Vadim I. Mazurov

Bio: Vadim I. Mazurov is an academic researcher. The author has contributed to research in topics: Rheumatoid arthritis & Population. The author has an hindex of 3, co-authored 19 publications receiving 24 citations.

Coronavirus disease 2019 (COVID-19) and immune-mediated rheumatic diseases. Recommendations of the association of rheumatologists of Russia

Abstract: In mid-2021, the SARS-CoV-2 (Severe Acute Respiratory coronavirus 2) infection, which caused the coronavirus disease (COVID-19) pandemic, affected more than 157 million people in all regions of the world and led to more than 3.2 million deaths. It is assumed that elderly age, uncontrolled inflammation, anti-inflammatory therapy, comorbid pathology, genetic and other factors can potentially lead to an increase in “sensitivity” to viral and bacterial infections, including SARS-CoV-2. The new version of the recommendations of the Association of Rheumatologists of Russia formulates the main provisions concerning the tactics of managing patients with Immune-mediated Rheumatic Diseases during the ongoing COVID-19 pandemic.

Factors affecting the results of analgesic therapy. Results of the Russian multicentre study of NOTE (NSAID: Open-label Trial of Efficacy).

Abstract: Non-steroidal anti-inflammatory drugs (NSAIDs) are most popular medications for the treatment of pain in common musculoskeletal diseases such as osteoarthritis (OA) and non-specific low back pain (LBP). However, the factors affecting the effectiveness of these drugs have not been determined fully. Aim: to identify factors affecting the effectiveness of NSAIDs in patients with OA and LBP. Materials and methods. An observational study was conducted to evaluate the effectiveness of a 2-week course of NSAIDs in OA and LBP in real clinical practice. The study group consisted of 3604 patients with OA and LBP (60.6% women and 39.4% men, mean age 55.0±13.4 years). According to the study design, aceclofenac (Airtal) and other NSAIDs used in the ratio 1:1. The main criterion of effectiveness was the frequency of complete pain relief after 2 weeks of therapy. In addition, the decrease of pain and general health were determined on a 10-point numerical rating scale (NRS). We compared the frequency of complete pain relief in patients who had and did not have the studied factors. The value of the studied factors was determined using OR (95% CI). Results and discussion. Most patients received aceclofenac (54.9%), as well as diclofenac (2.0%), ketoprofen (1.9%), lornoxicam (2.2%), meloxicam (13.7%), naproxen (2.1%), nimesulide (5.8%), celecoxib (5.9%), ethicoxib (7.1%) and other NSAIDs (4.4%); 56.2% of patients received muscle relaxants, mainly tolperisone (74.7%), vitamin B (10.4%), and proton pump inhibitors (42.8%). Complete pain relief was achieved in 54.8% of patients. The pain decrease and general health improvement were (for NRS) 63.9±13.4% and 61.7±14.8%, respectively. The efficacy of aceclofenac was slightly higher than in the whole group: complete pain relief was in 59.9% of patients. Adverse events in aceclofenac use were observed in 2.3% of patients, other NSAIDs-from 2.4 to 14.1%. The frequency of complete pain relief was higher in men: OR 1,239 (95% CI 1.08-1.418; p=0.002), who had the first episode of pain - OR 3.341 (95% CI 2.873-3.875; p=0.000), a good" response " to NSAIDs in history - OR 1.656 (95% CI 1.385-1.980; p=0.000) and received NSAIDs in combination with muscle relaxants - OR 1.218 (95% CI 1.067-1.390; p=0.004). The effect of therapy is lower in patients 65 years and older-OR 0,378 (95% CI 0.324-0.442; p=0,000), with body mass index >30 kg/m² - OR 0.619 (95% CI 0.529-0.723; p=0.000), with severe pain (≥7 points NRS) - OR 0.662 (95% CI 0.580-0.756; p=0.002), with pain at rest, - OR 0.515 (95% CI 0.450-0,589; p=0.000), pain at night - OR 0.581 (95% CI 0.501-0.672; p=0.000) and the presence of stiffness - OR 0.501 (95% CI 0.438-0,573; p=0.000). Treatment results are significantly worse in the cases of combination of LBP and joint pain, as well as pain in the trochanter major and pes anserinus area (p<0.001). Conclusion. NSAIDs are the first-line medications for the pain treatment in LBP and OA. Aceclofenac is effective and safe in this conditions. When carrying out analgesic therapy should take into account factors that affect the effectiveness of treatment: old age, overweight, insufficient effect of NSAIDs in history, severe pain, signs of "inflammatory" pain, multiple sources of pain.

Current, effectiveness of therapy and outcomes of new coronavirus infection: preliminary analysis

Abstract: Relevance. Verification of a new coronavirus infection (COVID-19) requires clear algorithms for the diagnosis and treatment of patients, depending on clinical, laboratory and instrumental dates. Timely and informed decisions on optimizing management tactics and prescribing proactive anti-inflammatory therapy before development of a complete symptom complex life threatening conditions are needed in some cases. Aim of the study. To analyze the course and outcomes of a new coronavirus infection, depending on the initial characteristics of the patients and treatment options. Materials and methods. A preliminary analysis of the case histories of 129 people hospitalized in the center for treating patients with a new coronavirus infection at North-Western State Medical University n.a. I.I. Mechnikov was made by random sampling. Among the hospitalized patients there were 67 men (51.9%), the average age was 57.9 ± 16.4 years, 62 women (48.1%), and the average age was 60.2 ± 13.6 years. During hospitalization, all patients underwent standard clinical laboratory and instrumental examination, as well as determination of saturation (S p O 2 ), markers of the cytokine storm (CRP, ferritin, AST, D-dimer, fibrinogen, lymphocytes), compute tomography (CT) of the lungs. The effectiveness and safety of therapy was evaluated by the outcome (recovery, death), as well as by the presence of adverse events in the background of the therapy. Statistical processing of the research results was carried out using the Statistica 12 for Windows application software package, the significance of differences between the two relative values was evaluated using the Student t -test ( t > 2, p < 0.05). Results. Fatal outcomes were significantly more frequently recorded among patients of older age groups and males. The presence of concomitant diseases such as obesity, diabetes mellitus, pathology of the cardiovascular system was accompanied by more frequent fatal outcomes. That allows considering comorbidity as a risk factor for severe course and poor prognosis of COVID-19. However, in general, in the presence of the indicated forms of concomitant diseases, it was not possible to establish significant differences with the outcomes of COVID-19, which may be due to an insufficient amount of patients. Predictors of fatal outcome was low values of saturation, the presence of respiratory failure, a significant amount of lung tissue damage (CT-3-4), as well as high values of CRP, ferritin, AST, D-dimer, neutrophilia, lymphopenia, thrombocytopenia. The use of anticytokine drugs (ACD) in complex therapy can be considered a favorable predictor of outcome, which indicates the advisability of wider use. The materials of the study allow not only a preliminary assessment of the course and effectiveness of complex therapy using anticytokine drugs with COVID-19 in patients with comorbid diseases, but also to develop therapeutic and diagnostic algorithms in patients of this category.

Fri0391 netakimab improves patient-related outcomes in patients with radiological axial spondyloarthritis: results from randomised phase 3 trial (astera)

Abstract: Background chronic pain, stiffness, fatigue and limited spinal mobility significantly affect quality of life (QoL) in patients (pts) with axial spondyloarthritis (axSpA). There is increasing evidence that IL-17 blockade is highly effective in this pts’ population and show benefits in terms of multiple patient-reported outcomes (PROs) in both non-radiological (nr) and radiological (r) axSpA. Objectives To evaluate early effects of netakimab (NTK) on PROs in pts with active r-axSpA, based on data of 16-week observation from ongoing phase 3 ASTERA study (NCT03447704). Methods ASTERA is a phase 3 international double-blind placebo(PBO)-controlled clinical study. After completion of screening 228 eligible adult pts with r-axSpA (mNew York criteria, 1984), which remained active (BASDAI ≥ 4.0) despite the standard non-steroidal anti-inflammatory drugs (NSAIDs), were randomly assigned (1:1) to receive 120 mg NTK or placebo (PBO) at Week (Wk) 0, 1, 2 and then q2wk through Wk 16. After Wk 16 all patients will continue/be switched to receive NTK up to week 52. PROs were total back pain (10-item numerical range scale), BASDAI, BASFI. Work productivity and QoL were also assessed by Work Productivity and Activity Impairment (WPAI) and 36-item Short Form Health Survey (SF-36), respectively. Results Baseline characteristics were similar between treatment arms. The mean age at baseline was 39.14±9.99 years, 75.88% of patients were male and the mean symptoms duration was 4.3±4.48 years. All patients had active (mean BASDAI: 6.21±1.55) r-axSpA, 76.8% of patients were naive to any biological treatment. Mean total back pain score at baseline was 6.7±1.6 in NTK group and 6.8±1.5 in PBO arm. At Wk1 the difference in total back pain score between study arms became statistically significant (Figure 1). At Wk 16 use of NTK was associated with statistically significant improvements from baseline in BASDAI (-2.8 vs 0.2, p Conclusion NTK in treatment of patients with r-axSpA showed rapid improvement in PRO, WP and QoL and was accompanied with improvement in physical function and disease activity. Disclosure of Interests Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: paiment from Pfizer, Novartis, Abbvie, Biocad, Selgene, MSD, Sanofy does not exceed 10 000 euros, V Mazurov Grant/research support from: JSC BIOCAD, Shandor Erdes Grant/research support from: JSC BIOCAD, Speakers bureau: JSC BIOCAD, Tatiana Dubinina: None declared, Olga Nesmeyanova Grant/research support from: JSC BIOCAD, Elena Ilivanova Grant/research support from: JSC BIOCAD, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Grant/research support from: JSC BIOCAD, Ekaterina Chernyaeva Employee of: JSC BIOCAD, Roman Ivanov Employee of: JSC BIOCAD

Fri0108 short-term efficacy of bcd-089, novel monoclonal anti-il-6 receptor antibody, in combination with methotrexate in patients with rheumatoid arthritis: 12-week results of phase 2 aurora study

Abstract: Background: In the previous phase 1 study BCD-089 (INN: levilimab) was well-tolerated, had favorable safety profile and low immunogenicity1. Here we report 12-week efficacy and safety results of ongoing phase 2 clinical study of BCD-089 in patients with active RA. Objectives: This study is aimed to assess efficacy and safety of 2 dosing regimens of BCD-089 in patients with MTX-IR active RA. Methods: During this multicenter double-blind placebo-controlled randomized clinical study (NCT03455842) 105 MTX-IR patients with active RA (ACR2010) were assigned (1:1:1) to receive 162 mg of BCD-089 s.c. (QW arm and Q2W arm) or PBO. MTX (10-25 mg/week) was used in all groups. After completion of 12-week blinded period patients from QW/Q2W arms continued the treatment, patients from PBO arm were switched to BCD-089 Q2W until Wk56. The primary efficacy endpoint was the rate of ACR20 at Wk12. Secondary endpoints included ACR50/70 and DAS28-CRP(4). The safety was routinely evaluated. Results: The efficacy analysis showed that 95% confidence interval for BCD-089 treatment effect relative to PBO was [38.45 – 81.55] for QW arm and [16.53 – 63.4] for Q2W arm, which confirms the superiority to PBO of either dosing regimens. Summary of efficacy results is presented in table 1. The majority of adverse events (AE) were laboratory abnormalities. The spectrum of AEs is similar to other IL6R inhibitors (Table 2). Three serious AE (SAEs) were reported: community-acquired pneumonia (QW arm, treatment-related), acute cholecystitis (PBO arm, not related, did not lead to treatment discontinuation), and acute heart failure leading to death (Q2W arm, not related). One case of moderate local reaction (erythema) was reported in QW arm. Conclusion: BCD-089 in combination with MTX had superior efficacy compared with MTX plus PBO in MTX-IR patients with active RA. BCD-089 showed safety profile consistent with other IL6R inhibitors. Further clinical studies are needed. Reference: [1] Khlyabova P, et al. doi: 10.1136/annrheumdis-2018-eular.2410 Disclosure of Interests: V Mazurov Grant/research support from: JSC BIOCAD, Evgeniy Zotkin: None declared, Elena Ilivanova Grant/research support from: JSC BIOCAD, Tatyana Kropotina Grant/research support from: JSC BIOCAD, Tatyana Plaksina Grant/research support from: JSC BIOCAD, Olga Nesmeyanova Grant/research support from: JSC BIOCAD, Nikolaj Soroka: None declared, Alena Kundzer: None declared, Anton Lutskii Employee of: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Ekaterina Chernyaeva Employee of: JSC BIOCAD, Roman Ivanov Employee of: JSC BIOCAD

Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

Abstract: Summary Background Since December, 2019, Wuhan, China, has experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Epidemiological and clinical characteristics of patients with COVID-19 have been reported but risk factors for mortality and a detailed clinical course of illness, including viral shedding, have not been well described. Methods In this retrospective, multicentre cohort study, we included all adult inpatients (≥18 years old) with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China) who had been discharged or had died by Jan 31, 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. We used univariable and multivariable logistic regression methods to explore the risk factors associated with in-hospital death. Findings 191 patients (135 from Jinyintan Hospital and 56 from Wuhan Pulmonary Hospital) were included in this study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p Interpretation The potential risk factors of older age, high SOFA score, and d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future. Funding Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Science Grant for Distinguished Young Scholars; National Key Research and Development Program of China; The Beijing Science and Technology Project; and Major Projects of National Science and Technology on New Drug Creation and Development.

Diagnosis and treatment of acute low back pain

Abstract: Low back pain (LBP) is frequent cause for visit to the doctor and common cause of disability. Modern experts’ recommendations for diagnostics and treatment of acute LBP are presented. Common mistakes, difficulties in diagnostics and treatment of acute LBP are discussed. Diagnosis of non - specific acute LBP is based on clinical examination and exclusion of specific causes of back pain. Instrumental studies are not needed in most cases of acute LBP. Key steps in the treatment of patients with acute non - specific LBP are to inform of patients about good prognosis of pain, to recommend daily activity and avoidance of bed rest, to prescribe nonsteroidal anti - inflammatory drug for pain reducing. Effectiveness of vitamins B in acute LBP is discussed.