Introduction: The newest intravenous (IV) iron products show an improved safety profile over predecessors, allowing for the rapid administration of relatively high doses. Ferric derisomaltose (FDI; also known as iron isomaltoside), ferric carboxymaltose (FCM), and ferumoxytol (FER), are successful treatments for iron deficiency (Europe; FDI and FCM) and iron deficiency anemia (US; FDI, FCM, and FER). Areas covered: This review focusses on the chemistry and structure of FDI, FCM, and FER, and on three key aspects of IV iron safety: (1) hypersensitivity; (2) hypophosphatemia and sequelae; (3) cardiovascular safety. Expert opinion: Although the safety of modern IV iron has improved, immediate infusion reactions and the development of hypophosphatemia must be appreciated and recognized by those who prescribe and administer IV iron. Immediate infusion reactions can occur with any IV iron and are usually mild; severe reactions – particularly anaphylaxis – are extremely rare. The recognition and appropriate management of infusion reactions is an important consideration to the successful administration of IV iron. Severe, persistent, hypophosphatemia is a specific side effect of FCM. No cardiovascular safety signal has been identified for IV iron. Ongoing trials in heart failure will provide additional long-term efficacy and safety data.

Background and Aims: The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, real-world German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods: Patients with CD receiving UST treatment in three hospitals and two outpatient centers were included and retrospectively analyzed. Rates for short- and long-term remission and response were analyzed with the help of clinical (Harvey–Bradshaw Index (HBI)) and biochemical (C-reactive protein (CRP), Fecal calprotectin (fCal)) parameters for disease activity. Results: Data from 180 patients were evaluated. One-hundred-and-six patients had a follow-up of at least eight weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin antibodies. The median follow-up was 49.1 weeks (95% CI 42.03-56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 48 (51.6%) responded to UST, and 25 patients (26.9%) were in remission. Steroid-free response and remission at week eight was achieved by 30.1% and 19.3% of patients, respectively. At week 48, 37.6% showed steroid-free response to UST, and 20.4% of the initial patient population was in steroid-free remission. Conclusion: Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment-exposed patients.

Background and Aims: Vitamin D has an inhibitory role in the inflammatory signaling pathways and supports the integrity of the intestinal barrier. Due to its immunomodulatory effect, vitamin D plays a role in chronic inflammatory bowel disease (IBD) and a deficiency is associated with an increased risk for a flare. We aimed to investigate to what extent the 25-hydroxyvitamin D (25(OH)D₃) level correlates with disease activity and whether a cut-off value can be defined that discriminates between active disease and remission. Methods: Patients with IBD, treated at the University Hospital Frankfurt were analyzed retrospectively. The 25(OH)D3 levels were correlated with clinical activity indices and laboratory chemical activity parameters. A deficiency was defined as 25(OH)D3 levels <30 ng/mL. Results: A total of 470 (257 female) patients with IBD were included, 272 (57.9%) with Crohn’s disease (CD), 198 (42.1%) with ulcerative colitis (UC). The median age of the patients was 41 (18–84). In 283 patients (60.2%), a vitamin D deficiency was detected. 245 (53.6%) patients received oral vitamin D supplementation, and supplemented patients had significantly higher vitamin D levels (p < 0.0001). Remission, vitamin D substitution, and male gender were independently associated with the 25(OH)D3 serum concentration in our cohort in regression analysis. A 25(OH)D3 serum concentration of 27.5 ng/mL was the optimal cut-off value. Conclusion: Vitamin D deficiency is common in IBD patients and appears to be associated with increased disease activity. In our study, vitamin D levels were inversely associated with disease activity. Thus, close monitoring should be established, and optimized supplementation should take place.

The factors that contribute to the development of ulcerative colitis (UC), are still not fully identified. Disruption of the colon barrier is one of the first events leading to invasion of bacteria and activation of the immune system. The colon barrier is strongly influenced by sphingolipids. Sphingolipids impact cell–cell contacts and function as second messengers. We collected blood and colon tissue samples from UC patients and healthy controls and investigated the sphingolipids and other lipids by LC-MS/MS or LC-QTOFMS. The expression of enzymes of the sphingolipid pathway were determined by RT-PCR and immunohistochemistry. In inflamed colon tissue, the de novo-synthesis of sphingolipids is reduced, whereas lactosylceramides are increased. Reduction of dihydroceramides was due to posttranslational inhibition rather than altered serine palmitoyl transferase or ceramide synthase expression in inflamed colon tissue. Furthermore, in human plasma from UC-patients, several sphinglipids change significantly in comparison to healthy controls. Beside sphingolipids free fatty acids, lysophosphatidylcholines and triglycerides changed significantly in the blood of colitis patients dependent on the disease severity. Our data indicate that detraction of the sphingolipid de novo synthesis in colon tissue might be an important trigger for UC. Several lipids changed significantly in the blood, which might be used as biomarkers for disease control; however, diet-related variabilities need to be considered.

This review provides an overview of the current data regarding sex- and gender-specific aspects in patients with inflammatory bowel diseases. A particular focus will be on disease course, medical and surgical treatment strategies, psychosocial differences, and special requirements during pregnancy and family planning. The most significant and clinically meaningful gender differences in IBD relate to psychosocial functioning. Although depression, fatigue, anxiety disorders, eating disorders, and sexual dysfunction also occur in male IBD patients, women seem to be affected much more frequently and severely in these areas.

Einleitung: Bei der Analyse der medikamentösen Therapie bei CED-Patienten, die in Schwerpunktpraxen und -zentren im Rhein-Main-Gebiet behandelt werden, ist auffällig, dass in den Praxen ein wesentlich höherer Anteil der MC-Patienten mit Aminosalizylaten und Kortikosteroiden behandelt wird, während in den Klinikambulanzen Immunsuppressiva (Azathioprin, 6-Mercaptopurin und Methotrexat) eine ungleich größere Rolle spielen. Aufgrund der hohen Therapiekosten werden Biologika (Anti-TNF-alpha-Antikörper) bevorzugt in Klinikambulanzen verabreicht. Ziel: Ziel der vorliegenden Subgruppenanalyse war es, Unterschiede in der Behandlung von Frauen und Männern mit CED im Rhein-Main-Gebiet, zu analysieren. Patienten und Methoden: Die Daten wurden in 10 gastroenterologischen Praxen und 3 Klinikambulanzen prospektiv vom 1.11.2005 – 31.7.2007 hinsichtlich Krankheitsaktivität, medikamentöser Therapie und Labor erhoben und geschlechtsspezifische Unterschiede im Therapiemanagement analysiert. Ergebnisse: Es zeigte sich kein genereller Trend für eine unterschiedliche medikamentöse Behandlung von Frauen und Männern mit CED. Die detaillierte Analyse deckte jedoch auf, dass 1. Frauen mit CU und MC in Kliniken unabhängig von der Krankheitsaktivität tendenziell häufiger immunsuppressiv behandelt wurden als Männer. 2. In den Praxen wurden sowohl Männer als auch Frauen wesentlich seltener mit Immunsuppressiva behandelt als in den Klinikambulanzen. Sie erhielten in nur weniger als 3 % eine immunsuppressive Therapie (vs. 17 % [Männer] und 42 % [Frauen] in den Klinikambulanzen). 3. Bez. der Therapie mit Anti-TNF-Medikamenten zeigte sich, dass dieses Behandlungskonzept in den Klinikambulanzen unabhängig von der Krankheitsaktivität deutlich mehr bei Männern als bei Frauen angewandt wurde. Schlussfolgerung: Die vorliegende Arbeit zeigt Tendenzen der geschlechtsspezifischen Behandlung von Patienten mit CED auf, die einer Untermauerung durch weitere Studien bedürfen. Introduction: The most frequently prescribed medications for patients suffering from inflammatory bowel disease (IBD) in the Rhein-Main region of Germany are aminosalicylates and corticosteroids irrespective of the disease activity. In contrast, immunomodulators only play a marginal role. As anti-TNF therapy is very costly, it is prescribed in outpatient services of hospitals rather than in gastroenterological practices. Aim: The aim of this study was to evaluate possible gender-related differences in the therapeutic management of IBD patients treated in the Rhein-Main region of Germany. Methods: Data records about past medical history, disease status, laboratory values and medical treatment of outpatients of 10 gastroenterological practices and 3 hospitals were collected from November 1st 2005 to July 31st 2007 and analysed with regard to gender-related differences in therapy and disease management. Results: Overall, no statistically significant difference in gender-specific medical treatment could be observed in the study cohort. However, detailed analyses revealed, that 1. women suffering from IBD, who are treated in outpatient services of hospitals, are more often under immunosuppressants, irrespective of disease activity, 2. in gastroenterological practices less than 3 % of patients are prescribed any immunosuppressive therapy (vs. 17 % [men] und 42 % [women] in hospital outpatient services), and 3. anti-TNF therapy is applied more frequently in men as compared to women in hospital outpatient services in both remission and active disease. Conclusion: This study discloses the gender-specific differences in the therapeutic management of IBD patients in a congested urban area in Germany. Further studies are required to confirm the tendencies detected.