A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence.

Introduction: The infliximab biosimilar SB2 was approved in the EU (2016, Flixabi®) and the US (2017, Renflexis®) for the same indications as the reference product (Remicade®) based on a robust analytical and clinical data package.

Areas Covered: This systematic literature review summarizes available analytical and clinical data on SB2, including randomized controlled clinical trials and real-world evidence studies. Overall, 184 articles and congress abstracts were identified (excluding duplicates), whereof 5 reports on analytical data, four reports on two randomized controlled trials and 13 reports of real-world evidence studies were included.

Personalizing Treatment in IBD: Hype or Reality in 2020? Can We Predict Response to Anti-TNF?

The advent of anti-TNF agents as the first approved targeted therapy in the treatment of inflammatory bowel disease (IBD) patients has made a major impact on our existing therapeutic algorithms. They have not only been approved for induction and maintenance treatment in IBD patients, but have also enabled us to define and achieve novel therapeutic outcomes, such as combination of clinical symptom control and endoscopic remission, as well as mucosal healing. Nevertheless, approximately one third of treated patients do not respond to initiated anti-TNF therapy and these treatments are associated with sometimes severe systemic side-effects.

Hierarchical Levels of Biological Systems and their Integration as a Principal Cause for Tumour Occurrence.

The development of new theories, mathematical methods and models for effective control of complex systems is one of the main problems for modern science. Biological systems are complex and hierarchically organized, with the behaviour of higher levels influencing the dynamics of the lower ones and vice versa. Hierarchical organization can be observed from subcellular to supercellular levels.

Invasion by the Alien Tree Alters Ecosystem Functions in a Temperate Deciduous Forest.

Alien invasive species can affect large areas, often with wide-ranging impacts on ecosystem structure, function, and services. is a widespread invader of European temperate forests, where it tends to form homogeneous stands and limits recruitment of indigenous trees. We hypotesized that invasion by would be reflected in the nutrient contents of the native species' leaves and in the respiration of invaded plots as efficient resource uptake and changes in nutrient cycling by probably underly its aggressive invasiveness.

Earlywood and Latewood Stable Carbon and Oxygen Isotope Variations in Two Pine Species in Southwestern China during the Recent Decades.

Stable isotopes in wood cellulose of tree rings provide a high-resolution record of environmental conditions, yet intra-annual analysis of carbon and oxygen isotopes and their associations with physiological responses to seasonal environmental changes are still lacking. We analyzed tree-ring stable carbon (δC) and oxygen (δO) isotope variations in the earlywood (EW) and latewood (LW) of pines from a secondary forest () and from a natural forest () in southwestern China. There was no significant difference between δC and δC in , while δC was significantly higher than δC in .

Facets of the Fundamental Content Dimensions: Agency with Competence and Assertiveness-Communion with Warmth and Morality.

Agency (A) and communion (C) are fundamental content dimensions. We propose a facet-model that differentiates A into assertiveness (AA) and competence (AC) and C into warmth (CW) and morality (CM). We tested the model in a cross-cultural study by comparing data from Asia, Australia, Europe, and the USA (overall = 1.

Membrane-Mediated Oligomerization of G Protein Coupled Receptors and Its Implications for GPCR Function.

The dimerization or even oligomerization of G protein coupled receptors (GPCRs) causes ongoing, controversial debates about its functional role and the coupled biophysical, biochemical or biomedical implications. A continously growing number of studies hints to a relation between oligomerization and function of GPCRs and strengthens the assumption that receptor assembly plays a key role in the regulation of protein function. Additionally, progress in the structural analysis of GPCR-G protein and GPCR-ligand interactions allows to distinguish between actively functional and non-signaling complexes.

Taurolidine and congeners activate hTRPA1 but not hTRPV1 channels and stimulate CGRP release from mouse tracheal sensory nerves.

Taurolidine has long been in clinical use as an antimicrobial irrigation that does not impede wound healing. It can even be administered intravenously (30 g/day) to treat sepsis or to exert newly recognized antineoplastic actions. Only one irritant effect is reported, that is, to temporarily induce burning pain of unknown origin when applied to body cavities or peripheral veins.

Low cytoplasmic and nuclear KPNA2 expression in radiotherapy-treated head and neck squamous cell cancer is associated with an adverse outcome.

Background: KPNA2 has effects on carcinogenesis, cell differentiation and transcriptional regulation. KPNA2 has been linked to DNA damage repair by its role to import the DNA double strand break repair complex MRN into the nucleus. The aim of our study was to evaluate the prognostic value of KPNA2 expression in both cytoplasmic and nuclear location in patients with HNSCC treated with radio(chemo)therapy.

H2S- and NO-Signaling Pathways in Alzheimer's Amyloid Vasculopathy: Synergism or Antagonism?

Alzheimer's type of neurodegeneration dramatically affects H2S and NO synthesis and interactions in the brain, which results in dysregulated vasomotor function, brain tissue hypoperfusion and hypoxia, development of perivascular inflammation, promotion of Aβ deposition, and impairment of neurogenesis/angiogenesis. H2S- and NO-signaling pathways have been described to offer protection against Alzheimer's amyloid vasculopathy and neurodegeneration. This review describes recent developments of the increasing relevance of H2S and NO in Alzheimer's disease (AD).

Pursuit of communal values in an agentic manner: a way to happiness?

The present research studies the association between traits, values, and life satisfaction. While values should influence the direction of an individual's goals and behavior, his/her traits impact effort-expenditure, efficiency, and persistence in goal-pursuit. We apply the framework of the "Big Two" of agency and communion (Bakan, 1966) for distinguishing the content of values and traits.

Bone morphogenetic protein-mediating receptor-associated Smads as well as common Smad are expressed in human articular chondrocytes but not up-regulated or down-regulated in osteoarthritic cartilage.

Bone morphogenetic proteins (BMPs) are supposed to be important for cartilage matrix anabolism. In this study, we investigated whether the intracellular mediators of BMP activity, Smads 1, 4, 5, and 8, are expressed in normal human articular chondrocytes in vivo and in vitro and whether alterations in expression and distribution pattern are found in osteoarthritic cartilage or in vitro after stimulation with interleukin (IL)-1, because down-regulation of these mediators could be responsible for the decrease of anabolic activity in osteoarthritic cartilage. RNA was isolated from normal and osteoarthritic human knee cartilage and analyzed by (quantitative) polymerase chain reaction (PCR) technology.