Rheumatoid arthritis (RA) is an immunoinflammatory (autoimmune) rheumatic disease of unknown etiology, which is characterized by chronic erosive arthritis and systemic visceral organ damage that results in early disability and shorter patient survival. Despite RA treatment advances associated with the design of novel drugs and the improvement of treatment strategies to achieve remission in many patients, there are still many theoretical and clinical problems concerning both the definition of the concept of remission, its characteristics and types and approaches to the optimum policy of symptomatic and pathogenetic drug therapy at different stages of the disease, the use of which will be able to rapidly induce and maintain remission in the long-term. Further investigations are needed to study the nature of heterogeneity of pathogenetic mechanisms of RA and approaches to early diagnosis, to improve methods for monitoring disease activity and biomarkers for the efficiency of and resistance to therapy and, finally, to develop differentiation therapy, including those related to a search for new therapeutic targets.

According to the materials of the 2015/2016 new European League Against Rheumatism (EULAR) guidelines for reducing cardiovascular risk in patients with inflammatory arthritis. The authors identify three main principles of prevention of cardiovascular diseases in rheumatoid arthritis and other chronic inflammatory arthritis and provide a general characterization of the guidelines, by reviewing the discussion problems.

Objective: to assess the long-term safety and efficiency of tocilizumab (TCZ) therapy in patients with early rheumatoid arthritis (RA) of moderate and high activity, who have completed the basic WA19926 study, as well as the rate of sustained drug-free remission.

Subjects and methods. A long-term open-label multicenter Phase III extension study (ML28124) was conducted using a group of 49 patients (36 (73.5%) women and 13 (26.5%) men; mean age 53.3±10.8 years) with early RA of moderate and high activity. All the patients received an intravenous infusion of TCZ 8 mg/kg every 4 weeks for 104 weeks (a total of 27 infusions). The safety assessment criteria were the rate and severity of all adverse events (AE), serious AE (SAE), and AE of particular interest; the rate of AE causing drug dosage changes or withdrawal from the study; the frequency of clinically significant laboratory abnormalities. The analysis of efficiency (secondary end points) included changes of DAS8, which was calculated using erythrocyte sedimentation rate (ESR) (DAS28-ESR) and SDAI, the of tender joint count (TJC) and swollen joint count (SJC); the number of patients who had achieved drug-free remission; and the time to a RA exacerbation in patients who had achieved non-drug remission.

Results and discussion. The total rate of AE was found to be 69.4%; that of SAE was 10.2%; SAE were 6.9% of the the total number of AE; AE of particular interest were 17.2% of the total number of AE. More than one-third (35.6%) of the AE caused drug dose changes or therapy discontinuation or complete cessation. The laboratory clinically significant abnormalities included those in complete blood cell counts (blood alanine aminotransferase, aspartate aminotransferase, total and direct bilirubin, creatinine, and glucose). The evaluation efficiency analysis showed that the main disease activity measures (DAS28-ESR, SDAI, SJC, and TJC) decreased at 104-week follow-up versus at baseline. The rate of drug-free remission was 71.4%; that of recurrence was 40.0% (the median time to recurrence was 23 weeks). The findings suggest that the safety profile of TCZ is acceptable in the long-term treatment of early RA and correspond to earlier results. 

Objective: to evaluate the effect of golimumab (GLM) on the receptor activator of NF-κB ligand (RANKL)/osteoprotegerin (OPG) transmembrane molecular system and arterial stiffness in patients with rheumatoid arthritis (RA).

Subjects and methods. Thirty-six patients with RA were examined and randomized into 2 groups based on disease duration (less than or more than 2 years). The serum levels of OPG, and RANKL, were investigated. Dual-energy X-ray absorptiometry and pulse wave contour analysis were performed before and 52 weeks after GLM treatment.

Results and discussion. Group 1 patients demonstrated increased serum OPG levels that were on average 3.6 times higher than in the controls (р=0.005) and 2.1 times higher than in Group 2 (р=0.01). In Group 2 patients, the RANKL concentration was 9-fold higher than that in the controls (p=0.001) and 30.6% higher than in Group 1 (p=0.01). The examinees were found to be diagnosed with subclinical damage to the great arteries (increases in augmentation index (AIp), stiffness index (SI), and reflection (RI) index), which progressed with a longer RA duration. After GLM treatment, serum OPG and RANKL levels decreased in Group 1 patients by 2.1- (p<0.001) and 1.7-fold (p<0.01), respectively. In Group 2, the level of RANKL dropped by 32.2% (p<0.01), without significant OPG concentration changes. After GLM treatment, the pulse wave contour analysis parameters in Group 1 did not differ from those in the controls; Group 2 showed significant decreases in AIp by an average of 1.8 times (p<0.01), in SI by 1.2 times (p<0.01), and in RI by 1.6 times (p<0.01).

Conclusion. GLM treatment in RA patients is accompanied by a lower imbalance in the RANKL/OPG transmembrane molecular system and exerts a vasoprotective effect on the large elastic vessels (reductions in AIp and SI) and small muscular arteries (a decrease in RI). 

The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).

Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.

Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.

Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable. 

Objective: to investigate the effect of various biological agents (BAs), including combined treatment with rituximab (RTM) and belimumab (BLM), on the activity of systemic lupus erythematosus (SLE) and to evaluate their efficacy and impact on some parameters of humoral immunity.

Subjects and methods. BAs were prescribed to 54 patients with a reliable diagnosis of SLE with high and medium activity according to SLEDAI-2K; 40 of them received RTM, 7 – BLM; 7 – combined therapy with RTM and BLM. Clinical and laboratory examinations were made in all the patients at the time of their inclusion and then every 3 months during a year. The results were assessed using SLEDAI-2K, BILAG index, Lupus Erythematosus National Assessment (SELENA)-SLEDAI Flare index (SFI) (a moderate, severe exacerbation), and SLE Responder Index (SRI).

Results and discussion. At 3, 6, and 12 months after start of therapy, the use of BAs in all the patients resulted in a disease activity reduction. It was statistically significant (p < 0.00001) in the RTM group; and no statistical analysis was carried out in the BLM and RTM+BLM groups due to the small numbers of patients. At the same time, there was a progressive decrease in the levels of anti-double-stranded DNA (ds-DNA) antibodies (Abs) and an increase in the concentration of the complement fractions C3 and C4 in the RTM and RTM+BLM groups (p < 0.05) at one-year follow-up. After 12 months of therapy with BAs, there was a decrease in IgG (p < 0.02) and IgM (p < 0.03) levels; but overall it remained within the reference ranges. Prior to therapy, irreversible organ damages were recorded in 23 (42.6%) of the 54 patients. The increased damage index at 12 month was observed only in patients receiving RTM, which is probably due to the use of higher-dose glucocorticoids.

Conclusion. All three methods of therapy with BAs in SLE patients demonstrated good efficiency shown as a significant decrease in clinical and laboratory activity measures that were assessed by SLEDAI-2K and the levels of anti-ds-DNA and complement components C3 and C4. The decrease in immunoglobulin levels did not go beyond the reference values. Therapy with BLM and RTM+BLM allowed for managing patients with the low and average doses of oral glucocorticoids, which contributed to the reduction of not only the activity, but also risk of irreversible organ damages. 

Rheumatoid arthritis (RA) and the use of glucocorticoids (GCs) are proven risk factors for osteoporosis (OP) and osteoporotic fractures (OPF). There are also other reasons for increased fracture risk in RA.

Objective: to determine the rate of RA in an epidemiological sample of persons aged 50 years and older and to identify those in need of antiosteoporotic therapy among the patients with RA in order to prevent OPF.

Subjects and methods. The epidemiological sample included 18,018 people aged 50 years and older (13,941 women and 4,077 men; mean age, 62±10 years). The survey consisted of a unified questionnaire, measurement of daily dietary calcium intake, and calculation of a 10-year fracture risk using the FRAX® algorithm.

Results and discussion. The prevalence of RA in the epidemiological population sample aged 50 years and older was 1.7% (1.9% in women and 1.2% in men; p=0.0047). The mean FRAX® values for major OPF in RA patients were significantly higher than those in non-RA individuals: 18.4±10 and 13.2±7.9%, respectively (p=0.0001) for women and 8.9±6.4 and 6.2±3.7%, respectively (p=0.0001) for men. 42% of the patients with RA were at high risk for OPF. Thus, 48% of the women with RA had FRAX® values above the therapeutic intervention threshold; and the non-RA group needed antiosteoporotic therapy significantly less (31%; p=0.00001). At the same time, the detection rate of high-risk OPF in men with and without RA did not differ significantly (8 and 5%, respectively; p>0.05). The most common risk factors (RFs) for OP and OPF in RA patients included previous fractures (33%), secondary causes of OP (30%), GC use (18%), and, additionally, smoking (33%) in male patients with RA. The female patients with RA significantly more frequently took GCs (17%) and had other secondary causes of OP and OPF (33%) than those without RA (7.7% (p=0.0001) and 23% (p=0.0004, respectively). The male patients with RA versus to the population-based control showed significant differences when they only used GCs (20 and 5%, respectively; p = 0.0001); the remaining RFs were encountered at the same frequency. Less than half of the normal daily calcium intake was observed in 20% of men and 16% of women (p=0.53).

Conclusion. 42% of the RA patients aged 50 years and older were at high risk for OPF and needed antiosteoporotic therapy. Every third woman with RA had at least one other comorbidity or condition associated with the increased risk of OPF. In the male patients with RA, the FRAX® algorithm could reveal only 8% of persons at high risk for fractures, while 58% of them had two or more additional RFs that can negatively affect bone mineral density and increase the risk of fracture. To identify those who require prevention and treatment of OP and OPF, it is preferable to perform bone densitometry of the axial skeleton among male patients with RA. 

Objective: to assess whether adalimumab (AD) can be gradually discontinued during continuous methotrexate (MTX) use in patients with early rheumatoid arthritis (ERA).

Subjects and methods. Within the REMARCA (the Russian study of methotrexate and biological agents in early active arthritis) study, the investigators examined 20 patients (17 women and 3 men; median age, 51 [41.5; 56] years) with ERA (disease duration, 10 [5.5; 20] months; DAS28, 5.17 [4.37; 6.51]; 85% of the patients were seropositive for rheumatoid factor and 85% for anti-cyclic citrullinated peptide antibodies.

Results and discussion. All the patients received subcutaneous MTX 25 mg/week. Twelve weeks after beginning therapy with MTX, due to its inefficiency, ADA was added according to the standard scheme. At week 24, the median DAS28 was 3.0 [1.65; 3.73]; 85% of the patients achieved remission or low disease activity. After 3 months of ADA therapy, high or moderate disease activity remained in 3 (15%) patients; median DAS28 was 4.4 [4.3; 6.1]; the drug was discontinued in them due to ineffective therapy. After 12-month follow-up, low DAS28 scores were observed in 5 (29.4%), DAS28 remission was in 12 (70.6%) of the 17 patients who continued ADA treatment; after 24 months, all the 17 patients were noted to have remission. After achieving sustained remission (≥ 6-month duration during ADA therapy), there was a carefully controlled reduction (titration) in the dose of ADA with its complete discontinuation, by maintaining remission at 36-month follow-up; the median DAS28 was 1.6 [1.4; 2.2]. During ADA treatment, one female patient developed pustular psoriasis and therefore the drug was discontinued at 24-month follow-up during the period of sustained remission. Other serious adverse events and tuberculosis cases were not recorded.

Conclusion. Thus, the results of the study are indicative of the high clinical efficiency of the therapy. After ADA discontinuation, sustained remission can be maintained in patients with ERA and if they took biological agents early. 

Objective: to determine the main factors associated with the development and manifestations of anxiety and depression spectrum disorders (ADSDs) in patients with Behcet’s disease (BD).

Subjects and methods. This investigation was conducted within the framework of the interdisciplinary scientific program «Stress factors and mental disorders in rheumatic diseases». A total of 116 patients with BD were examined. Most of them were men (69.8%), whose mean age (M±σ) was 33.4±9.82 years; the median duration of BD was 120.0 [70.0; 192.0] months; 51.9% of the patients were natives of the North Caucasus. All the patients had a reliable diagnosis of BD according to the International Study Group for Behcet’s disease (ISGBD) criteria (1990). Disease activity was assessed using the Behcet’s Disease Current Activity Form (BDCAF); the subjective status of patients was evaluated using the visual analog scale (VAS) for general health assessment. ADSDs were diagnosed by a psychiatrist according to the ICD-10 during semi-structured interviews using the Hospital Anxiety and Depression Scale (HADS), the Hamilton Anxiety Rating Scale (HAM-A), and the Montgomery-Asberg Depression Rating Scale (MADRS). Clinical and psychological techniques were applied to assess cognitive functions (memory, attention, and logical thinking); stress levels were estimated by the 10-Item Perceived Stress Scale (PSS-10).

Results and discussion. ADSDs were diagnosed in 91 (78.4%) patients with BD. The predominant RTDs were dysthymia (39.6%) and recurrent depressive disorder (38.4%). Generalized anxiety disorder was found in only 7.69%, a single depressive episode was in 13.2%. Different degrees of cognitive impairment (CI) were observed in 91 (78.4%) patients. Multivariate analysis and linear regression were used to build a predictive model, from which it follows that ADSDs in patients with BD are primarily associated with sleep disorders (β=0.412), asthenia (β=0.149), CI (β=0.137), chronic stress (β=-0.010) and its severity (β=0.134), early childhood psychic trauma (ECPT) before the age 7 years (β=0.152), the development of ADSD before the onset of BD (β =0.160), older age of eye involvement in the pathological process (β=0.089), gastrointestinal tract (GIT) involvement within BD (β=0.096), high C-reactive protein (CRP) levels (β=0.177), and poor subjective status of patients (β=0.120) (area under the ROC-curve, 0.940).

Conclusion. Chronic ADSDs are encountered with high frequency in patients with BD and frequently occur simultaneously with the latter or during its development. Their occurrence is favored to the greatest extent by ECPT and obvious chronic psychosocial stress preceding ADSDs. GIT involvement, late-onset ocular pathology, high CRP levels, and poor subjective status are common to patients with BD and ADSDs. Sleep disorders, asthenic syndrome, and CI are significant in the pattern of ADSDs. 

Objective: to investigate the impact of antirheumatic therapy carried out according to the treat-to-target (T2T) principle on the time course of changes in NT-proBNP levels in patients with early rheumatoid arthritis (RA) over an 18- month follow-up period.

Subjects and methods. The investigation enrolled 74 patients, comprising 56 (74%) women (median age, 54 years) with a reliable diagnosis of RA (ACR/AULAR criteria (2010)) (disease duration, 7 months); who were seropositive for IgM rheumatoid factor (87%) and/or anti-cyclic citrullinated peptide antibodies (100%) and had not previously taken disease-modifying antirheumatic drugs (DMARDs) and glucocorticoids. All the patients started therapy with subcutaneous methotrexate (MTX), with escalation of the dose to 25-30 mg/week; in the absence of any effect after 3 months, biological agents (BAs) were added in 47 (71%) patients. Following 18 months, 44% of patients achieved RA remission; 51 patients (77%) received cardioprotective therapy. NT-proBNP levels were measured in 66 patients with early RA before and 18 months after treatment. The NT-proBNP value <125 pg/ml was taken to be normal.

Results and discussion. During antirheumatic therapy, there was a decrease in the median level of NT-proBNP from 125 [65; 208] to 68 [33; 115] pg/ml (p < 0.05) and in the frequency of its elevated values from 49 to 21% (p < 0.02). In the patients with RA remission, there was a more pronounced decrease in the frequency of elevated NT-proBNP values (from 45 to 7%; p < 0.05), while in those who had not achieved RA remission, NT-proBNP values showed only a tendency to decrease (from 51 to 32%; p < 0.05). The level of NT-proBNP became normal in the patients who had achieved remission of RA during treatment. There was no progression of the existing chronic heart failure (CHF) or development of its new cases.

Conclusion. A significant decrease in NT-proBNP levels was recorded during antirheumatic therapy performed according to the T2T strategy, especially when using a combination of MTX+BAs and achieving RA remission. Therapy with MTX and BAs did not lead to the worsening of CHF or to the development of its new cases in patients with early RA. 

Certolizumab pegol (CZP) is the only pegylated biological agent (BA) that does not contain an Fc fragment, which minimizes its transplacental transfer. Takayasu arteritis mostly occurs in reproductive-aged women.

Objective: to evaluate the efficacy and safety of CZP used to treat standard immunosuppressive therapy-resistant Takayasu arteritis.

Subjects and methods. The retrospective study enrolled 6 female patients aged 18 to 35 years with Takayasu arteritis who received CZP. The median disease duration before BA usage was 66 months (24 to 204 months). The median duration of immunosuppressive therapy prior to CZP treatment was 92 months (14 to 132 months). All the female patients had taken glucocorticoids and methotrexate before and during CZP therapy. Only four patients had received two to five immunosuppressive drugs at different times prior to BA administration. Three patients had previously used other BAs. The disease activity was determined by the National Institute of Health (NIH) criteria. The Indian Takayasu Clinical Activity Score (ITAS2010) was used. The disease activity was recorded in all the patients prior to CZP therapy.

Results and discussion. The median duration of CZP treatment was 17 months (6 to 24 months). The median erythrocyte sedimentation rate after CZP usage decreased from 22.5 to 10.5 mm/h; the median C-reactive protein level dropped from 7.8 to 0.39 mg/dl (p<0.05), the median daily dose of prednisolone was reduced from 20 to 8.75 mg (p<0.05). All the patients achieved complete remission an average of 4 months after starting CZP therapy. Three patients were still in remission after 12–24 months. One relapse of the disease was recorded following 24 months. ITAS2010 reduced from 1–4 to 0 in five patients and to 2 in one patient with recurrence. There was a good tolerance in five female patients. The adverse events were herpes labialis in two cases, community-acquired pneumonia in one case, and postoperative abscess in one case too.

Conclusion. CZP in Takayasu arteritis was shown to be an effective drug for remission induction and maintenance. The presented results of the first experience in treating this disease with CZP are indicative of its promising further investigation as a steroid-sparing drug in patients with refractory vasculitis. One of the important advantages of CZP is its supposed high safety throughout pregnancy. 

Idiopathic lobular panniculitis (ILP) (synonym: Weber-Christian panniculitis) is the least studied disease in the group of systemic connective tissue lesions and characterized by systemic damage to subcutaneous adipose tissue (SAT). There is no unified concept of the etiology and pathogenesis of ILP now. The literature contains almost no data on the diagnostic value of laboratory studies and therapeutic approaches, which served as the basis for this investigation. Objective: to investigate the relationship between the clinical presentation of ILP and immune inflammatory parameters in patients with this disease.

Subjects and methods. Examinations were made in 67 patients (9 men and 58 women) aged 20 to 76 years with a verified diagnosis of ILP (median duration, 78.91 [48; 540] months), who were followed up at the V.A. Nasonova Research Institute of Rheumatology for the period 2007 to 2017. The determination of α1-antitrypsin titer, liver fractions, amylase, lipase, trypsin, ferritin, creatine phosphokinase, leptin, and tumor necrosis factor-α (TNFα), chest computed tomography, and induration morphological examination were done in addition to physical examination.

Results and discussion. The disease was found in all age groups, but it accounted for more than half (57%) of cases at the most able-bodied age (45–60 years). Analysis of the clinical manifestations of ILP could identify its four types: nodular (n=30), plaque (n=10), infiltrative (n= 5), and mesenteric (n=12), which were characterized by typical clinical features. The observed group showed a significant increase in erythrocyte sedimentation rate (ESR) (p=0.01) and C-reactive protein (CRP) level (p < 0.0001). ESR correlated with tenderness on the visual analogue scale (VAS) (p<0.05; r=0.29), induration area (p<0.05; r=0.50), and rises in body temperature (p<0.05; r=0.68) and CRP level (p<0.05; r=0.68). The concentration of CRP correlated with tenderness on visual analog scale (p<0.05; r=0.46), induration area (p<0.05; r=0.61), node stage (p<0.05; r=0.41), and TNF-α concentrations (p<0.05; r=0.32). The latter showed a direct correlation with node stage (p<0.05; r=0.41) and leptin levels (p<0.05; r=0.28) and an inverse correlation with the number of nodes (p<0.05; r=-0.24). Leptin levels were increased in 35 (52.23%) patients and displayed a direct correlation with body mass index (p<0.05; r=0.46), induration area (p<0.05; r=0.31), CRP level (p<0.05; r=0.36) and an inverse correlation with the number of nodes (p≤0.05; r=-0.33). Morphological examination of skin and SAT biopsy specimens was performed in 65 (97.01%) patients. Pre- and retroperitoneal adipose tissues were biopsied in three of five patients without skin and SAT lesions; this was not done in the remaining patients because of access difficulties. ILP was verified in all cases. Therapy was performed using the essential drugs adopted in rheumatology practice. Their therapeutic effects were noted in 62.68% of cases; inefficiency and health deterioration were detected in 12 (17.91%) patients, which necessitated an increase in the dose of disease-modifying antirheumatic drugs. Seven patients were given the following biological agents: abatacept (n=2), adalimumab (n = 3), etanercept (n=1), and rituximab (n=1).

Conclusion. There is an obvious need to expand knowledge about this pathology amongst physicians and to conduct further investigation in order to timely diagnose and search for the most effective treatment options for ILP. 

Objective: to compare the impact of continuous or on-demand use of nonsteroidal anti-inflammatory drugs (NSAIDs) on the activity and radiographic progression of early axial spondyloarthritis (axSpA).

Subjects and methods. The investigation enrolled patients from the early spondyloarthritis cohort who met the 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria for axSpA. This analysis included 68 patients who had been followed up for at least 24 months. The mean age at the time of inclusion in the investigation was 28.5±5.8 years; the mean disease duration was 24.1±15.4 months; 63 (92.6%) patients were HLA-B27-positive. The patients were divided into two groups: 1) 35 patients used NSAIDs at maximum therapeutic doses continuously during the follow-up period; 2) 33 patients received these drugs on-demand, depending on the presence and severity of back pain.

Results and discussion. After 2-year follow-up, the median stage of radiographic sacroiliitis (SI) in Group 1 was unchanged and remained equal to 4; that in Group 2 in this period significantly increased from 3 to 4 scores (p < 0.05). At baseline, the patient groups did not differ in C-reactive protein (CRP) levels, the Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP), and the Bath Ankylosing Spondylitis Functional Index (BASFI); however, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was higher in Group 1 (p < 0.05). The number of patients with active SI, as evidenced by magnetic resonance imaging (MRI), and the degree of its severity did not differ significantly between groups. After 2 years, all the patients retained low disease activity according to ASDAS-CRP, BASDAI, and CRP levels; and these measures did not differ significantly between groups either; the BASFI became higher in Group 1. MRI findings indicated that the number of patients with active SI decreased, but no differences were found between the groups.

Conclusion. In patients with early axSpA, the continuous intake of NSAIDs can slow radiographic progression to a greater extent than their on-demand use. 

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. 

Rheumatoid arthritis (RA) is an immune inflammatory (autoimmune) rheumatic disease of unknown etiology, which is characterized by chronic erosive arthritis and systemic damage to the viscera, and leads to early disability and reduced survival in patients. For its diagnosis, it is currently recommended to use the 2010 ACR/EULAR classification criteria for RA, which should be applied in clinical trials to identify at least one swollen joint, i.e. the presence of arthritis; therefore, the problem of extra-articular manifestations of RA is apparent to stay in the background.

At present, there is no general approach to choosing surgical tactics for hallux rigidus. Many surgical procedures are used to treat osteoarthritis (OA) of the first metatarsophalangeal joint (FMPJ), which are relevant at different stages of the disease. Nevertheless, this fact also suggests that all proposed methods have one or other disadvantages. At the same time, FMPJ arthrodesis that relieves pain and is functionally inferior to joint-sparing surgery remains the gold standard. However, due to the fact that not only persons over the age of 50 years, but also younger patients often suffer from FMPJ OA, the most non-damaging option of joint-sparing surgery is cheilectomy with chondroplasty of the FMPJ, which allows restoration of painless joint motions, thus sparing the anatomy of the foot. Chondroplasty using the authologous matrix-induced chondrogenesis (AMIC®) technique for knee, hip, and ankle cartilage defects is described. There are no reports on FMPJ chondroplasty with the AMIC method in either Russian or foreign literature.

The importance of comorbid infections in rheumatology has increased substantially in recent years, particularly in connection with the introduction of biological agents into clinical practice. One of the ways to solve this problem is to study and actively use vaccines. This review deals with the issues related to the use of vaccines against various infections in patients with systemic lupus erythematosus. It discusses the safety and immunogenicity of vaccination, including the use of adjuvant vaccines. Cardinal directions for future investigations of the problem are denoted.

With increased survival in patients with systemic lupus erythematosus (SLE), cardiovascular diseases have become the main causes of death. Heart failure (HF) is the final stage of the cardiovascular continuum; decompensation of this condition commonly results in death. Studies of HF, its frequency, risk factors, and diagnostic features in patients with SLE are extremely few. The paper details data on the definition, frequency, current classification, and the algorithm for the diagnosis of HF and comparatively analyzes the risk factors of the latter in the general population and among patients with SLE. HF diagnostic problems in this patient category and possible ways of their resolution are discussed.

The paper describes a clinical case of late diagnosis of malignant lung tumor with the development of skeletal and intracranial lymph node metastatic lesions. Right hip joint pain was the reason for seeking medical advice; coxitis was diagnosed. Weight loss, obvious blood inflammatory changes, and a long-term smoking history aim to find cancer. Further examination as multislice spiral computed tomography of the lungs and pelvic bones could establish a diagnosis.

The paper discusses the article «Common language description of the term rheumatic and musculoskeletal diseases (RMDs) for use in communication with the lay public, healthcare providers and other stakeholders endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR)» that appeared in the on-line first journal Annals of the Rheumatic Diseases in March 2018. It is shown that, on the one hand, the development of the definition is positive, but, on the other, blurs the verges of rheumatology due to the introduction of nosological entities that are absolutely unrelated to our profession.