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Aim to identify outdated terms and make changes to the terminology of spondyloarthritis. Materials and methods. At the first stage of the work, the terms divided into two categories: “outdated” definitions and terms that need to be improved or unified. Subsequently, each member of the Expert Group of Spondyloarthritis at the Association of Rheumatologists of Russia (ExSpA) presented by its own definition of the designated term or agreed with the previous term. At the next stage, the existing definitions were put together. After discussion, experts left a term that scored at least 2/3 of the votes. The special opinion of experts was recorded, whose did not coincide with the majority opinion. An open vote was conducted, when defining an “outdated” term with the unanimous decision of all group members, this term was not recommended for further clinical use. Results. The work carried out allowed us to identify a number of terms that are not recommended for use in clinical practice. Number of terms are defined, which should be used when discussing the problem of spondyloarthritis. Conclusion. The Expert Group of Spondyloarthritis at the Association of Rheumatologists of Russia suggests using or, accordingly, not using a number of terms and their definitions in clinical practice.

Progress and significant changes in the approaches to the diagnosis and treatment of arthritis determine the need for a comprehensive study of comorbidities in rheumatologic patients. Aim. The evaluation the occurrence of comorbidities in patients with inflammatory diseases of the spine and joints and the assessment of the general changes in comorbidities at the beginning of the XXI century compared to previous period. Materials and methods. Comorbidity was analyzed in 245 patients with spondyloarthritis who participated in the scientific program PROGRESS. Validated comorbidity assessment indices were used in the study. The analysis of 96 sources of literary bases RISC and PubMed were used in literature analysis. The results of their own observation and literary search were compared. Results and discussion. According to the patients’ cards, an analysis of the structure of comorbidities was conducted in 221 patients: 207 (93.66%) patients with spondyloarthritis had two or more comorbidities. The most common diseases were diseases of gastrointestinal tract (60.6%) and cardiovascular pathology (58.3%), secondary osteoarthritis (60.2%). According to literature sources, most of the comorbidities and spondyloarthritis are interrelated pathogenetically and undergo a change in the profile of rheumatic and/or related diseases undergo simultaneous changes. The emergence of new diseases in the structure of comorbidity and new drugs requires the development of recommendations that take into account the presence of comorbidity in patients with a rheumatic diseases. Conclusion. Most patients with spondyloarthritis has comorbidity. The change in rheumatic and non-rheumatic diseases that occurs in the 21st century has a mutual influence, changing the profile of patients and determining the change in the tactics of their management.

Aim. To evaluate changes in the concentration of biomarkers for osteoproliferation and bone resorption in ankylosing spondylitis (AS) patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs) in different regimens. Subjects and methods. Forty patients with AS (according to the modified New York criteria), who had BASDAI ≥ 4.0 at baseline and at 52 weeks of on-demand NSAID treatment were examined and randomized into 2 groups: 1) 30 patients who used continuously oral tenoxicam 20 mg daily (a study group); 2) 10 patients who continued previous therapy (a comparison group). BASDAI and ASDAS were calculated; the serum levels of C-reactive protein, C-terminal type I procollagen propeptide (PICP), and C-terminal telopeptide of type I collagen (CTX-I) were measured at baseline and at 52 and 56 weeks of treatment. A control group consisted of 19 healthy volunteers. Results. The continuous use of NSAIDs (tenoxicam) decreased higher baseline BASDAI and ASDAS scores. There were no changes in the indicators of AS activity in the patients who took on-demand NSAIDs. Baseline CTX-I levels did not differ between the patients with AS and the healthy individuals; those declined during continuous intake of tenoxicam and remained unchanged during on-demand administration. In the patients with AS, baseline PICP levels exceeded those in the healthy individuals. In the tenoxicam-treated patients, the concentrations of PICP at baseline and at 52 and 56 weeks were 17.1±9.0, 16.8±9.9, and 13.29±6.7 ng/ml, respectively (p=0.0001 for differences between the baseline and week 56 levels); in the comparison group, PICP levels did not change statistically significantly (p≥0.05 for all intergroup comparisons). Conclusion. Changing the inefficient long-term on-demand use of NSAIDs to their continuous intake is associated with a rapid decrease in clinical AS activity (within 4 weeks) with a reduction in the higher baseline concentration of the marker for osteoproliferation and in the normal level of the marker for bone resorption.

Aim. To estimate changes in the concentrations of adhesion molecules and vascular endothelial growth factor A after 30-day additional use of amtolmetin guacil (AMG) in patients with active ankylosing spondylitis (AS) who were unresponsive to previous one-year treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). Subjects and methods. 20 patients with active AS who had not reached a BASDAI score

Aim. To assess changes in the concentration of interleukin-17A (IL-17A) in patients with ankylosing spondylitis (AS) treated with tumor necrosis factor-α (TNFα) inhibitors during a year. Subjects and methods. Examinations were made in 30 patients (22 (73.3%) men) aged 38.35±9.19 years with AS (modified New-York criteria, BASDAI ≥4.0; AS duration, 11.4±9.6 years) and in 20 healthy individuals (12 (60%) men) aged 40.1±7.7 years) (a control group). All the patients were treated with infliximab (remicade, MSD) 5 mg/kg body weight during a year according to the recommended regimen. BASDAI and ASDAS were calculated; C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and TNFα and IL-17A concentrations were measured before and 52±2 weeks after TNFα inhibitors treatment. BASDAI/ASDAS improvement, ESR and CRP decreases; ASAS20/40 responses, ASAS partial remission, and an ASDAS improvement were estimated. Results. In the patients with AS, the concentrations of TNFα and IL-17A were higher than those in the healthy individuals (p < 0.000). Twelve (40%) AS patients treated with TNFα inhibitors achieved ASAS partial remission. The average estimated back pain, ASDAS and BASDAI scores, and CRP and ESR substantially reduced (p

Aim. To evaluate the efficacy and safety of intravenous methylprednisolone (MP) 500 mg in patients with active ankylosing spondylitis (AS) and the inefficiency, intolerability of or contraindications to treatment with 2 or more non-steroidal anti-inflammatory drugs (NSAIDs). Subjects and methods. The investigation enrolled 20 patients (age, 35.35±8.19 years) with a 10.2±9.2year history of AS who met the modified New York criteria) and had its activity defined as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 scores and an inadequate response to and intolerance of ≥2 NSAIDs; there were 13 (65%) men. MP was given in a single intravenous dose of 500 mg. The main efficiency criterion (primary study endpoint) was considered to be the number of patients who had achieved an ASAS20 response at week 2. Additional rating criteria (secondary endpoints) (improved BASDAI/ASDAS; decreased erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels; the number of patients achieving ASAS20/40/5/6 responses and ASAS partial remission, and improved ASDAS) were calculated 2, 4, and 12 weeks after MP administration. Safety was monitored estimating the frequency of adverse events (AEs) and controlling vital functions and laboratory indicators. Results. Nine (45%) patients achieved an ASAS40 response at week 2. ASDAS was 3.48 at baseline and 2.21 at week 2 (p

Aim. To study the clinical and laboratory efficiency and safety of different etoricoxib (ET) regimens in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis. Subjects and methods. Forty patients with high axSpA activity (Bath Ankylosing Disease Activity Index (BASDAI ≥4) were examined and randomized to 2 groups: 1) 30 patients who received ET 90 mg continuously every day; 2) 10 patients who took the drug in the same dose intermittently 1—3 times weekly. The activity of axSpA (BASDAI, Ankylosing Spondylitis Disease Activity Score (ASDAS), erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (hs-CRP)) was evaluated at baseline, 2 and 12 weeks; adverse events were recorded at baseline, 2, 6, and 12 weeks. The number of patients who had achieved an ASAS40 response at 2 and 12 weeks were taken into consideration. Results. At 12 weeks, the continuous administration group displayed decreases in BASDAI from 8 to 4, in ASDAS from 3.8 to 2.6, and in hs-CRP levels from 9.5 to 3.9 mg/l; the intermittent administration group exhibited decreases in BASDAI from 7.6 to 6.0, in ASDAS from 3.5 to 3.1, and hs-CRP from 8.8 to 4.5 mg/l (p

Aim. To study autonomous regulation of cardiac activity in patients with alkylosing spondylitis(AS) according to heart rate variability. Material and methods. A total of 51 male patients aged 35.4 ± 7.3 years with verified AS participated in the trial. Patients with manifest cardiovascular pathology, disturbances of cardiac rhythm or conduction were not included. All the patients were screened for basic cardiovascular risk factors. AS activity was studied with a clinical index BASDAI and acute phase indices. HRV was analysed by 5-min at rest ECG fragments. The control group consisted of 23 healthy males at the age 35.7 ± 11.5 years matched by basic cardiovascular risk factors with AS patients. Results. Basic time and frequency HRV parameters were much lower in AS patients than in healthy controls. A significant negative correlation was found between HRV parameters and acute phase parameters (ESR, C-reactive protein, fibrinogen) evidencing for a significant impact of persistent systemic inflammation on autonomic regulation of cardiac activity consisting in regress of parasympathic and/or enhancement of sympathetic activity and leading to reduction of HRV in AS patients. Conclusion. AS patients have abnormal autonomic regulation of cardiac activity manifesting with subnormal HRV. This is closely related with the activity of systemic inflammation. Reduced HRV may be one of the factors of a high cardiovascular risk in AS patients.

The efficacy and safety of levilimab (LVL) in patients with active rheumatoid arthritis (RA) has been confirmed in controlled clinical trials. This article presents the results of a preliminary analysis of a non-interventional observational study of LVL in RA patients. Objective: to evaluate the efficacy and safety of LVL in the treatment of patients with RA in real-world clinical practice. Materials and methods. The HELIOS study is a retrospective-prospective, multicenter, non-interventional study of retention rate of LVL therapy and the safety of LVL in patients with RA in real-world clinical practice. Patients received medical care, including LVL, according to routine clinical practice for the treatment of RA and Russian instructions for medical use of the drug. This article presents the results of an analysis of the efficacy and safety of LVL after 12 and 24 weeks of treatment. Efficacy was assessed using the DAS28-CRP/ESR, SDAI, CDAI and patient assessment of pain, fatigue and morning stiffness according to VAS (0–100 mm). Results and discussion. 524 patients from 42 medical centers in the Russian Federation were enrolled in the study from June 2022 to November 2023. The majority of patients were female (83.2 %) and the mean age of patients was 53 years. A statistically significant decrease in DAS28-CRP/ESR, SDAI, CDAI, patient assessment of pain, fatigue and morning stiffness (VAS) was observed after 12 and 24 weeks of treatment, regardless of previous treatment with biologics or Jak inhibitors (JAKi). LVL was well tolerated by patients, the most frequently reported adverse events were infections, changes in peripheral blood and laboratory abnormalities characteristic of treatment with IL-6R inhibitors. Conclusion. In real-world clinical practice, LVL has been shown to be highly effective and well tolerated in patients with RA when prescribed as the first biologic disease-modifying antirheaumatic drus (bDMARD) and after switching from other bDMARDs or JAKi.

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.

Relevance. Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by loss of immune tolerance and sustained production of autoantibodies.The aim of the study – to compare composition of peripheral blood cytotoxic CD8+ T lymphocytes (Tc) subsets and assess the clinical significance of them in systemic lupus erythematosus. Materials and methods. A total of 35 SLE patients and 49 healthy volunteers were included in the study. Phenotyping of peripheral blood T cell subpopulations was carried out by means of flow cytometry. T lymphocytes were determined using CD3+, CD4+, CD8+ antibodies. Tc were identified by using CD45RA and CD62L antibodies. Also the expression of chemokine receptors (CCR4, CCR6, CXCR3 and CXCR5) on Tc cells was assessed and the main Tc subpopulations were determined: Type 1 (Tc1), type 2 (Tc2), type 17 (Tc17), type 17/1 (Tc17.1), type 17/22 (Tc17.22) cytotoxic cells and T follicular cytotoxic cells (Tfc).Results. The absolute and relative number of Tc was significantly higher in the group of patients with SLE compared with the control group. Additionally, there was a significant decrease in the relative number of Tc1, Tc 17.1 and Tfc1 and a significant increase in the relative number of Tc2, Tfc 17 and Tfc17.1 within the SLE group when compared to the control group. There were significant positive correlationfor Tc1 and levels of C3 and C4 complement components (r=0.404, p

The article presents the results of the three-year use of netakimab (NTK) in patients with ankylosing spondylitis (AS) as part of the phase III BCD-085-5/ASTERA study.Objective: to evaluate the long-term efficacy and safety of NTK over a three-year period in patients with active AS.Material and methods. BCD-085-5/ASTERA – double-blind, multicenter, randomized phase III clinical trial that enrolled patients with active AS (BASDAI ≥4) and a back pain intensity ≥4 on a numeric rating scale with inefficacy or intolerance of non-steroidal anti-inflammatory drugs or biologic drugs. A total of 228 patients were randomized in a 1:1 ratio and assigned to either the NTK group or the placebo/NTK group. Starting at week 16, patients who did not achieve ASAS20 (20% improvement according to ASAS criteria) received NTK 120 mg once every 2 weeks in an open-label regimen. Patients who achieved ASAS20 response at week 52 in the NTK group and week 68 in the placebo/NTK group continued to receive NTK (120 mg every 2 weeks) until week 156 in the NTK group and until week 172 in the placebo/NTK group.Results and discussion. Over the course of three years of NTK use, most patients experienced a sustained decline in AS activity (according to ASDAS-CRP, BASDAI) with sustained response (ASAS20/40, ASAS5/6) to therapy. Most adverse events reported were mild to moderate. 36.7% of patients had adverse events, which were mainly laboratory abnormalities, blood and lymphatic system abnormalities and infectious complications.Conclusion. The clinical effect of NTK was maintained in most patients with AS over a three-year period, with no significant loss of response. NTK was well tolerated and the safety profile remained favorable.

Background. Netakimab has shown high efficacy in controlled clinical trials in the treatment of patients with ankylosing spondylitis (AS). This article presents results of an observational study of netakimab using in routine clinical practice.Methods. Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included patients who were prescribed netakimab therapy before enrollment, so clinical and medical history data for the first visit were entered retrospectively, and following visits at weeks 12, 24 and 52 of therapy were collected within the study. Drug survival rate has been calculated according to Kaplan – Meier analysis.Results. The study included 137 patients (93 men and 14 women) with AS. The average age of patients was 42.3 (±11.9) years, 34.3% of patients had previously received therapy with genetically engineered biologic drugs, mainly tumor necrosis factor inhibitors. At the end of the analyzed period (52 weeks of therapy), 90.4% [95% CI: 85.4–95.7] of patients continued treatment with netakimab. The BASDAI and ASDAS-CRP showed statistically significant decreases in scores from baseline at all time points. Netakimab was well tolerated by patients; adverse effects (AEs), related to therapy according to the investigator’s opinion, were reported in 7 (5.1%) patients. 2 patients stopped taking netakimab due to AEs: terminal ileitis and chronic colitis.Conclusions. In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy.

The article contains the data obtained during the 156-week follow-up of patients with ankylosing spondylitis (AS) in the ASTERA phase III study.Objective: to evaluate the effect impact of netakimab (NTK) on quality of life (QoL), back pain and work capacity in patients with active AS.Material and methods. The study enrolled 228 patients with active AS who were randomized 1:1 to receive NTK 120 mg or placebo. At week 52, patients in Group 1 (NTK) who achieved ASAS20 continued therapy (NTK at a dose of 120 mg once every 2 weeks) until week 156. Patients in Group 2 (placebo/NTK) received the study drug at a dose of 120 mg subcutaneously every 2 weeks from week 20 until week 68, after which the efficacy of therapy was determined (by achieving an ASAS20 response). Patients who achieved ASAS20 received treatment (NTK at a dose of 120 mg once every 2 weeks) until week 172.Results and discussion. Under NTK therapy, a significant improvement in QoL was observed in the assessment of the physical and psychological components of the SF-36 questionnaire, which was maintained during the three years of therapy: increase in indicator by 12.68±9.92; 13.27±10.14; 12.92±10.03; 14.10±10.35; 14.76±9.77 and 6.10±11.59; 5.50±11.82; 6.32±11.01; 5.87±11.45; 5.25±11.98 points at week 52, 76, 104, 128 and 156, respectively. During the extended therapy period, a reduction in the proportion of working hours missed for health reasons, an improvement in work capacity and work efficiency and an increase in daily activity were observed. Back pain (BASDAI question 2) and nocturnal back pain decreased steadily during the entire follow-up period compared to the screening values.Conclusion. NTK is an effective therapy for active AS that improves QoL scores, significantly reduces pain intensity and improves work productivity.

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.

Objective – to compare the clinical efficacy and cost-effectiveness of IL-17 inhibitors (SEC, IXE, NTK) in the treatment of adult patients with ankylosing spondylitis (AS) in the healthcare system of the Russian Federation.Material and methods. The study is a sub-analysis of a previously published systematic review and network meta-analysis of the comparative efficacy of biologics in adult patients with AS in the Russian Federation. NNT values were calculated for BASDAI 50 and ASAS 20/40 after 16 weeks of therapy for all studied drugs. CpR was estimated for each biologic after 16 weeks and one year of therapy. Additionally, we carried out an assessment of the financial burden of the most cost-effective strategies for the treatment of AS.Results. The use of NTK is characterized by an average of no more than three patients needed to treat to achieve one ASAS 20/40 or BASDAI 50 response, while on IXE and SEC – no more than 4–5 patients need to be treated, depending on the estimated effectiveness criterion. According to CpR estimate, NTK is the most cost-effective IL-17 inhibitor for the treatment of AS, both after 16 weeks and after one year of therapy.Conclusion. The obtained results make it possible to compare the effectiveness of IL-17 inhibitors from a clinical and economic points of view and can be used both in decision making process of treatment strategies for individual patients, and at the population level – when deciding on the reimbursement of drugs

Levilimab (LVL) is a monoclonal antibody against the interleukin-6 receptor (IL6R). The article presents data obtained during 56 weeks of the AURORA phase II study.Objective: to evaluate the efficacy safety and immunogenicity of LVL in methotrexate (MTX) resistant patients with active rheumatoid arthritis (RA).Materials and methods. 105 patients with active RA were randomized in a 1:1:1 ratio into two LVL or placebo groups. LVL was administered subcutaneously at a dose of 162 mg every week (QW) or every other week (Q2W). All patients received MTX. After evaluating the primary endpoint of 20% improvement in ACR criteria (ACR20) at week 12, patients in the placebo group were switched to LVL Q2W. The study duration was 56 weeks. The frequency, profile, degree and severity of adverse events were determined in each group for safety assessment. The immunogenicity of LVL was determined by the proportion of patients with identified binding and neutralizing antidrug antibodies. Results. LVL in both regimens was superior to placebo. At week 12, the incidence of ACR20 achievement was 77.1% (LVL QW), 57.1% (LVL Q2W), and 17.1% (placebo) with 95% confidence intervals [37.53; 82.54] (p

Netakimab is a humanized anti-interleukin-17А monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Herein, we report the accumulated efficacy data and safety findings of 54-week netakimab treatment during the PATERA study.The aim of the study was to assess the long-term efficacy and safety of netakimab in patients with active psoriatic arthritis.Materials and methods. 194 patients with active psoriatic arthritis despite the previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs were initially randomized to receive 120 mg netakimab or placebo (1:1) at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 inadequate responders in placebo group were reassigned to netakimab in a blinded manner. From week 24 all patients receive open-label netakimab. The analyzed period includes 54 weeks.Results. Netakimab demonstrated sustained treatment response. 94.9% of patients in the netakimab group achieved ACR20 at week 54; 89.5% achieved PASI75 response. Axial disease, dactylitis, and enthesitis significantly improved with netakimab. A similar pattern was observed for placebo/netakimab treated patients. Netakimab was well tolerated. The majority of adverse events were mild and moderate. The most frequent treatment-related adverse events were lymphopenia, increased alanine aminotransferase, hypercholesterolemia. Adverse events of grade 3–4 were observed in 2%.Conclusion. Netakimab demonstrated sustained efficacy in key psoriatic arthritis domains at week 54 with a favorable longterm safety profile.

IgA anti-CD74 can be a promising marker for diagnosis, assessment of activity and prognosis for ankylosing spondylitis.The aim of the study was to determine the level of IgA anti-CD74 in patients with ankylosing spondylitis and to evaluate its relationships with ankylosing spondylitis activity and carriership of genetic alleles.Materials and methods. In 48 patients with a reliable diagnosis of ankylosing spondylitis, aged 18 to 69 years were measured the ASDAScrp, BASDAI, level of highly sensitive С-reactive protein, concentration of IgA anti-CD74. The polymorphisms of the genes interleukin (IL)-17A197 a/g, IL-17F7 histidine (His) / arginine (Arg), IL-17F11139 c/g, TNF-a-863, TNFα-308, TNFα-238, IL-1B-31, IL- 4-590, IL-6-174, IL-10-1082, IL-10-592, vascular endothelial growth factor (VEGF)-2578, VEGF-936, matrix metalloproteinase (MMP)2-1306, MMP3-5A6A, MMP9-1562, HLA-B27 were evaluated in their relationships with AS activity and IgA anti-CD74 levels.Results. The mean age of patients was 45.1±14.2 years, male - 72.9%, psoriasis - 10.4%, IBD - 2.1%, BASDAI -2.99±0.28, ASDAS - 2.29±0.16, CRP - 6.5±1.65 mg/L, IgA эпй-СВ74 - 18.6±1.73 U/mL (72.9% of the patients with >12 U/mL). The relationship between an increase in concentration of IgA anti-CD74 and ASDAScrp, BASDAI activity indices, between an increase in the level of CRP and the presence of the IL-17A genotype heterozygous for the AA allele (r=0.965) was determined. CRP did not demonstrate the relationship with the BASDAI.An association of IL-17F-11139 СС and the presence of psoriasis (r=0.870) was established. 93.8% of patients with ankylosing spondylitis were carriers of the homozygous histidine allele IL-17F7 (his/his) and the TNF238 allele (GG).Conclusions. The increase in anti-CD74 IgA level was found in 72.9% of patients with ankylosing spondylitis receiving inhibitors of TNF-a and NSAIDs and associated with clinical and laboratory indicators of ankylosing spondylitis activity and with carriage of the homozygous histidine allele IL-17F7 (his/his) detected in 93.8% of patients. Carriage of TNF-238 GG; TNF-863 CC; HLA-B27; TNF-308 GG; IL-4-590 CC; IL-6-174 CG;MMP9-1562 CC; MMP9-1562 CC; VEGF- 936 CC alleles was not associated with an increase in concentration of IgA anti-CD74. CRP demonstrated an association with IL-17A-197 AA (r=0.965) detected in 29.2% of patients with no correlation with the clinical ankylosing spondylitis activity in patients receiving treatment with iTNF-α and NSAIDs.

The aim of the study was to evaluate the comparative efficacy and safety of biologics registered and reimbursed in the Russian healthcare system for the treatment of adult patients with active ankylosing spondylitis.Material and methods. We performed a systematic literature review of randomized controlled trials in PubMed, Embase, and eLIBRARY.RU databases. 17 articles reporting results from 16 trials were selected for qualitative and quantitative analysis. The main efficacy criteria were ASAS 20/40 over 12-16 weeks of therapy, additional criteria were BASDAI 50, changes from baseline in BASDAI and BASFI indexes. Safety criteria were determined based on the incidence of adverse events; we also analysed the proportion of patients suffering from at least one serious adverse event. Biologics were ranked based on the SUCRA values.Results. Subgroup analysis showed no statistically significant differences between IL-17 and TNF-a inhibitors, but the IL-17 inhibitor class had a higher SUCRA values. For the combination of all analyzed efficacy outcomes, netakimab, infliximab, and ixekizumab hold the first three ranks. The safety profiles of biologics included in the review were comparable with each other.Conclusion. The results of this review are intended to help healthcare professionals make decisions about optimal therapy for adult patients with active ankylosing spondylitis.

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 the data obtained during 52-week follow-up of AS patients in the phase III ASTERA study.Objective: to study the efficacy and safety of NTK when used long in patients with active AS.Patients and methods. The investigation enrolled 228 patients with active AS, in whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective. The patients were randomized in a 1:1 ratio to receive NTK 120 mg or placebo. The drug was administered subcutaneously at weeks 0, 1, 2, and then once every 2 weeks. Patients who received placebo and achieved a 20% improvement according to the ASAS criteria (ASAS20) were excluded from the study at week 16. At this week, patients who took placebo and did not achieve an ASAS20 response were switched to subcutaneous NTK at 120 mg dose once every two weeks. The follow-up period was 52 weeks.Results and discussion. Patients with active AS who received NTK were more likely to respond to treatment than those who took placebo. The proportion of people who achieved 40% improvement (ASAS40) during treatment with NTK increased throughout the follow-up period and amounted to 80.7% at week 52. Positive changes were achieved in all used clinical and laboratory parameters of AS activity. There was also a decrease in inflammatory changes, as shown by magnetic resonance imaging (MRI). The adverse events (AEs) were mainly laboratory abnormalities and upper respiratory tract infections. Treatment-related AEs were recorded in no more than one third of patients and they were mild to moderate. Severe AEs were singular.Conclusion. Response to NTK therapy generates in the first weeks of drug use and increases throughout a year. The safety profile of NTK when used long is generally favorable.

Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors.

Netakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A.Objective. The main objective of BCD-085-5/ASTERA study was to prove superiority of NTK over placebo and assess its’ safety in patients with active AS.Subjects and methods. BCD-085-5/ASTERA was a double-blind, multicenter, randomized, placebo-controlled, phase III study, which included 228 adult patients with active AS, persisting despite active treatment with NSAIDs. AS was considered active at BASDAI score ≥ 4.0. Patients were blindly randomized (1:1) to receive subcutaneous injections of NTK (120 mg) or placebo at weeks 0, 1, 2 and then every other week up to week 14. Starting from week 16 all patients from NTK group and patients from placebo group not achieving ASAS20 were switched to open label 120 mg NTK s/c once every two weeks. The total duration of treatment with NTK was 3 years.Results. Higher proportion of patients had ASAS40 response at week 16 (primary endpoint) in NTK arm compared to placebo (40,4 vs 2,6%, р

The beginning of the 21st century was marked by a simultaneous changes in view on pathogenesis, diagnostics and treatment of axial spondyloarthritis (axSpA). Anti-TNFα inhibitors were the first biologics prescribed in axSpA. 20 year after the biological treatment was first prescribed we have enough data to understand their long-term efficacy.The aim of this study is to evaluate the long-term efficacy of etanercept in patients with axial spondyloarthritis based on data published in periodicals and clinical practice.Patients and methods. An analysis of publications from medical database and data from the St. Petersburg register of patients with rheumatic diseases (n=68) was performed to assess the effectiveness of etanercept in axSpA treatment in the long-term perspectives. Descriptive statistics methods were used.Results. In clinical studies and in real word practice, etanercept has shown high efficiency in reducing clinical, laboratory and visual manifestations of non-radiographic and radiographic axial spondyloarthritis at early and advanced stages of their development.Conclusions. In the long term, the use of etanercept is associated with an increasing slowdown in structural progression while maintaining a stable clinical and laboratory improvement. Discontinuation of treatment in the majority of patients leads to exacerbation of axSpA. At the same time, the low immunogenicity of etanercept allows the resumption of axSpA treatment with a high probability of re-achieving the lost effect with a low probability of secondary ineffectiveness or anaphylaxis.

The paper presents the results of a double-blind (BCD-085-3/AILAS) phase II clinical trial of the original interleukin 17A (IL17A) inhibitor BCD-085 prescribed at different doses to patients with active ankylosing spondylitis (AS) and those of an extended (BCD-085-3ext/AILAS-II) trial characterizing the efficacy and safety of this drug when used for a year.The objective of the AILAS study is to determine the therapeutically effective and safe dose of BCD-085 in the treatment of active AS. The efficacy, safety, and immunogenicity of BCD-085 during its annual use were additionally evaluated in the extended trial.Subjects and methods. The investigation enrolled 89 patients diagnosed as having active (BASDAI scores >4.0; mean spinal pain scores >4.0) AS that met the 1984 New York classification criteria. After the end of the screening period, the patients were randomized at a ratio of 1:1:1:1 in one of four groups that received 40; 80 or 120 mg of BCD-085 subcutaneously or placebo on day 1 of weeks 0, 1, 2 and then once every two weeks up to week 12. The primary end point was the number of patients who achieved an ASAS20 response at week 16. The investigation evaluated the safety of the drug, by calculating the total incidence of adverse events (AEs) and serious AEs (SAEs) and the number of cases of premature therapy termination because of AEs.Results and discussion. An ASAS20 response at week 16 was achieved in 72.7% of patients receiving 40 mg of BCD-085, in 81.8% of those receiving 80 mg, in 90.9% of those receiving 120 mg, and in 42.9% of cases in the placebo group (p=0.004). The superiority of BCD-085 over placebo was proven for 80- and 120-mg doses. The fastest and most pronounced effect was observed in patients treated with 120 mg of BCD-085. In the extended study, an ASAS20 response at week 52 was recorded in 86.4% of patients. One or more AEs during the first 16 weeks of therapy were reported in 11 (50.0%) patients of the 40-mg group; in 6 (27.3%) of the 80 mg group; in 4 (18.2%) of the 120 mg group and in 7 (31.8%) of the placebo group (p=0.183). The frequency and spectrum of AEs did not significantly differ in patients who received placebo and BCD-085 in different doses. No SAE was recorded.Conclusion. Phase II study yielded data demonstrating the high efficacy and good tolerance of BCD-085 in the treatment of active AS. The best effect and optimal tolerance were demonstrated for a dose of 120 mg.

Spondyloarthritides (SpAs) is a group of chronic inflammatory diseases of the spine, joints, and entheses characterized by common clinical, radiological, and genetic features. According to international guidelines, one of the main goals of SpA treatment is to ensure the longest possible preservation of the patient's quality of life (QOL). The use of biological agents (BAs) allows rapid clinical improvement and positively affects QOL in patients.Objective: to evaluate the efficacy of BAs on QOL in patients with SpA in real clinical practice.Patients and methods. A total of 280 patients with SpA were examined. The inclusion criteria were ≥18 years of age; compliance of the clinical picture of the disease with the ASAS criteria for axial SpA (2009) or peripheral SpA (2011); and signing the informed consent form. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI); ASAS HI was used to comprehensively evaluate the impact of SpA on the patient's health. The European QL EQ-5D-5L and the SF-36 questionnaire were applied to determine quality of life in the patients.Results and discussion. The patients' mean age was 40.19±11.9 years; there was a male preponderance (64%); the HLA-B7-pisitive patients were 78%. The median scores were 5.40 [3.12; 6.80] for BASDAI, 3.37 [2.58; 4.15] for ASDAS, 5.30 [2.60; 7.50] for BASFI, 4.00 [2.60; 6.15] for BASMI, and 9.00 [7.00; 12.00] for ASAS HI. Forty-four patients received a variety of BAs. Patients receiving and not receiving BAs were matched for age and gender; however, the patients on biological therapy (BT) had longer disease duration and lower disease activity according to the ASDAS. There were no statistically significantly difference between the two groups in disease activity according to the BASDAI and in functional disorders according to the BASFI; but there was a tendency towards lower values in the patients on BT. Comparison of QOL in the patients of the two groups revealed statistically significant differences in SF-36 pain scale scores (p=0.02) and EQ-5D-5L indicators (p

The paper presents the results of the Osteoarthritis (OA) Expert Council held on September 8, 2019, which was attended by Russian and foreign specialists. The experts considered pharmacological treatment options for OA. The expert meeting resolution states that the treatment of patients with OA should be based on an individual assessment of the patient and on a modern evidence base of therapy efficacy.Treatment of patients with OA is based on the principles of evidence-based medicine that requires an integrated approach and the need of SYSADOAs prescription. Combined drugs with therapeutic dosages of chondroitin sulfate and glucosamine in the early stages of the disease are available as basic agents. The place of paracetamol in the anesthetic therapy algorithm in OA needs to be clarified. It is also noted that when choosing nonsteroidal anti-inflammatory drugs for OA treatment, it is important to take into account individual patient characteristics and the presence of comorbidities.

The Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) is a comprehensive tool for quantifying the health of patients with axial (ax) spondyloarthritis (SpA), including ankylosing spondylitis (AS). ASAS HI was developed on the basis of the International Classification of Functioning, Disability, and Health (ICF). The questionnaire contains 17 questions, each of which is associated with a specific ICF pool (pain, emotions, sleep, sexual function, ambulation, self-care, and communication).Objective: to study the psychometric properties of the Russian-language version of ASAS HI.Subjects and methods. Examinations were made in 245 patients older than 18 years with axSpA or peripheral SpA, who met the ASAS criteria. The main psychometric properties of a questionnaire, such as validity, reliability (reproducibility), and sensitivity, were evaluated. SpA activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI). The short-form 36 (SF-36) health questionnaire and the 5-dimensional EQ-5D version (EuroQoL) were used to assess quality of life in SpA patients. Patient satisfaction with their health status was estimated using the patient acceptable symptom state (PASS) index.Results and discussion. The median age of the patients enrolled in the investigation was 39.5 [28.00; 48.00] years; disease duration – 102.5 [23.0; 196.5] months; there were 64.58% of men were and 78% of HLA-B27 positive patients. The median scores were for: BASDAI, 5.40 [3.20; 6.80]; ASDAS, 3.19 [2.55; 4.15]; BASFI, 5.60 [2.60; 7.50]; BASMI, 4.20 [3.00; 6.60]; ASAS HI, 9.00 [7.00; 12.00]; ASAS EF Items Set, 4.00 [3.00; 7.00]. There were statistically significant relationships between ASAS HI scores and C-reactive protein levels (Spearman correlation coefficient r=0.56), BASDAI (r=0.62), BASFI (r=0.67), ASDAS (r=0.38), BASMI (r=0.46), and patient's global assessment on a visual analogue scale (VAS) (r=0.49; p

Objective: to evaluate kidney function in patients with spinal degenerative-dystrophic diseases (SDDDs) who take nonsteroidal anti-inflammatory drugs (NSAIDs) as repeated short cycles of treatment for severe back pain.Patients and methods. The investigation enrolled 97 patients with SDDDs who took NSAIDs for back pain (a study group). A control group consisted of sexand age-matched healthy individuals who had not used NSAIDs within the past year (n=40). Glomerular filtration rate (GFR) was estimated using the CKD-EPI equation and markers of kidney injury (albuminuria and globulinuria) were measured.Results. In the study group, GFR was decreased to 90 ml/min/1.73 m2 in the remaining 15 (37.5%) cases; the mean GFR was 82.5 [70.8; 90.0] ml/min/1.73 m2 (p≥0.05 for all pairwise comparisons). A decrease in GFR to

The paper discusses the process for validation of the Russian-language EQ-5D-5L version to assess quality of life. According to international and national guidelines, the primary goal of treating spondyloarthritis (SpA) is to preserve the quality of life (QOL) of a patient as long as possible, by achieving control of the main symptoms of the disease and inflammation, by preventing the development and progression of structural changes in the locomotor system, and by preserving/normalizing the patient's functional activity and social adaptation. QOL is the integral characteristic of the physical, psychological, social and emotional status of the patient, which is assessed on the basis of his subjective perception. At the moment, there are no generally accepted national tools for assessing QOL in Russia, so the problem of adaptation and validation of international questionnaires is very actual.Objective: to evaluate the psychometric properties of the Russian-language EQ-5D-5L version in patients with SpA.Subjects and methods. Examinations were made in 163 patients older than 18 years with axial or peripheral SpA, who met the Assessment of Spondyloarthritis International Society (ASAS) criteria. The disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); their functional status was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI). The ASAS Health Index (HI) was used to comprehensively analyze the impact of SpA on the patient's health. The EQ-5D-5L version was employed for the first time in Russia to assess the quality of life of patients. Its main psychometric properties, such as reproducibility, validity, sensitivity, were evaluated.Results and discussion. The median age of the patients was 39.50 [28.00; 48.00] years. Among them, there were 64.8% of men. The median value of EQ-5D (a 5L version) was 0.53 [0.29; 0.65]. There were statistically significant relationships between the EQ-5D-5L values and BASDAI, BASFI, ASDAS, BASMI, ASAS HI, and the SF-36 questionnaire for QOL assessment. The test-retest reliability study showed that the internal consistency (Cronbach's alpha) was 0.96. The median value of the EQ-5D-5L was 0.55 [0.37; 0.63] at the first visit and 0.60 [0.40; 0.69] at the second visit after prescribing therapy (p = 0.01).Conclusion. The validation has indicated that the EQ-5D-5L version is a reliable, change-sensitive, easy-to-use, and physician-patient-friendly tool to assess QOL.

Psoriatic arthritis (PsA) is a chronic inflammatory disease of the joints, spine, and entheses, which is associated with psoriasis. The pathological process is localized mainly in the tissues of the locomotor system and leads to the development of erosive arthritis and intra-articular osteolysis. PsA occurs in 5–7% of patients with moderate psoriasis. Despite advances in the treatment of psoriasis and PsA with diseasemodifying antirheumatic drugs (DMARDs) and biological agents (BAs), the problems associated with immunogenicity, infectious complications, and secondary inefficiency have not been fully solved. These factors have motivated the search for novel targeted synthetic drugs (signaling pathway inhibitors). This group of drugs includes apremilast, a phosphodiesterase 4 inhibitor. Recent data of controlled studies suggest that the drug is effective and safe in treating psoriasis and PsA. Prospects for the use of apremilast in PsA are associated with the possibility to use the drug in patients because of the inefficacy of DMARDs or BAs and with the ability to maintain long-term (more than 3-year) remission and to reduce the manifestations of enthesitis and dactylitis.

Objective: to show the characteristics of teaching this area of clinical medicine in the context of new knowledge and to identify ways of introducing new data into teaching practice by the example of development of the concept of spondyloarthritis (SpA). Material and methods. At Stage 1, by using the keywords: spondyloarthritis, ankylosing spondylitis, psoriatic arthritis, rehabilitation care, and Bechterew's disease, the articles published in January 1951 to January 2017 were sought in the electronic resources PubMed, MedLine, and e-library. The fundamental aspects of the pathogenesis, diagnosis, and treatment of SpA, which need to be introduced into a pedagogical process, were assessed. At Stage 2, by using the analyzed data, the authors proposed to optimize the teaching of the SpA concept in the clinical presentations of visceral diseases. Results. Analysis of the data available in the literature could determine the key points of the new concept of SpA and the ways of its introduction into teaching practice at medical universities and during postgraduate training of physicians.

Objective: to assess liver function changes in patients with spondyloarthritis (SpA) taking NSAIDs regularly over a long period.Patients and methods. The data obtained during a 10-year PROGRESS prospective single-center cohort study of functional status, activity, and comorbidity (including gastrointestinal tract diseases) in patients with SpA were analyzed. The data of 363 SpA patients receiving NSAIDs regularly over a long period and followed up for 10 years were also explored. The changes that had occurred over a decade in the liver enzyme levels, the number of discontinued NSAID treatments because of a persistent increase in liver enzyme levels, and the number of prescriptions of hepatoprotective agents were analyzed.Results. For 10 years, 18 patients with SpA discontinued their NSAID intake due to elevated liver enzyme levels (≥3 times greater than the reference value); during that time, the same increase in enzyme levels was observed in 2 healthy individuals (χ2 =1.39; p=0.2). In the patients with SpA as compared to the healthy individuals, the relative risk of abnormal liver function was 1.19 (95% CI, 1.009–1.405); odds ratio was 2.9 (95% CI, 0.65–12.95). There was no increased risk for discontinuation of some NSAIDs, including nimesulide (χ2 =0.03, p=0.85), the frequency of using hepatoprotective drugs was proved to be highest for diclofenac sodium, ibuprofen, nimesulide, and ketoprofen.Conclusion. The regular long-term (as long as 10 years) use of NSAIDs to treat SpA is associated with treatment discontinuation because of elevated enzyme levels in every 10 patients. The maximum rate of discontinuation of NSAIDs due to a persistent increase in liver enzyme levels is observed 6–8 years after their regular use, so long-term NSAID therapy requires continuous monitoring of hepatic safety. The longterm intake of nimesulide, as compared with other NSAIDs, is shown to be unassociated with the higher rate of its discontinuation because of worse liver function. Hepatoprotectors are less frequently prescribed to patients taking nimesulide than to those receiving diclofenac sodium or ibuprofen and more frequently to patients using meloxicam. In most cases, prescribing hepatoprotective agents to patients receiving NSAIDs does not require discontinuation of anti-inflammatory therapy.

Objective: to investigate the clinical efficacy and cardiovascular safety of the combined symptomatic slow-acting drug glucosamine and chondroitin sulfate in patients with osteoarthritis (OA) and hypertension.Subjects and methods. The investigation enrolled 44 patients (a female:male ratio of 40:4) aged 54.5±7.4 years with knee OA (duration, 6.4±1.54 years). The patients were blindly randomized into two groups: 1) those who received antihypertensive therapy, teraflex (chondroitin sulfate 400 mg and glucosamine sulfate 500 mg) with/without acetaminophen; 2) those who had antihypertensive therapy and acetaminophen. At baseline and 3 and 6 months after treatment, the investigators assessed a change in the degree of OA by the WOMAC and Lequesne indices, the treatment efficiency evaluated by a physician and a patient using a visual analogue scale, and cardiovascular safety (during the first and last visits) through examination of the antithrombogenic properties of the vascular wall and arterial stiffness.Results. All the patients taking teraflex for 6 months were observed to have a positive effect manifesting as a substantial reduction in WOMAC and Lequesne indices, pain syndrome, and needs for analgesics compared to both the baseline level and parameters in the patients receiving acetaminophen only. Teraflex therapy showed an increase in the fibrinolytic activity of the vascular wall. A more obvious fall in augmentation index and pulse wave velocity was seen in OA and AG patients receiving antihypertensive therapy and teraflex.Conclusion. Group 1 displayed not only reductions in pain syndrome and needs for analgesics, but also no blood pressure destabilization. They also had lower endothelial dysfunction manifesting as enhanced fibrinolytic activity of the vascular wall, decreased brachial and aortic augmentation indices, and lower pulse wave velocity.

The paper discusses possible approaches to determining remission in ankylosing spondylitis (AS) and other axial spondyloarthritides (axSpA). At present, there is no single definition of the concept of remission in axSpA and AS, which is due to both the diversity of manifestations of axSpA and a large number of tools to measure disease activity and the nonsimultaneous change in the degree of clinical and laboratory symptoms, signs of acute inflammation, as evidenced by imaging techniques, and signs of progressive structural changes in the locomotor apparatus in the same patient. Clinical, laboratory, magnetic resonance imaging, and radiographic remissions in a patient cannot be in time, which in turn affects the choice of optimal therapy.The case report demonstrates problems with treatment correction in a patient who has achieved clinical and laboratory remission in the presence of persistent inflammatory signs in the locomotor apparatus, as shown by imaging techniques. Since the guidelines for the follow-up and treatment of patients with nonradiographic axSpA and AS are similar today, the paper considers remission as a general problem for all subtypes of axSpA.

The paper considers a case of adult-onset Still's disease that occurred as acute pericarditis, two-spike hectic fever, and neutrophilic leukocytosis in a young man. It was difficult to establish a correct diagnosis because there were no characteristic clinical symptoms of Still's disease, such as salmon colored rash, arthralgia, and sore throat. The diagnosis of adult-onset Still's disease was verified on the basis of the classification criteria described by M. Yamaguchi et al. The special feature of the clinical case was the development of steroid resistance and the effective use of a combination of the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, given intravenously dropwise once every four weeks) and methotrexate (15 mg/week orally). During this treatment, a sustained clinical and laboratory response was achieved, which could reduce the dose of glucocorticoids to the maintaining one.

Objective: to evaluate the efficacy and tolerability of the combined symptomatic slow-acting combined agent Theraflex in gonarthrosis patients untreated with nonsteroidal antiinflammatory drugs (NSAIDs).Patients and methods. The investigation enrolled 84 patients (78 women and 6 men) aged 55.23±7.36 years with knee arthritis lasting 6.2±0.98 years who were blindly randomized into 2 groups. A study group took Theraflex (chondroitin sulfate 400 mg and glucosamine sulfate 500 mg) with or without acetaminophen. A comparison group received acetaminophen only. At baseline and 3 and 6 months after treatment, the investigators assessed changes in the magnitude of osteoarthritis (OA) using WOMAC and Lequen's indices, evaluated the therapeutic efficiency rated by a patient and a physician according to the visual analogue scale, and took into account adverse reactions (AR).Results. All the patients taking Theraflex for 6 months showed a positive effect in substantially lowering WOMAC and Lequen's indices and reducing pain and needs for analgesics as compared to both the values at baseline and those obtained in the patients receiving acetaminophen only.Conclusion. In osteoarthritis patients untreated with NSAIDs, Theraflex treatment was associated with a reduction in pain syndrome and stiffness and with better function and lower needs for analgesics. Six-month Theraflex therapy did not cause serious ARs, as well as in patients having controlled gastrointestinal and renal diseases and hypertension

Aim. To identify the disturbances of vegetative heart regulation and their associations with systemic inflammation activity in patients with psoriatic arthritic (PsA). Material and methods. The main group (MG) included 32 PsA patients without cardiovascular disease, CVD (mean age 44,62±11,6 years; mean PsA duration 10,32±10,2 years; 52,3% men). The control group (CG) included 25 healthy volunteers (mean age 40,33±11,8 years; 49,1% men). Time and spectral parameters of heart rate variability (HRV) were assessed. PsA activity was assessed by DAS index, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and fibrinogen (FG) levels. Cardiovascular risk (CVR) was calculated, based on the following parameters: lipid spectr arterial hypertension, body mass index, and family history of CVD. Results. Compared to CG, all HRV parameters were affected in MG patients (p

Aim – to identify disorders of autonomic regulation of cardiac activity in patients with psoriatic arthritis (PsA) by determining the heart rate variability (HRV), and also establish the relationship of HRV with systemic inflammation and traditional cardiovascular risk factors.Materials and methods. The study included 53 patients with PsA (mean age 43.64 ± 12.1 years), including 48.2 % men, mean disease durationwas 10.32 ± 10.2 years. The control group included 25 healthy volunteers (average age 46.7 ± 12.45 years, 49.1 % – men). Time andfrequency measures of HRV were analyzed. Active PsA was determined by an index DAS4, rate erythrocyte sedimentation rate (ESR), levels of C-reactive protein (CRP) and fibrinogen. Patients with clinical manifestations of cardiovascular disease, and patients with symptomsof carotid atherosclerosis, detected by duplex study were excluded.Results. Deterioration of HRV in patients with PsA compared with those in patients of the control group, the availability of statistically significant reverse relationship of temporal and spectral parameters of HRV with PsA activity (ESR, CRP, entezit score, DAS4), duration of arthritis, the classical factors of cardiovascular risk were established.Conclusion. Patients with PsA had noted a violation of autonomic regulation of cardiac activity in the form of reduced HRV and activation of the sympathetic part of it. Identified changes were associated with activity of systemic inflammation and classical factors of cardiovascular risk.