Squamous Cell Carcinoma with Prominent Eosinophils.

Eosinophils are often encountered in the stroma and peritumoral microenvironment of squamous cell carcinomas. Because eosinophils are readily identified on routine hematoxylin and eosin stained sections, researchers have explored multiple ways in which identifying the extent of eosinophil infiltration on routine biopsy and excisional specimens might provide diagnostic and prognostic information. We review the literature on this evolving topic.

The economic cost consequences of suboptimal infant and young child feeding practices: a scoping review.

Breastfeeding is important for women and children's health, but less than half of infants worldwide begin life with optimal breastfeeding. A growing literature shows consistently large economic costs of not breastfeeding, with global studies showing economic losses of around US$300 billion globally. However, existing studies are highly diverse in approaches, methods, data sources and country results. Building on a landmark 2012 UNICEF UK review focused on high-income countries, we conducted a scoping review to map and characterize the expanding literature and identify future research directions in this research area. We included studies (n = 36) in diverse country settings and outcomes for women and children. We used PubMed, Web of Science, EMBASE, MEDLINE, ProQuest and manual searches of cost of not breastfeeding studies published between 1996 and 2023. Articles were excluded if they were macroeconomic evaluations, did not assign monetary values or only evaluated breastfeeding or formula feeding costs and not outcomes or were cost of programs studies. We found considerable diversity in disciplinary approaches and differences in methodologies. Though there were different cost measurement perspectives (societal, institutional/payer and individual), all but two excluded the costs of unpaid care. Studies typically measured costs of medical treatment, with more recent studies using dynamic simulation models. The largest economic costs were derived from lifetime estimates of human capital losses, namely cost of premature death and loss of intelligence quotient points. Medical and death costs varied widely depending on method of calculation, but total costs consistently exceeded $US100 billion annually for the USA, and around $US300 billion in global studies. Our findings suggest that greater interdisciplinary collaboration is needed particularly to better define infant feeding exposures, and advance comprehensive measurement of costs and outcomes across lifetimes, in order to prioritize breastfeeding as a public health strategy of economic importance.

Persisting gaps in dementia carer wellbeing and education: A qualitative exploration of dementia carer experiences.

AIMS: To explore the emotional wellbeing of dementia carers in the lead up to and during transition of a person living with dementia to a residential aged care facility. DESIGN: An interpretative qualitative study. METHODS: Semi-structured interviews were conducted with informal carers of person living with dementia between February and June 2023. Data were analysed using an inductive thematic approach and resulted in three themes. RESULTS: The majority of carers were adult children (n = 19) and six were wives. Carers lived across metropolitan (n = 20) and regional settings (n = 5) in the most populous state of Australia. Three themes were identified which were attributed to different aspects of the carer role: (1) Carer emotional journey as dementia progresses - impacted by knowledge and lack of support; (2) Questioning decision making-underpinned by knowledge and confidence; and (3) Challenges in re-establishing identity - impacted by ongoing concerns. CONCLUSION: As dementia progresses carers of person living with dementia consistently reported gaps in knowledge including how to access support. Specifically, this study identified the need for more to be done to help carers to develop the skills needed for their role, including participation in care planning and identifying care preferences for the future. Nurses can play a key role in promoting referral to services that support carers. Findings offer practical solutions to ameliorate carer stress and promote shared decision making. REPORTING METHOD: This research was guided by the Consolidated Criteria for Reporting Qualitative Research.

Mounting agents with low toxicity and with fast curing time for digital pathology in the intraoperative frozen section laboratory.

AIMS: In intraoperative frozen tissue section laboratories (FS laboratories) conventional practice for mounting coverslips on tissue slides involves the use of xylene-based mounting agents, such as Pertex. However, toxic vapours pose a risk to biomedical laboratory scientists (BLS) and pathologists who handle the wet slides to provide fast and urgent diagnostic results to surgeons during operations. Our study aims to evaluate non-toxic mounting agents to substitute Pertex, preferably with a fast curing time suitable for the demands of the new digital era in pathology. METHODS: Five non-toxic mounting agents were purchased and tested through six different protocols and compared to xylene-based Pertex as our gold standard. With light microscopy, tissue slides were quality assessed by BLS. Mounting agents, which were evaluated comparable to Pertex, were also evaluated by a pathologist, hence scanned digitally and re-evaluated. RESULTS: The protocols for Eukitt UV, Eukitt UV R-1 and Eukitt UV R-2 had significantly more artefacts (bubbles) compared to gold standard Pertex (p<0.0001, p=0.004 and p<0.0001, respectively) and assessed inadequate as replacements. Neo-Mount and Tissue Mount were assessed applicable regarding quality, but curing times were long. Tek Select UV showed promising results in both quality and fast curing time (protocol was <2 min). CONCLUSIONS: Toxic mounting agents need replacement to health guard professionals, and also digital pathology is revolutionising laboratories. A digitalized FS laboratory requires fast dry/cured slides for digital scanning. Therefore, a substitute for the FS laboratory should have the qualities of being non-toxic to handle and having a fast curing time, and a UV-based mounting agent may solve both requirements.

Pseudoendocrine sarcoma: a rare new entity with unique radiologic and pathologic/molecular characteristics.

Pseudoendocrine sarcoma is a rare, recently described intermediate grade sarcoma of uncertain phenotype that most commonly affects the paraspinal location in older patients with a distinctive endocrine/paraganglioma-like morphology and unique CTNNB1 point mutation. While these tumors appear as epithelial or even benign endocrine tumors, these lack markers for such and are highlighted by nuclear expression of beta-catenin. This case is the first among the previously reported only twenty-five cases of this entity, including one original series and a few case reports, to correlate the radiologic imaging with the pathologic features. Furthermore, this case illustrates the oldest-to-date patient with this unique location as a palpable painful chest wall/paraspinal location, with new morphologic observations and, finally, this is only the second case to have this specific CTNNB1 hotspot point mutation for this rare entity.

Understanding Dementia Carer Experiences Before Admission to a Residential Aged Care Facility: Implications for Integrated Care.

In-depth understanding of dementia carer experience can assist clinicians by providing insight into dementia onset, symptoms and management, and help conceptualize and understand the pattern of dementia progress over time and what help is needed. We undertook a qualitative study to understand dementia carers experiences of providing care and reasons for admission to a residential aged care facility (RACF). Three themes were identified: (1) Challenges in the path to diagnosis and care, leading to delays accessing support; (2) Carer role impacted by living circumstances; and (3) Variation in decision support prior to admission to a RACF. Identifying dementia carer experiences, reinforces the need for more timely diagnosis, referral for support and interventions to promote better quality of life for a people living with dementia and their carer and to delay premature RACF placement.

"I could not find the strength to resist the pressure of the medical staff, to refuse to give commercial milk formula": a qualitative study on effects of the war on Ukrainian women's infant feeding.

Introduction: During emergencies, breastfeeding protects infants by providing essential nutrients, food security, comfort, and protection and is a priority lifesaving intervention. On February 24, 2022, the war in Ukraine escalated, creating a humanitarian catastrophe. The war has resulted in death, injuries, and mass internal displacement of over 5 million people. A further 8.2 million people have taken refuge in neighboring countries, including Poland. Among those impacted are infants and young children and their mothers. We conducted a study to explore the infant feeding challenges and needs of Ukrainian women affected by the war. Methods: We conducted a qualitative descriptive study involving in-depth interviews (IDIs) with 75 war-affected Ukrainian mothers who had at least one infant aged less than 12 months at the time of the interview. Eligible mothers were either (1) living as Ukrainian refugees in Poland, having crossed the border from Ukraine on or after February 24, 2022, when the war started (n = 30) or (2) living in Ukraine as internally displaced persons or as residents in the community (n = 45). All interviews were audio-recorded (either transcribed or had responses summarized as expanded notes) and analyzed using qualitative thematic analysis using a two-step rapid analysis process. Results: Participants in Ukraine who wanted to initiate breastfeeding right after birth faced opposition from healthcare workers at maternity hospitals. Ukrainian refugees who gave birth in Poland faced language barriers when seeking breastfeeding support. Half of the participants in Ukraine received commercial milk formula (CMF) donations even if they said they did not need them. Most respondents stated that breastfeeding information and support were urgently needed. Conclusion: Our data suggests that healthcare workers in Ukrainian maternity hospitals require additional training and motivation on delivering breastfeeding support. In addition, lactation consultants in maternity ward are needed in Ukraine, and interpretation support is needed for refugees to overcome language barriers. There is a need to control the indiscriminate donations of commercial milk formula and to ensure that complementary foods and commercial milk formula are available to those that need it. This study confirms the need for actions to ensure infant and young child feeding (IYCF) support is provided during emergencies.

Development of a Culture-Common Formal Characteristics of Behavior - Temperament Markers Inventory (FCB-TMI-CC).

The goal was to create a brief temperament inventory grounded in the Regulative Theory of Temperament (FCB-TMI-CC), with a user-friendly, online applicability for studies in different cultures. As the regulative role of temperament is strongly revealed under meaningful stress, the study was planned within the time of the COVID-19 pandemic. To ensure high diversity in terms of culture, economic and environmental conditions, data from nine countries (Poland, United States of America, Italy, Japan, Argentina, South Korea, Ireland, United Kingdom and Kazakhstan) were utilized (min. N = 200 per country). Validation data were gathered on the level of COVID-19 stressors, posttraumatic stress disorder (PTSD), depression, anxiety and stress symptoms, and Big Five personality traits. Multigroup confirmatory factor analysis served as the basis for the inventory's construction. The final culture-common version includes 37 items (5-6 in each of the 7 scales) and covers the core aspects of temperament dimensions. Temperament structure was confirmed to be equivalent across measured cultures. The measurement is invariant at the level of factor loadings and the reliability (internal consistency) and theoretical validity of the scales were at least acceptable. Therefore, the FCB-TMI-CC may serve as a valuable tool for studying temperament across diverse cultures and facilitate cross-cultural comparisons.

Estimating carbon and water footprints associated with commercial milk formula production and use: development and implications of the Green Feeding Climate Action Tool.

Carbon offset frameworks like the UN Clean Development Mechanism (CDM) have largely overlooked interventions involving food, health, and care systems, including breastfeeding. The innovative Green Feeding Climate Action Tool (GFT) assesses the environmental impact of commercial milk formula (CMF) use, and advocates for breastfeeding support interventions as legitimate carbon offsets. This paper provides an overview of the GFT's development, key features, and potential uses. The offline and online GFT were developed using the DMADV methodology (Define, Measure, Analyze, Design, Verify). The GFT reveals that the production and use of CMF by infants under 6 months results in annual global greenhouse gas (GHG) emissions of between 5.9 and 7.5 billion kg CO2 eq. and consumes 2,562.5 billion liters of water. As a national example, in India, one of the world's most populous countries, CMF consumption requires 250.6 billion liters of water and results in GHG emissions ranging from 579 to 737 million kg CO2 eq. annually, despite the country's high breastfeeding prevalence among infants under 6 months. The GFT mainly draws on data for low- and middle-income countries (LMICs), as many high-income countries (HICs) do not collect suitable data for such calculations. Despite poor official data on breastfeeding practices in HICs, GFT users can input their own data from smaller-scale surveys or their best estimates. The GFT also offers the capability to estimate and compare baseline with counterfactual scenarios, such as for interventions or policy changes that improve breastfeeding practices. In conclusion, the GFT is an important innovation to quantify CMF's environmental impact and highlight the significance of breastfeeding for planetary as well as human health. Women's contributions to environmental preservation through breastfeeding should be recognized, and breastfeeding interventions and policies should be funded as legitimate carbon offsets. The GFT quantifies CMF's carbon and water footprints and facilitates financing breastfeeding support as a carbon offset initiative under CDM funding facilities.

To disinfect or not to disinfect that is the question - Procedure when drawing blood for alcohol measurements in Denmark.

Swabbing with ethanol to disinfect the skin before venipuncture does not bias measurements of blood ethanol, as previously suspected. International evidence-based theory may not always be successfully integrated into local practices, where old customs may remain. So how are the local protocols for swabbing in practice - if they even do swab? Not disinfecting may risk patient safety. We aim to put a focus on the venipuncture disinfection procedure in practice when measuring blood alcohol for clinical matters and if their procedure refers to a guideline. Specialized biomedical laboratory scientists (BLS) are typically responsible for the phlebotomy procedure in Denmark, thus questionnaires were sent to the relevant BLS in 2020 to map disinfection procedures in all Danish hospitals and affiliated blood draw clinics (n = 58). The response rate was 93% (54/58). We observed an inter-laboratory dissimilarity in swabbing procedures, when measuring blood alcohol: A quarter did not use any disinfectant (26%), while the remaining disinfected with ethanol 55%, isopropanol 13%, and 6% with ethanol/chlorhexidine. Of the five Danish regions, three had a regional guideline (3/5), otherwise the swabbing protocol was locally based. There was a regional difference in disinfecting or not (Chi2 p < 0,0001). Danish protocols do not always parallel international literature and international guidelines. Not applying disinfectant may jeopardize patient safety. Laboratories are encouraged to work with evidence-based practice or follow newest standardized international guidelines.

A proposal to recognize investment in breastfeeding as a carbon offset.

Policy-makers need to rethink the connections between the economy and health. The World Health Organization Council on the Economics of Health for All has called for human and planetary health and well-being to be moved to the core of decision-making to build economies for health. Doing so involves valuing and measuring what matters, more and better health financing, innovation for the common good and rebuilding public sector capacity. We build on this thinking to argue that breastfeeding should be recognized in food and well-being statistics, while investments in breastfeeding should be considered a carbon offset in global financing arrangements for sustainable food, health and economic systems. Breastfeeding women nourish half the world's infants and young children with immense quantities of a highly valuable milk. This care work is not counted in gross domestic product or national food balance sheets, and yet ever-increasing commercial milk formula sales are counted. Achieving global nutrition targets for breastfeeding would realize far greater reductions in greenhouse gas emissions than decarbonizing commercial milk formula manufacturing. New metrics and financing mechanisms are needed to achieve the health, sustainability and equity gains from more optimal infant and young child feeding. Properly valuing crucial care and environmental resources in global and national measurement systems would redirect international financial resources away from expanding carbon-emitting activities, and towards what really matters, that is, health for all. Doing so should start with considering breastfeeding as the highest quality, local, sustainable first-food system for generations to come.

Les responsables politiques doivent repenser les liens entre économie et santé. Le Conseil de l'Organisation mondiale de la Santé sur l'économie de la santé pour tous a demandé que le bien-être et la santé, aussi bien de l'humain que de la planète, soient désormais au cœur du processus de prise de décisions afin de créer des économies au service de la santé. Il est donc impératif d'identifier et de valoriser ce qui compte, d'accroître et d'optimiser le financement de la santé, d'innover pour le bien commun et de renforcer les capacités du secteur public. En partant de cette réflexion, nous plaidons pour une reconnaissance de l'allaitement dans les statistiques relatives à l'alimentation et au bien-être, et estimons que tout investissement réalisé dans ce domaine devrait être considéré comme un crédit-carbone dans le cadre des modalités financières mondiales liées aux systèmes économiques et sanitaires ainsi qu'à une alimentation durable. Les femmes allaitantes nourrissent la moitié des enfants en bas âge dans le monde avec d'immenses quantités de lait extrêmement précieux. Ces activités de soins ne sont pas comptabilisées dans le produit intérieur brut ou les bilans alimentaires nationaux, contrairement aux ventes de lait maternisé en constante progression. Atteindre les cibles mondiales de nutrition pour l'allaitement contribuerait davantage à réduire les émissions de gaz à effet de serre que décarboner la production de lait maternisé. De nouveaux paramètres et mécanismes de financement sont nécessaires pour bénéficier des avantages en matière de santé, de durabilité et d'équité qui découlent d'une meilleure alimentation des nourrissons et jeunes enfants. Valoriser correctement les principales ressources consacrées à l'environnement et aux soins dans les systèmes de mesure nationaux et mondiaux permettrait de détourner les moyens financiers internationaux du développement d'activités à fort taux d'émissions pour les rediriger vers ce qui compte vraiment, c'est-à-dire la santé pour tous. Et pour y parvenir, la première étape consisterait à reconnaître l'allaitement comme l'aliment de base, local, durable et de qualité pour les générations futures.

Los responsables de formular las políticas deben volver a plantearse las conexiones entre la economía y la salud. El Consejo sobre la Economía de la Salud para Todos de la Organización Mundial de la Salud ha pedido que la salud y el bienestar humanos y del planeta se sitúen en el centro de la toma de decisiones a fin de desarrollar economías para la salud. Esto requiere valorar y medir lo que importa, más y mejor financiación sanitaria, innovación para el bien común y reconstrucción de la capacidad del sector público. Nos basamos en este pensamiento para argumentar que la lactancia materna debería reconocerse en las estadísticas de alimentación y bienestar, mientras que las inversiones en lactancia materna deberían considerarse como una compensación de emisiones de carbono en los acuerdos globales de financiación para sistemas alimentarios, sanitarios y económicos sostenibles. Las mujeres lactantes alimentan a la mitad de los bebés y niños pequeños del mundo con inmensas cantidades de una leche muy valiosa. Este trabajo de cuidados no se contabiliza en el producto interior bruto ni en los balances alimentarios nacionales y, sin embargo, sí se contabilizan las ventas cada vez mayores de leche de fórmula comercial. Alcanzar los objetivos mundiales de nutrición para la lactancia materna supondría una reducción mucho mayor de las emisiones de gases de efecto invernadero que descarbonizar la fabricación de leche de fórmula comercial. Se necesitan nuevas métricas y mecanismos de financiación para lograr los beneficios en materia de salud, sostenibilidad y equidad de una alimentación más óptima de los bebés y los niños pequeños. Una valoración adecuada de los cuidados esenciales y de los recursos medioambientales en los sistemas de medición globales y nacionales redirigiría los recursos financieros internacionales lejos de la expansión de las actividades que emiten carbono, y hacia lo que realmente importa, es decir, la salud para todos. En este contexto, habría que empezar por considerar la lactancia materna como el sistema de primera alimentación de mayor calidad, local y sostenible para las generaciones futuras.

Comparison of rectal swabs and fecal samples for the detection of Clostridioides difficile infections with a new in-house PCR assay.

The detection of Clostridioides difficile infections (CDI) relies on testing the stool of patients by toxin antigen detection or PCR methods. Although PCR and antigenic methods have significantly reduced the time to results, delays in stool collection can significantly add to the turnaround time. The use of rectal swabs to detect C. difficile could considerably reduce the time to diagnosis of CDI. We developed a new rapid PCR assay for the detection of C. difficile and evaluated this PCR assay on both stool and rectal swab specimens. We recruited a total of 623 patients suspected of C. difficile infection. Stool samples and rectal swabs were collected from each patient and tested by our PCR assay. Stool samples were also tested by the cell cytotoxicity neutralization assay (CCNA) as a reference. The PCR assay detected C. difficile in 60 stool specimens and 61 rectal swabs for the 64 patients whose stool samples were positive for C. difficile by CCNA. The PCR assay detected an additional 35 and 36 stool and rectal swab specimens positive for C. difficile, respectively, for sensitivity with stools and rectal swabs of 93.8% and 95.3%, specificity of 93.7% and 93.6%, positive predictive values of 63.2% and 62.9%, and negative predictive values of 99.2% and 99.4%. Detection of C. difficile using PCR on stools or rectal swabs yielded reliable and similar results. The use of PCR tests on rectal swabs could reduce turnaround time for CDI detection, thus improving CDI management and control of C. difficile transmission. IMPORTANCE: Clostridioides difficile infection (CDI) is the leading cause of healthcare-associated diarrhea, resulting in high morbidity, mortality, and economic burden. In clinical laboratories, CDI testing is currently performed on stool samples collected from patients with diarrhea. However, the diagnosis of CDI can be delayed by the time required to collect stool samples. Barriers to sample collection could be overcome by using a rectal swab instead of a stool sample. Our study showed that CDI can be identified rapidly and reliably by a new PCR assay developed in our laboratory on both stool and rectal swab specimens. The use of PCR tests on rectal swabs could reduce the time for the detection of CDI and improve the management of this infection. It should also provide a useful alternative for infection-control practitioners to better control the spread of C. difficile.

ABM Position Statement: Paid Maternity Leave-Importance to Society, Breastfeeding, and Sustainable Development.

Background: Paid maternity leave benefits all of society, reducing infant mortality and providing economic gains. It is endorsed by international treaties. Paid maternity leave is important for breastfeeding, bonding, and recovery from childbirth. Not all mothers have access to adequate paid maternity leave. Key Information: Paid leave helps meet several of the 17 United Nations' Sustainable Development Goals (2, 3, 4, 5, 8, and 10), including fostering economic growth. A family's expenses will rise with the arrival of an infant. Paid leave is often granted with partial pay. Many low-wage workers earn barely enough to meet their needs and are unable to take advantage of paid leave. Undocumented immigrants and self-employed persons, including those engaging in informal work, are often omitted from maternity leave programs. Recommendations: Six months of paid leave at 100% pay, or cash equivalent, should be available to mothers regardless of income, employment, or immigration status. At the very minimum, 18 weeks of fully paid leave should be granted. Partial pay for low-wage workers is insufficient. Leave and work arrangements should be flexible whenever possible. Longer flexible leave for parents of sick and preterm infants is essential. Providing adequate paid leave for partners has multiple benefits. Increasing minimum wages can help more families utilize paid leave. Cash benefits per birth can help informal workers and undocumented mothers afford to take leave. Equitable paid maternity leave must be primarily provided by governments and cannot be accomplished by employers alone.

Biomedical laboratory scientists and technicians in digital pathology - Is there a need for professional development?

Objective: Digital pathology (DP) is moving into Danish pathology departments at high pace. Conventionally, biomedical laboratory scientists (BLS) and technicians have prepared tissue sections for light microscopy, but workflow alterations are required for the new digital era with whole slide imaging (WSI); digitally assisted image analysis (DAIA) and artificial intelligence (AI). We aim to explore the role of BLS in DP and assess a potential need for professional development. Methods: We investigated the roles of BLS in the new digital era through qualitative interviews at Danish Pathology Departments in 2019/2020 before DP implementation (supported by a questionnaire); and in 2022 after DP implementation. Additionally, senior lecturers from three Danish University Colleges reported on how DP was integrated into the 2023 bachelor's degree educational curricula for BLS students. Results: At some Danish pathology departments, BLS were involved in the implementation process of DP and their greatest concerns were lack of physical laboratory requirements (69%) and implementation strategies (63%). BLS were generally positive towards working with DP, however, some expressed concern about extended working hours for scanning. Work-task transfers from pathologists were generally greeted positively from both management and pathologists; however, at follow-up interviews after DP implementation, job transfers had not been effectuated. At Danish university colleges, DP had been integrated systematically in the curricula for BLS students, especially WSI. Conclusion: Involving BLS in DP implementation and development may benefit the process, as BLS have a hands-on workflow perspective with a focus on quality assurance. Several new work opportunities for BLS may occur with DP including WSI, DAIA and AI, and therefore new qualifications are warranted, which must be considered in future undergraduate programmes for BLS students or postgraduate programmes for BLS.

Standardization of the Verification Nurse Role in the Delivery of Chemotherapy and Biotherapy.

After a chemotherapy overdose in 1994 resulted in the death of one patient and the permanent injury of another, the role of the verification nurse was created at a National Cancer Institute-designated comprehensive cancer c.

Neutrophil Reactivity Intensity and misclassification of immature granulocytes.

INTRODUCTION: Immature granulocyte percentage (IG%) is an important biomarker for infection control. We observed spurious cases where the IG% was dramatically underestimated on the automated Sysmex XN-series hehmatology analyzer compared with manual differential. These cases were associated with high values of "Neutrophil Reactivity Intensity" (NEUT-RI), which should reflect the metabolic activity of the neutrophils. METHODS: We conducted a three-stage study to evaluate whether NEUT-RI could be utilized to screen for misclassified IG% results defined as the manual differential estimating a 10 percentage points higher IG% compared with the automated Sysmex differential. First, 124 patient samples were selected for 800-cell manual smear analysis based on their NEUT-RI values and compared with the automatic Sysmex IG% results. Next, 11 098 routine 110-cell manual smear analyses were compared with the corresponding Sysmex IG% results. Finally, during a 19-day period 160 additional patient samples underwent smear based on NEUT-RI values ≥56 fluorescence intensity (FI) to screen for misclassified results beyond our current smear practice. RESULTS: NEUT-RI ≥56 predicted IG% misclassification with 91% sensitivity and 88% specificity, but primarily when the internal Sysmex flag "Abnormal WBC Scattergram" was present. 90.1% of misclassified results were identified by this flag. Beyond our existing smear rules including this flag, NEUT-RI ≥56 FI had a positive predictive value below 1%. CONCLUSION: Both NEUT-RI and the internal Sysmex flag "Abnormal WBC Scattergram" work well to identify cases of IG% misclassification. However, in our setting NEUT-RI ≥56 FI had no meaningful additional predictive capacity to identify misclassifications beyond our current smear rules.

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies.

OBJECTIVES: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated superior efficacy versus placebo in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) at Week 16. Here, the objective is to report the efficacy and safety of BKZ at Week 52. METHODS: BE MOBILE 1 (nr-axSpA; NCT03928704) and BE MOBILE 2 (r-axSpA; NCT03928743) comprised a 16-week, double-blind, placebo-controlled period, then a 36-week maintenance period. From Week 16, all patients received subcutaneous BKZ 160 mg every 4 weeks. RESULTS: Improvements versus placebo in Assessment of SpondyloArthritis International Society ≥40% response (primary endpoint), Ankylosing Spondylitis Disease Activity Score, high-sensitivity C-reactive protein levels and MRI inflammation of the sacroiliac joints/spine at Week 16 were sustained to Week 52 in BKZ-randomised patients. At Week 52, responses of patients switching from placebo to BKZ at Week 16 were comparable to BKZ-randomised patients. At Week 52, ≥1 treatment-emergent adverse events (TEAEs) were reported in 183 (75.0%) and 249 (75.5%) patients with nr-axSpA and r-axSpA, respectively. Serious TEAEs occurred in 9 (3.7%) patients with nr-axSpA and 20 (6.1%) patients with r-axSpA. Oral candidiasis was the most frequent fungal infection (nr-axSpA: 18 (7.4%); r-axSpA: 20 (6.1%)). Uveitis occurred in three (1.2%) and seven (2.1%) patients with nr-axSpA and r-axSpA, and inflammatory bowel disease in two (0.8%) and three (0.9%). CONCLUSIONS: At Week 52, dual inhibition of IL-17A and IL-17F with BKZ resulted in sustained efficacy across the axSpA spectrum; the safety profile was consistent with the known safety of BKZ. TRIAL REGISTRATION NUMBER: NCT03928704; NCT03928743.