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The aim of the study – Is to evaluate the effectiveness and safety of the use of a functional unloading orthosis with the possibility of varus–valgus correction (FUOVVC) in patients with stage III osteoarthritis of the knee joint.Materials and methods. The study involved 10 patients with stage III osteoarthritis of the knee joint who underwent outpatient treatment at the V.A. Nasonova Federal State Medical University of the Russian Academy of Medical Sciences. All patients used the FUOVVC for 3 months. To evaluate the results, pain intensity was determined using a visual analog scale (VAS) and knee joint function according to the knee injury and osteoarthritis KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire before using the orthosis, after 1 and 3 months. Additionally, the assessment of VAS was carried out immediately after fixation of the orthosis on the knee joint.Results. The median age of the patients was 63.5 [55.0; 74.0] years, body mass index – 29.9 [27.9; 34.0] kg/m2, pain according to VAS baseline – 40.0 [40.0; 60.0] mm, pain according to VAS 1 hour after the start of the use of The median age of the patients was 63.5 [55.0; 74.0] years, body mass index – 29.9 [27.9; 34.0] kg/m2, pain according to VAS baseline – 40.0 [40.0; 60.0] mm, pain according to VAS 1 hour after the start of the use of FUOVVC – 25.0 [10.0; 30.0] mm, pain according to VAS after 1 month – 10.0 [0.0; 20.0] mm, VAS after 3 months – 10.0 [0.0; 20.0] mm. The median score according to the KOOS questionnaire was initially 41.5 [38.0; 50.0], after 1 month – 61.0 [53.0; 63.0], after 3 months – 63.5 [58.0; 64.0]. None of the patients had any adverse events when wearing the FUOVVC. – 25.0 [10.0; 30.0] mm, pain according to VAS after 1 month – 10.0 [0.0; 20.0] mm, VAS after 3 months – 10.0 [0.0; 20.0] mm. The median score according to the KOOS questionnaire was initially 41.5 [38.0; 50.0], after 1 month – 61.0 [53.0; 63.0], after 3 months – 63.5 [58.0; 64.0]. None of the patients had any adverse events when wearing the FUOVVC.

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease of unknown etiology characterized by the overproduction of autoantibodies against various components of the nucleus of the patient's own cells with the development of immunoinflammatory tissue damage. In recent years, more and more data have accumulated on the involvement of neutrophils in the development of the clinical symptoms of SLE, and DNA-containing structures and neutrophil extracellular traps (NETs) playing an important role in this process. Effective neutralization of NETs in SLE can be achieved by removing circulating proteins and molecules associated with NETs from the bloodstream by selective plasma sorption of DNA using the NucleoCapture Device.This article describes the case of a patient who underwent three plasma sorption sessions aiming to suppress the activity of SLE. During the therapy, significant positive dynamics were achieved: the SLEDAI-2K index decreased from 32 to 12 points, the number of leukocytes in the blood normalized, renal function improved, and the immunological activity of the disease decreased.

Objective: a comparative study of the peculiarities of pharmacotherapy of rheumatoid arthritis (RA) in presence and in absence of interstitial lung disease (ILD).Material and methods. The study included 1034 patients with active RA who met the 2010 ACR/EULAR criteria. Patients were divided into two groups: with ILD according to high-resolution computed tomography of the lungs (n=82) and without ILD or other types of chronic obstructive pulmonary diseases, including bronchial asthma (52 patients excluded; n=900). Based on medical documentation, archived medical records and medical history, a “drug card” was created for all stages of pharmacotherapy of patients with active RA. The Cumulative Illness Index Score (CIRS) was used to assess the profile and severity of comorbidities.Results and discussion. The main indicators of RA activity in the patients of the two groups were comparable, but a greater number of comorbidities (p˂0.0001) and a higher value of the CIRS multimorbidity index (p˂0.0001) were found in the group with ILD. The presence of ILD had no influence on the frequency of prescription, the total duration of use and the maximum dose of glucocorticoids (GC) (p˂0.05). The average dose of GC was statistically significantly higher in the group with ILD (p=0.008). These patients were taking disease-modifying antirheumatic drugs (DMARDs): methotrexate (p=0.04), leflunomide (p=0.02) and sulfasalazine (p=0.03), less frequently, but they took hydroxychloroquine significantly more frequently (p=0.02) with a comparable total duration of use of each medication. RA patients with ILD and without ILD received biologic DMARDs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs) in 62.2 and 59.6% of cases, respectively (p˂0.05). At the same time, patients without ILD had experience of taking a greater number of different bDMARDs/tsDMARDs (p=0.03). In the group with ILD, patients more frequently received anti-B-cell therapy (p˂0.0001) and significantly less frequently drugs of other classes: tumour necrosis factor α inhibitors (p˂0.0001) and interleukin 6 inhibitors (p=0.01), T-cell costimulation blocker (p=0.04) and Janus kinase inhibitors (p=0.001). Patients with ILD were statistically significantly older at the start of bDMARD/tsDMARD therapy (p˂0.0001), and the period from the onset of RA to the start of bDMARD/tsDMARD therapy was comparable in both groups (p˂0.05).Conclusion. The observed peculiarities of pharmacotherapy in the group with ILD (frequency of use, choice and dose of GC, DMARDs, biologics and tsDMARDs) are probably related to the presence of ILD on the one hand and to the characteristics of concomitant pathology and older age on the other, as the activity of RA was comparable in our patients with and without ILD.

Anemia is still one of the most common comorbidities that affects the prognosis of the underlying disease and the quality of life of patients.Objective: to evaluate the value of serum hepcidin level determination for the differential diagnosis of anemia of chronic disease/inflammation (ACD) in patients with active rheumatoid arthritis (RA).Material and methods. The study included 47 patients with RA with anemia consecutively admitted to V.A. Nasonova Research Institute of Rheumatology for inpatient treatment. According to WHO recommendations, the criterion for anemia was a decrease in hemoglobin level ˂ 120 g/l in women and ˂ 130 g/l in men. The control group consisted of 29 patients without anemia. In all patients, the DAS28 index was determined, and clinical and biochemical blood parameters were examined: serum iron, total iron-binding capacity of serum, hepcidin, cytokines, including interleukin (IL) 6 and tumor necrosis factor α (TNFα).Results and discussion. Of 47 patients with active RA and anemia, only 13 (28%) were diagnosed with isolated ACD. Iron deficiency anemia (IDA) was found in 17 (36%), the remaining 17 patients had a mixed genesis of anemia (ACD + IDA). Patients with isolated ACD had a statistically significant higher level of hepcidin(120.3±56.1 pg/ml) compared to the control group (90.3±37.9 pg/ml) and to patients with RA + IDA. In isolated ACD, the levels of IL6, TNFα, rheumatoid factor and antibodies to cyclic citrullinated peptide were 2 times higher (p ˂ 0.05) than in RA with iron deficiency (both in IDA and in mixed genesis of anemia). Only in isolated ACD did the hepcidin level correlate with the IL6 concentrations (r=0.8); no such correlation was found in patients with IDA and anemia of mixed origin or in patients without anemia. No correlation with TNFα levels was found in any subgroup.Conclusion. Hepcidin levels are an informative indicator for the differential diagnosis of the type of anemia during active inflammation. In RA patients with ACD, the maximum hepcidin concentration in blood serum was determined, and in IDA it was found to be lower than the reference values. The importance of the hepcidin – IL6 axis and the lack of influence of the proinflammatory cytokine TNFα on iron metabolism were demonstrated.

Ensuring a long-lasting effect of the therapy and its safety are important tasks in the treatment of patients with osteoarthritis (OA). Parenteral forms of chondroitin sulfate (CS) used for the background therapy of OA are characterized by proven efficacy and safety and, compared to oral forms, have greater bioavailability, faster onset of symptom-modifying effect and maintenance of more stable remission, which can significantly improve patients' quality of life.Objective: to evaluate the clinical efficacy and safety of two-month therapy with injectable CS and the duration of positive dynamics after the end of treatment in patients with knee OA (KOA).Material and methods. The open prospective observational study involved 35 patients (mainly women) aged 50–75 years with stage II–III KOA. All patients were prescribed intramuscular therapy with a CS solution (Mucosat® solution), with the first three injections of 1 ml, followed by 2 ml every second day (25 injections in total). Standard indices and questionnaires were used to assess the main clinical indicators at baseline and over time (14, 30, 60 days, 5 and 8 months after the start of treatment), as well as the results of ultrasound examination of the knee at baseline and at the end of treatment.Results and discussion. 14 days after the start of therapy, a statistically significant decrease in pain was observed applying the visual analogue scale (VAS), and after 2 months, 94% of patients had a significant decrease in knee pain according to VAS, Lequesne index and WOMAC index (total score and components). The KOOS parameters and quality of life according to EQ-5D-3L improved significantly. There was no pain or only minor pain (VAS ≤40 mm) in 54% of patients. The number of patients who had to take nonsteroidal anti-inflammatory drugs (NSAIDs) constantly fell threefold, while occasional use fell fivefold. The thickness of the synovial membrane of the knee joint and the number of patients with signs of synovitis decreased significantly. At 3 and 6 months after the end of therapy, most patients (60%) still had minor pain (≤40 mm according to VAS) and a significantly lower need for NSAIDs compared to baseline. The injectable CS was well tolerated and no adverse drug events were noted.Conclusion. We demonstrated both safety and efficacy and long-term maintenance of the clinical effect (6 months after the end of therapy) of injectable CS in the majority of OA patients, against the background of a low need for NSAIDs.

Rituximab is a chimeric (mouse and human) monoclonal antibody against B-lymphocytes (CD20). This drug is widely used in rheumatology in the treatment of rheumatoid arthritis, Sjogren’s syndrome, some systemic connective tissue diseases and vasculitis, as well as in hematology in lymphoproliferative diseases. Administration of rituximab leads to depletion of B-lymphocytes through various mechanisms, including antibody-dependent and complementdependent cytotoxic effects, as well as the regulation of apoptosis. Considering the mechanism of autoimmune damage in Graves’ disease, an autoimmune thyroid disease accompanied by thyrotoxicosis and endocrine ophthalmopathy (an autoimmune lesion of the accessory apparatus of the eye), the use of rituximab may be effective in these diseases. The review considers the currently available results of studies on the use of various doses of rituximab in these diseases.

Objective: to compare the course of “rheumatoid disease” in multimorbid patients with and without interstitial lung disease (ILD).Material and methods. Two groups were formed of 1034 patients with active rheumatoid arthritis (RA) who met the 2010 ACR/EULAR criteria: one group with ILD identified by high-resolution computed tomography of the lungs (n=82) and another – without ILD (n=900). In all patients, estimated glomerular filtration rate (eGFR) was determined using the Cockroft–Gault formula. The presence and stage of chronic kidney disease (CKD) was assessed depending on the eGFR level: stage I CKD was diagnosed in eGFR

The problem of comorbidity is widely discussed in modern medical literature. Its role in rheumatic diseases is of particular interest due to their multifactorial nature and the involvement of a wide range of pathogenetic mechanisms. For many years, researchers around the world have noted correlations between the presence of active autoimmune disorders and the complicated course of cardiovascular diseases. A deeper understanding of the pathogenetic mechanisms at the present stage of development of rheumatology allows us to take a fresh look at the relationship between atherosclerosis and rheumatoid arthritis. The definition of multimorbidity developed in recent years and the results of recent scientific studies may contribute to a more correct choice of tactics for managing patients with a combination of these two diseases.

Objective: to evaluate the effectiveness of therapy with AMBENE®Bio (AB) in comparison with the comparator drug (bioactive concentrate of small marine fish, BCSMF) in patients with osteoarthritis (OA) of large and small joints in routine clinical practice.Patients and methods. KOLIBRI multicenter, observational, non-randomized, comparative study included 233 patients with OA of the small hand joints (HJ) or knee joints (KJ) from three Russian centers (two in Moscow and one in Tula). Patients with a generalized form of OA were excluded from the analysis. The remaining patients were divided into two groups depending on the localization of OA. The first group included 174 patients with knee OA, 105 of them received AB, and 69 received the reference drug (BCSMF) according to the same regimen. The second group consisted of 21 women with HJ OA: 13 patients were prescribed AB, and 8 — the reference drug.The duration of the study averaged 330±14 days, the total number of visits was 4. The main indicator of effectiveness was the dynamics of pain during movement according to VAS (0—100 mm) 30±7 days after the start of treatment compared with the baseline value. All patients underwent radiography of the HJ and KJ, as well as ultrasound of the involved joints.Results and discussion. Both drugs provided significant clinical improvement in patients with OA, which is consistent with other studies with similar design and long follow-up. These data confirm the symptom-modifying properties of the presented group of combined drugs in the OA treatment. The Russian injectable drug AB in OA was not inferior in effectiveness to the foreign BCSMF. According to the OMERACT-OARSI criteria, 85.2% and 88.9% of patients, respectively, responded to treatment with AB and the reference drug. In both groups, half of the patients managed to stop further use of non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis.Conclusion. The use of AB was accompanied not only by a decrease in the severity of clinical symptoms of OA, but also by a decrease in the daily requirement for NSAIDs almost by 2 times.

One of the main tasks of modern complex therapy of rheumatoid arthritis (RA) is to improve the quality of life of patients. To do this, it is necessary not only to achieve remission or low activity, but also to successfully control the main, most painful, manifestations of the disease. Therefore, when evaluating the results of RA treatment, the dynamics of not only standard indices (DAS28 (Disease Activity Score 28), CDAI (Clinical Disease Activity Index), SDAI (Simplified Disease Activity Index)), but also the so-called “patient reported outcomes” (PRO) – a patient’s global assessment of disease activity (PGA), pain, functional disorders and fatigue.This review examines the effect of one of the main classes of anti–rheumatic drugs - biological disease-modifying antirheumatic drugs (bDMARDs) on the PROs. The results of a series of randomized controlled trials are presented, in which changes in PROs were studied using various tumor necrosis factor α (TNF-α) inhibitors, abatacept T-lymphocyte co-stimulation inhibitor, rituximab CD20 inhibitor and interleukin (IL) 6 inhibitors.The use of bDMARDs in combination with methotrexate (MTX) provides a reduction in PGA and pain by 50-60%, functional disorders according to HAQ (Health Assessment Questionnaire) and fatigue according to FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) – by 15-30%. B DMARDs monotherapy (with the exception of the effect of tocilizumab on HAQ) does not exceed MTX monotherapy in its effect on PROs. Monotherapy with tocilizumab provides more favorable dynamics of PGA and pain than monotherapy with TNF-α inhibitors. An important advantage of IL-6 inhibitors is the rapid achievement of a clinical effect, which is noted already in the first 2 weeks after the first administration of the drug.

The need for effective drugs for the treatment of knee osteoarthritis (OA) is constantly growing. Current guidelines recommend the use of symptomatic slow acting drugs for osteoarthritis (SYSADOA) such as glucosamine (GCA) in this disease. Among various drugs containing GCA, high bioavailability and clinical efficacy have been shown only for prescription crystalline GCA sulfate (pGCAS) administration. Several meta-analyses and network meta-analyses have shown that efficacy of pGCAS 1500 mg once daily is superior to other GCA-based products (such as GCA hydrochloride with or without sodium sulfate) and the combination of GCA with chondroitin sulfate (CS) in terms of reducing the intensity of pain and improving the functional state. These studies confirmed the favorable safety profile of pGCAS, which was comparable to placebo in the incidence of adverse events. Pharmacoeconomic studies have also demonstrated greater cost-effectiveness of pGCAS compared to other GCA drugs.A group of Russian experts at a meeting of the advisory committee reviewed the evidence in favor of the use of pGCAS and evidence of its effectiveness in the treatment of knee OA in comparison with other products that include GCA, and the fixed combination of GCA with CS. Taking into account the results obtained, the use of pGCAS at a dose of 1500 mg once a day is recommended as a rational choice for the treatment of knee OA.

Objective: to compare the course of the disease and therapy in rheumatoid arthritis (RA) patients who meet and do not meet the criteria for difficult- to-treat RA (D2T).Patients and methods. The study included RA patients who met the 2010 ACR/EULAR criteria and who were hospitalized in the V.A. Nasonova Research Institute of Rheumatology from March to October 2021. All patients underwent a conventional clinical and laboratory examination, radiography of the hands and distal feet, and the radiological stage of RA according to Steinbroker was assessed. To determine the inflammatory activity, the DAS28-ESR and DAS28-CRP indices were calculated.Results and discussion. The study included 303 patients with RA, 25 (8.4%) of them had D2T RA. The duration of RA in the D2T group was significantly longer than in other patients (15.9±11.8 and 11.9±9 years, respectively; p=0.04). X-ray changes in the joints in D2T were more pronounced. Patients with D2T had higher inflammatory activity at the time of hospitalization than patients who had continued prior therapy with biologic/targeted synthetic DMARDs. The dose of glucocorticoids (GC) in patients with D2T RA was higher compared to patients of other groups: on average 8.3±5.1 and 6.4±2.9 mg/day, respectively (p=0.02).Conclusion. The results of this study suggest that in Russia, as well as abroad, the treat-to-target principle has not yet become widespread, and the selection of adequate therapy takes too much time. At the same time, Russian rheumatologists primarily use GC to suppress inflammatory activity. The introduction of modern recommendations for the management of patients with RA into routine clinical practice, could possibly restrain the formation of D2T RA.

The prescribing of biological disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase inhibitors (iJAK) during the COVID-19 pandemic requires a balanced approach and tight monitoring of the patients.The aim of the study was to study the effect of bDMARDs and iJAK inhibitors on the condition of patients with rheumatoid arthritis (RA), taking the patients reported outcomes, as well as the incidence of COVID-19 in these patients.Materials and methods. A telephone survey was conducted of 254 patients with RA (average age – 49.8±13.7 years; 64.4% of patients are positive for rheumatoid factor; women – 83.5%; DAS28 score – 5.4±1.6 points), who in the period from January 2020 to June 2021 were prescribed bDMARDs or iJAK for the first time: 148 (58.3%) – rituximab; 57 (22.4%) – tumor necrosis factor α inhibitors; 20 (7.9%) – iJAK; 17 (6.7%) – interleukin 6 inhibitors; 12 (4.7%) – abatacept.Results. At the time of the survey, 204 (80.3%) patients continued taking prescribed medications. The main reason for the interruption of treatment was administrative problems. Synthetic DMARDs (mainly methotrexate and leflunomide) were received by 68.0%, glucocorticoids – 45.3%, nonsteroidal anti-inflammatory drugs – 44.5% of respondents. Among patients treated with bDMARDs or iJAK, 68.1% noted «the state of symptoms acceptable to the patient», the absence of frequent joint pain – 65.3%, the absence of increased fatigue – 14.3%. The incidence of COVID-19 and hospitalization associated with this disease did not differ in individuals who continued and stopped using bDMARDs or iJAK: 41.2% and 44.6%, 13.7% and 14.0%, respectively (p=0.80884). There were no statistically significant differences in the incidence of COVID-19 and hospitalization associated with this disease in patients taking various bDMARDs or iJAK.Conclusion. Despite the COVID-19 pandemic, rituximab remains one of the most popular bDMARDs. About a third of patients receiving bDMARDs or iJAK are not satisfied with their condition. More than 40% of patients who received these drugs suffered COVID-19; 14.0% required hospitalization.

Objective: to assess the quality of life (QoL) using general and special questionnaires and to identify the relationship between fatigue and sarcopenia (SP) in elderly and senile people.Patients and methods. The cohort study included 230 patients, including 177 women (77%) and 53 men (23%) over 65 years old (median age 75 [68; 79] years). The presence of SP was determined according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP2, 2018). QoL was studied using the general questionnaires EQ-5D, SF-36 and a special questionnaire SarQoL, the level of fatigue – using the FACIT-F questionnaire. To assess the possibility of using the FACIT-F scale for SP screening, its sensitivity, specificity, diagnostic accuracy, positive and negative predictive value were determined, a receiver operating characteristic (ROC) curve (ROC analysis) was constructed, and the area under the ROC curve (AUC) was calculated.Results and discussion. The assessment of QoL using the EQ-5D and SF-36 questionnaires did not reveal significant differences between the groups of patients with and without SP (p>0.05). When analyzing the state of health in the study cohort using the special SarQoL questionnaire, the overall indicator was 63.12±18.83 points, while in patients with SP it was significantly lower than in patients without SP (50.65±14.23 and 75,10±14.46 points, respectively; p10 mg/L (p

The widespread introduction into clinical practice of modern approaches to the treatment of rheumatoid arthritis (RA), the rational use of traditional and targeted antirheumatic drugs can effectively suppress inflammatory activity, restrain the progression of the disease and improve the quality of life of patients. At the same time, in some patients, even after the repeated change of targeted drugs, it is not possible to achieve the target level of RA activity. Serious difficulties arising in the management of such patients raised the question of identifying a special variant of the disease – difficult-to-treat (D2T) RA. The presence of various variants of D2T RA and the need to use a personalized approach to therapy justify the creation of special recommendations for the management of this category of patients. The first step in preparing these recommendations was the definition of D2T RA recently presented by the EULAR working group. It includes three criteria: 1) insufficient effectiveness of the therapy; 2) the presence of an active symptomatic disease; 3) clinical perception.

Objectives: evaluation of the clinical efficacy and safety of the healthy joints maintaining compound Artroflex® in knee osteoarthritis (OA) in postmenopausal overweight women in outpatient clinical practice.Patients and methods. An open, prospective observational single-center post-marketing study included 30 postmenopausal women 50–75 years old (mean age 62.3±6.3 years) with knee OA. Patient body mass index (BMI) was >25 (mean body weight 85.3±15.3 kg). Radiographically confirmed primary gonarthrosis stage II according to Kellgren–Lawrence was detected in 26 (87.0%) patients, stage III – in 4 (13.0%). The duration of knee OA ranged from 1 to 21 years (average 7.8±6.1 years).Artroflex® was prescribed 1 capsule 2 times a day for 3 months. During three visits (baseline, after 1 and 3 months), the need for analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) and the occurrence of adverse reactions (AR) were determined. Health status and pain level were also assessed using a visual analogue scale (VAS), the severity of pain and stiffness, limited function according to the WOMAC questionnaire, fatigue/fatigue according to the FACIT scale, the Charlson comorbidity index, satisfaction of the doctor with the results of treatment using the IMOS scale, and satisfaction of the patient with using the IMPSS scale.Results and discussion. A statistically significant decrease in the pain score according to the VAS, an improvement in health status, and the WOMAC index were found in the overwhelming number of patients, regardless of BMI. 90% of women noted decrease in fatigue/fatigue on the FACIT scale, and 93% of patients reported satisfaction with treatment, regardless of the Charlson comorbidity index. The need for NSAIDs after one month of use of the Artroflex® compound decreased by 7%, after 3 months – by 23%. A negative feedback was found between the baseline indicator of health status and the assessment of the effectiveness of therapy. No serious ARs were identified during the study.Conclusion. Feasibility of using the Artroflex® compound in real clinical practice in patients with knee OA and excessive body mass has been shown.

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

The paper gives the current definition of osteoarthritis (OA), which reflects the pathogenetic and clinical characteristics of this disease, as well as general principles for choosing an OA treatment. It describes the effect of glucosamine and chondroitin on the key pathogenetic mechanisms of OA. It is noted that one of the promising areas of therapy for OA is the intra-articular administration of biopolymer-based hydrogels that provide not only an anti-inflammatory, but also regenerative effect that has been experimentally confirmed during their injection into the tendon sheaths. There are data on the efficacy and safety of the Russian drug Sphero®gel, a biopolymer-based microheterogeneous collagen-containing hydrogel that belongs to a class of multicomponent biopolymer-based extracellular matrix mimetics. It consists of the cross-linked farm animal tissue-derived collagen microparticles placed in the gel base. The gel is not only a structural base for collagen microparticles; it also has its own therapeutic potential, since it is structurally similar to the natural extracellular matrix. The drug contains collagen, biologically active components of the extracellular matrix, such as proteoglycans, glycoproteins, uronic acids, growth factors, monosaccharides, and chondroitin sulfate. Extended-release symptomatic agents, Sphero®gel among them, are currently recommended for the treatment of OA. Application of Sphero®gel contributes to increased joint mobility and reduced pain, which allows the limited use of nonsteroidal anti-inflammatory drugs that cause adverse reactions, especially in the presence of comorbid diseases.

The prevalence of sarcopenia in different countries of the world has been well studied. However, the criteria of different international professional groups are used to diagnose the disease, which leads to large variability in data on the frequency of sarcopenia in the population. The paper presents the results of studying the frequency of sarcopenia, by using the diagnostic criteria of different working groups. The measures characterizing muscle strength and skeletal muscle function were analyzed; the components that are most important for the diagnosis of sarcopenia were identified in the studied patient group.Objective: to determine the detection rates of sarcopenia among people aged over 65 years in accordance with the guidelines of different international professional groups and to identify the most significant component for its diagnosis.Subjects and methods. The investigation enrolled 230 people older than 65 years (mean age, 74.0±6.5 years) who were followed up in an outpatient setting. Sarcopenia was diagnosed according to the 2010 European Working Group on Sarcopenia in Older People (EWGSOP) criteria. To confirm its diagnosis, the appendicular muscle mass index (AMMI) was calculated using dual-energy X-ray absorptiometry (DXA) on a HOLOGIC QDR Explorer; muscle strength was measured with a Jamar-J00105 handheld dynamometer (Sammons Preston Inc., USA). Muscle function was also examined using the short physical performance battery (SPPB). The frequency of sarcopenia diagnosed by the criteria of the International Working Group on Sarcopenia (IWGS), the Foundation for the National Institutes ofHealth (FNIH), and EWGSOP were comparatively analyzed. Results and discussion. The frequency of sarcopenia in the sample of people aged over 65 years was the same when using the diagnostic EWGSOP and IWGS criteria (30%) and was significantly higher than when applying the FNIN criteria (19.8%). The frequency of sarcopenia increased from 21.4% at the age of 65–74 years to 52.9% at the age of over 85 years according to the EWGSOP and IWGS criteria and from 16.2% to 29.4%, respectively, by the FNIN criteria. Dynamometry showed that the muscle strength was significantly lower in patients with low muscle mass than in those with normal muscle mass (the average mass was 15.1±5.4 and 18.2±5.4 kg, respectively; p

These clinical guidelines have been developed under the auspices of the All-Russian public organization «The Association of Rheumatologists of Russia» and the public organization «Russian Osteoporosis Association» and are dedicated to the diagnosis of the risk of falls and their prevention in elderly people who have a high frequency of falls and their serious consequences as injuries varying in severity, as fractures, developed pain, a loss of ability to perform everyday activities and to take care of themselves. The paper presents risk factors for falls and risk assessment methods and formulates main provisions for preventing falls in older people, by taking into account their place of stay: at home, hospital or social services facilities.

In recent years, the long-term survival of patients with systemic lupus erythematosus (SLE) has increased to more than 90%, but there are still quite a few unresolved problems. Although the main objective of the concept of «Treatment of SLE to target» is «remission of symptoms and absence of organ damage», it was recognized that there is currently no generally accepted definition of remission in SLE. The article discusses different variants of the definition of «remission» in SLE.

Pathological changes of large joints (knee, hip) in osteoarthritis (OA) are accompanied by the development of muscle weakness, decreased proprioception and imbalance.Objective: assessment of skeletal muscles state in women over 65 years old with OA of large joints and determination of the main factors affecting the risk of sarcopenia.Subjects and methods. In 159 women with OA (mean age 74±6 years), muscle mass was assessed with the appendicular lean mass index (ALM) using dual-energy X-ray absorptiometry (DXA). Muscle strength was measured by hand dynamometer, muscle function was determined by the results of a brief set of physical activity tests (short physical performance battery – SPP). The quality of life was analyzed by the EQ-5D questionnaire, pain assessment was carried out using a visual analog scale (VAS).Results and discussion. Patients with sarcopenia were significantly more likely to have lower rates of ALM index (p

The aim is to carry out language adaptation and validation on the Russian sample of a special SarQoL questionnaire, designed to assess the quality of life of elderly people with sarcopenia. Material and methods. 100 patients over 65 years, mean age 74.0±6.5 years, observed on an outpatient basis were included. 50 from them had sarcopenia and 50 participants were without it. The diagnosis of sarcopenia was based on criteria developed by the European working group on sarcopenia (EWGSOP, 2010). The validation procedure was carried out in accordance with the Protocol. Results and discussion. There was a significant decrease in the overall quality of life according to SarQoL questionnaire in patients with sarcopenia compared with the control group without sarcopenia (50.65±14.23 and 75.10±14.46, respectively; p

Objective: to identify irreversible organ damages and factors influencing their development and to compare existing musculoskeletal injuries with the activity of systemic lupus erythematosus (SLE).Patients and methods. The investigation enrolled 197 peri- and postmenopausal female outpatients (mean age, 50.94±9.1 years) with SLE, who were followed up at Clinical Rheumatology Hospital Twenty-Five, Saint Petersburg. The mean disease duration was 9.7±7.5 years. Cytostatic and glucocorticoid (GC) treatment regimens and dosages in the examinees were analyzed on the basis of their primary medical records. The investigators assessed the current disease activity by the SLE Disease Activity Index (SLEDAI-2K) and the Lupus Low Disease Activity State (LLDAS) and irreversible organ damages by the Systemic Lupus International Collaborating Clinics (SLICC) Damage Index (DI).Results and discussion. 93.4% of the patients continued to receive GS therapy at the time of inclusion in the study. The median GS maintenance dose was 12.5 mg/day. Almost half of the patients (n=86/43.7%) were in menopause (its mean duration was 12.8±7.1 years). Half of the examinees were noted to have remission (n=36/18.3%) or low SLE activity (n=92/46.7%) according to the SLEDAI-2K. Fifty-seven (28.9%) patients met all 5 LLDAS criteria; at the same time other 96 (48.7%) patients met 4 out of the 5 criteria, the 5th criterion being a high GC maintenance dose. High DI scores of ≥4 were found in two thirds (n=131/66.5%) of the examinees. Musculoskeletal system injuries ranked first among other disorders: osteoporosis (OP) and muscle weakness were detected in 76 (38.6%) and 69 (35.0%) patients, respectively. Regression analysis involving all statistically significant factors showed that the degree of damage was influenced by age (p=0.013215), total GS dose (p=0.000047), and previous therapy with cyclophosphamide (p=0.041505).Conclusion. The contribution of GS therapy to irreversible damage accrual is obvious in peri- and postmenopausal women with SLE. Timely dose adjustment or complete withdrawal of GS during remission in SLE is one of the key factors that substantially reduce the risk of progression of irreversible organ damages due to the prevention of OP and osteoporotic fractures in these patients.

Objective: to analyze the dynamics of quality of life (QOL) in patients with prior osteoporotic vertebral compression fracture during an 18-month follow-up study. Subjects and methods. The investigation enrolled 219 patients (mean age, 67.6 years) with vertebral fracture from seven centers of the Russian Federation. QOL was assessed four times using the EQ-5D (EuroQoL-5D) and TTO (Time Trade-Off) questionnaires during an 18-month prospective follow-up study. The work was done within the framework of the International Multicenter Study ICUROS (The International Costs and Utilities Related to Osteoporotic Fractures Study) organized by the International Osteoporosis Foundation (www.icuros.org).Results and discussion. The patients with vertebral compression fracture showed a statistically significant decrease in QOL throughout the follow-up period. Immediately after the fracture, there was a dramatic decrease in the total EQ-5D score, followed by its gradual increase. However, the emerging trend in QOL recovery proved to be unstable, and by the end of the 18th month, it was significantly lower than that before the fracture. On the contrary, the TTO questionnaire showed that QOL drastically decreased immediately after fracture, but at month 4 it reached the level that was before the fracture, and remained stable until the end of the follow-up period.Conclusion. The performed investigation enabled us to obtain data on QOL using the EQ-5D (QOL assessment from the social point of view) and TTO (individual QOL assessment) in the population of residents of the Russian Federation, in men and women aged 50 years and older with osteoporotic vertebral compression fracture.

The investigators carried out an analysis of the efficacy and safety of secukinumab (SEC) in the randomized placebocontrolled trials (RPCTs) FUTURE 1 and FUTURE 2, as well as a subanalysis of the data obtained in the Russian population of patients with active psoriatic arthritis (PsA). The FUTURE 1 and FUTURE 2 trials enrolled a total of 1003 patients with active PsA. They received SEC (n = 703) or placebo (PL) (n = 300). The use of SEC 300 or 150 mg without previous intravenous (IV) loading dose or either 150 or 75 mg with the IV loading dose led to a significant improvement in patients with PsA. The positive changes in the main clinical manifestations of PsA at 24 weeks persisted until 52 weeks of therapy. SEC was effective in both the patients who had not previously received tumor necrosis factor-α inhibitors and those who had previously taken these drugs, and the result of therapy did not depend on concomitant methotrexate use.The incidence of cancer was low and comparable in the SEC and PL groups. Analysis of the combined data on the safety of the two RPCTs showed that the treatment duration-adjusted incidence of malignant neoplasms was 0.5 per 100 patient-years in the SEC groups and 0.9 in the PL groups. The safety profile of SEC in these RPCTs corresponds to that in the previous studies of the drug.The data from the pooled analysis of the Russian subpopulation of patients with PsA fully agree with the results obtained in the evaluation of all the patients included in FUTURE 1 and FUTURE 2 and confirm the most important role of IL-17А in the pathogenesis of PsA.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that most commonly occurs in women. Improved treatments for SLE have led to a substantial increase in the life expectancy of patients, so the problems of complications of both the disease itself and its therapy have come to be top priority. The most common complications of SLE among the musculoskeletal system lesions are osteoporosis and related vertebral compression fractures (VCFs). However, only one third of these fractures has clinical manifestations and causes the patient to seek medical advice. More VCFs remain undetected because they have no or scarce symptoms. The question of the influence of various factors (gender, age, menopause, etc.) on the incidence of VCFs in patients with SLE remains open. It should be expected that in postmenopausal women with SLE, the incidence of VCFs may be considerably higher than that in the population.Objective: to determine the frequency of and to evaluate the role of various factors in the development of asymptomatic vertebral fractures in postmenopausal women with SLE (a retrospective study).Subjects and methods. A total of 86 postmenopausal women (mean age, 59±7.9 years) with a diagnosis of SLE, which met the 2012 Systemic Lupus Collaborating Clinics (SLICC) criteria, were examined. The mean duration of the disease and menopause was 15±8.3 and 12.8±7 years, respectively. All the patients with SLE were treated with glucocorticoids (GC) at a dose of 15±5 mg/day calculated with reference to prednisolone for more than 12 months (mean, 159.7±90.9 months) and had a low disease activity (the mean SLEDAI-2K score was 5.1±3.9). The ACR damage index for SLE averaged 5.5±2.6. All the patients underwent vertebral fracture assessment (VFA) using a Hologic Explorer bone densitometer to identify VCFs in the thoracic and lumbar spine. The anterior, middle, and posterior heights of ТhIV–LV, and the height of each vertebra as well as the underlying vertebra were calculated and compared. If the differences in the anterior, middle, or posterior vertebral heights were >20–25%, this deformation was regarded as VCFs. Bone mineral density (BMD) in the hip and spine was measured with an X-ray bone densitometer. Results. VFA revealed VCFs in 40 (46.5%) patients with SLE; these were detected for the first time in 22 (55%) patients since they had no significant clinical manifestations. VCFs happened most commonly in the mid-thoracic spine (ThVI–IX). All the patients with asymptomatic VCFs had a fracture of only one vertebra. The patients with VCFs had a longer duration of SLE and menopause, more frequently received cytostatic therapy, and had a higher cumulative dose and a longer duration of GC therapy. They also had a higher damage index and lower BMD values in LI–IV than patients without VCFs (p < 0.05). Neither SLE activity nor hip BMD was associated with VCFs (p > 0.05).Conclusion. The detection rate for VCFs is nearly 50% in postmenopausal women with SLE, and about every two VCFs remain undetected. The long duration of SLE, menopause, and GC treatment, a high cumulative dose, a high damage index and low BMD values in LI–IV were associated with VCFs. VFA is an effective screening method to detect asymptomatic VCFs.

Medico-social significance of osteoporosis is determined by the high frequency of low-traumatic fractures of bone. According to the European Vertebral Osteoporosis Study the prevalence of vertebral fractures was 11,5% in women of 50-54 years of age and reached 34.8% in women of 75-79. The only prospective population-based study conducted in Russia have showed that the incidence of new vertebral fractures was 5,9% in men and 9,9% in women over 50. Stratified epidemiologic study conducted in St. Petersburg, have showed that in men the peak of clinical fractures, developed with minimal trauma, was at the age of 20-24 and 65-69. In women the peak of fractures was determined at the ages 50-54 years. It has been suggested that early administration of antiosteoporotic drugs can effectively prevent vertebral and peripheral fractures.

The paper presents data on the role of vitamin D and calcium in the function of many human organs and tissues. Lifestyle, dietary preferences, and insufficient physical activity contribute to the high prevalence of vitamin D and calcium deficiencies in the adult population of Russia, causing different diseases and abnormalities. The authors have worked out recommendations for the preventive use of vitamin D and calcium in healthy population, give consumption rates for these substances, and describe the clinical and laboratory signs of vitamin D deficiency and indications for screening. They also propose treatment regimens for vitamin D deficiency and depict the signs of intoxication inoverdose. Particular emphasis is laid on the place of vitamin D and calcium in the therapy of osteoporosis.

This article is dedicated to the problem of creating off fracture liaison services (FLS) for patients with osteoporosis including overview of the problem and some recommendations on it. The article presents there levance of the problem discussed, gives recommendations of the IOF working group,shows an international and Russian experience of FLS creation, its medical-economic effectiveness and discus the key moments that provide effectiveness of fracture liaison services for patients with osteoporosis. The recommendations part includes goals, main working directions and principles of FLS creation in the Russian Federation. They are based on the "Prometheus" program that was introduced by the Russian Osteoporosis Association and became the first national experience of organizing fracture liaison service. According to author’s point of view the information from this article can be help full in organizing FLS invarious medical institutionsin our country and can be used to reduce the negative effects of repeated osteoporosis fractures.

Медико-социальную и экономическую значимость остеопороза определяют его неуклонно нарастающая распространенность, а также затраты на лечение собственно остеопороза и его прямых осложнений - переломов, приводящих к развитию хронической боли, деформации скелета и потере трудоспособности. В Российской Федерации данные об экономических и социальных последствиях остеопоротических переломов практически отсутствуют, и имеют ограниченную ценность для применения в экономике здравоохранения. Исследование проведено в рамках международного многоцентрового исследования ICUROS. Целью исследования являлось единообразное (с использованием единой методологии сбора и анализа данных) изучение странах экономических и социальных последствий остеопоротических переломов. В Российской Федерации в исследовании участвовали 9 центров. В тезисах впервые использована окончательная версия базы данных. Материал и методы. Всего включено 1143 пациента от 50 лет и старше, перенесших низкоэнергетический перелом, из них 251 (21,96%) - с переломами шейки бедра, 255 (22,33%) - с переломами запястья, 219 (19,16%) - с переломами позвонков, 182 (15,92%) - с переломами плечевой кости, и 236 (20,65%) - с переломами лодыжки. Опрос пациентов проводился непосредственно после перелома и касался информации о качестве жизни (КЖ) до перелома и непосредственно после перелома (Фаза I). Далее сбор информации осуществлялся через 4 (Фаза II), 12 (Фаза III) и 18 месяцев (Фаза IV) после перелома. Средний возраст включенных пациентов составил 65,2 года (95% доверительный интервал (ДИ) от 64.65 до 65,72). Одним из интегральных параметров КЖ исследовании был опросник EQ-5D, включающий данные по подвижности, самообслуживанию, повседневной активности, боли и дискомфорту, выраженности тревоги и депрессии. Отдельные шкалы данного опросника были преобразованы в общий балл, стандартизованный к шкале от нуля до единицы. Результаты. Ретроспективные данные о КЖ по стандартизованному суммарному баллу EQ-5D составили 0,824 (95% ДИ: 0,812-0,836). На момент перелома у пациентов значимо падало КЖ - 0,290 (95% ДИ: 0,273-0,307) (р0,05). Выводы. Таким образом, если общая субъективная оценка здоровья по ВАШ возвращается к значениям «до перелома» уже к 4 месяцам после перелома, то суммарный балл по EQ-5D) достигает значений, близких к исходным, только к 12 месяцам, и продолжает улучшаться и через 18 месяцев. Эти данные свидетельствуют о важности изучения отдельных компонентов качества жизни пациентов, входящих в EQ-5D, а не только суммарных результатов.