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Objective: validation of the Russian-language version of Ankylosing Spondylitis Quality of Life (ASQoL) specific questionnaire for patients with ankylosing spondylitis (AS). Materials and methods. Тhe study included 100 patients with a definite diagnosis of AS according to the modified New York criteria of 1984. Patients were mostly men (58.5%), average age – 38.6±10 years, disease duration – 10.3±7.0 years, median disease activity by ASDAS-CRP – 2.32 [1.45; 2.94]. At the initial visit and after 3 months, all patients underwent a standard rheumatological examination, with assessment of the tender joint count (TJC) and swollen joint count (SJC) out of 44 joints assessed, the number of inflamed entheses using MASES index, spinal mobility using BASMI index. Assessment of patient reported outcomes included an assessment of spinal pain, night spinal pain, spinal pain during the day using a numerical rating scale, patient’s global assessment of health, assessment of functional status using BASFI index and health related quality of life (HRQoL) using EQ-5D, SF-36 and ASQoL questionnaires. To determine reliability of ASQoL questionnaire, a test-retest analysis and determination of internal consistency by calculating the Cronbach's α coefficient were used. The reliability of the questionnaire was analyzed in 39 patients. To assess the validity of the ASQoL questionnaire, i.e. its ability to reliably measure its inherent characteristics, construct and criterion validity were determined. The sensitivity of the questionnaire was assessed after 3 months during therapy in 79 patients. Results and discussion. According to the test-retest analysis, there was no difference between the initial assessment and re-assessment after 3 days (p>0.05), the Cronbach α coefficient was 0.884, indicating high reliability. Construct validity analysis was carried out using factor analysis and the “known groups” method. 3 main factors were identified: pain, physical health, emotional health. The “known groups” method showed that in patients with high disease activity according to ASDAS-CRP and BASDAI, HRQoL was significantly worse than in patients with low disease activity (р

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

The Association of Rheumatologists of Russia (ARR) is one of the largest and most influential public medical organizations in Russia, whose activities have allowed us to preserve and strengthen the rheumatology service in the country, train highly qualified personnel, and work productively and successfully for the benefit of our patients. Today we celebrate the 60th Anniversary of the ARR, we remember the history, the stages of a long journey and our achievements.

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

Objective: to compare the clinical efficacy of seniprutug (BCD-180) and adalimumab (ADA) in the treatment of adults with active radiographic axial spondyloarthritis (r-axSpA).Materials and methods. Based on the results of a previously conducted systematic review, an unanchored matching-adjusted indirect comparison (MAIC) was performed, adjusting for confounding factors. The analysis was based on the results of randomized placebo-controlled clinical trials of seniprutug (BCD-180-2/ELEFTA, NCT05445076) and ADA (ATLAS, NCT00085644) that met the selection criteria. We chose ASAS40 and ASAS20 measurements at week 24 as efficacy outcomes. Initial BASDAI and BASFI indices, proportion of women in the study population, time from disease onset, and baseline C-reactive protein (CRP) levels were considered as confounders.Results and discussion. The MAIC showed a statistically significant advantage in the clinical efficacy of seniprutug (BCD-180) over ADA. When adjusted, the odds ratios (OR) with 95% confidence intervals (CI) for seniprutug (BCD-180)/ADA were 1.86 (1.15; 3.02) and 2.21 (1.34; 3.72) for ASAS40 and ASAS20, respectively, at week 24.Conclusion. The MAIC demonstrated statistically significant superiority of seniprutug (BCD-180) over ADA on the key efficacy endpoints ASAS40 and ASAS20 at week 24 in adults with active r-axSpA. The inclusion of the innovative domestic drug seniprutug into treatment paradigm of active r-axSpA will potentially reduce the socio-economic burden of this disease by providing an affordable, effective and safe therapy while optimizing healthcare costs

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

Contraception is an important aspect of reproductive health in patients with rheumatic diseases. This is primarily due to the fact that in most immuneinflammatory rheumatic diseases (IRD) pregnancy must be planned. On one hand, the presence and activity of IRD can influence the course of the pregnancy, but on the other hand, pregnancy, which is accompanied by changes in general hormonal levels, is often a factor that alters the activity of IRD. Some patients take medication with potentially teratogenic effects. Planning a pregnancy during IRD can contribute to its optimal progression and minimize the risks of exacerbation of IRD. Given the wide range of barrier and hormonal contraceptives currently in use and the introduction of new drugs into clinical practice, data on the possibility of their use are of particular importance to rheumatologists in practical healthcare.

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

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

Introduction. Currently, there is a small number of studies devoted to the differences in the manifestations of axial spondyloarthritis (axSpA) in men and women, and there are no studies assessing the frequency of coxitis in axSpA in patients of different sexes. The purpose of the study is to compare the main manifestations of coxitis in axial spondyloarthritis in men and women. Material and methods. The study was conducted on the Moscow Cohort of Early SpondyloArthritis (CoRSAr), which currently includes 175 patients. Their age at the time of inclusion in the cohort was on average 28.5±5.8 years, the duration of the disease was 24.1±15.4 months. 92.6% of patients were positive for HLA-B27 (human leukocyte antigen B27). All patients were assessed for pain in the hip joints (HIP) using a numerical rating scale (NRS) (0–10), and pelvic radiography, magnetic resonance imaging (MRI) and ultrasound examination of the Hip joint were performed. An increase in the cervical-capsular distance (NCD) of more than 7.0 mm was considered a sign of coxitis according to ultrasound data. When analyzing MRI results, signs of coxitis were considered to be synovitis and/or osteitis of the femoral head or acetabulum. X-ray changes in the hip joint were assessed using the BASRI-hip index (Bath Ankylosing Spondylitis Radiology Hip Index). Results and discussion. Among the 175 patients, there were 97 (55.4%) men and 79 (44.6%) women. At the time of inclusion in the study, women were older than men (p0.05). According to ultrasound data, coxitis was detected in 15 (18.9%) women and 27 (27.8%) men; NCD averaged 6.2 mm in men and 5.9 mm in women (p>0.05). In men, signs of damage to the hip joint according to MRI were more common than in women (in 27.8% and 15.1% of cases, respectively; p

Coxitis belongs to the extraaxial manifestations of ankylosing spondylitis (AS) and is considered as an unfavorable prognostic factor that may play a significant role in the development of functional limitations. The aim of the study – to evaluate the functional status of the hip joints (HJ) before total hip replacement (THR) in AS patients. Materials and methods. The retrospective study included 170 patients with AS who met the modified New York criteria of 1984, who were hospitalized in the traumatology and orthopedics department of the V.A. Nasonova Research Institute of Rheumatology from 1998 to 2020, and all patients underwent scheduled THR. Most of them were males (80.6%). The average age of the patients was 38,1±11,3 years, duration of the disease from the moment of the first symptoms appearance – 17,0±8,5 years, duration of pain in HJ before THR – 7,4±4,8 years. Disability was established in 80% of cases: in 14,1% – group 1, in 50% – group 2, in 15,9% – group 3. Did not work due to the disease – 64% of patients. The preoperative functional state of HJ was determined using the modified Harris scale. Results and discussion. The preoperative total Harris score averaged 38.0±15.4 points and the pain score averaged 15.6±8.4 points. In the vast majority (82.9%) of patients it ranged from 10–20 points (“severe” and “moderate constantly”). The intensity of pain according to VAS was 72,3±14,0 mm. The median severity of lameness in the HJ was 5 [0; 5] points. Claudication was absent in 2.4% of patients, moderate in 42.9% of cases, severe in another 42.9%, and mild in 11.8%. Additional support was needed in the majority of patients (69.4%). One (29.4%) or two (26.5%) crutches were more frequently required. There was no need for additional support in 30.6% of patients. In 68.8% of cases, there were varying degrees of limitation in distance walking. Climbing stairs caused difficulties in 167 (98.2%) patients, only 3 (1.8%) of them did not use a handrail. Only 1 in 4 patients could use public transportation. Various anatomical deformities were determined in 88.8% of cases. Almost all patients were found to have pronounced restrictions in the volume of movements in the HJ. Conclusion. The result of function assessment according to the Harris scale, as well as the presence of deformities and significant limitation of the range of motion indicate a high degree of severity of the HJ lesion in patients with AS before THR.

Coxitis is one of the characteristic clinical manifestations of ankylosing spondylitis (AS). Hip joint (HJ) involvement in AS is considered an un-favorable prognostic factor. Early detection of coxitis is of great importance, since with the timely initiation of adequate treatment, the risk of developing irreversible changes in HJ can be reduced.The lecture discusses the issues of clinical and instrumental diagnosis of coxitis in AS and presents an algorithm for its early detection developed by the authors.

The “Treat-to-target” (T2T) strategy for axial spondyloarthritis (axSpA) has made it possible to optimize therapy in most patients, but in some of them the treatment goals are not achieved.Objective: to analyze the clinical features of patients with ankylosing spondylitis (AS) with inefficacy of two or more biological disease modifying antirheumatic drugs (bDMARDs).Material and methods. From February 2020 to March 2022 458 patients with AS, who met the modified New York criteria of 1984, were admitted to V.A. Nasonova Research Institute of Rheumatology. From this group, 30 (6.6%) patients with high clinical disease activity and inefficacy of at least two bDMARDs were selected. The control group consisted of 139 (30.5%) patients with AS, who either had no history of bDMARDs use, or had previously received only one of them. All patients were examined in accordance with generally accepted methods and underwent a double expert control.Results and discussion. Men predominated in the main and control groups (67 and 60%, respectively). In patients of the main group, there was a higher laboratory activity of the disease, especially ESR (p=0.002), more often peripheral arthritis was detected. In both groups, there was a high incidence of coxitis (69.2 and 69.7%, respectively), while in the main group there were significantly more patients who underwent total joint arthroplasty, and the frequency of detected syndesmophytes was 2 times lower compared to the control. Differences in the features of AS onset were also established: in the main group, the disease often began with reactive arthritis (ReA), while in the control group, with inflammatory back pain.Conclusion. The T2T strategy in axSpA does not always lead to the achievement of the intended goals, and, according to our data, among inpatients with AS, the number of people with a history of inefficacy of two or more bDMARDs reaches 6%. In these patients, compared with the control, the following features of the disease can be distinguished: frequent onset with ReA, a significant incidence of peripheral arthritis and joint arthroplasty, and a higher ESR.

Rheumatoid arthritis (RA) is an immunoinflammatory rheumatic disease (IMRI) characterized by chronic erosive arthritis and systemic damage to internal organs, leading to early disability and reduced life expectancy in patients. Thanks to the progress in the study of the mechanisms of the development of the IVRI and industrial biotechnology, new anti-inflammatory drugs have been created, the use of which has significantly increased the effectiveness of the pharmacotherapy of RA. However, the possibilities of pharmacotherapy for RA are limited, since all biologics, regardless of the mechanism of action, have approximately the same effectiveness in achieving remission. It is believed that the relatively unsatisfactory results of RA therapy are due to the heterogeneity of the mechanisms of inflammation and pain. The significance of the Th17 type of immune response in the pathogenesis of RA, the results of controlled studies of IL-17 inhibitors, and the advisability of further studying the effectiveness of these drugs in patients with certain RA phenotypes are discussed.

Ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are the two most common diseases from the group of spondyloarthritis (SpA), which are often accompanied by permanent disability. Maintaining an acceptable quality of life, preventing the development and progression of structural changes in the musculoskeletal system, maintaining/normalizing functional and social activity are the main goals of their therapy. Over the past decades, the introduction of biological disease modifying antirheumatic drugs has made it possible to achieve significant success in the sustainable control of AS and PsA activity. However, the high cost of treatment significantly limits access to innovative drugs. Specifics of drug supply call for prescription of these drugs in the presence of the status of "disabled", which is assigned on the basis of the results of the medical and social examination (MSE). Execution of the necessary medical documentation for the implementation of the MSE is one of the functions of a rheumatologist.The lecture analyzes the main regulatory legal acts of the Russian Federation regulating the issues of establishing disability and discusses peculiarities of medical reports processing when referring patients with AS and PsA to the MSE.

In population of Russian patients with ankylosing spondylitis (AS), the frequency of clinical manifestations (pain and limitation of functions) of coxitis reaches 56%. Total hip arthroplasty (THA) can be considered as the only alternative that can relieve the suffering of the patient. Radiography and magnetic resonance imaging are widely used methods for assessing structural damage to the hip joint in AS. However, at the moment these methods can’t allow us to fully describe the lifetime changes of these joints. The aim of the study: to analyze the external changes of the femoral heads (HF) and acetabulums during the THA in patients with AS. Materials and methods. The retrospective study included 170 patients with a reliable diagnosis of AS, who met the modified New York criteria of 1984, who were treated in the traumatological and orthopedic department of the V.A. Nasonova Research Institute of Rheumatology in the period from 1998 to 2020, all patients underwent THA as planned. Most of them were male (80.6%). The average age of patients was 38.1±11.3 years and the average duration of the disease since the onset of the first symptoms was 17.0±8.5 years. The duration of pain in hip joints before performing THA is 7.4±4.8 years. The assessment of macroscopic changes in the FH and acetabulum was performed intraoperatively. Results and discussion. Acetabulum protrusion was detected in 108 (63.5%) patients, bone cysts – in 65 (38.2%). Filling of acetabulum with granulation tissue was recorded in 155 (91.2%) patients, presence of osteophytes on its edges – in 153 (90%). Cartilage in the acetabulum was completely absent in 122 (71.8%) patients. FH deformation was detected in 98.2% of cases, erosion in 46.4%. Cartilage on FH was completely absent in 130 (76.5%) patients. In 119 (70%) patients, macroscopic signs of osteonecrosis of FH were found. 79 (46.4%) patients had ankylosis of the hip joint, including fibrous ankylosis – in 77.2% of patients and bone ankylosis – in 22.8%. Conclusion. In patients with AS, the necessity for THA occurs on average after 7.4±4.8 years from the moment of the appearance of first clinical signs of coxitis. In 70% of cases, the macroscopic picture of hip joint lesion was characterized by the development of Avascular necrosis of the femur head (AVNFH), in most patients there was no cartilage in the most loaded segments of acetabulum and FH, in almost half of cases – ankylosis of hip joint and mainly fibrous (77.2%).

Objective: to study the clinical and economic aspects of the use of biological disease modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs), Janus kinase inhibitors (JAKi), for the treatment of psoriatic arthritis (PsA).Patients and methods. The study included adult patients (age ≥18) with active PsA, bionaive or previously treated with bDMARDs. Comparison technologies included: adalimumab (ADA), guselcumab, golimumab, ixekizumab, secukinumab (SEC), tofacitinib (TOFA), certolizumab pegol (CZP), upadacitinib (UPA), ustekinumab, etanercept. The efficacy and safety of the bDMARDs and tsDMARDs included in the study were evaluated based on the results of a systematic search and analysis of data on the comparative clinical efficacy and safety of their use. First of all, the results of phase III randomized controlled trials of drugs that are used to treat active PsA in adult patients as active treatment compared with placebo or with another active drug, or systematic reviews with meta-analysis (MA) and network MA based on them, were considered. The period from the 12th to the 24th week after the start of therapy was taken as the time point for assessing the clinical efficacy of drugs, and the frequency of achieving the ACR20/50/70 criteria was taken as the performance indicator. Cost per responder (СpR), calculated on the basis of the cost of PsA therapy by the time a response is achieved according to the ACR20/50/70 criteria, was used as a criterion for clinical and economic efficiency and to analyze the impact on the budget.Results and discussion. The data of the performed MA indicate a significantly greater effectiveness of the analyzed bDMARDs and JAKi compared to placebo in terms of the frequency of achieving a response according to the ACR20/50/70 criteria both in the group of bionaive patients and in the group of PsA patients, previously treated with bDMARDs. There were no differences between the drugs included in the study in terms of the frequency of achieving ACR20/50/70 response during the treatment of PsA. According to the study, by the 24th week of therapy, ADA, UPA and SEC 150 mg were characterized by the lowest costs to achieve the ACR20/50/70 criteria in bionaive patients and ACR20/50 in patients who were previously treated with bDMARDs. A low CpR value was determined in cases of ADA 40 mg and UPA 15 mg use for the treatment of patients with PsA who had not previously received bDMARDs. Among interleukin inhibitors, the lowest CpR value was registered for SEC 150 mg. By the 12th week of treatment, the CpR of TOFA 5 mg was higher compared to that of UPA 15 mg. CpR indicators for achieving ACR20/50 criteria in patients who were previously treated with bDMARDs were lower in UPA 15 mg and CZP compared to other drugs.Conclusion. The results of the study demonstrate the clinical and economic feasibility of introducing different bDMARDs and JAKi into real practice of PsA treatment. At the same time, the use of original drugs is not always associated with significant costs per 1 patient who responded to treatment. In the absence of direct comparisons, real clinical practice provides important information about the relative efficacy and safety of alternative therapies in the management of PsA patients.

Objective: to study the dynamics of back pain severity and the frequency of its individual components, characterizing the inflammatory and mechanical rhythm, on the background of gestation in women with ankylosing spondylitis (AS) and compare them with manifestations of dorsopathy in healthy pregnant women; to determine the information value of BASDAI during pregnancy, i.e. to identify its components with the optimal sensitivity and specificity ratio for assessing AS activity during gestation.Patients and methods. The main group consisted of 49 pregnant women with AS who met the modified New York criteria of 1984. The average age of patients was 31.7±4.9 years, the average duration of the disease was 134.4±85.8 months. BASDAI for trimesters of pregnancy was: 2.3 [1.2; 4.4], 2.8 [1.4; 4.2] and 2.2 [1.6; 4.0]. The control group included 51 pregnant women with back pain associated with gestation, without rheumatic diseases. The average age was 28.0±4.4 years. The intensity of back pain was assessed on a numerical rating scale. ROC-analysis was performed with calculation of the area under the curve (AUC) of each component of BASDAI in each pregnancy trimester.Results and discussion. More than 80% of pregnant women with AS experienced back pain, while the intensity of general back pain did not differ from that in the control group. Night back pain with improvement on awakening in the main group was present in 70%, 58% and 68.8% of women, respectively, in the I-III trimesters; its intensity was 3 [1; 5], 3.5 [3; 6] and 3.4 [2; 5] respectively; the frequency and severity of night pain were higher than in the control group. The number of women with improvement after exercise in the II and III trimesters did not differ in both groups. In the second half of pregnancy, 40% of AS patients noted improvement during rest, 52.1% – increased pain after exercise; the frequency of mechanical rhythm pain elements remained lower than in the control group. The AUC value for BASDAI in the first trimester was 0.74; AUC of all BASDAI components was >0.5. In the II and III trimesters, the AUC values for fatigue and back pain were 0.8.Conclusion. During pregnancy the vast majority of women with AS experience back pain, the nature of which changes in the second half of gestation. Night pain that improves on awakening reflects AS activity and is not related to pregnancy. The BASDAI components of severity and duration of morning stiffness have the highest classification value during pregnancy.

Objective – to describe the course of COVID-19 and its effect on ankylosing spondylitis (AS) activity in women infected with SARS-CoV-2 during pregnancy and within one 1 year after childbirth.Material and methods. 78 pregnant women with confirmed AS (modified New York criteria, 1984) were included for prospective observation. In the course of the COVID-19 pandemic (03.2020 – 04.2022) 26 of them were followed during pregnancy and 22 within maximum 12 months after childbirth. The average age of pregnant patients was 33.0±3.9 years, the duration of the disease was 117.0±72.0 months. The average age of patients after delivery was 31.5±4.3 years. The activity according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the 1st, 2nd and 3rd trimester of pregnancy was 2.0±1.4, 2.0±1.4 and 1.9±1.5. The activity according to BASDAI at 1, 6 and 12 months after delivery was 2.0±1.3, 2.2±1.3 and 2.5±2.0 respectively.Results. 4 women were COVID-positive: 3 of them at the beginning of 3rd trimester, 1 – on the 38th week of pregnancy. In 3 cases, the activity of AS was low, in one – high due to axial manifestations and arthritis. In 3 women, the course of COVID-19 was mild, in one – moderate (febrile temperature for more than 3 days); only 1 woman had a dry cough. One pregnant woman canceled AS therapy (certolizumab pegol (CZP)), against which the back pain of the inflammatory rhythm increased. In other cases, AS therapy was not canceled, there was no effect of COVID on AS activity.Within one year after delivery 5 women were COVID-positive. At the time of infection, AS activity in all patients was low, 3 women received CZP. In all cases, COVID proceeded with febrile fever for at least 1 day, while general symptoms disappeared within a maximum of 7 days. Only 1 woman had a dry cough. No effect of COVID on AS activity was found, including in 2 patients who canceled CZP. None of the patients were vaccinated against COVID.Conclusion. According to preliminary data, COVID in pregnant women with AS is to be characterized by a mild to moderate course. During pregnancy, against the background of ongoing therapy, there was no increase in AS activity. During lactation, there was also no effect of COVID on the initially low AS activity. One of the main symptoms of COVID during lactation was a febrile fever, regardless of the period between the childbirth and infection.

Objective: clinical and economic evaluation of the use of biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs), Janus kinase inhibitors (iJAK), for the treatment of ankylosing spondylitis (AS).Patients and methods. Among comparison technologies for further analysis were included: adalimumab (ADA), golimumab (GLM), ixekizumab (IXE), secukinumab (SEC), tofacitinib (TOFA), certolizumab pegol (CZP), upadacitinib (UPA), etanercept (ETC). The efficacy and safety of the bDMARDs and tsDMARDs included in the study were evaluated based on the results of a systematic search and analysis of data on the comparative clinical efficacy and safety of their use. Any phase III randomized controlled trials of drugs used to treat active AS in adults (age ≥18) were considered as an investigational treatment versus placebo or versus another active drug. Analysis of the economic consequences of the use of bDMARDs and tsDMARDs for AS treatment was carried out only taking into account drug therapy. For the clinical and economic evaluation of the use of bDMARDs and tsDMARDs, the cost minimization indicator was calculated. As a criterion for clinical and economic efficiency and for the analysis of the impact on the budget, the cost per responder (CpR) indicator was estimated, which was calculated based on the cost of treating AS by the time the response was achieved according to the ASAS20/40 criteria and BASDAI50.Results and discussion. The results of the meta-analysis indicated a greater effectiveness of bDMARDs and iJAK compared with placebo in terms of the frequency of achieving ASAS 20/40, BASDAI 50 criteria. From an economic point of view, compared with the reference (minimum) value (ETC biosimilar, Erelzi®), the difference in the treatment cost of 1 patient with AS during the year varied widely (from +4.22 to +40.29%) and depended on the selected therapy option. At the same time, UPA 15 mg was characterized by the lowest cost of a course of treatment in the first year among original drugs. Among the original drugs, the lowest CpR values before reaching the ASAS20 criterion were in ADA (380,986.58 rubles), ETC (426,868.81 rubles), GLM (559,619.28 rubles) and UPA 15 mg (582,003.89 rub.), according to the ASAS40 criterion – for ADA (534,518.49 rubles.), ETC (726,347.45 rubles) and UPA 15 mg (557,753.73 rubles), according to the BASDAI50 criterion – for ADA (488,911.11 rubles), ETC (636,386.99 rubles) and UPA 15 mg (640,204.28 rubles).Conclusion. The study confirmed the clinical and economic feasibility of using various options for treatment of AS in real practice, including bDMARDs and iJAK. At the same time, the use of original drugs is not always associated with significant costs per 1 patient who responded to treatment. The creation of full-fledged patient registries will make it possible to introduce a system for monitoring clinical outcomes depending on the chosen treatment strategy, as well as smooth out the assumptions and limitations that are used in the study of the clinical and economic aspects of medical technologies, which will save resources and increase the availability of drugs for patients with rheumatic diseases.

Study of the interleukin 6 (IL-6) role in chronic autoimmune inflammation has led to the development of innovative treatments for various autoimmune inflammatory rheumatic diseases, including Takayasu’s arteritis (TAK). Given the important role of IL-6 in the pathogenesis of TAK and its association with high clinical and laboratory activity of the disease, tocilizumab (TCZ) is recommended as a second-line drug if both glucocorticoids and basic antiinflammatory drugs are inefficient, and previous therapy with tumor necrosis factor-α (alpha) inhibitors. The article presents our own observation of the successful use of TCZ in a patient with refractory TAK.

Objective: to assess the economic burden of ankylosing spondylitis (AS) and non-radiological axial spondyloarthritis (nr-axSpA) in the Russian Federation, as well as the availability and economic prospects for more complete provision of biological disease-modifying antirheumatic drugs (bDMARDs) to patients with AS and nr-axSpA.Patients and methods. The prevalence of AS and nr-axSpA and organizational aspects of providing with bDMARDs to this category of patients were analyzed.A variant model has been developed in Microsoft Excel, allows to calculate the indicators of the economic burden of AS and nr-axSpA in the Russian Federation, taking into account the economic losses associated with disability, as well as the low availability of bDMARDs. During study preparation, data from real clinical practice and the opinions of experts in the field of AS from various regions of the Russian Federation were studied.The economic burden was calculated as the sum of direct and indirect costs per patient and the population. Additionally, the specific economic burden per capita was determined.Results and discussion. According to expert estimates, the prevalence of AS and nr-axSpA today is 105.0 and 33.2 thousand people, respectively.The current economic burden of the AS for 2019 is estimated at 21.9 billion rubles per population, or 395.5 thousand rubles for 1 patient. The ratio of direct and indirect costs was 1:4, i.e. 4.7 billion rubles – direct costs (84.3 thousand rubles per 1 patient) and 17.2 billion rubles – indirect costs (311.2 thousand rubles per 1 patient). The burden per capita – 149 rubles.Nr-axSpA's current economic burden in 2019 reached 3.0 billion rubles, or 182.9 thousand rubles for 1 patient. The ratio of direct and indirect costs is estimated as 2:5, or 0.9 billion rubles – direct costs (53.0 thousand rubles per 1 patient) and 2.2 billion rubles – indirect costs (130.0 thousand rubles per 1 patient). The burden per capita – 21 rubles.Conclusion. The economic burden of AS and nr-axSpA can be reduced by providing patients with bDMARDs in the required amount: 15% of patients with AS and 10% with nr-axSpA. Due to the imperfection of the regulatory framework, patients with nr-axSpA experience serious difficulties in receiving this therapy within the framework of preferential drug coverage and compulsory health insurance. With the provision of bDMARDs for about 15 and 10% of patients with AS and nr-axSpA, respectively, on the horizon of 5 years, a decrease in disability by 75% and temporary disability by 60% is expected. At the same time, the economic burden for 5 years will decrease by about 40% for each nosology.

The article summarizes literature data on the use of radiography and magnetic resonance imaging to monitor axial spondyloarthritis in real clinical practice.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease with predominant involvement of the sacroiliac joints (SIJ) and/or the spine. Despite the fact that the prevalence of axSpA is almost the same in men and women, there is evidence of a delay in diagnosis and a more severe course of the disease in females. The available reports on the progression of structural changes in the SIJ in men and women with early axSpA are contradictory. Meanwhile, the analysis of radiographic progression in the SIJ has fundamental importance both for timely diagnosis and for assessing the effectiveness of therapy in axSpA. Such studies have not yet been carried out in the Russian Federation.Objective: to assess the radiographic progression of sacroiliitis (SI) over 3 years in men and women with early axSpA.Material and methods. The study included patients from the cohort of early axSpA CORSAR, formed at the V.A. Nasonova Research Institute of Rheumatology. Currently, it includes 175 patients with axSpA. We analyzed the data of 64 patients, followed for at least 3 years. To assess the radiographic progression of the disease at baseline and after 3 years, the sum of X-ray stages of SI in the left and right SIJ was determined (the total stage of SI). Progression was assessed by the change in the total stage of SI in the right and left SIJ (0-8) during the observation period. We also calculated the proportion of patients with deterioration (increase in the total stage of SI by at least 1 stage), with improvement (decrease in the total stage of SI by at least 1 stage) and without progression. In order to fully exclude the error in measuring the radiographic progression of SI, we counted patients with “net” progression, that is, the proportion of patients with improvement was subtracted from the proportion of patients with deterioration.Results. Among 64 patients with early axSpA, there were 37 (57.8%) men and 27 (42.2%) women. For 3 years, the median of the total stage SI in men was 0 [0; 1], in women - 0 [0; 2] (p>0.05). When assessing the progression of the total stage SI over 3 years, no significant differences were found between the number of men and women with improvement, with deterioration, “net” progression and without progression. Men with early axSpA showed a higher level of C-reactive protein (CRP) at baseline, women had higher BASDAI and ASDAS CRP values after 3 years. In 8% of patients, there was a regression of X-ray signs of SI.Conclusion. The radiographic progression of SI in patients with early axSpA does not depend on gender and disease activity. In some patients with early axSpA, reverse development of structural damage to the SIJ is possible.

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

Objective: to present our own experience of tumor necrosis factor α (TNFα) inhibitors (iTNFα) usage during pregnancy in women with ankylosing spondylitis (AS), to assess AS activity and outcomes of gestation.Patients and methods. A prospective observation of 55 pregnant women with AS who met the modified New York criteria of 1984. Fifty-six pregnancies were followed. The average age of the patients was 31.7±4.7 years, the duration of the disease was 132.2±85.4 months. The median BASDAI for pregnancy trimesters was 2.4 [1.2; 4.4], 2.7 [1.4; 4.2] and 2.2 [1.5; 4.0], respectively. 14 women received iTNFα 3 months before pregnancy.Results and discussion. In the first trimester, TNFα was used in 9 (16.1%) patients, in the second – in 9 (16.1%) and in the third – in 5 (9.3%); the median BASDAI for trimesters was 2.3 [1.0; 3.7], 3.4 [1.2; 3.5], 3.0 [0.8; 3.4], respectively. All patients who discontinued iTNFα just before or in early pregnancy had indications for resuming therapy in the second half of gestation. Cancellation of iTNFα at the end of the second trimester was not a risk factor for high activity in the third trimester. There was 1 adverse pregnancy outcome. In other cases, childbirth occurred at 38.9±1.4 weeks, newborns' body weight was 3273.1±435.6 g.Conclusion. Women with AS who plan a pregnancy should be prescribed drugs with the maximum allowed duration of use during gestation. Cancellation of iTNFα before and in early pregnancy is a risk factor for high AS activity, while renewal of iTNFα therapy during pregnancy is not always effective.

In mid-2021, the SARS-CoV-2 (Severe Acute Respiratory coronavirus 2) infection, which caused the coronavirus disease (COVID-19) pandemic, affected more than 157 million people in all regions of the world and led to more than 3.2 million deaths. It is assumed that elderly age, uncontrolled inflammation, anti-inflammatory therapy, comorbid pathology, genetic and other factors can potentially lead to an increase in “sensitivity” to viral and bacterial infections, including SARS-CoV-2. The new version of the recommendations of the Association of Rheumatologists of Russia formulates the main provisions concerning the tactics of managing patients with Immune-mediated Rheumatic Diseases during the ongoing COVID-19 pandemic.

Aims of the trial – to study the frequency of drug use in pregnant women with ankylosing spondylitis (AS), to determine the effect of discontinuation of drugs of various groups, as well as the dose of non-steroidal anti-inflammatory drugs (NSAIDs) used, on AS activity during gestation.Material and methods. 50 pregnancies in 49 patients with AS that met the modified New York criteria of 1984. The average age of the patients was 31.7±4.9 years, the duration of the disease was 134.4±85.8 months. The visits were conducted at 10–11, 20–21 and 31–32 weeks of gestation. The BASDAI in the month of conception and in the I, II and III trimesters of pregnancy was: 1.4 [0.6; 3.3], 2.3 [1.2; 4.4], 2.8 [1.4; 4.2] and 2.2 [1.6; 4.0], respectively. The total dose of NSAIDs was determined by the NSAID intake index (Dougados M., 2011).Results and discussion. NSAIDs. After inclusion in the study, the drug of choice was ibuprofen, which was canceled for all women not later than on 32 week of gestation. At the time of conception and in the first, second and third trim. NSAIDs were taken by 23 (46%), 20 (40%), 30 (60%) and 21 (43.8%) women, respectively. NSAIDs intake index in I trimester (5.8 [2.9; 11.8]) was lower than before pregnancy (28.6 [16.7; 50]) and in II (15.5 [4.7; 30.9]) and III trimesters (24.4 [9.5; 50]) (p0.05). TNFα inhibitors: 3 months before pregnancy and in the trim. of pregnancy were taken by 11 (22%), 7 (14%), 6 (12%) and 2 (4.2%) patients. In those who canceled therapy (both independently and on the recommendation of a rheumatologist) on the eve of pregnancy, an increase in AS activity was noted; BASDAI in the month of conception and in I, II, III trimesters was: 2.7 [0.8; 3.5], 5.1 [3.1; 5.9], 5.5 [5; 6] and 6.7 [5.3; 7.3] (p4) in the II trimester (OR=30.4; 95% CI: 1.5–612.3; p=0.03) and in the III trimester (OR=32.7; 95% CI: 1.6–662.2; p=0.02).Conclusion. NSAIDs and GC in low doses do not reduce the activity of AS. Withdrawal of TNF-α inhibitors on the eve of pregnancy is a predictor of high AS activity. It is necessary to increase the knowledge of rheumatologists and patients about the therapeutic possibilities during pregnancy to avoid unjustified drug withdrawal.

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

Netakimab (NTK) is a humanized anti-interleukin-17A monoclonal antibody. To date, the drug has been approved to treat ankylosing spondylitis (AS), psoriatic arthritis, and plaque psoriasis. The paper gives the data obtained during 52-week follow-up of AS patients in the phase III ASTERA study.Objective: to study the efficacy and safety of NTK when used long in patients with active AS.Patients and methods. The investigation enrolled 228 patients with active AS, in whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective. The patients were randomized in a 1:1 ratio to receive NTK 120 mg or placebo. The drug was administered subcutaneously at weeks 0, 1, 2, and then once every 2 weeks. Patients who received placebo and achieved a 20% improvement according to the ASAS criteria (ASAS20) were excluded from the study at week 16. At this week, patients who took placebo and did not achieve an ASAS20 response were switched to subcutaneous NTK at 120 mg dose once every two weeks. The follow-up period was 52 weeks.Results and discussion. Patients with active AS who received NTK were more likely to respond to treatment than those who took placebo. The proportion of people who achieved 40% improvement (ASAS40) during treatment with NTK increased throughout the follow-up period and amounted to 80.7% at week 52. Positive changes were achieved in all used clinical and laboratory parameters of AS activity. There was also a decrease in inflammatory changes, as shown by magnetic resonance imaging (MRI). The adverse events (AEs) were mainly laboratory abnormalities and upper respiratory tract infections. Treatment-related AEs were recorded in no more than one third of patients and they were mild to moderate. Severe AEs were singular.Conclusion. Response to NTK therapy generates in the first weeks of drug use and increases throughout a year. The safety profile of NTK when used long is generally favorable.

Objective: Assessment of ankylosing spondylitis activity patterns during pregnancy using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score — C-Reactive Protein) disease activity indices.Materials and methods. The prospective study included 36 pregnant women with AS (modified New York AS criteria, 1984). Patients’ mean age was 31.6±4.8 years, mean age at AS onset was 21.8±10.9, and disease duration 134.9±89.3 months. The control group included 30 healthy pregnant women with no history of back pain and arthritis, their mean age was 28.2±4.5 years. In the I trimester of pregnancy 10 (33.3%) As patients experienced back pain, while in the III trimester already 15 (50%) had back pain. Throughout pregnancy, the intensity of back pain in the I, II и III trimesters based on numeric scale was on average 1.9±0.9; 2.1±1.1 and 2.1±0.8. BASDAI and ASDAS-CRP were used to measure disease activity on gestational Weeks 10–11, 20–21 and 31–32. The time of conception BASDAI score was assessed retrospectively at the 1st visit.Results and discussion. BASDAI mean values at the time of conception and I, II и III trimesters of pregnancy were: 2.3±1.9; 2.8±1.72 (p0.7) of fatigue severity with the BASDAI index in the I and II trimesters of pregnancy and moderate correlation (rs >0.53) in the III trimester; as wells as moderate (rs >0.5-0.69) correlation between back pain and BASDAIConclusion. A trend towards increasing AS activity based on BASDAI and ASDAS-CRP scores and CRP levels was established for the first half of pregnancy. Later in pregnancy these increased values failed to return to normal until the end of gestation. The percentage of AS patients with highto-moderate disease activity throughout pregnancy was lower based on BASDAI score vs based on ASDAS-CRP. Some BASDAI components (fatigue and back pain) reflect not only the activity of AS, but also changes associated with physiological pregnancy. The BASDAI index requires adaptation for use in pregnancy

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the first-line medications for ankylosing spondylitis (AS); their action is associated with blockade of the enzyme cyclooxygenase 2 and with a mediated decrease in the synthesis of prostaglandins (PGs). However, PGs play an important role in regulating the functions of the female reproductive system. The paper presents an update on the participation of PG in folliculogenesis, ovulation, implantation, and development of the embryo, and labor activity. Based on experimental and clinical findings, the authors discuss whether due to inhibition of the synthesis of PGs, NSAIDs are able to cause ovulation failure, including luteinized unovulated follicle syndrome and spontaneous abortions. Further investigation is justified to determine the most optimal NSAID therapy regimens when planning pregnancy and during gestation in women with AS.

Objective: To evaluate maternal and neonatal pregnancy outcomes in ankylosing spondylitis (AS) patients.Subjects and methods. The prospective study included 36 pregnant women with AS (modified New York AS criteria, 1984), all participants were followed. Mean patients’ age was 31.6±4.8 years, age at disease onset – 21.8±10.9 years, duration of the disease – 134,9±89.3 months. Stage II-III sacroiliitis was diagnosed in 88.9% of women, stage IV – in 11.1%. AS activity levels measured by mean BASDAI score in I, II and III trimesters were 2,8±1,7 – 3,2±1,9 – 3,3±2,1, respectively.Results. 34 pregnancies resulted in live births at median 39 [38; 40] weeks of gestation. Adverse pregnancy outcomes were documented in 2 cases (5.6%): a missed miscarriage at 18 weeks of gestation in a woman with burdened maternal obstetric history and moderate AS activity; and medical abortion at 23d week of gestation because of fetal critical condition owing to persistent high AS activity with severe axial and extra-articular manifestations of the disease. Most common pregnancy complications included threatened early miscarriage (11.1%), threatened premature labor (11.8%), infectious and inflammatory conditions (pyelonephritis in pregnancy, acute respiratory viral infections – 36,1%), iron-deficiency anemia (19,4%), gestational hypothyroidism (11,1%). Preterm birth was documented in 5,9% patients. No association was found between disease activity, therapy, and preterm birth. There were no cases of preeclampsia. 52.9% of the patients had vaginal delivery, and 47.1% had a caesarean section (CS), which was elective in 87.5% of all CS cases. Indications for elective CS included severe hip joints involvement with altered function, and scar on the uterus. Emergency C-section was performed in cases of uterine inertia and preterm discharge of amniotic fluid. Average birthweight of newborns was 3384.4±382.0 g, and length –51.5±2.0 cm, Apgar score was 8.0±0.4/8.9±0.4. Early neonatal complications were documented in 14,3% newborns, Congenital abnormalities were registered in 3 (8.6%) newborns: a slit-like defect of the atrial septum, a defect of the interventricular septum, and unilateral hydronephrosis.Conclusion. Pregnancy outcomes in AS patients practically do not differ from those in general population, except for higher rates of elective C-sections, being generally favorable given AS activity is adequately controlled and gestation &delivery are thoroughly monitored. AS is not associated with higher rates of severe pregnancy complications and preterm birth. AS seemed to have no negative impact on newborn anthropometric data and health condition in general. No severe neonatal complications occurred. Considering the small sample size, it is impossible to draw definite conclusions about occurrence of various malformations in newborn to mothers with AS at this particular stage of the research. Interdisciplinary consensus is necessary in place to optimize pregnancy and birth management in AS patients

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

In addition to damage to the spine and joints in ankylosing spondylitis (AS), as in other diseases from a group of spondyloarthritides (SpA), there can be the following extra-articular manifestations: inflammatory bowel disease (IBD), uveitis, psoriasis, and kidney and heart diseases. In the last decade, much attention has been paid to the association between SpA and IBD; the common pathogenetic mechanisms of these diseases have been identified. The relationship between inflammation and blood coagulation has been known since ancient times, and its evidence base is constantly expanding. Both of these processes are accompanied by platelet activation and fibrin formation. The authors present a clinical case of a female patient with the comorbidity of AS with IBD and iliocaval thrombosis.

Recently, various visualization techniques have been used to study spondyloarthritis (SpA); indices are also being elaborated to assess the progression of radiographic changes in the spine and sacroiliac joints. Most studies dedicated to the problem of coxitis in SpA have shown that its progression parallels with a spinal inflammatory process; however, no indices for assessing the time course of changes in the hip joints (HJs) have been developed.Objective: to develop a method for assessing the radiographic progression of coxitis in early axial SpA (axSpA).Subjects and methods. Examinations were made in 175 patients (mean age, 28±6 years) with axSpA who met the 2009 ASAS criteria and had an inflammatory back pain duration of no more than 5 years. The analysis included 62 patients who had been followed up for at least 2 years and had plain pelvic bone X-ray films at the inclusion in the cohort and at 2 years after starting the follow-up. The sum of stages of radiographic coxitis (ssrC) was used to assess HJ injury progression. During the study, a formula was developed to assess the progression rate of radiographic coxitis.Results and discussion. The median difference in ssrC (ΔssrC) was 0.78 [0; 4] at baseline and at 2 years. During the study period, 63% of the patients showed no progression of ssrC; the latter increased by 1 score in 7 (11%) patients, by 2 scores in 11 (18%), by 3 scores in 1 (2%), and by 4 scores in 4 (6%). The ssrC averaged 0.54±0.79 at baseline and increased by 0.78 up to 1.32±1.34 (p=0.06) at 2 years. At baseline, the coxitis progression rate averaged 0.45 per year (it was conventionally accepted that the patients exhibited no signs of HJ injury at onset of the disease: ssrC was zero); that was 0.54 and 0.1 per year at 1 and 2 years of follow-up, respectively.Conclusion. The proposed calculation procedure is easily feasible and applicable in real practice, does not lead to additional investigations, and is economically feasible. This procedure allows monitoring the rate of radiographic coxitis progression in patients with axSpA throughout the course of the disease.

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

Objective: to present cases of Behcet's disease (BD) concurrent with axial spondyloarthritis (axSpA).Subjects and methods. A total of 470 patients with BD who met the International Standard Bibliographic Description (ISBD) criteria were examined at the V.A. Nasonova Research Institute of Rheumatology in the period from 1990 to2018. In 9 of them, BD was concurrent with axSpA; 7 out of the 9 patients met the 1984 modified New York criteria for ankylosing spondylitis (AS) and two patients fulfilled the 2009 ASAS non-radiographic axSpA criteria.Results and discussion. Most (55.6%) patients were men. BD was preceded by axSpA in 6 patients. The symptoms of AS joined an average of 8.4 [2; 10] years after the onset of the clinical manifestations of BD. Three patients developed BB 9–15 years after the onset of the first symptoms of axSpA. The mean duration of BD was 14.0±7.8 years and that of axSpA was 10.9±6.2 years. All the patients were HLA-B27-positive; three were found to have B5 antigen.All the 9 patients had mucocutaneous manifestations that were characteristic of BD. Four patients were diagnosedas having eye injuries: generalized uveitis with retinal vasculitis, posterior uveitis with or without retinal vasculitis. Gastrointestinal tract lesions were detected in 44.4% of cases. Peripheral arthritis was present in all the patients. Entheseal involvement was observed in 66.7% of patients. The radiographic signs of bilateral sacroiliitis according to the modified New York criteria were found in 7 (77.8%) patients; MRI revealed active inflammatory changes in the area of the sacroiliac joint in 3 (33.3%) patients.Conclusion. The fact that there may be an overlap between BD and axSpA should be taken into account in everyday clinical practice, which will assist in choosing the optimal treatment strategy.

In Russia, coxitis is one of the most common extra-axial manifestations of ankylosing spondylitis (AS). However, many issues regarding its early diagnosis remain unresolved.Objective: to compare the clinical manifestations of coxitis with the data from an instrumental examination of CoRSAR cohort (Cohort of Early Axial Spondyloarthritis) patients.Patients and methods. Examinations were made in 175 patients (mean age, 28.2±5.7 years) diagnosed as having axial spondyloarthritis (axSpA) with inflammatory back pain lasting up to 5 years, which occurred at the age of ≤45 years. There was non-radiographic axSpA (nraxSpA) in 69 patients and AS in 106 patients. 87% of patients were HLA-B27-positive. The median disease duration was 23.8 [1–60] months; BASDAI was 3.3±1.94. Regardless of complaints, all the patients underwent hip X-ray and ultrasound studies and 54 more patients had magnetic resonance imaging (MRI).Results and discussion. The clinical signs of coxitis were present in 95 (54%) patients, of them 60% were diagnosed with AS and 40% had nraxSpA. According to the numerical pain rating scale (NPRS), the median hip joint pain was 4 [3; 7]. Limited joint movement was observed in 6 (3.4%) patients. The level of hip joint pain correlated with BASDAI (r=0.53) and ASDAS (r=0.30). The ultrasound signs of coxitis were detected in 42 (24%) patients; of them 26 (62%) had the clinical manifestations of hip joint injury, and such changes were absent in 16 patients. The patients with ultrasound signs of coxitis were noted to have a higher disease activity; peripheral arthritis and enthesitis were more common. According to MRI, coxitis was diagnosed in 39 (72%) of the 54 examinees, while the disease was asymptomatic in 10%.Conclusion. Different diagnostic methods used in patients with early axSpA could reveal coxitis in 33% of cases. The patients with coxitis show higher laboratory disease activity than those without hip joint injury. It is necessary to include MRI and ultrasound in the mandatory examination of patients with axSpA.

Objective: to analyze trends in the incidence and prevalence of major rheumatic diseases (RDs) among the adult population of Russia in 2013 to 2017.Material and methods. The trends in the incidence and prevalence of major RDs were analyzed among the adult population of Russia over 5 years (in 2013 to 2017) according to the statistical reports of the Ministry of Health of Russia, which are based on the data of accounting form No. 12 “Information on the number of diseases recorded in patients living in the region served by a health care facility”. The analysis was carried out in eight Federal Districts (FDs).Results and discussion. Over 5 years, there was a slight increase in the number of patients (by 21,677) with musculoskeletal diseases (MSDs) among the adult population of Russia and a small (0.64%) decrease in their prevalence. Noninflammatory osteoarticular diseases, such as osteopathy, chondropathy, deforming dorsopathies, and arthropathies (74%), were leading among MSDs. The incidence of osteoarthritis (OA) was highest: more than 4 million people, which is a quarter of all RDs. The increase in the number of patients with OA was observed annually, but was insignificant for 5 years – 190.400 people; the prevalence of OA increased by 3.7%. The largest number of patients with OA was registered in the Central (1.1 million) and Volga (0.9 million) FDs.The incidence of rheumatoid arthritis (RA) increased insignificantly in the Central, Northwestern, Southern, Ural, and Siberian FDs and decreased in the Volga and Far Eastern FDs. There was a substantial (21%) decrease in the prevalence of RA in the North Caucasian FD. There was a significant increase in both the incidence and prevalence of spondylopathy (SP) in almost all FDs, except for the Volga FD. In contrast, these indicators for reactive arthritis (ReA) had decreased in five FDs by 2017 and slightly increased in three FDs. These indicators fluctuated in almost all FDs for 5 years.The incidence and prevalence of psoriatic arthritis (PsA) showed a annual increase particular in the North Caucasian FD by 29%. The incidence of PsA slightly decreased only in the Siberian FD. The number of patients with systemic connective tissue diseases (SCTD) increased insignificantly in all FDs, with the exception of the North Caucasian FD, in which the prevalence of SCTD reduced dramatically (by 42%). The incidence of osteoporosis (OP) fluctuated during 5 years; by 2017, there had been its rise in five FDs, especially in the Northwestern FD. The prevalence of OP was found to increase significantly (by 33.5%) in the North Caucasian FD.Evaluation of the age composition of patients showed that OA and OP were more common in the older age group; and ReA; SP and SCTD were in the younger age one. There were no differences in the age composition of patients with RA.Conclusion. The analysis of the statistical incidence and prevalence rates of RDs in the adult population of Russia suggests that there is an increase in the number of patients with this pathology throughout the country.

Inflammatory rhythm back pain and enthesitis are one of the main clinical manifestations of ankylosing spondylitis (AS), which increase in severity during pregnancy. However, addition of back pain and, possibly, enthesis in the second half of gestation, which is associated with normal pregnancy, needs to make a differential diagnosis for clarifying the genesis of pain and choosing the right management tactics, which determines the relevance of this study.Objective: to investigate the course of pain in the back, enthesis, and inguinal region, as well as the functional status in AS patients during pregnancy and to reveal clinical signs that most accurately reflect inflammatory activity during gestation.Patients and methods. A study included 36 pregnant women with a reliable diagnosis of AS according to the modified New York criteria (1984). Their mean age was 31.6±4.8 years, the mean age at the onset of AS was 21.8±10.9 years; the duration of the disease was 134.9±89.3 months. A control group comprised 30 healthy pregnant women with no history of back pain and arthritis; their mean age was 28.2±4.5 years. The pregnant women of both groups were matched for parity. They made visits at 10–11, 20–21, and 31–32 weeks of pregnancy. Pain intensity was estimated using the numerical pain rating scale (NPRS) and the functional status was assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI). The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) was used to assess enthesitis.Results and discussion. During pregnancy, 94% of AS patients had back pain; its intensity by trimesters was 3 [2; 4], 4 [3; 5.5], 3 [2; 7] and was higher than in healthy pregnant women (p

Recently, more attention has been given to Th17 cells, the pathological activation of which plays a leading role in the development of a wide spectrum of human immunoinflammatory diseases (IID), including rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel diseases, etc. This has served as an incentive to design new biological agents and small molecules, the main mechanism of action of which is based on blocking the pathological effects of interleukin-17 (IL-17), others are associated with the activation of Th17 cells cytokines or signaling pathways that regulate the effects of these cytokines. The review discusses current ideas about the mechanisms regulating the formation and functional activity of IL-17 family cytokines, as well as evidence for the importance of these cytokines in the pathogenesis of IID.

Currently, there have been a small number of works on differences between males and females with axial spondyloarthritis (axSpA) and there have been no studies estimating a gender difference in radiographic sacroiliitis progression in axSpA.Objective: to compare the main clinical manifestations of sacroiliitis and its radiological progression in axSpA in men and women over time during a 2-year follow-up period.Subjects and methods. The investigation was conducted using the Moscow cohort from the early SpondyloArthritis (CoRSAr) study, which currently consisted of 175 patients. The analysis included 68 patients followed up for ≥2 years. Their mean age at the time of inclusion in the cohort was 28.5±5.8 years; the mean disease duration was 24.1±15.4 months. 92.6% of patients were HLA-B27-positive.Results and discussion. Among the 68 patients followed up over 2 years, there were 33 (48.5%) men and 35 (51.5%) women. At baseline, the females were older than the males (p

Objective: to evaluate the effect of golimumab (GLM) on the clinical, functional, and instrumental manifestations of coxitis in ankylosing spondylitis (AS).Subjects and methods. The non-interventional prospective multicenter cohort study GO-COX conducted in the medical centers of the Russian Federation enrolled 39 patients with AS (meeting the modified New York criteria) and coxitis with BASRI-hip score 0–2, who were prescribed GLM as the first biologic agent at a dose of 50 mg per month. The patient's health status was assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), the Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP), and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) before and at 6 and 12 months after GLM treatment initiation. Based on the data of radiographs (the Bath Ankylosing Spondylitis Radiology Hip Index (BASRI-hip) scoring system), ultrasonography (USG), and STIR and T1 magnetic resonance imaging (MRI), the investigators assessed the manifestations of coxitis. The planned follow-up duration was 2 years. This paper includes 12-month follow-up results in 22 patients.Results and discussion. At 12 weeks of GLM therapy, there were significant positive index changes: a decrease in BASDAI by an average of 3.28±1.62, in ASDAS-CRP by 2.20±0.95, in BASFI by 2.52±2.09, and in BASMI by 1.41±1.50 (p

Family and twin studies have shown that ankylosing spondylitis (AS) has a hereditary nature that is based on a strong association with the leukocyte antigen HLA-B27. However, only 1–5% of HLA-B27 carriers develop AS, which indicates that there are other genetic markers involved in the formation of a predisposition to this disease. A number of genome-wide association studies have convincingly confirmed the role of the STAT4 gene. This gene encodes the protein – the signal transducer and activator of transcription (STAT) protein, which is a predisposing factor for the development of many autoimmune diseases. There are not so many studies of the relationship of STAT4 polymorphisms to the predisposition to AS, and there are no these studies regarding the Russian population.Objective: to study whether there is a possible association of STAT4 rs7574865 gene polymorphism with the predisposition to AS and to assess the activity of this disease using BASDAI and ASDAS scores in the Russian patient population.Patients and methods. A cohort of 203 individuals, including 100 patients (79 men and 21 women) with AS, and 103 healthy volunteers (a control group) was surveyed. Age, gender, duration, and specific features of AS onset, ESR, and CRP levels were assessed. BASDAI and ASDAS scores were calculated to evaluate disease activity.Results and discussion. There was a significant relationship between STAT4 polymorphism and C-reactive protein (CRP) levels and BASDAI and ASDAS-CRP scores. The TT genotype carriers had significantly higher mean activity indices compared to the GG (p=0.001) and GT (p=0.005) genotype carriers for CRP, BASDAI (p=0.0001 and p=0.009, respectively) and ASDAS-CRP (p=0.009 and p=0.001, respectively). High disease activity (BASDAI >4 and ASDAS-CRP >3.5) was also associated with the high frequency of the T allele (p=0.046 and p=0.004, respectively). The value of STAT4 rs7574865 gene polymorphism in the pathogenesis of autoimmune diseases is confirmed by a study in which the T allele in STAT4 rs7574865 enhances mRNA transcription and protein expression. Italian authors have shown that there is a relationship between the minor T allele of rs7574865 and the high risk of arthritis. We have previously established a relationship between the T allele and the predisposition to diffuse systemic scleroderma, interstitial lung damage, and elevated anti-topoisomerase I antibody levels.Conclusion. The present study has shown for the first time a significant association of STAT4 rs7574865 polymorphism with the main AS activity indicators: CRP levels, BASDAI and ASDAS-CRP scores. The studied polymorphism may be a new genetic marker for predicting the severity of AS.

The onset of ankylosing spondylitis (AS) more frequently occurs at the end of the third decade of life, which corresponds to the time of marriage and the birth of the first child and determines the relevance of a study of the interaction of AS and pregnancy.Objective: to describe the clinical presentations of AS and its therapy during pregnancy and to study AS activity dynamics and the patients' functional status during gestation.Patients and methods. The investigation enrolled 19 pregnant women who met the 1984 modified New York AS criteria. The mean age of the women was 32.2±1.1 years; their mean age at the onset of AS was 22.6±3.1 years; the duration of the disease was 147±20.7 months. The patients visited their physician at 10–11, 20–21, and 31–32 weeks of pregnancy. The investigators determined AS activity by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS) and functional status by the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Bath Ankylosing Spondylitis Metrology Index (BASMI). The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) was used to assess enthesitis.Results and discussion. At the time of conception, 78.9% of the patients had inflammatory back pain with an intensity of 2.2±0.4 on a numerical rating scale; during pregnancy, 95% of the pregnant women experienced pain, its intensity increased by the second trimester (4.6±0.7) and remained at this level in the third trimester (p

The evolution of axial spondyloarthritis (axSpA) and the transition of its nonradiographic to radiographic stage, when ankylosing spondylitis (AS) can be diagnosed, concern many researchers. To clarify this issue, an active search for predictors of the progression of this disease is underway; special cohort studies are being conducted.Objective: to analyze two-year changes in the magnetic resonance imaging (MRI) signs of sacroiliac joint (SIJ) inflammation and disease activity in patients with axSpA who form a Moscow CoRSAr cohort (a Cohort of early SpondylArthritis) and the role of these indicators in the progression of sacroiliitis.Subjects and methods. The investigation enrolled 68 CoRSAr cohort patients followed up for two years. All the patients underwent pelvic radiography and SIJ MRI at inclusion in the cohort and then every year. At inclusion in the cohort, nonradiographic axSpA was present in 28 patients, and AS was in 40. Disease activity was determined by BASDAI and ASDAS-CRP. The progression of sacroiliitis was assessed by the total scores of radiographic sacroiliitis.Results and discussion. The patients' age at inclusion in the cohort averaged 28.5±5.8 years, with a mean disease duration of 24.1±15.4 months and a male proportion of 51.5%; the HLA-B27-positive patients were 92.6%. At two years, 39% of the patients with nonradiographic axSpA went to the AS group. 24-month sacroiliitis progression was observed in 40% of the patients. Disease activity had little impact on the progression of sacroiliitis.Conclusion. Over two years, almost 40% of patients with axSpA showed an increase in the radiographic stage of sacroiliitis in the CoRSar cohort; this progression was primarily associated with the foci of osteitis according to MRI and correlated little with the activity of the disease.

Objective: to study the impact of the diagnosis of ankylosing spondylitis (AS) on the planning of pregnancy by patients and their attitude towards the use of drugs during gestation and to assess the competency of physicians in the issues relating to pregnancy in AS.Patients and methods. The data of three studies based on the questionnaire surveys of female AS patients and rheumatologists.Results and discussion. The questionnaire survey revealed a decline in the number of pregnancies per woman after the onset of AS. Having learned about their diagnosis, 70% of patients reported a change in their maternity plans; however, most (80%) women said that they were still going to become pregnant, but they would constantly feel discomfort and fear for their own health and the health of their future child. Pregnancy was rejected due to AS development by 13.9% of patients, regardless of the presence or absence of children born in the healthy period of their life. Only 50% of women discussed the issues relating to pregnancy with a rheumatologist, and one third of them did not obtain the necessary information. Only one fourth of patients were ready to continue treatment for AS in the period of preparation for conception and during gestation.On the whole, Russian rheumatologists have enough knowledge about pregnancy outcomes in AS, and, in particular, about the factors which may influence the favorable outcome and about the fundamentals of follow-up for pregnant women. At the same time, 18% of rheumatologists expect increased AS activity during gestation, more than two thirds consider sacroiliitis to be an indication for surgical delivery, and 30% are ready to discontinue the drugs which are permitted for use before pregnancy.Conclusion. Lack of information about the planning and course of pregnancy in AS, the risk of disease exacerbation and the safety of therapy during gestation is noted in both patients and rheumatologists. It is necessary to implement educational measures on the problem of pregnancy in AS for rheumatologists and women of fertile age and their family members.