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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] (pConclusion. In MTX-resistant patients with active RA, the efficacy of both LVL regimens at a dose of 162 mg in combination with MTX was significantly superior to MT monotherapy. LVL QW lead to highest treatment response. LVL has been shown to be well tolerated and low immunogenicity. LVL safety profile is similar to IL6R inhibitors.

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 of Health (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.

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; pConclusion. The Russian version of the SarQoL questionnaire is valid, consistent and reliable and can be used to assess the quality of life in older patients with sarcopenia.

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.

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 in overdose. Particular emphasis is laid on the place of vitamin D and calcium in the therapy of osteoporosis.

Development Bisphosphonates are a major class of drugs used to treat osteoporosis (OP) and other diseases characterized by increased bone resorption. The literature contains indisputable evidence for the efficacy of alendronate in the registered oral dose of 70 mg once weekly in the treatment of postmenopausal OP. Alendronate reduces a risk for vertebral and non-vertebral (peripheral) fractures, including those of the hip and forearm. Just one-year therapy with the drug results in increased bone mineral density and decreased bone resorption, which is associated with a reduced risk for osteoporotic fractures. Undesirable side effects of alendronate are rare, if it is correctly used, and generally appear as dyspeptic events in the upper gastrointestinal tract. In addition to its antiresorptive effect on the bone, the combination drug (alendronate 70 mg/cholecalciferol 2800 IU) additionally elevates the serum level of vitamin D, which allows the patients to be simultaneously treated with the drugs of the two groups (a bisphosphonate and vitamin D) recommended for use by the Russian Osteoporosis Association.

Brief information about modem osteoarthritis treatment with simple analgesics, NSAIDs and chondroprotective drugs is presented. Results of a clinical study of ARTRA in combination with diclofenac (31 pts) comparing with diclofenac only (31 pts) for the treatment of knee osteoarthritis ofll-lll stage are discussed. ARTRA was administered 2 capsules a day during a months and than 1 capsule a day during 5 months. A mean therapeutic dose of diclofenac was given to all pts. ARTRA with diclofenac was more effectively than diclofenac monotherapy improved WOMAC functional index and suppressed pain on visual analog scale and WOMAC. ARTRA was well tolerated.