) berichtet, mindestens eine Impfung gegen SARS-CoV-2 erhalten zu haben. Die Vakzinierung gegen SARS-CoV-2 war nicht mit einer erhöhten Frequenz an CED-Schüben (p=0,319) oder ungeplanten Vorstellungen beim CED-Behandler (p=0,848) assoziiert. Des Weiteren war die Impfung nicht mit einer erhöhten Stuhlfrequenz, vermehrten abdominellen Schmerzen oder rektalen Blutabgängen assoziiert.Die Vakzinierung gegen SARS-CoV-2 war in unserem Kollektiv nicht mit einer nachfolgend gesteigerten Krankheitsaktivität der CED assoziiert. Unsere Resultate können helfen, Ängste von CED-Patienten vor einer Impfung gegen SARS-CoV-2 zu reduzieren.

Background Ulcerative colitis (UC) is a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms negatively affecting work productivity and health-related quality of life (HRQoL). The use of biologics in UC treatment improves work and HRQoL but prospective long-term data concerning the treatment with TNFα inhibitor golimumab in UC patients are still rare. Therefore, our study aimed to evaluate the change in work productivity, capacity for daily activities and HRQoL in UC patients treated with golimumab in Germany. Methods Using the Work Productivity and Activity Impairment questionnaire, the change in work productivity and in capacity for daily activities after 3 months and over the whole observational period of 24 months were assessed (both primary endpoints). Disease-specific and health-related quality of life (QoL) were analyzed with the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12 Health Survey Questionnaire (SF-12), and the Partial Mayo Score (secondary endpoints). Further, disease-related hospitalization rates were assessed. Results This prospective non-interventional study included 286 patients. Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. Three months after initiation of golimumab therapy, total work productivity impairment (TWPI) score and activity impairment score improved significantly from baseline with a mean change of − 17.3% (p Conclusions Golimumab leads to notable long-term improvements in work productivity, daily activity, HRQoL, and disease-related hospitalization rates in patients with moderate to severe UC. Trial registration: PEI (Paul-Ehrlich-Institute, Langen, Germany) Registration Nr: NIS#255 (https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html)

Fatigue is a common symptom in patients with inflammatory bowel diseases (IBD). To date, there is no instrument to assess IBD-specific fatigue in German. The aim of this study was to translate the IBD Fatigue (IBD-F) scale and to test its psychometric properties in a German IBD population.After completing the translation process, 20 IBD patients participated in a pilot testing phase. For further analyses, 180 IBD patients with fatigue answered the IBD-F (Sections I, II, III) and the IBD Questionnaire (IBDQ-D). Reliability was tested by using Cronbach's alpha and corrected item-total correlation. Exploratory factor analyses (EFA) were carried out. Spearman's correlation was calculated between the IBD-F and IBDQ-D . 78 patients could be included to calculate the test-retest reliability.The German version of the IBD-F shows high face and content validity. Internal consistency was excellent, with a Cronbach's alpha of 0.93-0.98. Corrected item-total correlations ranged from 0.51 to 0.89. The correlation between the IBD-F and the IBDQ-D was statistically significant for Section I (rs=-0.59; p0.01) and Section II (rs=-0.76; p0.01) of the IBD-F. The EFA identified one relevant factor for each section. Test-retest reliability was acceptable for Section I (intraclass correlation coefficient (ICC)=0.73) and Section II (ICC=0.84).The German version of the IBD-F is a reliable and valid tool to assess fatigue in IBD.Fatigue ist ein häufiges Symptom bei chronisch-entzündlichen Darmerkrankungen (CED). Derzeit existiert kein geeignetes deutschsprachiges Instrument zur Erfassung von Fatigue bei CED. Ziel ist es, den Inflammatory Bowel Disease Fatigue (IBD-F)-Fragebogen zu übersetzen und die Gütekriterien an einer deutschsprachigen Stichprobe zu validieren.Nach Übersetzung des IBD-F nahmen 20 PatientInnen an einer Probetestung teil. Für weitere Analysen beantworteten 180 CED-PatientInnen mit Fatigue den IBD-F (Teil I, II, III) und den Inflammatory Bowel Disease Questionnaire (IBDQ-D). Die Reliabilität wurde mithilfe von Cronbachs α und Trennschärfen ermittelt. Explorative Faktorenanalysen (EFA) wurden durchgeführt. Die Korrelationen von IBD-F und IBDQ-D wurden evaluiert. 78 PatientInnen wurden zur Berechnung der Test-Retest-Reliabilität eingeschlossen.Die deutsche Version des IBD-F hat eine hohe Inhalts- und Augenscheinvalidität. Die interne Konsistenz war exzellent (Cronbachs α = 0.93–0.98). Die Trennschärfekoeffizienten lagen zwischen 0.51 und 0.89. Die Korrelationen zwischen IBD-F und IBDQ-D waren statistisch signifikant für Teil I (rs=-0.59; p0.01) und Teil II (rs=-0.76; p0.01) des IBD-F. Die einfaktorielle Struktur konnte für beide Teile bestätigt werden. Die Test-Retest-Reliabilität kann für Teil I (Intraklassenkorrelationskoeffizient (ICC)=0.73) und Teil II (ICC=0.84) als akzeptabel bewertet werden.Die deutsche Version des IBD-F ist ein zuverlässiges und valides Instrument zur Erfassung von Fatigue bei CED.

Aims i] To evaluate the evolution of pregnancies and offspring after inflammatory bowel disease [IBD] surgery during pregnancy; and ii] to describe the indications, the surgical techniques, and the frequency of caesarean section concomitant with surgery. Methods Patients operated on due to IBD during pregnancy after 1998 were included. Participating clinicians were asked to review their databases to identify cases. Data on patients’ demographics, IBD characteristics, medical treatments, IBD activity, pregnancy outcomes, surgery, delivery, and foetal and maternal outcomes, were recorded. Results In all, 44 IBD patients were included, of whom 75% had Crohn’s disease; 18% of the surgeries were performed in the first trimester, 55% in the second, and 27% in the third trimester. One patient had complications during surgery, and 27% had postsurgical complications. No patient died. Of deliveries, 70% were carried out by caesarean section. There were 40 newborns alive. There were four miscarriages/stillbirths [one in the first, two in the second, and one in the third trimester]; two occurred during surgery, and another two occurred 2 weeks after surgery; 14% of the surgeries during the second trimester and 64% of those in the third trimester ended up with a simultaneous caesarean section or vaginal delivery. Of the 40 newborns, 61% were premature and 47% had low birth weight; 42% of newborns needed hospitalisation [25% in the intensive care unit]. Conclusions IBD surgery during pregnancy remains an extremely serious situation. Therefore, surgical management should be performed in a multidisciplinary team, involving gastroenterologists, colorectal surgeons, obstetricians, and neonatal specialists.

Introduction: Infliximab (IFX) therapy is efficacious for inducing and maintaining symptomatic remission in patients with Crohn’s disease (CD), but whether this benefit results in reduced hospitalization rates and therefore may improve patients’ quality of life in an economically sensible way is conflicting so far. Methods: We conducted a noninterventional, multicenter, open-label, prospective study to evaluate the effect of originator IFX treatment on patient-reported outcomes and disease-related hospitalizations in adult CD patients in Germany treated for the first time with IFX according to label. Results: Two hundred and ninety-four patients were included in the study. We observed a statistically significant reduction in the number of CD-related hospitalizations from the year before baseline (mean 1.00 per patient, SD ± 0.93) to the mean value of the 1st (0.62, SD ± 0.95) and 2nd year (0.32, SD ± 0.75) of the observation period (p < 0.0001). After 3 months of IFX therapy, work productivity and activity increased by an average of 12.6 and 17.1%, respectively. Patient’s clinical outcome was markedly improved as the total CD activity index (CDAI) sum score continuously decreased from baseline to month 24 and the mean score of the total inflammatory bowel disease questionnaire (IBDQ) changed substantially from 141 at baseline to 172 after 24 months of IFX treatment. Additionally, the number of work incapacity days declined. Recently, no new safety issues of IFX have been identified. Conclusion: In this large, prospective, multicenter study on disease-related hospitalization rates, work productivity, capacity for daily activities, and HRQoL in patients with CD, IFX significantly reduces their hospitalization rates and improves work productivity, daily activity, and quality of life over 24 months.

The COVID-19 pandemic is significantly affecting the lives of patients with inflammatory bowel disease (IBD). Those affected and their relatives have numerous questions about the risk of the disease, the course of a possible SARS-CoV-2 infection or the influence of CED-specific therapy on these. Many IBD patients also have additional questions about the safety and effectiveness of a vaccination against SARS-CoV-2. The aim of this review is to summarize the latest findings on COVID-19 and IBD, but also to discuss vaccine response (humoral/cellular), the influence of ongoing therapy on the vaccine response as well as the frequency of side effects and the importance of booster immunizations and to create an evidence-based basis for discussion with patients.Die COVID-19-Pandemie beeinflusst das Leben von Patient*innen mit chronisch-entzündlichen Darmerkrankungen (CED) in erheblicher Weise. Betroffene und Angehörige haben zahlreiche Fragen zum Erkrankungsrisiko, zum Verlauf einer möglichen SARS-CoV-2-Infektion oder auch zum Einfluss der CED-spezifischen Therapie. Auch bestehen bei vielen CED-Patient*innen zusätzliche Fragen zu Sicherheit und Wirksamkeit einer Impfung gegen SARS-CoV-2. Ziel dieser Übersicht ist die Zusammenfassung der neusten Erkenntnisse zu COVID-19 und CED, aber auch die Diskussion zum Impfansprechen (humoral/zellulär), zum Einfluss laufender Therapie auf die Impfantwort sowie zur Häufigkeit von Nebenwirkungen und zur Bedeutung der Booster-Immunisierungen zu führen und für das Gespräch mit Patient*innen eine Evidenz-basierte Grundlage zu schaffen.

Background Gastroenteropancreatic neuroendocrine neoplasms [GEP-NENs] have rarely been reported in association with inflammatory bowel diseases [IBDs]. Methods An ECCO COllaborative Network For Exceptionally Rare case reports project [ECCO-CONFER] collects cases of GEP-NENs diagnosed in patients with IBD. Results GEP-NEN was diagnosed in 100 IBD patients; 61% female, 55% Crohn’s disease, median age 48 years (interquartile range [IQR] 38-59]). The most common location was the appendix [39%] followed by the colon [22%]. Comprehensive IBD-related data were available for 50 individuals with a median follow-up of 30 months [IQR 11-70] following NEN diagnosis. Median duration of IBD at NEN diagnosis was 84 months [IQR 10-151], and in 18% of cases NEN and IBD were diagnosed concomitantly. At diagnosis, 20/50 were stage-I [T1N0M0], and 28/50 were graded G1 [ki67 ≤2%]. Incidental diagnosis of NEN and concomitantly IBD diagnosis were associated with an earlier NEN stage [p = 0.01 and p = 0.02, respectively]. Exposure to immunomodulatory or biologic therapy was not associated with advanced NEN stage or grade. Primary GEP-NEN were more frequently found in the segment affected by IBD [62% vs 38%]. At the last follow-up data, 47/50 patients were alive, and only two deaths were related to NEN. Conclusions In the largest case series to date, prognosis of patients with GEP-NEN and IBD seems favourable. Incidental NEN diagnosis correlates with an earlier NEN stage, and IBD-related therapies are probably independent of NEN stage and grade. The association of GEP-NEN location and the segment affected by IBD may suggest a possible role of inflammation in NEN tumorigenesis

Background Hereditary colorectal cancer syndromes [HCCS] are rare polyposis or nonpolyposis syndromes with a higher risk of developing colorectal cancer [CRC]. Coexisting inflammatory bowel disease [IBD], including ulcerative colitis [UC] and Crohn’s disease [CD], with HCCS is exceedingly rare and presumably increases the risk of early-onset CRC. Methods This was a multicentre case series performed as a part of the European Crohn’s and Colitis Organisation [ECCO] Collaborative Network of Exceptionally Rare case reports [CONFER] project. Results This report includes 26 patients with IBD (10 UC, 15 CD, and one with IBD unclassified [IBD-U]) and concomitant HCCS. Among these 26 patients([median age 33 years, interquartile range [IQR] 20–44], 15 [57.7%] were males, 24 [92.3%] Caucasians, and two [7.7%] of Arab origin. HCCS was diagnosed before the IBD diagnosis in 11 patients [42.3%], after diagnosis of IBD in 11 patients [42.3%], and concurrently in four patients [15.4%]. Sixteen patients had Lynch syndrome, seven had familial adenomatous polyposis [FAP], two had MYH-associated polyposis [MAP], and one had attenuated FAP [AFAP]. The most frequent genetic mutations were those of APC [n = 7] and MLH1 [n = 7]. Overall, CRC developed in 38.5% of patients [n = 10]: in four patients [40%] after IBD diagnosis, in four [40%] patients before IBD diagnosis, and in two patients the two conditions were diagnosed simultaneously. Eighteen [69.2%] patients underwent colectomy or abdominal surgery: nine patients due to CRC diagnosis, five patients preventively due to the underlying HCCS, three due to the underlying HCCS and concomitant active IBD disease, and one patient because of active IBD disease. One patient died due to CRC. Conclusions To date, this is the largest case series of patients with IBD and HCCS. The most frequent diagnosis of HCCS associated with IBD was Lynch syndrome. These data demonstrate the high malignancy rate and surgical intervention rate in this IBD cohort, despite the endoscopic surveillance. The optimal medical approach still needs to be addressed.

Background There is a small but measurable increased risk of lymphoma in inflammatory bowel disease [IBD], with a suggestion that primary intestinal lymphoma [PIL] in IBD is associated with inflamed tissue and immunosuppressant use, mainly thiopurines. Methods This multicentre case series was supported by the European Crohn’s and Colitis Organisation [ECCO] and performed as part of the Collaborative Network of Exceptionally Rare case reports [CONFER] project. Clinical data were recorded in a standardized case report form. Results Fifteen patients with intestinal lymphoma from eight centres were included (12 males, 11 patients with Crohn’s disease [CD], mean age 47.8 [±16.4 SD, range 26–76] years at lymphoma diagnosis). Lymphoma type was diffuse large B-cell lymphoma [DLBCL] in eight, Hodgkin’s disease in two, mucosa-associated lymphoid tissue [MALT] lymphoma in three, and single cases of immunoblastic lymphoma and indolent T-cell lymphoma. Lymphoma was located within the IBD-affected area in ten patients. At lymphoma diagnosis, nine patients had a history of azathioprine or anti-tumour necrosis factor [TNF] use. Lymphoma was diagnosed at a mean time of 10.4 [±7.07, 1–24] years after IBD diagnosis in 11 patients, prior to IBD in two and concurrently in two. Sustained remission over a median follow-up time of 6.5 [1.5–20] years was achieved in ten patients after treatment; five of them had started biological therapy [including anti-TNFs, vedolizumab and ustekinumab] for active CD subsequent to their PIL treatment. Conclusion In this small case series, two-thirds of patients developed lymphoma in the IBD-affected area, and almost two-thirds had a history of thiopurine or anti-TNF use. Biologics were restarted without recurrence of lymphoma in half of the remitters.

The influence of a SARS-CoV-2 infection on inflammatory bowel disease (IBD) has not yet been well characterized and it is unclear whether this requires an adaptation of the immunosuppressive therapy.A national register was established for the retrospective documentation of clinical parameters and changes in immunosuppressive therapy in SARS-CoV-2 infected IBD patients.In total, only 3 of 185 IBD patients (1.6 %) were tested for SARS-CoV-2 infection because of abdominal symptoms. In the course of COVID-19 disease, 43.5 % developed diarrhea, abdominal pain or hematochezia (risk of hospitalization with vs. without abdominal symptoms: 20.0 % vs. 10.6 %, p 0.01). With active IBD at the time of SARS-CoV-2 detection, there was an increased risk of hospitalization (remission 11.2 %, active IBD 23.3 % p 0.05). IBD-specific therapy remained unchanged in 115 patients (71.4 %); the most common change was an interruption of systemic therapy (16.2 %).New abdominal symptoms often appeared in SARS-CoV-2 infected IBD patients. However, these only rarely led to SARS-CoV-2 testing. A high IBD activity at the time of SARS-CoV-2 detection was associated with an increased risk of hospitalization.Der Einfluss einer SARS-CoV-2-Infektion auf chronisch entzündliche Darmerkrankungen (CED) ist bislang nicht gut charakterisiert, und es ist unklar, ob diese eine Anpassung der immunsuppressiven Therapie erfordert.Für die retrospektive Dokumentation klinischer Parameter und Veränderungen einer immunsuppressiven Therapie von mit SARS-CoV-2 infizierten CED-Patienten wurde ein nationales Melderegister etabliert.Insgesamt wurden nur 3 von 185 CED-Patienten (1,6 %) wegen abdomineller Symptome auf eine SARS-CoV-2-Infektion getestet. Im COVID-19-Krankheitsverlauf entwickelten 43,5 % Durchfall, abdominelle Schmerzen oder Hämatochezie (Hospitalisierungsrisiko mit vs. ohne abdominelle Symptome: 20,0 % vs. 10,6 %, p 0,01). Bei aktiver CED zum Zeitpunkt des SARS-CoV-2-Nachweises bestand ein erhöhtes Hospitalisierungsrisiko (Remission 11,2 %, aktive CED 23,3 % p 0,05). Die CED-spezifische Therapie blieb bei 115 Patienten (71,4 %) unverändert; die häufigste Änderung bestand in einer Unterbrechung der systemischen Therapie (16,2 %).Bei mit SARS-CoV-2 infizierten CED-Patienten traten häufig neue abdominelle Symptome bei Infektion auf. Diese führten aber nur selten zur SARS-CoV-2-Testung. Eine hohe CED-Aktivität zum Zeitpunkt des SARS-CoV-2-Nachweises war mit einem erhöhten Hospitalisierungsrisiko assoziiert.

Background and study aims The success of colonoscopy is mainly dependent on the effectiveness of prior bowel preparation (BP). Patients often consider BP to be the most burdensome part of colonoscopy, which might be a main barrier to the procedure. The aim of this study was to evaluate safety and effectiveness of colonic irrigation with a new colon hydrotherapy (CHT) device as an alternative to traditional oral BP. Patients and methods A prospective, non-randomized observational study was conducted to evaluate the quality of BP. A BP was considered effective if a score of 6 or better through the Boston Bowel Preparation Scale (BBPS) could be reached. Colonoscopy was performed immediately following colonic irrigation. For safety analysis, data on adverse events (AEs) were collected. Among the secondary outcomes, the BBPS assessed in each bowel segment and cecal intubation rate were analyzed. Results Twenty-eight consecutive patients (11 male [39.3%] and 17 [60.7 %] female) undergoing screening/surveillance or diagnostic colonoscopy were enrolled. Mean age was 54 ± 12.4 years (range 19–80). The evaluated mean BBPS was 7.8 ± 1.5. Twenty-five patients (89.3 %) had a BBPS score of 6 or above. Colonic irrigation was performed without any complications and no AEs were reported within 30 days. The cecal intubation rate was 100 %. Conclusions Colonic irrigation with a new CHT device is an effective and low-risk alternative to traditional oral preparation prior to colonoscopy.

Background Several patient-reported outcomes (PROs) have been established and are widely used in the assessment of patients with inflammatory bowel disease (IBD). However, it has never been investigated which PRO items are experienced by and are considered most relevant for IBD patients. Methods A review of IBD-related disease scores by a steering committee led to the identification of relevant PRO questions and assignment to 16 different PRO categories (9 symptoms and 7 impacts) that characterize patient’s disease burden. In a cross-sectional study, a digital patient survey was carried out to determine the self-reported experience by multiple response, the relevance of these PRO categories by pairwise comparison and the suitability of the respective questions and answer possibilities by yes-or-no-question. Results Sixty patients with Crohn’s disease (CD) (56.7% women; mean age 40.6 years; mean disease duration 12.4 years) and 60 patients with ulcerative colitis (UC) (51.7% women; mean age 37.3 years; mean disease duration 9.0 years) participated in the patient survey. All predefined symptoms and impacts, with the exception of nausea, were experienced by at least 50% of patients. Stool urgency and pain were rated the 2 most important symptoms in CD patients with similar ratings for relevance. Stool urgency was also the most important symptom in patients with UC, followed by stool frequency. Differences in self-reported experience between CD and UC patients were seen for the symptoms of rectal bleeding, pain, and nausea. Most important impact of symptoms in both patient groups were general wellbeing followed by social activities, while sexual activity was the least relevant impact category. Conclusions Stool urgency was the most relevant and most self-reported symptom for both CD and UC. Relevance and self-reported experience of pain and rectal bleeding differed between the 2 diseases. Therefore, the future collection of PROs should take these disease specificities into consideration.

Background and Aims The Observational Postmarketing Ulcerative colitis Study [OPUS] was conducted to obtain the first long-term [5 years] safety data assessing treatment with originator infliximab versus conventional therapies in patients with ulcerative colitis [UC] in real-world clinical practice. Methods The OPUS registry was a prospective, non-randomised, observational study that measured adverse events in nine prespecified categories of interest in UC patients whose treatment with either originator infliximab or conventional therapy [defined as initiation or dose-increase of corticosteroids and/or immunosuppressants] was determined by their treating physician. Results Data for 2239 patients were available: N = 1180 enrolled to conventional therapy [including N = 296 who switched to originator infliximab during follow-up] and N = 1059 enrolled to originator infliximab. Patients in the originator infliximab group, compared with the conventional therapy group, had more severe disease at baseline, based on partial Mayo score [PMS]: 46.0% of patients in the originator infliximab group had severe disease (PMS of 7–9 [out of 9]), compared with 30.5% in the conventional therapy group. In adjusted time-to-event analyses, enrolment into the originator infliximab group was associated with a higher risk of serious infection (hazard ratio = 1.98 [95% confidence interval: 1.34, 2.91; p Conclusions UC patients treated with infliximab had higher risk for serious infection, compared with conventional therapies. No new safety concerns were observed with originator infliximab in the OPUS registry. [ClinicalTrials.gov: NCT00705484.]

Zusammenfassung Einleitung Der Einfluss einer SARS-CoV-2-Infektion auf chronisch entzündliche Darmerkrankungen (CED) ist bislang nicht gut charakterisiert, und es ist unklar, ob diese eine Anpassung der immunsuppressiven Therapie erfordert. Methodik Für die retrospektive Dokumentation klinischer Parameter und Veränderungen einer immunsuppressiven Therapie von mit SARS-CoV-2 infizierten CED-Patienten wurde ein nationales Melderegister etabliert. Ergebnisse Insgesamt wurden nur 3 von 185 CED-Patienten (1,6 %) wegen abdomineller Symptome auf eine SARS-CoV-2-Infektion getestet. Im COVID-19-Krankheitsverlauf entwickelten 43,5 % Durchfall, abdominelle Schmerzen oder Hämatochezie (Hospitalisierungsrisiko mit vs. ohne abdominelle Symptome: 20,0 % vs. 10,6 %, p Diskussion Bei mit SARS-CoV-2 infizierten CED-Patienten traten häufig neue abdominelle Symptome bei Infektion auf. Diese führten aber nur selten zur SARS-CoV-2-Testung. Eine hohe CED-Aktivität zum Zeitpunkt des SARS-CoV-2-Nachweises war mit einem erhöhten Hospitalisierungsrisiko assoziiert.

OBJECTIVE: Knowledge about SARS-CoV2 and coronavirus disease 2019 (COVID-19) is growing fast. Massive changes in the health care system imposed by the COVID-19 pandemic clearly impact the overall quality of medical care. In this survey, we aim to explore experiences and concerns of patients with inflammatory bowel disease (IBD) regarding the current pandemic. METHODS: A 40-item web-based questionnaire on disease-related experiences and concerns during the COVID-19 pandemic was made available to patients with IBD from 28 April 2020 to 31 July 2020. RESULTS: An increased risk of SARS-CoV2 infection was a concern for 56.7% of the 1199 patients (aged 41.3±12.8, women 77%, Crohn's disease 58.8%, ulcerative colitis 38.5%); 61.7% feared an increased risk of severe disease course of COVID-19. Effective preventive measures in either outpatient practices or hospitals were observed by 84.7% of the patients. Appointments with an IBD specialist were canceled in 38.7%, frequently on the patients' initiative. Telecommunication visits were considered an acceptable alternative to personal visits by 71.0%. Medication was reduced or paused in 6.9% because of the pandemic. A swab (SARS-CoV2-PCR) was done in 13.2% of the patients; only 3 patients (0.25%) were tested positive. CONCLUSION: The COVID-19 pandemic is a major concern of patients with IBD. However, the cumulative prevalence in our cohort is low. Patients at risk should be identified and counseled individually. When required because of the local COVID-19 situation, telecommunication visits and liberal prescription policies are advisable to reduce in-person contacts, while ensuring continuous therapy and maintaining communication with patients.

Introduction: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is a challenging operation. Especially the mobilization of the pouch into the pelvis can be complex. Adequate perfusion of the pouch is required for optimal healing and functioning. Methods: With hyperspectral imaging (HSI) wavelengths between 500 and 1,000 nm can be analyzed in addition to visible light and by reflecting patterns. This intraoperative procedure is non-invasive, contact-free, and no contrast medium is needed. Fifteen patients undergoing IPAA were examined prospectively, and the pouch was evaluated by HSI intraoperatively. HSI was measured in standardized fashion at 4 defined locations of the J-pouch. Each measurement took about 10 s. The clinical postoperative course was assessed in all patients and correlated to the intraoperative HSI findings. Results: Mean near-infrared perfusion and oxygenation of patients showed values ≥74% for all defined pouch areas, revealing good blood supply. Three minor anastomotic leaks were detected by standard pouchoscopy in the postoperative course, which could be treated conservatively with endosponge therapy. Conclusion: HSI values of perfusion and oxygenation of the IPAA were high. The leak rate is associated with redo procedures. This is reflected by the current literature and most likely related to the higher complexity of the revisional pouch operation. HSI has proved itself as a quick and effective new intraoperative tool to evaluate pouch perfusion objectively and quantitatively.

Background This analysis of the Observational Postmarketing Ulcerative Colitis Study examined incidence rates of colectomy in patients with ulcerative colitis who received originator infliximab (IFX) or conventional therapies (ConvRx) as per their treating physician. Methods Cox proportional hazards models compared time to colectomy for both treatment groups. A secondary analysis examined colectomy incidence rates based on IFX exposure timing (defined by a 90-day window after the last IFX dose date). Results Of 2239 patients with data, 1059 enrolled in IFX and 1180 enrolled in ConvRx (including 296 patients who switched to IFX). Patients in the IFX group had more severe disease at baseline vs the ConvRx group (percentage with baseline partial Mayo score 7-9: 46.0% vs 30.5%, respectively). During 5 years of follow-up, 271 patients (12.1% of enrolled patients) had colectomy. Enrollment in the IFX group was associated with a higher risk of colectomy (hazard ratio = 3.12; 95% confidence interval, 2.25-4.34; P Conclusions Colectomy was reported at a higher rate in the IFX group than in the ConvRx group, although patients in the IFX group had more severe disease at baseline and most of the colectomies occurred after patients had been off of IFX for ≥90 days.

Background The coronavirus disease 2019 [COVID-19] pandemic is affecting lives worldwide. The influence of inflammatory bowel disease [IBD] medication and IBD itself on COVID-19 is controversial. Additionally, IBD-focused guidance is scarce. Objective Our aims were to determine COVID-19 prevalence/exposure, perception and information sources, medication compliance, patient behaviour and physician contact among patients with IBD compared with non-IBD controls. Methods A cross-sectional anonymous survey of patients with IBD [N = 415] at one university IBD clinic and one gastroenterology practice, matched 4:1 with control participants [N = 116], was performed. Results Patients with IBD had a high fear of infection. This was more pronounced in patients taking immunosuppressants and it extended to hospitals, private practices and public places, such as supermarkets. IBD patients reported leaving their homes less frequently than their peers without IBD. A total of 90% of patients with IBD reported washing their hands more frequently. Patients taking immunosuppressants were concerned about interactions between medication and COVID-19, whereas patients taking 5-aminosalicylates were not. Nonetheless, 96.4% of patients adhered to continuing their medication. Patients sought guidance primarily from television and internet news sites. Video consultations were found to be a suitable solution for a subset of patients who are young, have a high level of fear and leave their home less frequently than their peers, whereas overall acceptance of video consultations was limited. Conclusion Patients with IBD are significantly more affected by the COVID-19 pandemic than their non-IBD peers, but they continue to adhere to their medication regimens. IBD-focused COVID-19 information should be actively conveyed.

Background: Physicians can improve their relationships with patients by understanding and meeting patients’ treatment targets, leading to higher adherence to therapy and improved disease prognosis. In the current study, we performed a questionnaire-based survey to further understand treatment targets in patients with inflammatory bowel disease (IBD). Methods: We created a questionnaire based on a point-allocation scale with 10 treatment target items. A total of 234 patients with IBD [Crohn’s disease ( n = 129) and ulcerative colitis ( n = 105)] participated in three German IBD centers. Patients were asked to allocate a total of 10 points across the 10 items, with more points indicating more importance. Results: The most important treatment targets for patients regarding their therapy were quality of life (2.78 points), control of defecation (1.53 points), and avoidance of IBD-related surgery (1.69 points). Avoiding surgery for IBD was less important in patients who had already undergone a surgical procedure than in those who had not (1.26 points versus 1.89 points, p Conclusion: Treatment targets for patients were primarily related to quality of life, such as therapy side effects. Knowing these targets may improve patient–physician relationships and communication, and consequently, adherence to therapy.

BACKGROUND The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease, ulcerative colitis (UC), with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole. In Germany, there are no prospective data > 3 mo that assess the work productivity, daily activities and quality of life (QoL) of patients with moderate-to-severe UC treated with golimumab. AIM To assess change in work productivity, capacity for daily activities and QoL in UC patients treated with golimumab in Germany. METHODS The validated Work Productivity Activity Impairment (WPAI) Questionnaire was used to analyze the change in work productivity, the capacity for daily activities after three months (primary endpoint) and disease specific and health related QoL (HRQoL) up to 1 year (secondary endpoints). The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline. Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire (SF-12). RESULTS This prospective non-interventional study included 287 patients. The analysis population was comprised of 282 patients who had completed at least two visits. At baseline, 61% of patients had moderate UC and 18% had severe UC. Furthermore, 75% of patients worked full-time or part-time at baseline. A total of 212 patients who were employed at the start of the study (employed population) were evaluated for the primary endpoint. Golimumab significantly reduced all WPAI sub-scores compared to baseline after three, six, nine and twelve months after the start of treatment (P < 0.0001). In addition, disease-specific QoL and HRQoL, as measured by the SF-12 questionnaire, improved significantly with golimumab at all evaluation times (P < 0.0001 in each case vs baseline). CONCLUSION Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity, daily activity and QoL over twelve months.

The hygiene hypothesis suggests that a reduction in microbial exposure contributes to an impaired immune response later in life and increases the incidence of immune-mediated diseases such as inflammatory bowel diseases (IBD). Thumb sucking and nail biting are two early habits that modulate the oral microbiota composition and antigen load. We hypothesized a lower risk of Crohn’s disease (CD) and ulcerative colitis (UC) in adults with prior thumb sucking and nail biting. 918 IBD cases and their 918 siblings without IBD were asked to fill out a survey containing 32 questions on environmental factors in childhood and early adulthood. Prevalence of thumb sucking and/or nail biting at the usually well-remembered time of (1) school enrollment and (2) coming-of-age ceremonies was the predefined combined risk factor of this study. 65% of the patients were female and 57% suffered from CD. About 49% of IBD patients but only 44% of their siblings reported thumb sucking/nail biting at the time of school enrollment or coming-of-age (p = .007). Sensitivity analysis revealed that this difference was observed in patients with CD (50% versus 41%; RR= 1.22; 95% CI 1.09–1.37, p = .001) but not in patients with UC (49% versus 48%; RR= 1.02; 95% CI 0.90–1.17; p = .83). Contrary to our expectation and challenging the hygiene hypothesis, we found that common oral habits are not protective against IBD. Instead, nail biting at the time of school enrollment and coming-of-age was a statistically significant risk factor for CD in our cohort. Key summary Evidence available before this study: The hygiene hypothesis suggests that a reduction in microbial exposure due to improved health activities has contributed to an immunological imbalance in the intestine and an increased incidence of allergic and autoimmune diseases. A population-based birth cohort study has demonstrated that thumb-sucking and nail biting in children lead to a reduction of the risk of atopic sensitization, asthma, and hay fever. Added value of this study: Contrary to the hypothesis, thumb sucking and nail biting were not associated with a reduced risk of IBD. Instead, thumb sucking and/or nail biting at the usually well-remembered points in time of school enrollment and of religious or secular coming-of-age ceremonies was associated with a higher risk of Crohn’s disease but not of ulcerative colitis. Our data did not support the hygiene hypothesis, one pathogenic concept in the context of IBD.

Patienten mit chronisch-entzundlichen Darmerkrankungen (CED) sind infolge ihrer Grundkrankheit, aber auch durch die haufig notwendige immunsuppressive Therapie gefahrdet, an einer impfpraventablen Infektionskrankheit zu erkranken. Mehrere Erhebungen des Impfstatus von CED-Patienten mit CED ergaben jedoch erhebliche Abweichungen von den offiziellen Empfehlungen. Zudem erlaubt die fruhzeitig initiierte individualisiert eingesetzte immunmodulierende Therapie ein haufig beschwerdearmes bis – freies Leben und viele Patenten mochten reisen. Dieses Kapitel soll auf die aktuellen Impfempfehlungen eingehen und zu einer erhohten Wachsamkeit fur Impflucken von immunsuppressiv behandelten Patienten anregen.

Cytomegalovirus (CMV) infection has been found to be associated with a reactivation of ulcerative colitis (UC) and with an impaired response to medical therapy. In the past, only limited data were available on the long-term outcome for UC patients with positive tissue CMV-PCR in the colonic mucosa. Between January 2010 and April 2015, we performed a qualitative PCR screening for CMV DNA in one biopsy from most actively inflamed rectal mucosa (tCMV-PCR). All tCMV-PCR-positive patients received 900 mg of valganciclovir b.i.d. for at least 15 days. We analyzed the association of the tCMV-PCR status with the time to steroid-free remission (SFR) and with the risk of proctocolectomy during the further course. One hundred eight consecutive patients (50 women, 58 men, median age 41 years, median UC duration 6 years) with active UC not responding to anti-inflammatory medication were analyzed. Eight of the 24 tCMV-PCR-positive patients (33.3%) compared to ten of the 84 tCMV-PCR-negative patients (11.9%) underwent proctocolectomy during a median follow-up of 52 months (p

ZusammenfassungPatienten mit chronisch-entzündlichen Darmerkrankungen (CED) haben ein deutlich erhöhtes Risiko für Clostridioides [Clostridium] difficile Infektionen (CDI). Eine CDI kann ihrerseits die Aktivität der luminalen Entzündung erhöhen. Daher ist eine rasche Diagnostik und Therapie erforderlich. Viele Diagnose- und Behandlungsstudien zu Patienten mit CDI ohne entzündliche Darmerkrankung lassen sich nicht deckungsgleich auf CED-Patienten übertragen. Diese Übersicht fasst deshalb die alltagsrelevanten Daten der letzten Jahre zusammen und kondensiert diese in vier Leitsätzen. 1) Eine CDI verschlechtert nicht nur kurzfristig die Krankheitsaktivität, sondern bedingt langfristig eine erhöhte Morbidität (z. B. Kolektomiegefahr) und Mortalität. 2) Bei Verdacht auf eine CDI sollte rasch ein Glutamat-Dehydrogenase (GDH)-Nachweis geführt werden. Ist dieser positiv und ist die Krankheitsaktivität hoch, ist eine Therapie gegen C. diff. einzuleiten und diese ggf. bei negativen Bestätigungstests zu beenden. 3) CED-Patienten mit einer nachgewiesenen CDI sollten primär mit Vancomycin behandelt werden. 4) Bei einer rezidivierenden CDI bei Patienten mit CED ist der fäkale Mikrobiomtransfer eine effektive Therapiemaßnahme. Allerdings muss in ca. 15 % der Fälle mit einer Aktivierung der CED gerechnet werden. Ein konsequentes Beachten dieser Leitsätze kann im Umgang mit einer CDI bei CED-Patienten helfen.

Significant increases in Crohn’s disease incidence have been noticed in recent decades. Therefore it gets more important to increase practical knowledge, present therapy innovations and draw attention to the need for vaccinations of immunosuppressed IBD patients as well as useful supportive therapy options.