Hyaluronidase is an enzyme that helps maintain an optimal balance of hyaluronic acid in connective tissue and ensures full tissue regeneration. Currently, hyaluronidase drugs are used in various fields of medicine. Meanwhile, there are no oral preparations based on hyaluronidase on the pharmaceutical market due to its low bioavailability in this method of administration. One of the options to increase enzyme bioavailability is electron-beam pegylation, which involves obtaining drugs with a modified pharmacokinetic profile in the direction of increasing enteral bioavailability, as well as having additional protection from the action of proteolytic enzymes. Aim of the study was using the electron beam pegylation method to obtain a laboratory batch of a preparation based on highly purified hyaluronidase, which can be further used in the development of an oral drug product. Material and methods. Hyaluronidase, which was isolated from bovine testicular hyaluronidase and polyethylene glycols of different molecular weight, was used in the experimental study. Experiments were carried out using a pulsed linear accelerator ILU-10 for enzyme electron beam immobilization on a water-soluble polymer matrix of polyethylene glycol molecules. The formation of hyaluronidase and polyethylene glycols conjugates was confirmed by exclusion chromatography. Results. As a result of accelerated electron irradiation of hyaluronidase and polyethylene glycol of molecular mass 1500 Da conjugates of enzyme and polymer matrix were formed. After electron-beam pegylation, the specific activity of the enzyme was retained. Conclusions. A laboratory batch of prototype pharmaceutical substance based on immobilised hyaluronidase on polyethylene glycol was obtained.

On 30 May, 2024, an expert meeting was held to update the approaches for the treatment of axial spondyloarthritis (axSpA). A new approach to the treatment of axSpA was considered, which consists of depleting autoreactive TRBV9+ T- lymphocytes by introducing a monoclonal antibody – the drug seniprutug. The value of the drug seniprutug in the treatment of the disease was discussed and key aspects for the incorporation of the drug seniprutug into real-world clinical rheumatological practice were agreed.

Objective: The aim of the NiSaXPA study is to evaluate the quality of diagnosing, socio-demographic characteristics and treatment tactics of patients with axial psoriatic arthritis (axPsA) in real-world clinical practice in the Russian Federation.Material and methods. The study involved 600 patients from 21 clinical centers in the Russian Federation.Results and discussion. The diagnosis of axPsA was confirmed in 357 (59.5%) of 600 patients according to the centralized expert assessment. All 357 patients with axial lesions met criteria of the clinical guidelines for the treatment of patients with PsA. Of these, 201 (69%) patients had radiologically significant sacroiliitis (SI) according to Kellgren and 103 (59.2%) had active SI according to magnetic resonance imaging. The presence of syndesmophytes was confirmed in 119 (43.9%) patients. Inflammatory back pain was observed in approximately 80% of patients, most commonly in the lumbar and cervical spine. "Silent" sacroiliitis were found in 1.1–3.5 % of cases. 26.8% of patients were positive for HLA-B27. In the 6 months prior to the study, high PsA activity was present in 21.6% of patients according to the rheumatologist's assessment, while high activity according to the BASDAI index was found in 71.9 % of patients, and moderate and high activity according to the DAPSA index – in 82.7%. On the 24th week of observation, the number of patients with low activity according to BASDAI doubled and reached 66.3 %, while low activity and remission according to the DAPSA index amounted to 52.5% and 8.1% of patients, respectively. In most cases (about 27%), patients with axial manifestations were prescribed interleukin (IL) 17A inhibitors, about 14% of patients received tumor necrosis factor-α inhibitors, and about 4% received IL23 inhibitors.Conclusion. In 40.5% of patients, axial skeletal involvement in PsA was over-diagnosed due to misinterpretation of clinical and imaging data. The vast majority of patients (77%) were treated with synthetic disease-modifying antirheumatic drugs, mainly methotrexate, which do not affect the activity of spondylitis. Biologic disease-modifying antirheumatic drugs (bDMARDs) were taken by 46.5% of patients. Switching therapy to bDMARDs led to a significant reduction in disease activity.In order to improve the quality of medical care, the Russian clinical guidelines for the treatment of patients with PsA and the algorithms for the diagnosis of axial involvement need to be comprehensively implemented.

The COVID-19 pandemic has brought significant changes in managing of patients with rheumatoid arthritis. Rituximab-treated patients were more susceptible to severe infection. This required a "switch" to another genetically engineered drug in the patients with high risk of adverse COVID-19. In this study, we assessed the severity of immune response to SARS-CoV-2 antigens in rituximab-treated patients with rheumatoid arthritis vaccinated with the combined vector vaccine Gam-COVID-Vac. Insufficient formation of the humoral response and a high level of T-cell response to SARS-CoV-2 antigens in this group of patients were revealed. An imbalance of cellular and humoral response may play a role in more severe COVID-19 in rituximab-treated patients with rheumatoid arthritis.

NiSpAR is a non-interventional, multicenter study whose aim was to describe a cohort of patients with non-radiological axial spondyloarthritis (nr-axSpA) and approaches to its diagnosis in the Russian Federation.Material and methods. The study involved 20 research centers in different regions of the Russian Federation. The work consisted of two phases: retrospective data collection 12 months before enrolment in the study and prospective observation of patients in whom the diagnosis of nr-axSpA was confirmed (104 weeks).The study included 272 patients who met the inclusion and exclusion criteria (Full Analysis Set, FAS). The mean age of the FAS-population was 38.7±11.0 years. The diagnosis of nr-axSpA was confirmed in 159 (58.5 %) of the 272 patients. Of the remaining 113 (41.5%) participants, 57 (50.4%) did not have the information required to confirm the diagnosis, 34 (30.1%) did not have pelvic radiographs, and 22 (19.5%) did not fulfil the ASAS criteria for nr-axSpA.Results and discussion. The mean age of patients with nr-axSpA was 37.6±10.4 years, more than half of them (52.8%) were women. The median disease duration was 36 [12; 80] months. In half of the patients the disease duration was more than 2 years, in more than one third – less than 2 years. The median CRP and ESR values were 5.0 [2.0; 12.0] mg/l and 11.0 [5.0; 18.0] mm/h, respectively. The BASDAI averaged 3.5±2.0 and was >4 in more than half of the cases (64.2%). The mean ASDAS-CRP value reached 2.6±1.1. Only 1 in 5 participants (20.8%) had low axSpA activity, while in 61.1% it was high (44.7%) or very high (16.4%). An inactive state was found in a small number of patients (9.4%). Twenty two (13.8%) patients had treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) in anamnesis, and 21 (13.2%) patients were still taking them.Conclusion. The results of the retrospective phase of the study show that in real-life clinical practice in the Russian Federation there is a continued positive trend towards improving the diagnosis of nr-axSpA. The median duration of the disease at the time of enrolment in the study was 3 years. The frequency of use of magnetic resonance imaging has increased by more than 1.8 times. At the same time, practitioners still have difficulties in establishing the diagnosis of nr-axSpA and a shortage of bDMARDs for treatment of these patients.

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 and methods. 260 patients with active r-axSpA and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized into three groups: seniprutug (BCD-180) at doses of 5 mg/kg or 7 mg/kg, or placebo. BCD-180 was administered on weeks 0–12–36. Patients in the placebo group were switched to BCD-180 at a dose of 5 mg/kg at week 24 and continued therapy at week 36. The primary endpoint was the proportion of patients achieving 40% improvement by Assessment in Spondyloarthritis International Society scale (ASAS40) at week 24. Secondary endpoints were proportion achieving ASAS20/40, improvement of 5 out of 6 criteria of ASAS (ASAS5/6), ASAS partial remission, clinically important improvement in ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) (ASDAS-CII) and major improvement in ASDAS-CRP (ASDAS-MI). The dynamics of the disease activity status according to ASDAS-CRP, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and BASFI (Bath Ankylosing Spondylitis Functional Index) indices, as well as the dynamics of laboratory markers (C-reactive protein anderythrocyte sedimentation rate (ESR)) were analyzed. Safety was assessed by the frequency and profile of adverse events (AEs) and adverse reactions (ARs).Results. The proportion of patients achieving ASAS40 at week 24 with seniprutug (BCD-180) at the dose of 7 mg/kg and 5 mg/kg was 51.4% and 40.8%, respectively, compared with 24% in the placebo group (p=0.0012 and p=0.0417, respectively). Analysis of secondary endpoints showed that in patients with r-axSpA, BCD-180 at both study doses was significantly superior to placebo at week 24 in the following measures: decrease in the proportion of subjects with very high disease activity (ASDAS-CRP>3.5) achieving ASDAS-CII, ASAS20, ASAS5/6. A statistically significant decrease in the ASDAS-CRP, BASDAI, BASFI indices, as well as the concentration of CRP and ESR were demonstrated. Tolerability of seniprutug therapy was assessed as acceptable. Infusion reactions were the most common observed adverse events, the vast majority of which were mild to moderate in severity according to CTCAE 5.0 (Common Terminology Criteria for Adverse Events) and developed predominantly during the first administration. The proportion of patients with binding antibodies was 5.1%. However, no neutralizing antibodies were detected.Conclusion. Seniprutug (BCD-180) demonstrated superiority over placebo in clinical efficacy with a favorable safety profile and low immunogenicity as a treatment of r-axSpA.

The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic anti-inflammatory drugs (DMARDs) and biological DMARDs on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biological DMARDs and to search for alternative therapy programs to maintain control over disease activity.Purpose of the study – to evaluate the efficacy and safety of the drug Artlegia® (olokizumab), solution for subcuta neous injection, 160 mg/ml – 0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheuma toid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic.Materials and methods. The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000–500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. At 4, 8, 12 weeks after the switch, the severity of pain was assessed on the VAS scale, the number of painful and swollen joints (TJC28 and TSC28), the level of acute phase markers of inflammation, the DAS28 disease activity index calculated using ESR and CRP, and the CDAI (clinical activity index), functional state index HAQ, as well as assessment of the safety profile of therapy.Results. Data analysis was performed using median values (Me) were used for data analysis. A significant decrease of TJC28 was after the injection of olokizumab (Artlegia®) in 8 and 12 weeks (Me baseline = 10; Me 8 weeks = 4; Me 12 weeks = 4; p<0.05) and a decrease of TSC28 in 4, 8 and 12 weeks (Me baseline = 9; Me 4 weeks = 3.5; Me 8 weeks = 2.5; Me 12 weeks = 2.0; p<0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me baseline = 21, Me 4 weeks = 1 (p<0.05); ESR: Me baseline = 31, Me 4 weeks = 7 (p<0.05)). Positive dynamics persisted at 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0; ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by the fourth week 4 became within the normal range, regardless of the initial values. All activity indices improved from the fourth week in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22 (p<0.05); DAS28-CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45 (p<0.05); CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0 (p<0.05). All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by the 12th week of the study: Me baseline = 1.62, Me 12 weeks = 1.31 (p<0.05).Conclusion. The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.

Background. 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.Objective – to evaluate the efficacy and safety of levilimab in combination with methotrexate (MTX) in subjects with MTX resistant active RA.Methods. The study was conducted at 21 clinical sites in Russia and Belarus. All randomized subjects have completed the study between November 2019 and October 2021.154 adults, aged ≥18 years with confirmed diagnosis of RA were randomly assigned (2:1) to receive either levilimab (162 mg, SC, QW) + MTX (n=102) or placebo + MTX (n=52).After W24 of the study all subjects continued to receive open label levilimab. Subjects who have achieved DAS28-CRP≤2.6 at W24 were switched to maintenance (Q2W) regimen of levilimab at W28 (LVL QW/Q2W and PBO/LVL Q2W arms). Those with DAS28-CRP>2.6 at W28 continued with QW regimen (LVL QW and PBO/LVL QW arm). The PBO/LVL Q2W arm contained only one subject, thus not included in the analysis. The efficacy analysis was done in a population of all randomized subjects. Those with missing data due to study discontinuation or rescue therapy prescription were considered non-responders. Otherwise, the analysis was performed on complete cases.Safety was assessed through monitoring of adverse events (AEs) in a population of those, who received at least on dose of LVL (n=152).Results. Better response to treatment was observed in LVL QW/Q2W as it composed of those who reach DAS28-CRP≤2.6 at W24. At this time point 15/27 (55.6%) of them achieved ACR70; 23/27 (85.2%) achieved DAS28-CRP remission (<2.6) and 7/27 (25.9%) achieved ACR/EULAR 2011 remission of RA. After switching to LVL Q2W, rates of ACR70 and DAS28-CRP<2.6 did not significantly changed until W52: 17/27 (63.0%) and 21/27 (77.8%), respectively, yet the proportion of subject with ACR/EULAR 2011 remission further increased and reached 12/27 (44.4%).LVL QW arm was diminished by subjects who achieved high response to treatment at W24 and composed LVL QW/Q2W arm. Thus, ACR70, and remissions rate in this arm was close to zero at W24. However, continuation of LVL QW in those who not achieved DAS28-CRP≤2.6 at W24 induced ACR70 response in 37/75 (36.0%), DAS28-CRP remission in 35/75 (46.7%) and ACR/EULAR 2011 remission in 8/75 (10.7%) at W52.The most common adverse events (reported in ≥5% of subjects) were blood cholesterol increase (30.3%), ALT increase (23.0%), lymphocyte count decrease (17.1%), ANC decrease (16.4%). blood triglycerides increase (13.8%), bilirubin increase (11.2%), AST increase (9.9%), WBC decrease (9.9%), IGRA with Mycobacterium tuberculosis antigen positive (7.2%) and injection site reactions (5.9%). No deaths were occurred.Conclusions. Open label period confirmed the lasting efficacy and safety of levilimab in combination with MTX in subjects with MTX resistant active RA and suggested the possibility of switching to maintenance (Q2W) regimen in those who achieved remission of RA at week 24.

A retrospective analysis of the database of the register of patients with immuno-inflammatory rheumatic diseases receiving treatment with biologic disease-modifying anti-rheumatic drugs in the Novosibirsk region was carried out, which included 318 patients, 94 of whom had indications of pneumonia during the period from 01.04.2020 to 31.12.2020. There was a statistically significant increase in the risk of developing pneumonia over the age of 60 years and in patients receiving rituximab, while the therapy with TNF-alpha inhibitors significant-reduced the risk of

The effects of a lithium-modified sorbent based on aluminum oxide and polydimethylsiloxane (Al2O3@PDMS/Li) and a lithium-free sorbent (Al2O3@PDMS) on some indicators characterizing blood clotting under hemosorption conditions were compared in vitro. Sorbent Al2O3@PDMS/Li had significantly lower reactogenic effect on the blood passed through the column than the sorbent without lithium. This was seen from the degree of platelet reduction (66×109 vs 19×109/liter) as well as a less pronounced hypercoagulation shift in chronometric indicators. In contrast to lithium-free sorbent, Al2O3@PDMS/Li demonstrated the ability to reduce the concentration of fibrinogen. However, this had no impact on the density characteristics of the blood clot assessed by thromboelastometry such as maximum clot firmness, angle and fibrin clot formation time, amplitudes at 10 and 15 min after clotting time, which are known to depend on the quantity of platelets and the concentration of functionally active fibrinogen.

The article presents a clinical case of a rare autoinflammatory disease – a family case of Muckle – Wells syndrome. The diversity of clinical manifestations and the impossibility of confirming the diagnosis without a genetic study by DNA sequencing determine the complexity of and delay in the diagnosis. The development of severe complications and, as a consequence, a fatal outcome necessitates early diagnosis. The described clinical case demonstrates the importance of DNA sequencing for the timely diagnosis of the disease, the features of the disease course, and the familial nature of the disease. The diagnosis of Mackle – Wells syndrome in young family members before the development of severe complications will allow to start adequate and timely treatment and prevent the development of amyloidosis.

At the meeting of the Expert Council on May 20, the safety of treatment for patients with osteoarthritis (OA), the most common form of joint disease, was discussed. The first step in the treatment of OA should be the administration of symptomatic delayed-acting agents (SYSADOA) and nonsteroidal anti-inflammatory drugs (NSAIDs). However, given the current understanding of the pathogenesis of inflammation, as well as the fact that it is an active process involving multiple proinflammatory and pro-resolving mediators, it is reasonable to limit the cyclooxygenase-2 suppressive treatment and to include medications with multipurpose effects that contribute to the resolution of inflammation, in particular Zeel® T and Traumeel® S. Traumeel® S affects all stages of inflammation, mostly on the pro-resolving mediators synthesis, and Zeel® T affects chondrogenesis, inflammation, metabolic processes in cartilage tissue and prevents angiogenesis. It was found that it is advisable to use Traumeel® S when it is not possible to prescribe systemic NSAIDs for pain relief. The combination of the proven therapeutic efficacy of Zeel® T and Traumeel® S with a minimal number of adverse events and the absence of interactions with other drugs allows them to be used as an independent treatment regimen for OA.

Проведено доклиническое изучение безопасности лекарственного средства на основе комплекса лития цитрата, полидиметилсилоксана и оксида алюминия. Однократное его введение внутрижелудочно в максимально возможной дозе (12000 мг/кг) мышам и крысам не вызывало гибели животных. В хроническом эксперименте на крысах при введении этого препарата в дозах, значительно превышающих рекомендуемые для человека (4000 мг/кг), внутрижелудочно в течение 90 дней не наблюдалось изменений массы тела относительно крыс контрольных групп, не выявлено токсического действия препарата на функциональную активность и морфологическое состояние основных органов и систем (ЦНС, кровь и костный мозг, печень, почки, сердце, желудочно-кишечный тракт, половые органы).

Autoimmune diseases currently take a leading place in terms of frequency of occurrence in the population, among which 1 percent is occupied by rheumatoid arthritis (RA). Remission in this type of disease is extremely rare and requires constant use of pharmacotherapy. Studying the pathogenesis of RA is necessary to study to search for new drug targets. It is known that T helpers 1 (Th) and Th17 are involved in the development of RA. However, some researchers suggest that ILCs play a role in the development of RA. ILCs are “innate analogues” of Th, due to the fact that this subpopulation synthesizes the same cytokines. ILC1 is innate analogs of Th1, ILC2-Th2, ILC3-Th17. ILCs are tissue-resident innate lymphoid cells that have functional diversity and regulate the direction of the immune response through the production of cytokines.We used peripheral blood mononuclear cells (PBMCs) from patients (n = 19) and conditionally healthy donors (n = 10) as material. The group of patients was divided biologic disease-modifying anti-rheumatic drugs (bDMARDs) and Metotrexate (MTX) and of stage of RA (early and very early arthritis, advanced and late). PBMCs were stained with monoclonal antibodies. ILCs were identified as Lin-CD127+, CD294+ILCs (ILC2) were measured in the general population, CD117-CD294-ILCs were identified as ILC1, and CD117+CD294-ILCs were identified as ILC3.We obtained the following results: ILC1 was significantly reduced in patients treated with MTX comparison with patients on bDMARDs and healthy donors. However, patients on MTX with advanced RA had low levels of ILC2 and ILC3 compared to patients on bDMARDs. ILC2 significantly increased in patients with early stages of RA comparison with patients with advanced RA. However, ILC1 was significantly reduced in patients treated with MTX, and ILC3 increased significantly in patients treated with MTX comparison with bDMARDs. Expression of PD1 on ILC1 was increased compared to patients treated with bDMARDs. However, ILC3 patients with advanced stages on MTX had increased expression of PD1 comparison with patients taking bDMARDs. The ILC3 of donors was significantly increased comparison with patients on bDMARDs.

The development of safe drugs occupies a special place in the pharmaceutical industry. One of the main tasks of its preclinical phase is to evaluate possible toxic effects of the developed drug on the body and on various systems, including the immune system. The aim of our work was to study immunotoxic properties of pegylated hyaluronidase (PEG- HYAL). Material and methods. Mice F1(CBA/C57Bl/6) were divided into subgroups which were intragastric and intraperitoneally administered with PEG-HYAL in different dosages (50, 500, 1250, 2500 and 5000 U/kg). The number of antibody-producing cells in the spleen, the mass and cellularity of central and peripheral immune organs, phagocytic activity of peritoneal macrophages and neutrophils, delayed hypersensitivity reaction (DHR), level of hemagglutinin to sheep erythrocytes, spontaneous and mitogen-induced splenocyte proliferation were determined. Results. PEG-HYAL did not induce DHR, did not suppress phagocyte activity of peritoneal macrophages, at a dose of 50 ED/kg did not significantly affect the hemagglutinin content to erythrocytes, but at a dose of 500 ED/kg did statistically significantly reduce the titer of specific antibodies. When experimental animals were exposed to PEG-HYAL at doses of 50 and 500 U/kg, spontaneous and mitogen-induced proliferation of splenocytes decreased. Conclusions. The PEG-HYAL trial produced results that can be used to substantiate the administration of the PEG-HYAL-based medication.

Psoriatic arthritis (PsA) is a chronic immunoinflammatory disease of the joints, spine and entheses from the group of spondyloarthritis, which is usually observed in patients with psoriasis. In recent years, the axial form of PsA (axPsA) has been actively researched. However, there is insufficient data on approaches to the diagnosis and treatment of patients with axPsA in real-life clinical practice. This article presents the results of an interim analysis of data from a non-interventional multicenter observational study on the treatment of patients with axPsA in real-life clinical practice (NiSaXPA) in Russian centers. Objective : to identify patients with axPsA, their characteristics and describe treatment tactics in real-life clinical practice. Material and methods . Patients with PsA who met the inclusion criteria were prospectively followed up during routine visits to a rheumatologist. Participants' axial radiographs were uploaded to a database in order for it to be confirmed the presence or absence of axPsA by two independent experts, a rheumatologist and a radiologist. Patients with a confirmed axPsA diagnosis participated in a further data collection phase (Visit 2, week 24). Results and discussion . Six hundred patients were enrolled into the study. At the time of analysis, 386 (64.3%) of them (209 men and 177 women) were screened for axPsA. The diagnosis of axPsA was confirmed in 241 (62.4%) cases; these patients formed the Per Protocol (PP) population. The mean age of patients with axPsA in the PP population was 46.30±12.6 years and the body mass index (BMI) was 27.4±5.2 kg/m2 . In 14.9% of patients, the duration of psoriasis was less than 1–5 years, in 21.5% – 5–10 years and in 63.6% – more than 10 years. The duration of PsA symptoms was less than 1–5 years in 31.2 % of patients, 5–10 years in 31.6 % and more than 10 years in 37.2 %. Low disease activity (BASDAI ˂ 4) was achieved in 33.3 % of patients with axPsA at visit 1 and in 64.3 % at visit 2; the BASDAI index declined on average from 4.67±1.95 to 3.31±1.89 points. In real-life clinical practice, patients were most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) – 88.7% and 71.7% (visits 1 and 2, respectively), and synthetic disease-modifying antirheumatic drugs (sDMARDs) –79.1% and 70.7%, respectively; therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) was initiated in 40.2% and 60.6% of patients, respectively. Conclusion . The results of the interim analysis of this observational study showed that in 87.2% of patients who met the CASPAR criteria for PsA there was a suspicion of axial manifestations of PsA on the primary care level. However, only 62.4% of them had a confirmed diagnosis of axPsA on centralized expert assessment, which may indicate a possible overdiagnosis of axial lesions in real-life practice and emphasizes the importance of collaboration between a rheumatologist and a radiologist when analyzing the results of imaging studies. 33.3% of patients with axPsA had low disease activity according to BASDAI at baseline and 64.3% after 24 weeks, meaning that the disease was only adequately controlled in one third of cases despite therapy; the number of these patients doubled after a change in therapy. In real-world clinical practice, patients with axPsA are most commonly prescribed drugs from the NSAID and sDMARD groups; the frequency of use of biologic drugs varied between 40.2 and 60.6% by the end of the observation period.

In ankylosing spondylitis, the pathological metabolism of the bone tissue is regulated by various proteins; of these, Dkk-1 protein, an antagonist of the Wnt-signaling pathway, is of particular interest. We compared the methods of Dkk-1 detection in the blood serum of patients with ankylosing spondylitis (conventional ELISA and aptamer/antibody assay) and analyzed the relationship between Dkk-1 level and structural progression of ankylosing spondylitis and secondary osteoporosis. Dkk-1 levels in patients were significantly increased and depended on the stage of the disease, but not on the presence/absence of osteoporosis. Thus, Dkk-1 is a potential serum marker of progression of ankylosing spondylitis reflecting a tendency to structural progression of the disease before the appearance of radiographic changes. The results obtained by both methods practically coincided, which suggests good prospects for applying DNA aptamer-based test system.

Background. According to the scientific literature, anti-CD74 IgA antibodies (IgA anti-CD74) are considered as a possible marker for the diagnosis of axial spondyloarthritis (SpA). The level of IgA anti-CD74 in patients with back pain due to degenerative spine disease has not been studied. Therefore, it could be interesting to compare the serum levels of IgA anti-CD74 in patients with chronic back pain in various diseases. Aim: to compare the levels of IgA anti-CD74 in patients with SpA and degenerative spine diseases. Material and methods. A total of 87 SpA patients (55 male, mean age 41 [29; 49] years) fulfilling the Assessment of Spondyloarthritis International Society (2009) criteria for Axial SpA, and 39 patients (25 male, mean age 45 [34; 53] years) with neurologist-verified degenerative spine diseases (ICD 10 codes — M 51.1 and M 54.4) were enrolled to the study. The serum levels of IgA anti-CD74 were analyzed by enzyme-linked immunosorbent assay (ELISA) in all patients. Results. The median levels of IgA anti-CD74 in patients with SpA were 11.3 [5.4; 19.4] U/ml, in patients with degenerative spine disease — 6.9 [4.5; 13.7] U/ml (p=0.024). IgA anti-CD74 serum levels were above the cut-off value in 58 (66.7 %) patients with SpA and only in 11 (28.2 %) patients with degenerative spine disease (p<0,001). The elevated serum levels of IgA anti-CD74 were detected in 10 (40 %) of 25 male patients and in 1 (7.1 %) of 14 female patients (p = 0.029, χ2 = 4.785) with degenerative spine disease. Conclusion. Serum levels of I gA anti-CD74 were increased in two-thirds of patients with SpA. IgA anti-CD74 was significantly higher in SpA patients compared to patients with degenerative spine disease. >< 0,001). The elevated serum levels of IgA anti-CD74 were detected in 10 (40 %) of 25 male patients and in 1 (7.1 %) of 14 female patients (p = 0.029, χ2 = 4.785) with degenerative spine disease. Conclusion. Serum levels of I gA anti-CD74 were increased in two-thirds of patients with SpA. IgA anti-CD74 was significantly higher in SpA patients compared to patients with degenerative spine disease.

Aim – to investigate relationship of trabecular bone score (TBS) with activity and structural progression of ankylosing spondylitis (AS) in males younger than 50 years old without osteoporosis.Materials and methods. 26 male AS patients took part in the investigation. AS activity was evaluated by BASDAI and ASDAS-CRP indices, and highly sensitive C-reactive protein level. Structural AS progression was evaluated by sacroiliitis (SI). TBS was evaluated using the double-energy X-ray absoptiometry. Correlation between clinical measures and TBS was obtained using the Spearman r-criterion for quantitative variables and Kendall’s τ coefficientfor qualitative variables.Results. There was obtained no correlation between AS activity and TBS. Among clinical characteristics, SI stage was negatively correlated with TBS (τ=–0.313; p<0.05). Conclusion. TBS is associated with the severity of sacroiliitis in young AS male patients. Key words: ankylosing spondylitis, trabecular bone score, structural progression>˂ 0.05).Conclusion. TBS is associated with the severity of sacroiliitis in young AS male patients.