Efficacy and Safety of Levilimab in Combination with Methotrexate in Patients with Active Rheumatoid Arthritis: 56-Week Results of Phase III Randomized Double-Blind Placebo-Controlled Trial SOLAR.

Unlabelled: . Previously, 24-week results of phase III double-blind, placebo-controlled randomized clinical study (SOLAR) of levilimab in subjects with active rheumatoid arthritis (RA) proved a superiority of levilimab over placebo. Here, we present 1-year efficacy and safety data of the SOLAR study.

[Long-term efficacy and safety of divozilimab during 2-year treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-4/MIRANTIBUS].

Objective: To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg every 24 weeks during 100 weeks for the treatment of patients with multiple sclerosis (MS), including relapsing-remitting multiple sclerosis (RRMS) and secondary progressive MS (SPMS) with relapses.

Material And Methods: The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS (NCT05385744) included 338 adult patients with MS distributed in a 1:1 ratio into two groups: DIV 500 mg and teriflunomide (TRF) 14 mg. After screening, subjects were included in the main CT period, which consisted of two cycles of therapy over 48 weeks, then entered an additional period from weeks 49 to 100, which included three cycles of therapy.

Automation of the control system for drying grain crops of the technological process for obtaining biodiesel fuels.

Process of grain drying is discussed by the authors, which is considered one of the preliminary stages in the technology of biodiesel production. The drying process has a number of disadvantages that affect the quality and cost of biodiesel fuel. The impossibility of uniform heating and maintaining the required temperature with minimal energy costs is considered one of the most important defects that deserve scientific research.

[Efficacy and safety of antiCD20 monoclonal antibody divozilimab during 48-week treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-4/MIRANTIBUS].

Objective: To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in comparison with the teriflunomide (TRF). The study of the efficacy and safety of the use of the drug DIV was carried out for 48 weeks of therapy.

Material And Methods: The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS included 338 adult patients with RRMS distributed in a 1:1 ratio into two groups: DIV 500 mg and TRF 14 mg.

Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study.

Objectives: Netakimab is a humanised camelid-derived monoclonal antibody targeting interleukin-17A. Here, we report the results of post-hoc analysis of the ASTERA phase 3 study (NCT03447704, February 27, 2018) in patients with active radiographic axial spondyloarthritis (r-axSpA) grouped by baseline C-reactive protein (CRP), baseline sacroiliac joint (SIJ) inflammation through magnetic resonance imaging (MRI) or presence of peripheral arthritis (PA).

Methods: In this double-blinded, multicentre, randomised, placebo-controlled, phase 3 ASTERA study, 228 adult patients with active r-axSpA received 120 mg of subcutaneous netakimab or placebo at weeks 0, 1, 2, and thereafter every other week.

The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study.

Objective And Design: The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19.

Subjects: The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.

Expanding TREC and KREC Utility in Primary Immunodeficiency Diseases Diagnosis.

Primary immunodeficiency diseases (PID) area heterogeneous group of disorders caused by genetic defects of the immune system, which manifest clinically as recurrent infections, autoimmune diseases or malignancies. Early detection of PID remains a challenge, particularly in older children with milder and less specific symptoms. This study aimed to assess TREC and KREC diagnostic ability in PID.

Statistical Approaches in the Studies Assessing Associations between Human Milk Immune Composition and Allergic Diseases: A Scoping Review.

A growing number of studies are focusing on the associations between human milk (HM) immunological composition and allergic diseases. This scoping review aims to identify statistical methods applied in the field and highlight pitfalls and unmet needs. A comprehensive literature search in MEDLINE and Embase retrieved 13,607 unique records.

A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study.

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis.

Primary efficacy of netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults.

Objectives: Netakimab (NTK) is a humanised monoclonal antibody targeting interleukin-17A, previously investigated in a phase 1 trial in healthy volunteers. Here, we report the results of a phase 2 trial, conducted to assess safety and pharmacokinetics (PK), to establish a therapeutic dose of NTK in a target population of patients with active ankylosing spondylitis (AS).

Methods: 89 patients with active AS, despite non-steroidal anti-inflammatory (NSAID) drug treatment, were randomised to receive 40, 80 or 120 mg of subcutaneous NTK or placebo at weeks 0, 1, 2 and q2wk thereafter until week 12.

[Cholelithiasis and cholesterosis of a gallbladder: a comparison of pheno-genetypic characteristics of patients].

A study was and comparison was carried out of the phenotypical and genotypical features in 115 patients with cholelythiasis and 97 patients with cholesterosis of the gallbladder. The received data proves that cholelythiasis is characterized by the domination of (prevalence) of type O I blood type, decrease of blood types B III and AB IV in comparison to the control group and to the group with cholesterosis of the gallbladder (p < 0.05), increase of the frequency of gene O decrease of frequency of gene B, decrease of heterozygosis.

[Duodenal atresia in the newborn].

The specific features of intrauterine development and pheno- and genotypic characteristics were studied in newborn infants with duodenal atresia. Main anthropometric parameters at birth (weight, height, and head and chest circumferences), concomitant developmental malformations, gene frequencies and phenotypic combinations of ABO and Rhesus factor blood groups were analyzed. The babies with duodenal atresia were found to have considerably impaired intrauterine development, multiple concomitant hypoplastic developmental abnormalities, significantly higher frequencies of the ORh+ phenotype, and lower frequencies of the ARh+ phenotype.

[Intestinal malrotation: genetics features and other congenital malformations in children].

The article is devoted to features of prenatal development of children with intestinal malrotation. Mass, height, head and chest circumferences of children after birth have been studied. In addition all associated malformations, a blood group (ABO system) and the rhesus-factor have been investigated.

[Primary cardiomyopathies in children].

Available are two cases of primary cardiomyopathy (congestive and oncocytic, respectively) in 8.5-year-old and 18-day-old girls. Analysis of section material indicates that hypertrophic cardiomyopathy is not a rare finding in newborns with interventricular septal affections.

[Iatrogenic pathology in pediatrics].

Literature and original data have been analyzed concerned with iatrogenic diseases in fetuses and children at various time periods, as well as the sequelae due to iatrogenic childhood disturbances.

[Pseudotumor processes in children ( according to material from the Filatov Children's Clinical Hospital)].

Pseudoneoplastic tumors are considered as a clinicoanatomic entity with a characteristic macro- and microscopic pattern, obscure etiology and genesis. The dissection data have demonstrated the forms of pseudoneoplastic processes. Observations of the most rare pseudotumors, such as "inflammatory" pseudotumor and tumor-like myositis ossificans are presented.

[Changes in various biochemical indices and ultrastructure of ascites tumors after combined administration of cyclophosphamide and levorin].

The fractional composition of chromatin proteins and an electron-microscopic pattern of cell ultrastructure of the Ehrlich ascite tumours and ascite lymphoma NK/Ly were studied when suppressing their growth by a combined action of cyclophosphane and polyene antibiotic. Changes in the fractional composition of chromatin proteins were found under the effect of levorin. A sharp increase in this effect and summation of heterogeneous morphological changes provoked by each of the preparation occur under a combined application of the preparations.

[Acute appendicitis in newborn infants].

Twenty-two observations of acute destructive appendicitis in newborns of 4 to 28 days of age are presented. A marked necrotic component of the inflammation with perforation and partial self-amputation is noted. It is assumed that a combination of general and local factors is important in the pathogenesis of acute appendicitis in newborns, with the leading role of systemic factors developing in newborns under conditions of hypoxia or infection: disturbance of the circulation in organs increased permeability of the histohematic barrier, loss of resistance and protective role of the intestinal flora with increasing activity of conditionally-pathogenic gram-negative (endogenous and exogenous) microbial flora.

[Changes in the state of plasma membrane proteins of tumor cells exposed to a polyene antibiotic and cyclophosphamide].

The fractional composition of the proteins of the plasmatic membranes of the Ehrlich's tumor cells treated with various drugs was studied with the use of electrophoresis in polyacrylamide gel. It was shown that the character of the changes in the fractional composition of the plasmatic membrane proteins under the effect of levorin and cyclophosphamide was different. When the drugs were used in combination, summation of the changes induced by every drug alone was observed.

[Characteristics of the ultrastructural alteration in ascitic lymphoma NK/Ly cells as affected by cyclophosphane].

The ultrastructure of cells of mouse ascites lymphoma was studied by transmission electron microscopy. It was established that cyclophosphamide treatment (6 days) reduces cell concentration in ascitic fluid and alters tumor cell ultrastructure. Apart from dystrophic and necrotized ones, there are cells exhibiting the signs of active protein synthesis.