Anaemia is an important complication of inflammatory bowel disease [IBD]. The aim of this study was to determine the prevalence of anaemia and the practice of anaemia screening during the first year following diagnosis, in a European prospective population-based inception cohort. Newly diagnosed IBD patients were included and followed prospectively for 1 year in 29 European and one Australian centre. Clinical data including demographics, medical therapy, surgery and blood samples were collected. Anaemia was defined according to the World Health Organization criteria. A total of 1871 patients (Crohn’s disease [CD]: 686, 88%; ulcerative colitis [UC]: 1,021, 87%; IBD unclassified [IBDU] 164. 81%) were included in the study. The prevalence of anaemia was higher in CD than in UC patients and, overall, 49% of CD and 39% of UC patients experienced at least one instance of anaemia during the first 12 months after diagnosis. UC patients with more extensive disease and those from Eastern European countries, and CD patients with penetrating disease or colonic disease location, had higher risks of anaemia. CD and UC patients in need of none or only mild anti-inflammatory treatment had a lower risk of anaemia. In a significant proportion of patients, anaemia was not assessed until several months after diagnosis, and in almost half of all cases of anaemia a thorough work-up was not performed. Overall, 42% of patients had at least one instance of anaemia during the first year following diagnosis. Most patients were assessed for anaemia regularly; however, a full anaemia work-up was frequently neglected in this community setting.

Etrasimod, a novel selective sphingosine-1-phosphate receptor modulator, was recently approved by the U.S. Food and Drug Administration and the European Medicinal Agency for the treatment of moderately to severely active ulcerative colitis in adults. In this research, the forced degradation study as an integral part of drug product and packaging development, which generates data on degradation mechanisms, is published. The development and validation of the stability-indicating method using a superior high-performance liquid chromatography technique coupled with a diode array detector and tandem mass spectrometer was performed to support the forced degradation study and monitor the formation of degradation products. Etrasimod demonstrated good stability under elevated temperature and basic stress conditions, while acidic hydrolysis, oxidative, and photolytic degradation produced eight degradation products. The knowledge of degradation products will be useful in the long-term stability study for establishing the acceptance criteria of etrasimod as a drug substance and dosage form during quality control and stability assessment. The eco-friendliness of the developed forced degradation procedure was evaluated using various greenness appraisal tools. The green metric tools showed that the forced degradation procedure obeys eco-friendly conditions.

Background/Objectives: Janus kinase inhibitors open new horizons for small-molecule drugs in treating inflammatory bowel disease, with ritlecitinib demonstrating significant efficacy in clinical trials for ulcerative colitis and Crohn’s disease. Ritlecitinib, a second-generation JAK3 inhibitor, is a novel therapeutic agent for alopecia areata and other autoimmune conditions. Methods: A new stability-indicating UHPLC-DAD-MS/MS method was developed, validated, and applied for a forced degradation study of ritlecitinib under ICH guidelines. Results: The method demonstrated high specificity, sensitivity (LOD: 0.04 µg/mL; LOQ: 0.14 µg/mL), precision (RSD ≤ 0.15%), and accuracy (99.9–100.3%). Forced degradation studies under acidic, basic, oxidative, thermal, and photolytic conditions revealed four novel degradation products. Basic degradation followed second-order kinetics, while oxidative degradation followed zero-order kinetics. Conclusions: The validated method reliably characterized ritlecitinib’s stability and degradation products, providing essential data for optimizing formulation, determining proper storage conditions, anticipating drug–excipient interactions, and ensuring quality control. The eco-friendliness and applicability of the developed forced degradation procedure were evaluated using various green and blue metric tools. Incorporating green analytical principles underscores its potential for sustainable pharmaceutical analysis.

Size exclusion chromatography (SEC) has become a powerful tool for analysing size variants of biologic drugs in their native form. Modern SEC can be defined by the use of chromatographic columns packed with sub-3 µm particles, allowing an increase in method throughput compared to that of conventional SEC. We performed the forced degradation study of adalimumab, the first genetically engineered fully humanised immunoglobulin G1 monoclonal antibody, and evaluated tha possibilities of an advanced SEC column packed with sub-3 µm particles for elucidation of the degradation pathway. Our results revealed the main adalimumab degradation products to be antibody fragments. Acidic and basic conditions had the most intensive effect on the degradation of the adalimumab while the drug exhibits relative stability under thermal and photolytic stress conditions. The AGREE and AGREEprep calculators were used for the evaluation of the environmental performance of the forced degradation procedure. The results of the green score evaluation are presented as round pictograms with a circle in the centre that shows the overall score of 0.81 and 0.61, respectively. Both pictograms are highlighted in green, indicating the eco-friendly conditions.

Background/Objectives: Etrasimod is a novel, oral, selective sphingosine-1-phosphate (S1P) receptor modulator approved for the treatment of ulcerative colitis. Due to its high lipophilicity and strong plasma protein binding, quantification of etrasimod in human plasma is significantly challenged by co-extracted proteins and phospholipids that induce column degradation and severe mass spectrometry matrix effects. This study presents the first eco-friendly LC–MS/MS assay for etrasimod in human plasma utilizing advanced phospholipid removal technology, combining protein precipitation and targeted phospholipid depletion into a single step. It achieved matrix purification while reducing sample processing time and solvent volumes. Methods: Chromatographic separation was achieved on a C18 column using a gradient elution of 0.1% formic acid in water and acetonitrile. Detection was performed on a triple quadrupole mass spectrometer in positive electrospray ionization (ESI) mode using multiple reaction monitoring (MRM) transitions at m/z 458 → 159 for etrasimod and m/z 405 → 146 for ozanimod (internal standard). Results: The method was fully validated according to ICH M10 guidelines, demonstrating excellent linearity, accuracy, precision, and robustness. Comprehensive sustainability assessment using AGREE (0.55), AGREEprep (0.58), ComplexMoGAPI (78), and BAGI (52.5) confirmed an eco-friendly profile and high operational practicality. Conclusions: The proposed method provides a reliable and green tool suitable for analysis of etrasimod in human plasma.

Inflammatory bowel diseases (IBD) usually affect women in their fertile years and, therefore, have implications for their fertility and pregnancy. The presence of IBD during pregnancy has been shown to adversely affect pregnancy outcomes, and increased rates of preterm delivery and of spontaneous abortion have been reported. An onset of acute severe colitis in pregnancy has rarely been seen. We present the case of a 42-year-old woman who conceived after 9 attempts of in vitro fertilization and whose pregnancy was the result of a donated oocyte. Shortly after conception, she was diagnosed with severe active ulcerative colitis, and biologic therapy was introduced in the 28th week of pregnancy. Although therapy for IBD in pregnancy is considered safe for most drugs, this was not very well known in 2015. We also consider our case exceptional because we now have a 5-year follow-up of our patient and her child after having begun biologic therapy during late pregnancy.