Elisabeth Schnoy

10.1055/a-2596-8934 In the above-mentioned article in Table 1 a bullet point in the rectum column for Salofalk Granu-Stix was included and “pH-dependent plus additional enzymatic activation (non-pH-dependent)” in the pH release profile column for Asacol 1600 mg modified-release tablets was added ([Table 1]). Additionally in reference number 79 the link to the "Fachinformation (SmPC) Claversal 500 mg magensaftresistente Tabletten” was changed. The correct link in this case is as follows: https://www.fachinfo.de/fi/detail/021892/claversal-r-500-mg-tabletten?query=claversal%20500. This was corrected in the online version on March 13th, 2026. Article published online: 13 March 2026 © 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/). Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Mesalazine is the first-line treatment for mild-to-moderate ulcerative colitis (UC) of any extent, as recommended by all major international and national guidelines. Approximately 85% of UC cases are classified as mild-to-moderate, making mesalazine a cornerstone therapy for the majority of patients. It rapidly induces clinical response and clinical remission, sustains steroid-free clinical, endoscopic, and histologic remission over the long term, and has a safety profile comparable to placebo. This paper reviews the recommendations for mesalazine use in the German UC guideline and provides practical advice (including do’s and don’ts) for their implementation in daily clinical practice. Examples include explaining the expected timeline and nature of the clinical response to mesalazine treatment; outlining the practical implications of the dose-dependency of the drug’s therapeutic effect; and emphasizing the importance of rectal mesalazine as the first-line treatment for proctitis. Additionally, we conducted a systematic literature search to evaluate whether mesalazine should be continued after escalation to biologics or small molecules. While no clear evidence of short-term clinical benefit was found, there was also no evidence of harm. In light of the potential long-term chemoprotective effect of mesalazine, continuation may be considered on a case-by-case basis. Lastly, we provide an overview of the various mesalazine formulations available in Germany, detailing how they are not interchangeable due to differences in drug-release profiles, excipients, and dosing strengths. Understanding these differences may help clinicians personalize treatment, improving adherence and clinical outcomes.

Background/Objectives: Patients with inflammatory bowel disease (IBD) are at an increased risk of various cancers; such as colorectal cancer; skin cancer; bile duct cancer; or lymphoma; with IBD itself not being the sole cause. Inappropriate or ineffective IBD therapy with a continuous inflammatory burden within the gut leads to an increased risk of malignancy. Our study aimed to investigate the risk of malignancy in our patient cohort; focusing on concomitant therapy; disease duration; and inflammatory burden. Methods: A total of 333 consecutive adult patients with IBD (Crohn’s disease; ulcerative colitis; and IBD unclassified) were included in this study. Data from patients were collected retrospectively using patient charts. The patients were treated in the gastroenterological outpatient clinic of the University Hospital of Augsburg; Germany; between 1 January 2014 and 31 December 2018. Results: The study group included 333 patients; 32 (9.61%) of whom suffered from malignancy (any form). Men (n = 21; 65.62%) tended to develop malignancy more often than women (n = 11; 34.38%, p = 0.051). It was also observed that the probability of developing cancer was 2.40 times higher in male patients than in female patients in our cohort. However, this trend was non-significant (HR = 2.412; p = 0.075). Furthermore; the probability of developing cancer increased with the increasing age at the time of the first diagnosis of IBD (HR = 1.088; p < 0.025). A total of 20 patients (6.00%) received their cancer diagnosis after being diagnosed with IBD. The majority of those patients had skin (n = 6; 30.00%) or colon cancer (n = 5; 25.00%). Other diseases such as CML; NHL; HL; HCC; liver sarcoma; prostate cancer; breast cancer; seminoma; thyroid cancer (a second cancer in one of the patients); or CUP syndrome/lung cancer were diagnosed in single patients. Patients with IBD and colon cancer (n = 5; 25.00%) shared some of the known risk factors for tumour development; such as a long-lasting IBD (n = 5; 100.00%), diagnosis at a young age (under 30; n = 3; 60.00%), and the coexistence of PSC (n = 1; 20.00%). The cancer prevalence rate was relatively low in our cohort despite the use of diverse biologics and immunosuppressive drugs. Faecal calprotectin was confirmed as a relevant tool for inflammation monitoring in this cohort. Conclusions: In our study cohort; we could show a low prevalence rate of malignancy in IBD. There were more malignancies in men and in patients who were diagnosed with IBD at later ages. It can be observed that the prevalence rate of cancer was relatively low despite the use of diverse biologics and immunosuppressive drugs; which is the major conclusion of this study. Additionally; the known correlation between elevated levels of faecal calprotectin and gut inflammation was confirmed through our statistical analysis. The use of calprotectin as a non-invasive screening tool for gut inflammation is advised.

Background: Patients with inflammatory bowel disease (IBD) often suffer from extra-intestinal manifestations in addition to intestinal symptoms. One of these is fatigue. Fatigue is described as persistent tiredness with episodes of sudden energy loss, which cannot be relieved by rest or sleep and has a huge impact on quality of life. The aim of this study is to identify possible risk and influencing factors for the development of fatigue in IBD. Methods: For this purpose, a questionnaire survey was conducted at two German university outpatient clinics for IBD (n = 164). Based on this, the frequency and impact of fatigue on daily life was assessed and analyzed in relation to various health parameters such as patient gender, age, disease activity, and laboratory parameters. Results: Of the 164 patients, 86 were men (52.4%) and 78 were women (47.6%). A total of 75 (45.7%) patients had ulcerative colitis, 84 (51.2%) suffered from Crohn’s disease, and 5 (3.0%) had IBD-unclassified. A total of 17 out of the 164 (10.4%) patients denied that fatigue had affected their daily activities in the past two weeks. None of the examined health parameters had a significant impact on fatigue. Conclusions: Fatigue is a common syndrome in IBD patients and affects their daily activities and quality of life. The results of the present study emphasize the need for further research for a better scientific understanding of fatigue in IBD.

Inzwischen steht eine Vielzahl an Medikamenten zur Behandlung eines Morbus Crohn zur Verfügung, deren Therapieziele von klinischer Symptomkontrolle bis hin zu mukosaler Heilung reichen. Die Chancen steigen, dass Morbus-Crohn-Patienten in Remission bleiben. Allerdings sind die Medikamente nicht bei allen Patient*innen langfristig wirksam. Oft treten Sättigungseffekte ein, die die Therapie unwirksam machen. Der folgende Beitrag gibt einen Überblick über die neuesten und die zeitnah zu erwartenden Therapieoptionen bei Morbus Crohn. Crohn’s disease is a chronic inflammatory bowel disease (IBD) that can manifest throughout the entire gastrointestinal tract from mouth to anus. It is characterized by so-called “skip lesions”, which are affected sections of the intestine interspersed with healthy sections. In recent years, there have been significant progress and an expansion of medical treatment options for Crohn’s disease with the approval of many new substances. Treatment goals have also become more ambitious, going beyond clinical symptom control to mucosal healing and, according to the STRIDE II criteria, to transmural healing in Crohn’s disease in the future. If these goals are achieved, patients with Crohn’s disease have a good chance of remaining in long-term remission and can expect fewer complications such as disease progression, hospitalization, anemia, fistulas, strictures, or surgeries. Despite having access to a variety of different substance classes in the treatment of Crohn’s disease, in everyday practice we can see that these medications are not effective for some patients in the long-term. There is a so-called “therapeutic ceiling” in IBD, meaning that only about 40–50% of those affected are successfully managed long-term with one substance. Therefore, new medical treatment options for Crohn’s disease always represent an opportunity to treat patients even better. Article published online: 31 March 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Background: Inflammatory bowel disease (IBD) frequently manifests at a young age, during the peak fertility years. Understanding the risks of negative pregnancy outcomes associated with IBD is crucial for effective pregnancy management and support. Additionally, it is essential to provide patients with the necessary knowledge to make informed choices and foster their confidence in navigating pregnancy while maintaining effective disease management. Although IBD frequently appears during the peak fertility years, knowledge about managing pregnancy in the context of IBD remains limited and often inaccurate among both physicians and patients. Our study aims to assess the complications occurring during pregnancy in patients with IBD, considering the level of disease activity, and to evaluate the standard of care provided to patients with chronic inflammatory conditions through a cohort analysis. Methods: Patients with IBD who had children were included in this single-center mixed-method (retrospective and prospective) study. Clinical data, disease progression, course of pregnancy, and complications were examined in women. Outcomes for children of men with IBD were also analyzed. To supplement the data, a survey addressing various pregnancy-related topics, including all patients from the university outpatient clinic for IBD, was conducted over a period of six months. Results: A total of 410 patients were screened retrospectively between 2010 and 2021. In total, 134 patients who had children were included in the study: 51.4% (n = 69) had Crohn’s disease, 44% (n = 59) had ulcerative colitis, and 4.6% (n = 6) had unclassified inflammatory bowel disease. Of the women, 85% (n = 34) were in remission for at least three months before pregnancy, 14.6% (n = 6) experienced an acute flare-up during pregnancy, and 10.3% (n = 4) and 7.7% (n = 3) had active disease at the time of delivery and during breastfeeding, respectively. Patients with IBD who were in remission before pregnancy did not experience a higher risk of pregnancy complications (no cases of pre-eclampsia or placental abruption were reported in this group). However, the rates of gestational diabetes and fever during pregnancy were 10% for those in remission, compared to 25% for those with active disease. Conclusions: Patients with IBD in remission did not present an increased risk of pregnancy complications. However, our survey indicates that those with active disease at conception were more likely to experience complications such as gestational diabetes and fever. These findings underscore the importance of adequate patient education regarding the safety of various IBD medications during pregnancy in order to avoid pregnancy-related complications.

Background: Many patients with moderately to severely active Crohn’s disease do not respond to available therapies or lose response over time. The GALAXI-1 study previously found that three intravenous guselkumab dosages showed superior clinical and endoscopic outcomes over placebo at week 12 in patients with moderately to severely active Crohn’s disease. We report the safety and efficacy of subcutaneous guselkumab maintenance regimens to week 48 in the GALAXI-1 study. Methods: We did a phase 2, randomised, multicentre, double-blind trial. Adult patients with moderately to severely active Crohn’s disease were randomly allocated with a computer-generated randomisation schedule to receive one of five treatment groups, with regimens consisting of an intravenous induction phase transitioning to a subcutaneous maintenance phase starting at week 12 in a treat-through design: (1) guselkumab 200→100 mg group (200 mg intravenous at weeks 0, 4, and 8, then 100 mg subcutaneous every 8 weeks; (2) guselkumab 600→200 mg group (600 mg intravenous at weeks 0, 4, and 8, then 200 mg subcutaneous every 4 weeks); (3) guselkumab 1200→200 mg group (1200 mg intravenous at weeks 0, 4, and 8, then 200 mg subcutaneous every 4 weeks); (4) ustekinumab group (approximately 6 mg/kg intravenous at week 0, then 90 mg subcutaneous every 8 weeks); or (5) placebo group (placebo induction followed by either placebo maintenance [for those with CDAI clinical response at week 12] or crossover to ustekinumab [for those without CDAI clinical response at week 12]). Endpoints assessed at week 48 included CDAI remission (CDAI score <150), endoscopic response (≥50% improvement from baseline in SES-CD or SES-CD score ≤2), and endoscopic remission (SES-CD score ≤2) in the primary efficacy analysis population of all randomised patients who received at least one dose of study drug, excluding those discontinued during a temporary study pause. Safety analyses included all randomised patients who received at least one study drug dose. This trial is registered at Clinical Trials.gov (NCT03466411) and is active but not recruiting. Findings: Among 700 patients screened, 309 (112 biologic-naive; 197 biologic-experienced) were included in the primary efficacy analysis population: 61 in the guselkumab 200→100 mg group, 63 in the guselkumab 600→200 mg group, 61 in the guselkumab 1200→200 mg group, 63 in the ustekinumab group, and 61 in the placebo group. 126 (41%) women and 183 (59%) men were included, with median age 36·0 years (IQR 28·0-49·0). At week 48, the numbers of patients with CDAI clinical remission were 39 (64%) in the guselkumab 200→100 mg group, 46 (73%) in the guselkumab 600→200 mg group, 35 (57%) in the guselkumab 1200→200 mg group, and 37 (59%) in the ustekinumab group. The corresponding numbers of patients with endoscopic response were 27 (44%), 29 (46%), 27 (44%), and 19 (30%), respectively, and endoscopic remission was seen in 11 (18%), 11 (17%), 20 (33%), and four (6%) patients, respectively. In the placebo group, 15 patients were in CDAI clinical response at week 12 and continued placebo; of these, nine (60%) were in clinical remission at week 48. 44 patients in the placebo group were not in CDAI clinical response at week 12 and crossed over to ustekinumab; of these, 26 (59%) were in clinical remission at week 48. Up to week 48, adverse events frequencies in the safety population (n=360) were 46 (66%) of 70 patients (464·9 events per 100 patient-years of follow-up) in the placebo group, 163 (74%) of 220 patients (353·1 per 100 patient-years) in the three guselkumab groups combined, and 60 (85%) of 71 patients (350·7 per 100 patient-years) in the ustekinumab group. Among patients treated with guselkumab or ustekinumab, the most frequently reported infections up to week 48 were nasopharyngitis (25 [11%] of 220 guselkumab recipients, 12 [11%] of 114 ustekinumab recipients) and upper respiratory infections (13 [6%] guselkumab recipients, eight [7%] ustekinumab recipients). After week 12, one patient who responded to placebo induction and two guselkumab-treated patients had serious infections. No active tuberculosis, opportunistic infections, or deaths occurred. Interpretation: Patients receiving guselkumab intravenous induction and subcutaneous maintenance treatment achieved high rates of clinical and endoscopic efficacy up to week 48. No new safety concerns were identified. Funding: Janssen Research & Development. Reprinted from The Lancet Gastroenterol Hepatol. 2024;9(2), Danese S, Panaccione R, Feagan BG, Afzali A, Rubin DT, Sands BE, Reinisch W, Panés J, Sahoo A, Terry NA, Chan D, Han C, Frustaci ME, Yang Z, Sandborn WJ, Hisamatsu T, Andrews JM, D’Haens GR; GALAXI-1 Study Group. Efficacy and safety of 48 weeks of guselkumab for patients with Crohn’s disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial, pp 133–146, © 2024 with permission of Elsevier.

Background: Vedolizumab (VDZ) is a well-established and important therapeutic option in the treatment of patients with inflammatory bowel disease (IBD). However, the significance of therapeutic drug monitoring (TDM) with VDZ remains a contradictory field in daily clinical practice. Our study aims to clarify the predictive impact of VDZ drug levels in long-term clinical outcomes in a real-world cohort. Methods: Patients with moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD) from a tertiary IBD referral center at the University Hospital Augsburg, Germany, were enrolled in this single-center retrospective data analysis. Clinical and endoscopic data were collected at month 6, month 12, and at the last time of follow-up, and outcomes were correlated with VDZ levels at week 6. Results: This study included 95 patients, 68.4% (n = 65) with UC, 24.2% (n = 23) with CD, and 7.4% (n = 7) with indeterminate colitis (CI). Patients with a mean VDZ treatment time of 17.83 months ± 14.56 showed clinical response in 29.5% (n = 28) and clinical remission in 45.3% (n = 43) at the end of the study. Endoscopic response occurred in 20.0% (n = 19) and endoscopic remission in 29.5% (n = 28) at the end of the study. The sustained beneficial effect of VDZ was also reflected in a significant change in biomarker levels. VDZ trough level at week 6 was determined in 48.4% (n = 46) with a mean of 41.79 µg/mL ± 24.58. A significant association between VDZ level at week 6 and both short and long-term outcomes could not be demonstrated. However, numerically higher VDZ levels were seen in patients with endoscopic and clinical improvement at month 6 and at the time of last follow-up. Conclusions: This study demonstrated efficacy and safety for VDZ in a real-world cohort. Although, for some parameters, a clear trend for higher VDZ levels at week 6 was seen, the efficacy of VDZ was not significantly correlated to VDZ level at week 6, which questions the predictive value of VDZ levels in the real world.