Objective: to investigate the efficacy and safety of olokizumab (OKZ) in patients with knee osteoarthritis (OA) with synovitis, persistent pain and ineffectiveness of previous conservative therapy. Material and methods. The study included 15 patients with stage II–III knee OA who fulfilled the ACR criteria and had pain ≥50 mm on a visual analogue scale (VAS), synovitis and treatment failure. The age of patients ranged from 54 to 75 years; the duration of the disease was from 1 to 23 years. The duration of the study was 12 weeks, during which the patients received 3 subcutaneous injections of OKZ at a dose of 64 mg. The effectiveness of the treatment was assessed by the dynamics of pain intensity according to VAS, WOMAC and KOOS indices, the values of the DN4 questionnaire and the quality of life according to EQ-5D. In addition, the general assessment of the patient's health (GHA) according to VAS, the assessment of treatment efficacy by doctor and patient and the need for non-steroidal anti-inflammatory drugs (NSAIDs) were considered. All patients underwent laboratory testing. Results and discussion. During treatment, there was a significant decrease in pain intensity according to VAS, a statistically significant improvement in the KOOS and WOMAC indices (p<0.05), quality of life according to the EQ-5D questionnaire and GHA. Patients and doctors rated the treatment results very positively: an improvement or significant improvement was observed in 92.3% of cases. Adverse events were identified in 4 patients, which in 2 cases served as the reason for discontinuation of OKZ treatment and termination of participation in the study. During treatment with OKZ, a statistically significant decrease in CRP and ESR values, an increase in the concentration of interleukin 6 (p = 0.003), COMP (p = 0.03) and PIINP (p = 0.01) were observed. Conclusion. The results obtained suggest a significant symptomatic and anti-inflammatory effect of OKZ in patients with the inflammatory phenotype of OA.

Background. Non-pharmacological treatments based on collagen as a dietary supplement are emerging as a new area of interest to support preventive or therapeutic effects in patients with osteoarthritis (OA). Aim. In a multicenter, prospective, double-blind, placebo-controlled, randomized study, to evaluate the effectiveness and safety of the use of the Artneo complex containing undenatured chicken collagen type II in patients with OA of the knee joints. Materials and methods. The study enrolled 212 outpatients from 12 centers in the Russian Federation with knee OA, stages II and III according to the Kellgren–Lawrence classification. The participants included 171 women (80.7%) and 41 men (19.3%), with an average age of 60.2±9.0 years (range: 40 to 75 years). The study population was randomly allocated in equal proportions into two groups using an interactive web response system (IWRS). Group 1 (Artneo) consisted of 106 patients who took one capsule of the drug once daily for 180 days. Group 2 (Placebo) also had 106 patients, with the dosage form and regimen identical to Group 1. During the treatment period, the following outcomes were assessed: WOMAC index, KOOS, pain according to VAS, quality of life using the EQ-5D questionnaire, and the need for NSAIDs. All patients underwent a clinical blood test, general urine analysis, biochemical blood test, and ultrasound examination of the affected knee joint. Results. In a prospective, double-blind, placebo-controlled, randomized study, it was demonstrated that the Artneo combination, containing undenatured chicken collagen type II, has a positive effect on all clinical manifestations of OA: it effectively reduces pain, stiffness, and improves the functional state of joints and quality of life. It has a good safety profile and is superior to placebo in all parameters studied. Conclusion. The results of the study confirm the good effectiveness and safety of the Artneo combination in patients with OA of the knee joints.

Aim. To evaluate the relationship of hypercholesterolemia (HCE) with clinical, instrumental, and laboratory parameters in osteoarthritis (OA) in a multicenter, cross-sectional study. Materials and methods. The study included 183 patients aged 40–75 years, with a confirmed diagnosis of stage I–III OA (ACR) of the knee joints, who signed an informed consent. The mean age was 55.6±10.7 years (40 to 75), body mass index was 29.3±6.3 kg/m2, and disease duration was 5 [1; 10] years. For each patient, a case record form was filled out, including anthropometric indicators, medical history, clinical examination data, an assessment of knee joint pain according to VAS, WOMAC, KOOS and comorbidities. All patients underwent standard radiography and ultrasound examination of the knee joints and laboratory tests. Results. HCE was detected in 59% of patients. Depending on its presence or absence, patients were divided into two groups. Patients were comparable in body mass index, waist and hip measurement, and disease duration but differed significantly in age. Individuals with elevated total cholesterol levels had higher VAS pain scores, total WOMAC and its components, an overall assessment of the patient's health, a worse KOOS index, and ultrasound findings (reduced cartilage tissue). HCE patients showed high levels of cholesterol, low-density lipoproteins, triglycerides, STX-II, and COMP (p0.05). However, after stratification by age, many initial intergroup differences became insignificant, and differences in the WOMAC pain score persisted. Conclusion. The results of the study confirmed the high prevalence of HCE in OA patients (59%). Patients with OA and increased total cholesterol have more intense pain in the knee joints.

Objective: to analyze the extent of analgesic effect and to determine predictors of inadequate response to local therapy with non-steroidal antiinflammatory drugs (NSAIDs) in a prospective, comparative, randomized trial of the efficacy and safety of Artoxan® gel 1% versus Diclofenac gel 1% in patients with knee OA.Material and methods. The study included 60 patients with a definite diagnosis of stage II–III Kеllgren–Lawrence knee OA who fulfilled ACR criteria and were observed on an outpatient basis in V.A. Nasonova Research Institute of Rheumatology. Patients were 40–80 years old (mean 62.50±8.04 years), body mass index (BMI) 24.9±4.67 kg/m2 , median OA duration 5.7 [3;15] years. According to the randomization scheme, the patients were divided into two groups. In the 1st group (n=30), local therapy with 1% Artoxan gel was applied to the target area of the knee twice daily for 14 days. Patients in the 2nd group (n=30) were prescribed local therapy with the comparator drug, 1% Diclofenac gel with a similar application regimen. Patients in both groups were comparable in terms of the main parameters.Results and discussion. Patients in both groups showed a significant decrease in pain intensity in the target joint during walking according to the visual analogue scale (VAS) after two weeks of treatment (p <0.05). A decrease in pain (to mild or moderate) in the target joint to <40 mm according to VAS after 7 days of therapy reported 43.3% of patients in the 1st group, and 63.3% of patients after 14 days of therapy (p=0.09). In the 2nd group, 43.3 % of patients also reported a reduction in pain in the target joint to <40 mm according to VAS after 7 days of therapy, and after 14 days it was observed in 56.7% of cases (p=0.22). Although the differences between the groups did not reach statistical significance, a reduction in pain to <40 mm according to VAS and a high BMI (r= -0.28; p=0.029).Conclusion. The results of the study demonstrate a significant analgesic effect of local NSAIDs in knee OA. In most patients, pain was <40 mm according to VAS after 2 weeks of local NSAID therapy. At the same time, there was a tendency towards a higher frequency of pain reduction to <40 mm according to VAS in the group receiving local therapy with 1% Artoxan gel. It was concluded that excessive body weight and high BMI may be predictors of inadequate analgesic effect in patients with knee OA.

Objective: to investigate in a multicentre single-stage study the relationships between hyperuricemia (HU) and clinical, instrumental and laboratory parameters of osteoarthritis (OA).Material and methods. The study included 200 patients aged 40 to 75 years with a definite diagnosis of knee (KN) OA that met ACR criteria, with stage I–III OA by Kellgren–Lawrence. The mean age of the patients was 55.9±10.3 years and the body mass index (BMI) was 29.4±6.2 kg/m2. An individual chart was completed for each patient, including anthropometric parameters, medical history and clinical examination data, visual analogue scale (VAS) assessment of KN pain, WOMAC, patient's general health assessment (GHA) and information on comorbidities. All patients underwent standard radiography and magnetic resonance imaging (MRI) of the KN (WORMS), dual-energy X-ray absorptiometry of the lumbar spine and femoral neck, and laboratory examination.Results and discussion. HU was diagnosed in 57 (28.5) patients when the serum uric acid (UA) level was above 360 μmol/L. Patients were divided into two groups according to the presence or absence of HU. The age of the patients in the two groups was comparable, but they differed significantly in terms of disease duration, BMI, waist and hip circumference, which were greater in the HU group (p <0.05). Statistically significant differences were also found in the assessment of the severity of OA course: there were higher pain indices according to VAS, WOMAC total score and its components (pain and functional impairment, FI), GHA in the HU group. On MRI, osteitis was more common in the medial aspect of the tibia (odds ratio 5.75; 95% confidence interval 1.29–25.6; p=0.03). Patients with HU had higher concentrations of CRP, COMP, leptin, insulin, triglycerides and creatinine (p <0.05 for all values).Spearman correlation analysis confirmed the association between HU and duration and radiological stage of OA, the presence of osteitis in the medial aspect of tibia detected by MRI, pain according to VAS and WOMAC, FI according to WOMAC and GHA (p<0.05).Conclusion. At high UA levels, pain values according to VAS and WOMAC are higher, GHA is worse, and CRP and COMP levels are elevated. MRI shows more frequent osteitis in the medial aspect of the tibia in patients with HU. Deciphering the mechanisms that determine the relationship between HU and OA is important for the development of new methods for the prevention and treatment of these diseases.

Objective: to investigate in a multicenter study relationship between type 2 diabetes mellitus (DM) and clinical manifestations of osteoarthritis (OA). Material and methods. The study involved 767 patients aged 40–75 years with a confirmed diagnosis of stage I–III knee OA who had signed an informed consent form. The mean age of patients was 57.9±9.6 years, body mass index (BMI) was 30.8±6.4 kg/m2 and median duration of disease was 5 [2; 11] years. An individual record card was filled out for each patient, it contained anthropometric parameters, medical history and clinical examination data, knee pain assessment using a visual analogue scale (VAS), WOMAC, parameters of KOOS questionnaire and patient's global assessment of health. Results and discussion. DM was detected in 17.2% of cases. Patients were categorized into two groups according to the presence or absence of DM. In the presence of DM, more severe clinical manifestations of OA were noted. However, patients with DM were older, had higher BMI values, longer disease duration and were more frequently diagnosed with radiological stage III OA. After stratification by age and disease duration, individuals with DM retained worse pain scores according to VAS compared to patients without DM (median 51.5 [41.5; 70] mm versus 36 [25; 50] mm, p=0.049), total WOMAC index (1047.5 [792; 1260] mm versus 823 [536; 1145] mm; p=0.005) and its components (pain – 200 [160; 254] mm versus 155 [108; 230] mm, p=0.002; stiffness – 90 [50; 115] mm versus 60.5 [35; 100] mm, p=0.03; functional impairment – 765 [550; 918] mm versus 595 [350; 820] mm, p=0.009). Conclusion. Type 2 DM is common in patients with OA (in 17.2% of cases) and is associated with more severe clinical manifestations: greater pain intensity according to VAS and higher WOMAC scores (total index and its components).

The interdisciplinary council of leading experts has presented recommendations for the effective and safe use of non-steroidal anti-inflammatory drugs in osteoarthritis and non-specific back pain in general outpatient practice.