scholarly journals Biosimilars Have Arrived: Rituximab

Arthritis ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Maria Greenwald ◽  
John Tesser ◽  
K. Lea Sewell
Keyword(s):  
Patient Outcomes ◽  
Patent Protection ◽  
Inflammatory Diseases ◽  
Clinical Development ◽  
Web Pages ◽  
The European Union ◽  
Inflammatory Conditions ◽  
Data Exclusivity ◽  
Biologic Product ◽  
Potential Benefits

A biosimilar is a biologic product that is highly similar to a licensed biologic (“originator”) such that there are no clinically meaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data exclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to the availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential biosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety. Approval of a biosimilar is based upon the totality of the evidence demonstrating similarity to the originator. An understanding of the process of the interchangeable designation of a biosimilar is important in the context of patient outcomes. We conducted an analysis of the properties and benefits of rituximab in the treatment of inflammatory diseases, the development and approval of biosimilars, and the potential benefits of rituximab biosimilars. PubMed and ClinicalTrials.gov databases were searched for “biosimilar” and “rituximab” and regulatory and pharmaceutical company web pages were screened regarding biosimilars in development and specific guidelines developed for the approval of biosimilars. The results indicate that, at present, six rituximab biosimilar candidates are undergoing comparative clinical development, and two were recently approved in the European Union. Our analysis indicates rituximab biosimilars are expected to have a continuing role in treating inflammatory conditions such as rheumatoid arthritis.

Hyperferritinaemia: An Iron Sword of Autoimmunity

2019 ◽  
Vol 25 (27) ◽  
pp. 2909-2918 ◽  
Author(s):  
Joanna Giemza-Stokłosa ◽  
Md. Asiful Islam ◽  
Przemysław J. Kotyla
Keyword(s):  
Immune Response ◽  
Macrophage Activation ◽  
Inflammatory Diseases ◽  
Acute Phase Reactant ◽  
Catastrophic Antiphospholipid Syndrome ◽  
Inflammatory Conditions ◽  
Phase Reactant ◽  
Signalling Molecule ◽  
Cytokine Synthesis

Background:: Ferritin is a molecule that plays many roles being the storage for iron, signalling molecule, and modulator of the immune response. Methods:: Different electronic databases were searched in a non-systematic way to find out the literature of interest. Results:: The level of ferritin rises in many inflammatory conditions including autoimmune disorders. However, in four inflammatory diseases (i.e., adult-onset Still’s diseases, macrophage activation syndrome, catastrophic antiphospholipid syndrome, and sepsis), high levels of ferritin are observed suggesting it as a remarkable biomarker and pathological involvement in these diseases. Acting as an acute phase reactant, ferritin is also involved in the cytokine-associated modulator of the immune response as well as a regulator of cytokine synthesis and release which are responsible for the inflammatory storm. Conclusion:: This review article presents updated information on the role of ferritin in inflammatory and autoimmune diseases with an emphasis on hyperferritinaemic syndrome.

scholarly journals Chronic Inflammation in PCOS: The Potential Benefits of Specialized Pro-Resolving Lipid Mediators (SPMs) in the Improvement of the Resolutive Response

2020 ◽  
Vol 22 (1) ◽  
pp. 384
Author(s):  
Pedro-Antonio Regidor ◽  
Anna Mueller ◽  
Manuela Sailer ◽  
Fernando Gonzalez Santos ◽  
Jose Miguel Rizo ◽  
...  
Keyword(s):  
Chronic Inflammation ◽  
Unsaturated Fatty Acids ◽  
Inflammatory Diseases ◽  
Reproductive Age ◽  
Lipid Mediator ◽  
Female Population ◽  
Tnf Α ◽  
Potential Benefits ◽  
Cardinal Symptoms ◽  
Resolution Processes

PCOS as the most common endocrine disorder of women in their reproductive age affects between 5–15% of the female population. Apart from its cardinal symptoms, like irregular and anovulatory cycles, hyperandrogenemia and a typical ultrasound feature of the ovary, obesity, and insulin resistance are often associated with the disease. Furthermore, PCOS represents a status of chronic inflammation with permanently elevated levels of inflammatory markers including IL-6 and IL-18, TNF-α, and CRP. Inflammation, as discovered only recently, consists of two processes occurring concomitantly: active initiation, involving “classical” mediators including prostaglandins and leukotrienes, and active resolution processes based on the action of so-called specialized pro-resolving mediators (SPMs). These novel lipid mediator molecules derive from the essential ω3-poly-unsaturated fatty acids (PUFAs) DHA and EPA and are synthesized via specific intermediates. The role and benefits of SPMs in chronic inflammatory diseases like obesity, atherosclerosis, and Diabetes mellitus has become a subject of intense research during the last years and since PCOS features several of these pathologies, this review aims at summarizing potential roles of SPMs in this disease and their putative use as novel therapeutics.

scholarly journals Illuminating an Invisible Epidemic: A Systemic Review of the Clinical and Economic Benefits of Early Diagnosis and Treatment in Inflammatory Disease and Related Syndromes

2019 ◽  
Vol 8 (4) ◽  
pp. 493 ◽  
Author(s):  
Wylezinski ◽  
Gray ◽  
Polk ◽  
Harmata ◽  
Spurlock
Keyword(s):  
Healthcare System ◽  
Inflammatory Diseases ◽  
The United States ◽  
Economic Benefits ◽  
Systemic Review ◽  
Best Interest ◽  
Delayed Treatment ◽  
Inflammatory Conditions ◽  
Slow Development ◽  
The U.S

Healthcare expenditures in the United States are growing at an alarming level with the Centers for Medicare and Medicaid Services (CMS) projecting that they will reach $5.7 trillion per year by 2026. Inflammatory diseases and related syndromes are growing in prevalence among Western societies. This growing population that affects close to 60 million people in the U.S. places a significant burden on the healthcare system. Characterized by relatively slow development, these diseases and syndromes prove challenging to diagnose, leading to delayed treatment against the backdrop of inevitable disability progression. Patients require healthcare attention but are initially hidden from clinician’s view by the seemingly generalized, non-specific symptoms. It is imperative to identify and manage these underlying conditions to slow disease progression and reduce the likelihood that costly comorbidities will develop. Enhanced diagnostic criteria coupled with additional technological innovation to identify inflammatory conditions earlier is necessary and in the best interest of all healthcare stakeholders. The current total cost to the U.S. healthcare system is at least $90B dollars annually. Through unique analysis of financial cost drivers, this review identifies opportunities to improve clinical outcomes and help control these disease-related costs by 20% or more.

Inflammatory and Obstructive Disorders of Salivary Glands

1987 ◽  
Vol 66 (1_suppl) ◽  
pp. 675-679 ◽  
Author(s):  
A. Blitzer
Keyword(s):  
Salivary Glands ◽  
Fine Needle Aspiration ◽  
Chronic Conditions ◽  
Viral Infections ◽  
Inflammatory Diseases ◽  
Needle Aspiration ◽  
Ct Scans ◽  
Fine Needle ◽  
Inflammatory Conditions ◽  
Chronic Sialadenitis

Obstructive and inflammatory diseases of the salivary glands can have a congenital, traumatic, metabolic, or infectious-inflammatory cause. The acute inflammatory conditions include bacterial and viral infections, and the chronic conditions include sialoliths, strictures, chronic sialadenitis, sialectasis, and lymphoepithelial disease. The neoplastic diseases can cause obstruction and/or infection and often make the diagnosis elusive. In addition to a working knowledge of possible etiology, one needs experience with clinical examination, salivary analysis, sialography, CT scans, MRI, and fine-needle aspiration and cytology in order successfully to evaluate and manage patients with these conditions.

Inflammatory and Obstructive Disorders of Salivary Glands

1987 ◽  
Vol 66 (2_suppl) ◽  
pp. 675-679 ◽  
Author(s):  
A. Blitzer
Keyword(s):  
Salivary Glands ◽  
Fine Needle Aspiration ◽  
Chronic Conditions ◽  
Viral Infections ◽  
Inflammatory Diseases ◽  
Needle Aspiration ◽  
Ct Scans ◽  
Fine Needle ◽  
Inflammatory Conditions ◽  
Chronic Sialadenitis

Obstructive and inflammatory diseases of the salivary glands can have a congenital, traumatic, metabolic, or infectious-inflammatory cause. The acute inflammatory conditions include bacterial and viral infections, and the chronic conditions include sialoliths, strictures, chronic sialadenitis, sialectasis, and lymphoepithelial disease. The neoplastic diseases can cause obstruction and/or infection and often make the diagnosis elusive. In addition to a working knowledge of possible etiology, one needs experience with clinical examination, salivary analysis, sialography, CT scans, MRI, and fine-needle aspiration and cytology in order successfully to evaluate and manage patients with these conditions.

scholarly journals Σύνθεση και μελέτη αναστολέων λιπολυτικών ενζύμων

2016 ◽  
Author(s):  
Αικατερίνη Νικολάου
Keyword(s):  
Fatty Acids ◽  
Lysophosphatidic Acid ◽  
Inhibitory Activity ◽  
Functional Group ◽  
Inflammatory Diseases ◽  
Hydroxamic Acids ◽  
Pharmacological Properties ◽  
Ester Bond ◽  
Phospholipases A2 ◽  
Inflammatory Conditions

Phospholipases A2 (PLA2) are enzymes that hydrolyze the sn-2 ester bond of phospholipids releasing free fatty acids and lysophospholipids. Among them, arachidonic acid can be converted into a variety of eicosanoids by metabolic enzymes, while lysophosphatidylcholine (LPC), the most abundant lysophospholipid in plasma and tissues, can be converted into lysophosphatidic acid (LPA) by a secreted enzyme that exhibits lysophospholipase D activity, known as autotaxin (ATX). Both enzymes are involved in inflammatory conditions and, as a consequence, constitute attractive targets for the development of novel agents for the treatment of inflammatory diseases. Due to the fact that molecules which bear the 2-oxoamide functional group and long aliphatic chains exhibit inhibitory activity against cytosolic GIVA cPLA2, 2-oxoamideswith reduced lipophilicity were designed and synthesized. Taking into consideration that in recent years hydroxamic acids have attracted considerable attention due to their pharmacological properties, hydroxamic acids and derivatives there of were designed and synthesized, so as to evaluate their inhibitory activity against ATX.

scholarly journals DNAM-1 regulates Foxp3 expression in regulatory T cells by interfering with TIGIT under inflammatory conditions

2021 ◽  
Vol 118 (21) ◽  
pp. e2021309118
Author(s):  
Kazuki Sato ◽  
Yumi Yamashita-Kanemaru ◽  
Fumie Abe ◽  
Rikito Murata ◽  
Yuho Nakamura-Shinya ◽  
...  
Keyword(s):  
Treg Cell ◽  
Intracellular Signaling ◽  
Cell Function ◽  
Inflammatory Diseases ◽  
Mammalian Target Of Rapamycin ◽  
Foxp3 Expression ◽  
Treg Cells ◽  
Cell Dysfunction ◽  
Inflammatory Conditions ◽  
Treg Cell Function

Regulatory T (Treg) cells that express forkhead box P3 (Foxp3) are pivotal for immune tolerance. Although inflammatory mediators cause Foxp3 instability and Treg cell dysfunction, their regulatory mechanisms remain incompletely understood. Here, we show that the transfer of Treg cells deficient in the activating immunoreceptor DNAM-1 ameliorated the development of graft-versus-host disease better than did wild-type Treg cells. We found that DNAM-1 competes with T cell immunoreceptor with Ig and ITIM domains (TIGIT) in binding to their common ligand CD155 and therefore regulates TIGIT signaling to down-regulate Treg cell function without DNAM-1–mediated intracellular signaling. DNAM-1 deficiency augments TIGIT signaling; this subsequently inhibits activation of the protein kinase B–mammalian target of rapamycin complex 1 pathway, resulting in the maintenance of Foxp3 expression and Treg cell function under inflammatory conditions. These findings demonstrate that DNAM-1 regulates Treg cell function via TIGIT signaling and thus, it is a potential molecular target for augmenting Treg function in inflammatory diseases.

scholarly journals Contrasting Suitability and Ambition in Regional Carbon Mitigation

2021 ◽  
Author(s):  
Mingxi Du ◽  
Yu Liu ◽  
Qi Cui ◽  
Jintai Lin ◽  
Yawen Liu ◽  
...  
Keyword(s):  
Economic Effect ◽  
The European Union ◽  
Social Cost Of Carbon ◽  
Carbon Mitigation ◽  
Potential Cost ◽  
Cost And Benefit ◽  
Climate Action ◽  
Potential Benefits ◽  
Nationally Determined Contributions ◽  
Reduce Emissions

Abstract Substantially enhancing carbon mitigation ambition is a crucial step towards achieving the Paris climate goal. Yet this attempt is hampered by poor knowledge on the net economic effect of mitigation for each emitter, by taking into account potential cost and benefit. Here we use a global economic model with regional and sectoral disaggregation details to assess the mitigation costs for 27 major emitting countries and regions, and further contrast the costs against the potential benefits of mitigation valued as avoided social cost of carbon. We find substantial variabilities across these emitters in both cost and benefit of mitigating each ton of carbon dioxide and, more importantly, a strong negative spatial correlation between cost and benefit. The relative suitability of carbon mitigation, defined as the ratio of normalized benefit to normalized cost, shows great spatial mismatch with the mitigation ambition of emitters indicated in their first intended nationally determined contributions. China is relatively suitable for domestic carbon mitigation and could largely enhance their mitigation ambition. The European Union, which is economically less suitable to reduce domestic emissions, could work with many developing countries which are more suitable but less capable to reduce emissions. Our work provides important information to improve concerted climate action and formulate more efficient mitigation strategy.

Review of characteristics and analytical methods for determination of indomethacin

2022 ◽  
Vol 41 (1) ◽  
pp. 34-62
Author(s):  
Andrea Dandić ◽  
Katarina Rajkovača ◽  
Marija Jozanović ◽  
Iva Pukleš ◽  
Aleksandar Széchenyi ◽  
...  
Keyword(s):  
Analytical Methods ◽  
High Performance ◽  
Inflammatory Diseases ◽  
Uv Spectroscopy ◽  
Multicomponent System ◽  
Inflammatory Conditions ◽  
First Choice ◽  
Validation Parameters ◽  
Anti Inflammatory

Abstract Nonsteroidal anti-inflammatory drugs (NSAIDs) are the first choice of treatment for rheumatic disorders and other degenerative inflammatory diseases. One of them, indomethacin (INDO), is highlighted in this study. With its analgesic, antipyretic, and anti-inflammatory properties, it is one of the most powerful drugs used in various clinical trials and therapies related to the mechanism of blocking prostaglandin synthesis, thus reducing and eliminating many inflammatory conditions in patients. To ensure the efficacy and safety of this drug in pharmaceutical and clinical use, precise product quality control is required. Such control is performed with routine pharmaceutical analysis using various chemical methods by which INDO is identified as a separate active ingredient in the multicomponent system of a complete pharmaceutical form. In addition, the determination of INDO is important in clinical practice, where its concentration is determined in different biological samples, ensuring better monitoring of a particular therapy. The most commonly used methods for the determination of INDO are high-performance liquid chromatography (37% of developed methods), voltammetry (16% of developed methods), and UV spectroscopy (11% of developed methods). However, each of these methods must provide precise validation parameters. A combination of analytical methods can lead to more precise results and safer application in practice.

22. Data Protection and Data Exclusivity

2019 ◽  
pp. 497-512
Author(s):  
Justine Pila ◽  
Paul L.C. Torremans
Keyword(s):  
Data Protection ◽  
Patent Protection ◽  
Personal Data ◽  
Pharmaceutical Sector ◽  
Data Exclusivity ◽  
The Law ◽  
Data Subject

This chapter examines the law on data protection and data exclusivity. It focuses on the new GDPR Regulation. It covers rules on lawful processing of personal data, on the security of the processing, on the transparency of the processing, and on promoting compliance. It also discusses the rights of the data subject, the transfer of personal data to third countries, and the period of data exclusivity granted to the pharmaceutical sector independent of any form of patent protection.

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