Management of radiation-induced proctitis using submucosal endoscopic injections of autologous adipose-derived stromal vascular fraction: a case report.

Background: Standard approaches to the treatment of chronic post-radiation proctitis are associated with a high risk of complications and a high percentage of unsatisfactory results due to the reduced regenerative potential of irradiated tissues. Regenerative surgery techniques using the stromal-vascular cell fraction (SVF) based on the patient's autologous adipose tissue are a promising direction for study.

Clinical Case Description: A 76-year-old patient suffering from chronic post-radiation erosive-ulcerative proctitis, grade 4 according to RTOG-EORTC, complicated by recurrent profuse rectal bleeding, underwent local autotransplantation of SVF into the submucosal layer of the rectum and pararectal connective tissue.

Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study.

Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, has been developed as a treatment for relapsing multiple sclerosis (RMS) which can be self-administered at home.

Objective: To investigate the efficacy and safety of ofatumumab in RMS patients from Japan and Russia.

Methods: APOLITOS included a 24-week, double-blind, placebo-controlled core-part followed by an open-label extension-part.

Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.

Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS).

Objective: To demonstrate the bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore the effect of ofatumumab on B-cell depletion.

Methods: APLIOS (NCT03560739) is a 12-week, open-label, parallel-group, phase-2 study in patients with RMS receiving subcutaneous ofatumumab 20 mg every 4 weeks (q4w) (from Week 4, after initial doses on Days 1, 7, and 14).

[The efficacy and safety of siponimod in the Russian population of patients with secondary progressive multiple sclerosis].

Aim: To study the efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis (SPMS) in the Russian population of the EXPAND study.

Material And Methods: Ninety-four patients with SPMS from Russia were included in the analysis. Sixty-three patients received siponimod and 31 patients received placebo.

[Efficacy, tolerability and safety of the treatment with teberif: the results of a 2-year randomized clinical trial of treatment naïve patients with remitting multiple sclerosis, who have not received DMT, after switching from other interferon β-1a].

Objectives: To evaluate efficacy, safety, and tolerability of the treatment with teberif/interferon β-1a, to analyze safety, tolerability and dynamics of key efficacy variables after switching from referent drug rebif to biosimilar teberif in patients with remitting multiple sclerosis (RMS).

Material And Methods: During the main period of the international multicenter randomized study patients were randomized to receive treatment with teberif for 52 weeks, or rebif for 52 weeks, or placebo for 16 weeks to evaluate efficacy and safety of treatment. After the main study period, patients were group-independently switched to take open-label teberif treatment during the next 48 weeks.

[An impact of glatiramer acetate (timexon) on the signs of neurodegeneration process in the neuronal layer of the retina in patients with relapsing-remitting multiple sclerosis].

Aim: To perform a comparative study of the results of optical coherence tomography of the retina in patients with relapsing-remitting multiple sclerosis, treated with glatiramer acetate (timexon).

Material And Methods: The study included 19 patients (16 women and 3 men) with relapsing-remitting multiple sclerosis who were treated with the glatiramer acetate generic drug timexon (BIOCAD, Russia). Dynamic changes in the main parameters of the optical coherence tomography linked with neurodegeneration manifestations in the retina during the year of the study were evaluated.

[A comparative placebo-controlled clinical study on the efficacy and safety of interferon beta-1a for subcutaneous injections in patients with remitting multiple sclerosis: results of the first year of observations].

Aim: To prove the equivalent efficacy of teberif (BCD-033, interferon beta-1) and rebif (interferon beta-1a) in patients with remitting multiple sclerosis (RMS).

Material And Methods: A multicenter double blind placebo-controlled comparative randomized III phase study included 163 patients with RMS. Patients were randomized into three equal groups (teberif, rebif or placebo).

[Comparative, placebo-controlled clinical study of efficacy and safety of glatiramer acetate 20 mg in patients with relapsing-remitting multiple sclerosis: results of the first year of the study].

Unlabelled: The article presents the results of international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. The goal of the study was to demonstrate non-inferiority of BCD-063 (glatiramer acetate, manufactured by JSC «BIOCAD», Russia) to copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd.

[A retrospective analysis of the effect of pregnancy on the course of multiple sclerosis].

Aim: For a long time it was believed that pregnancy worsens the clinical course of multiple sclerosis. In several European countries, there have been several studies that have demonstrated remission of autoimmune aggression during pregnancy. We studied the effect of pregnancy on the course of multiple sclerosi.

The case of diagnostics of invasive pulmonary aspergillosis by in vivo probe-based confocal laser endomicroscopy of central and distal airways.

We present a case of 41-year-old patient with invasive pulmonary aspergillosis (IPA) in which probe-based confocal laser endomicroscopy (pCLE) imaging of central and distal airways was first performed in vivo. pCLE imaging showed the signs of complete or partial destruction of elastin network of alveolar wall with fibrillar branching fluorescent structures in the zone with typical IPA changes on HRCT.

Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics.

Background And Objective: Probe-based confocal laser endoscopy (pCLE) allows for real-time non-invasive histological imaging via bronchoscopy. Interpreting CLE images and correlating with traditional histopathology remains challenging. We performed an ex vivo study to evaluate the correlation between light microscopy findings and pCLE imaging of primary lung carcinoma.

[The effect of genetic factors on the phenotypic expression of multiple sclerosis].

A total of 326 patients with multiple sclerosis (MS) according to the McDonald criteria (2005) were recruited to the study. Single nucleotide polymorphisms in the CD40 gene (rs6074022, rs1883832, rs1535045 and rs11086998) and the KIF1B gene (rs10492972 and rs3135388) were genotyped using TaqMan technology. We found a significant association of rs1883832 (risk allele T, OR=1.

[Combined therapy of aggressive remitted multiple sclerosis with mitoxantrone in combination with copaxone].

Patients with so called aggressive multiple sclerosis were treated. The course of disease is considered aggressive if there are clinical and tomographic signs of high disease activity with the frequency of exacerbations not less than 3 during 2 years. Nine patients with this course of disease were examined.

[Chronic non-specific splanchnopathies in patients with lung tuberculosis].

The aim of this work was to study the frequency and structure of chronic splanchnopathies and their influence on the outcome of lung tuberculosis. Comorbidity was investigated in 1229 patients attending a regional TB dispensary. Pathogens isolated in 44.