A5018132469- Rheumatoid Arthritis Research and Therapies
- Spondyloarthritis Studies and Treatments
- Psoriasis: Treatment and Pathogenesis
- Biosimilars and Bioanalytical Methods
- Autoimmune and Inflammatory Disorders Research
- Systemic Lupus Erythematosus Research
- Monoclonal and Polyclonal Antibodies Research
- Fibromyalgia and Chronic Fatigue Syndrome Research
- Lymphoma Diagnosis and Treatment
- Dermatological and COVID-19 studies
- Osteoarthritis Treatment and Mechanisms
- Gout, Hyperuricemia, Uric Acid
- Inflammatory Myopathies and Dermatomyositis
- Chemotherapy-related skin toxicity
- Autoimmune Bullous Skin Diseases
- Pain Mechanisms and Treatments
- Chronic Lymphocytic Leukemia Research
- Cutaneous lymphoproliferative disorders research
- Bone and Joint Diseases
- Dermatologic Treatments and Research
- Pharmacological Effects of Natural Compounds
- Viral Infections and Immunology Research
- Medical and Biological Sciences
- Tuberculosis Research and Epidemiology
- Inflammatory mediators and NSAID effects
Hospital at Smolensk Station
2016-2024
Central Clinical Hospital
2024
Center for Rheumatology
2023-2024
Russian Railways
2018-2024
Clinical Hospital No. 8
2024
Smolensk State Medical University
2021-2022
Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"
2012-2021
To evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment methotrexate (MTX).In this 24-week multicentre, placebo-controlled, double-blind study, were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, 4 or placebo plus MTX. The primary endpoint was proportion achieving an American College Rheumatology 20% (ACR20) response at week 12. secondary endpoints included percentage subjects Disease...
The aim – to evaluate the clinical effectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of seniprutug (BCD-180) in patients with radiographic active axial spondyloarthritis (r-axSpA, or ankylosing spondylitis). Subjects methods . 260 r-axSpA inadequate response nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized into three groups: at doses 5 mg/kg 7 mg/kg, placebo. BCD-180 was administered on weeks 0–12–36. Patients placebo group switched a dose week 24...
The search for new therapeutic options the treatment of systemic sclerosis (SSc) is an urgent issue in rheumatology. article presents results double-blind, randomized, placebo-controlled phase III clinical trial BCD-132-5/LIBERIUS on efficacy and safety divozilimab (BCD-132) SSc. Objective : to investigate patients with SSc compared placebo. Material methods . After enrolment study, received or placebo 48 weeks, after which they were switched open-label therapy until week 96. Results...
The article considers the results of an international multicenter randomized clinical trial efficacy and safety brand-name drug rituximab (MabThera), a monoclonal antibody against CD20 antigen B cells, its biosimi-lar (Acellbia®) (the BIORA study) in patients with rheumatoid arthritis (RA) refractory to therapy tumor necrosis factor- а inhibitors. Objective: provide evidence for therapeutic equivalence Acellbia® MabThera® also assess their interchangeability. Subjects methods. enrolled adult...
The article presents the results of three-year use netakimab (NTK) in patients with ankylosing spondylitis (AS) as part phase III BCD-085-5/ASTERA study. Objective : to evaluate long-term efficacy and safety NTK over a period active AS. Material methods . – double-blind, multicenter, randomized clinical trial that enrolled AS (BASDAI ≥4) back pain intensity ≥4 on numeric rating scale inefficacy or intolerance non-steroidal anti-inflammatory drugs biologic drugs. A total 228 were 1:1 ratio...
Netakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A. Objective . The main objective of BCD-085-5/ASTERA study was to prove superiority NTK over placebo and assess its’ safety in patients with active AS. Subjects methods double-blind, multicenter, randomized, placebo-controlled, phase III study, which included 228 adult AS, persisting despite treatment NSAIDs. AS considered at BASDAI score ≥ 4.0. Patients were blindly randomized (1:1) receive subcutaneous injections...
Netakimab (NTK) is a humanized anti-interleukin-17A monoclonal antibody. To date, the drug has been approved to treat ankylosing spondylitis (AS), psoriatic arthritis, and plaque psoriasis. The paper gives data obtained during 52-week follow-up of AS patients in phase III ASTERA study. Objective : study efficacy safety NTK when used long with active AS. Patients methods . investigation enrolled 228 AS, whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective....
NiSpAR is a non-interventional, multicenter study whose aim was to describe cohort of patients with non-radiological axial spondyloarthritis (nr-axSpA) and approaches its diagnosis in the Russian Federation. Material methods. The involved 20 research centers different regions work consisted two phases: retrospective data collection 12 months before enrolment prospective observation whom nr-axSpA confirmed (104 weeks). included 272 who met inclusion exclusion criteria (Full Analysis Set,...
Objective: to analyze the results of tofacitinib (TOFA) therapy in real clinical practice according All-Russian Arthritis Registry (OREL). Subjects and methods. The OREL included 347 patients (286 (82%) women 61 (18%) men) with rheumatoid arthritis (RA) who initiated TOFA therapy. male:female ratio was 1:4.7. patients’ median age at onset disease 42 years; its duration 8 years. Most registry had extended- (n=171 (52%)) or late- (n=148 (45%)) stage RA. Results discussion. Prior initiation...
The Russian biotechnological company «BIOCAD» has designed a chimeric monoclonal antibody against CD20 (BCD-020, Acellbia®) that is biosimilar of rituximab (RTM; MabThera®, F. Hoffmann-La Roche Ltd., Switzerland). In recent years, there been evidence RTM can be used at lower doses than those given in the standard recommendations and instructions for use this drug. This serves as basis BCD-020-4/ALTERRA (ALTErnative Rituximab regimen Rheumatoid Arthritis) trial, objective which was to...
<h3>Background</h3> BCD-085 is an innovative humanised monoclonal antibody against interleukin-17 with genetically modified Fc- and CDR-regions, aimed to improve treatment outcomes in patients several autoimmune disorders. <h3>Objectives</h3> This abstract presents the results of double-blind placebo controlled dose-finding phase II clinical study efficacy safety subcutaneous ankylosing spondylitis. <h3>Methods</h3> The was conducted as international multicenter randomised study. enrolled 88...
To compare the efficacy and safety of ketoprofen plasters diclofenac after 3 weeks administration in patients with osteoarthritis-related knee pain.This multicenter, randomized, active-controlled, open-label, parallel-group, noninferiority phase III study randomized 236 adults pain for plaster 30 mg twice daily (n = 118) or 15 once 118). The primary end point was mean change from baseline to week intensity score during walking, as measured by a 100-mm visual analog scale predefined margin...
Background . Previously, 24-week results of phase III double-blind, placebo-controlled randomized clinical study (SOLAR) levilimab in subjects with active rheumatoid arthritis (RA) proved a superiority over placebo. Here we present 1-year efficacy and safety data the SOLAR study. Objective – to evaluate combination methotrexate (MTX) MTX resistant RA. Methods The was conducted at 21 sites Russia Belarus. All have completed between November 2019 October 2021.154 adults, aged ≥18 years...
Psoriatic arthritis (PsA) is a chronic immunoinflammatory disease of the joints, spine and entheses from group spondyloarthritis, which usually observed in patients with psoriasis. In recent years, axial form PsA (axPsA) has been actively researched. However, there insufficient data on approaches to diagnosis treatment axPsA real-life clinical practice. This article presents results an interim analysis non-interventional multicenter observational study practice (NiSaXPA) Russian centers....
The article contains the data obtained during 156-week follow-up of patients with ankylosing spondylitis (AS) in ASTERA phase III study. Objective : to evaluate effect impact netakimab (NTK) on quality life (QoL), back pain and work capacity active AS. Material methods . study enrolled 228 AS who were randomized 1:1 receive NTK 120 mg or placebo. At week 52, Group 1 achieved ASAS20 continued therapy (NTK at a dose once every 2 weeks) until 156. Patients (placebo/NTK) received drug...
This article presents results from two clinical trials of infliximab biosimilar, BCD-055, including comparative data on the pharmacokinetics (PK), efficacy and safety BCD-055 innovator (IFX) in patients with ankylosing spondylitis (AS). Objective : The purpose phase I study ASART-1 was to evaluate pharmacokinetic profile prove its equivalence Remicade®, III ASART-2 conducted tolerability comparison Remicade® active AS. Patients methods Both studies were as international multi-center...
The JAK inhibitor tofacitinib (TOFA) blocks the intracellular signaling pathway that activates synthesis of cytokines and mediators involved in development pain central sensitization (CS), which determines rapid analgesic effect. However, it is not clear how reduction associated with achieving low activity rheumatoid arthritis (RA). aim study was to assess relationship between early clinical response a decrease after 3 6 months. Material methods. group consisted 88 RA patients (age – 53±11.5...
Научно-практическая ревматология.2019;57(6):668-677 О р и г н а л ь ы е с д о в я 1 ФГБНУ «Научно-исследовательский институт ревматологии им.В.А.Насоновой», Москва, Россия; 2 ФГБОУ ВО «Северо-Западный государственный медицинский университет им.И.И.Мечникова» Минздрава России, Санкт-Петербург, 3 «Казанский университет» Казань, 4 ГАУЗ НСО «Городская клиническая поликлиника №1», Новосибирск, 5 НУЗ «Отделенческая больница на станции Смоленск ОАО «РЖД», Смоленск, 6 ГБУЗ НО «Нижегородская...
Prevalence of ankylosing spondylitis (AS) is about 0.2–0.8% and increasing during last decades in Russia. Coronary Heart Disease (CHD) plays an important role mortality patients with rheumatic diseases. AS mainly affects able-bodied age persons thus having a significant social economic impact. There plenty biomarkers AS, including those for early diagnosis. Purpose. To study the level uric acid (UA) its development AS. Materials methods. A total 72 medical charts hospitalized at Smolensk...
A description of the clinical case a female patient with onset rheumatoid arthritis (RA) in an old age is presented. The disease began acutely against background comorbid pathology and was manifested by high activity, multiple involvement large small joints, their swelling. thorough examination performed to exclude paraneoplastic syndrome. Comorbid conditions impaired renal function did not allow prescription basic drugs; good effect obtained from methylprednisolone. Management elderly...
The article discusses the results of a comparative phase III clinical trial efficacy and safety biosimilar Complarate (CPR; JSC Generium, Russia) reference drug Actemra (ACT; F. Hoffmann-La Roche Ltd., Switzerland) to assess their equivalence in patients with rheumatoid arthritis, RA (NCT06475508 clinicaltrials.gov). Materials methods. Male female aged 18–75 years moderate high disease activity insufficient response methotrexate (MTX) monotherapy and/or poor tolerability MTX or intolerance...
Objective : The aim of the NiSaXPA study is to evaluate quality diagnosing, socio-demographic characteristics and treatment tactics patients with axial psoriatic arthritis (axPsA) in real-world clinical practice Russian Federation. Material methods . involved 600 from 21 centers Results discussion. diagnosis axPsA was confirmed 357 (59.5%) according centralized expert assessment. All lesions met criteria guidelines for PsA. Of these, 201 (69%) had radiologically significant sacroiliitis (SI)...
INTRODUCTION. Low-dose methotrexate (less than 30 mg/week) is the standard therapy for rheumatic diseases. Methotrexate overdose due to errors by patients or medical staff may lead severe complications and life-threatening conditions. CASE DESCRIPTION . This article presents a retrospective analysis of records three clinical cases with toxic reactions (one probable two confirmed cases) observed in rheumatology at general preventive medicine clinics Kaliningrad Smolensk regions 2019–2024. The...