Comparison of Perioperative Outcomes of Holmium Laser Enucleation of the Prostate for Standard (≤149 ml) Versus Very Large (≥150 ml) Prostate Glands: Retrospective Analysis of a Propensity Score Matched Cohort of 326 Patients.

Background And Objective: Our objective was to evaluate whether a very large prostate volume significantly affects the incidence of perioperative complications and compromises outcomes among patients undergoing holmium laser enucleation of the prostate (HoLEP).

Methods: We retrospectively analyzed data for 1815 adult patients who underwent HoLEP at Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, between January 2019 and May 2024. Patients were divided into two groups according to their prostate volume: ≤149 ml (group A) and ≥150 ml (group B).

Specificity of the short-story task for autism diagnosis when controlling for depression.

Securing an accurate autism-spectrum-condition diagnosis, particularly among women, remains challenging for autistic adults. Building upon previous research highlighting the short-story task (SST) as a promising tool for detecting fiction-based mentalizing difficulties in autistic adults, this study expands its scope. We investigated the SST's discriminative capacity across three distinct groups: autistic individuals (n = 32), nonautistic individuals without mental health problems (n = 32), and nonautistic individuals with clinical depression (n = 30).

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).

The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Comparison of the efficacy and safety of a proposed biosimilar MSB11456 with tocilizumab reference product in subjects with moderate-to-severe rheumatoid arthritis: results of a randomised double-blind study.

Objective: To evaluate the efficacy, immunogenicity and safety of the proposed biosimilar MSB11456 versus European Union (EU)-approved tocilizumab reference product in patients with rheumatoid arthritis (RA) in a multicentre, randomised, double-blind, multinational, parallel-group study (NCT04512001).

Methods: Adult patients with moderate-to-severe active RA and inadequate clinical response to ≥1 disease-modifying antirheumatic drug (synthetic or biologic) receiving methotrexate were randomised to receive 24 weekly subcutaneous 162 mg injections of either MSB11456 or EU-approved tocilizumab. Equivalence between treatments was considered if the 95% CI (European Medicines Agency)/90% CI (US Food and Drug Administration) for the difference in mean change from baseline to week 24 in Disease Activity Score-28 Joint Count with erythrocyte sedimentation rate (DAS28-ESR) between treatments was entirely within prespecified equivalence intervals (-0.

Perioperative continuation or ultra-early resumption of antithrombotics in elective neurosurgical cranial procedures.

Objective: Discontinuation of antithrombotics (AT) prior to elective cranial procedures is common practice, despite the higher risk of thromboembolic complications in these patients. The aim of this study was to investigate the risks and benefits of a new perioperative management protocol of continuation or ultra-early AT resumption in elective cranial procedures.

Methods: This study was an analysis of a prospectively collected cohort of patients undergoing elective cranial surgery with (AT group) and without (control group) AT.

Multiparametric Orthogonal Characterization of Extracellular Vesicles by Liquid Chromatography Combined with In-Line Light Scattering and Fluorescence Detection.

Extracellular vesicles (EVs) are membrane-enclosed biological nanoparticles with potential as diagnostic markers and carriers for therapeutics. Characterization of EVs poses severe challenges due to their complex structure and composition, requiring the combination of orthogonal analytical techniques. Here, we demonstrate how liquid chromatography combined with multi-angle light scattering (MALS) and fluorescence detection in one single apparatus can provide multiparametric characterization of EV samples, including concentration of particles, average diameter of the particles, protein amount to particle number ratio, presence of EV surface markers and lipids, EV shape, and sample purity.

Mortality of Surgically Treated Neurotrauma in Elderly Patients and the Development of a Prediction Score: Geriatric Neurotrauma Mortality Score.

Background: As the population worldwide is aging, the need for surgery in elderly patients with neurotrauma is increasing. The aim of this study was to compare the outcome of elderly patients undergoing surgery for neurotrauma with younger patients and to identify the risk factors for mortality.

Methods: We retrospectively analyzed consecutive patients undergoing craniotomy or craniectomy for neurotrauma at our institution from 2012 to 2019.

Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456: results of a randomized, single-dose study in healthy adults.

Background: Tocilizumab is a monoclonal immunoglobulin G interleukin-6 receptor antagonist. MSB11456 is a proposed tocilizumab biosimilar.

Objective: To determine the pharmacokinetic equivalence of a single subcutaneous injection of MSB11456, when delivered via autoinjector (AI) and prefilled syringe (PFS), in healthy adult subjects.

Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults.

Background: Tocilizumab, a recombinant monoclonal immunoglobulin G, targets the interleukin-6 receptor. MSB11456 is a proposed tocilizumab biosimilar.

Objectives: To assess pharmacokinetic equivalence of intravenous MSB11456 to US-licensed tocilizumab.

"Why do they do it?": The short-story task for measuring fiction-based mentalizing in autistic and non-autistic individuals.

This study aimed to validate the short-story-task (SST) based on Dodell-Feder et al. as an instrument to quantify the ability of mentalizing and to differentiate between non-autistic adults and autistic adults, who may have acquired rules to interpret the actions of non-autistic individuals. Autistic (N = 32) and non-autistic (N = 32) adult participants were asked to read "The End of Something" by Ernest Hemingway and to answer implicit and explicit mentalizing questions, and comprehension questions.

Microstructural and Textural Investigation of an Mg-Zn-Al-Ca Alloy after Hot Plane Strain Compression.

The formability of magnesium alloys can be significantly improved by Ca as an alloying addition. Compared to conventional alloy sheets such as AZ31, texture modification can be found in rolled Mg-Ca sheets, which reveal a randomized orientation distribution. The hot deformation behavior of a twin-roll cast and homogenized Mg-2Zn-1Al-0.

Orthotropic Behavior of Twin-Roll-Cast and Hot-Rolled Magnesium ZAX210 Sheet.

Magnesium sheet metal alloys offer a deformation asymmetry, which is strongly related to grain size and texture. In order to predict deformation behavior as well as to provide methods to eliminate anisotropy and yield asymmetry, a lot of effort is invested in studying the tension-compression asymmetry of magnesium alloys. However, only a few studies deal with the characterization of the yield asymmetry of magnesium wrought alloys, especially Ca-containing alloys, related to temperature and strain.

When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.

The determination of a tailored anti-drug antibody (ADA) testing strategy is based on the immunogenicity risk assessment to allow a correlation of ADAs with changes to pharmacokinetics, efficacy, and safety. The clinical impact of ADA formation refines the immunogenicity risk assessment and defines appropriate risk mitigation strategies. Health agencies request for high-risk biotherapeutics to extend ADA monitoring for patients that developed an ADA response to the drug until ADAs return to baseline levels.

Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial.

Background: Tocilizumab is a recombinant humanized monoclonal immunoglobulin G1 antibody against the interleukin-6 receptor (IL-6 R). MSB11456 is a proposed tocilizumab biosimilar.

Objectives: To assess the pharmacokinetic and pharmacodynamic similarity of MSB11456 to both US-licensed and EU-approved tocilizumab.

The effect of anti-thrombotics on the postoperative bleeding rate in patients undergoing craniotomy for brain tumor.

Objective: The peak prevalence of many brain tumors is in elderly patients. These patients are often treated with platelet inhibitors (PIs) or anticoagulants (ACs), creating a challenge for neurosurgeons concerning the perioperative management. The aim of this study is to analyze the effect of PI/AC treatment on the postoperative bleeding rates in patients undergoing craniotomy due to a brain tumor.

A Comparative Study on the Hot Deformation Behavior of As-Cast and Twin-Roll Cast Mg-6.8Y-2.5Zn-0.4Zr Alloy.

The Mg-6.8Y-2.5Zn-0.

Does the discontinuation time of antiplatelet or anticoagulation treatment affect hemorrhagic complications in patients undergoing craniotomy for neurovascular lesions?

Background: The number of patients treated with platelet inhibitors (PI) and/or anticoagulants (AC) in neurosurgery is increasing. The aim of this study was to analyse the effect of PI/AC discontinuation time on hemorrhagic events after craniotomy for neurovascular pathologies.

Methods: The 30-day postoperative bleeding rates were retrospectively compared between short (≤5 days) and long (>5 days) discontinuation time of PI/AC before and after surgery.

Hot Deformation and Dynamic Recrystallisation Behaviour of Twin-Roll Cast Mg-6.8Y-2.5Zn-0.4Zr Magnesium Alloy.

In this work, the deformation behaviour of a twin-roll cast (TRC) Mg-6.8Y-2.5Zn-0.

Mortality and Outcome in Elderly Patients Undergoing Emergent or Elective Cranial Surgery.

Objective: Due to the aging population, the number of elderly patients in need of cranial surgery for various neurosurgical pathologies is growing. We sought to compare mortality and outcome of elderly patients undergoing cranial surgery with a younger population.

Methods: This was a retrospective analysis of adult patients undergoing craniotomy or craniectomy for various indications.

Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial.

Purpose: MSB11455 is a proposed biosimilar to the reference pegfilgrastim (Neulasta®). This pivotal equivalence study (NCT03251248) assessed the pharmacokinetic and pharmacodynamic equivalence of MSB11455 to the reference product.

Methods: This 2-way, 2-sequence, group-sequential, crossover study was conducted in healthy subjects.

Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta in healthy subjects: A randomized, double-blind trial.

MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta ). This study was designed primarily to compare the immunogenicity of MSB11455 and Neulasta . As secondary objectives, the safety and tolerability of MSB11455 and Neulasta were also compared.

Effect of preoperative antiplatelet or anticoagulation therapy on hemorrhagic complications in patients with traumatic brain injury undergoing craniotomy or craniectomy.

Objective: Traumatic brain injury (TBI) is common among the elderly, often treated with antiplatelet (AP) or anticoagulation (AC) therapy, creating new challenges in neurosurgery. In contrast to elective craniotomy, in which AP/AC therapy is mostly discontinued, in TBI usually no delay in treatment can be afforded. The aim of this study was to analyze the effect of AP/AC therapy on postoperative bleeding after craniotomy/craniectomy in TBI.

Treatment with DNases rescues hidden neutrophil elastase from aggregated NETs.

The release of neutrophil extracellular traps (NETs) is one of the weapons neutrophils have in their armory. NETs consist of extracellular chromatin fibers decorated with a plethora of cytoplasmic and granular proteins, such as the antimicrobial serine protease neutrophil elastase (NE). Because the first description of NETs as beneficial to the host, reports on their double-faced role in health and disease have considerably increased recently.

Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis.

Objectives: To compare the safety, efficacy, and immunogenicity of MSB11022 (acetate-buffered formulation), an adalimumab biosimilar, with the reference product.

Method: AURIEL-RA study was a phase 3, multicenter, randomized, double-blind, parallel group trial (NCT03052322). Patients with moderately-to-severely active rheumatoid arthritis (RA) with an inadequate response to methotrexate were randomized 1:1 to MSB11022 or reference adalimumab.

AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.

Background: MSB11022 is a proposed adalimumab biosimilar.

Objectives: To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab.

Methods: AURIEL-PsO was a double-blind randomized controlled equivalence trial, in which patients with moderate-to-severe chronic plaque-type psoriasis were randomized 1 : 1 to MSB11022 or reference adalimumab.