Sovremennaâ Revmatologiâ最新文献

{"title":"Urate-lowering therapy and the risk of developing type 2 diabetes mellitus in patients with gout (results of a prospective study)","authors":"M. S. Eliseev, O. V. Zhelyabina","doi":"10.14412/1996-7012-2023-5-73-78","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-73-78","url":null,"abstract":"Objective: to analyze the association between medications intake and the development of type 2 diabetes mellitus (T2DM) in patients with gout. Material and methods. The study included 444 patients with gout without T2DM. The median follow-up time was 5.9 [2.9; 8.7] years. The primary end point was the diagnosis of T2DM. At baseline, therapy was initiated or adjusted according to current guidelines. Medication use was recorded: allopurinol, febuxostat, diuretics, glucocorticoids (GC), canakinumab, for which the odds ratio (OR) of developing T2DM was calculated. Results and discussion. T2DM occurred in 108 (24.3 %) patients enrolled in the study. 405 patients completed the study. 311 (76.7 %) patients were taking urate-lowering drugs: 263 (90.7 %) allopurinol, 48 (9.3 %) febuxostat. The mean dose of allopurinol was 153.4 ± 28.4 mg/day, and that of febuxostat was 91.6 ± 12.1 mg/day. During treatment with febuxostat, the probability of developing T2DM was lower: OR 0.433 (95 % confidence interval, CI 0.188–0.996; p = 0.044). When diuretics were used OR was 2.212 (95 % CI 1.303–3.753; p = 0.003), GC – 1.566 (95 % CI 1.003–2.445; p = 0.048). Conclusion. Febuxostat use is associated with a lower likelihood of developing T2DM.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"46 2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136038239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Results of a clinical study of Traumeel® S and Zeel® T in patients with knee osteoarthritis and concomitant cardiovascular disease","authors":"L. I. Alekseeva, V. I. Mazurov, E. V. Zonova, O. B. Ershova, O. V. Reshetko","doi":"10.14412/1996-7012-2023-5-79-86","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-79-86","url":null,"abstract":"Objective: to evaluate the efficacy and safety of simultaneous intramuscular administration of Traumeel® S and Zeel® T followed by therapy with the tablet medication Zeel® T in patients with knee osteoarthritis (OA) and concomitant cardiovascular diseases. Material and methods. The analysis included 119 patients aged 45–79 years (78.2 % women and 21.8 % men) with confirmed diagnosis of knee OA according to Altman criteria, stage II–III according to Kellgren–Lawrence and confirmed cardiovascular disease. The main indicator of efficacy was the change in pain intensity in the target knee joint according to the “Pain” subscale of the WOMAC questionnaire (A) at the final examination compared to the baseline. Other criteria were the dynamics of each symptom of knee OA according to the WOMAC questionnaire (pain, stiffness, and functional impairment, total score) on each visit, pain intensity in the target joint on a visual analogue scale (VAS), time it takes to travel 15 m, and the patient's overall disease assessment on the VAS. In addition, duration of use and dose of paracetamol (if used) were assessed, as well as quality of life by EuroQol and adverse events (AEs). Treatment safety was also analyzed in patients who had received at least one dose of the study drug. Results and discussion. WOMAC pain intensity decreased by on average of 3.8 points: from 7.6 to 3.8 points (95 % confidence interval, CI from -4.3 to -3.3). Data on changes in knee OA symptoms (pain, stiffness, and functional impairment) for each WOMAC subscale and the total score showed significant improvement at each follow-up visit (p < 0.0001). The VAS pain level decreased by 52%. An improvement in joint function was noted: the time it takes to travel 15 m fell from 19.5 to 16.4 s (p < 0.0001). The EuroQol quality of life score also improved from 57.1 ± 16.2 points at baseline to 71.1 ± 14.8 points on the 84^th day of therapy. Thirty (25.2 %) patients had AEs, mainly neurological: headache (7.6 %) and hypoesthesia (1.7 %). No serious AEs were recorded. An association between AEs and study drug use was noted in 4 patients (headache, hypoesthesia, muscle cramps, and injection site pain). Conclusion. The results of the study confirm the efficacy and safety of the use of Traumeel® S and Zeel® T in patients with knee OA who have concomitant cardiovascular disease. During therapy, a significant decrease in pain and other clinical signs of OA (stiffness, limitation of physical activity) was observed, which allows us to recommend this treatment regimen for patients with comorbid pathology, as well as with the risk of developing of AEs during non-steroidal anti-inflammatory drugs therapy.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136038529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical picture of ankylosing spondylitis in HLA-B27 positive and negative patients","authors":"Sh. F. Erdes, K. V. Sakharova","doi":"10.14412/1996-7012-2023-5-61-66","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-61-66","url":null,"abstract":"The link between the HLA-B27 gene and ankylosing spondylitis (AS) has been known for almost 50 years. During this time, it has been discovered that some of the clinical manifestations of the disease are uniformly associated with the disease in almost all populations, while the other part depends on the ethnicity of the patients. Unique associations characteristic only of certain ethnic groups are also periodically described. Objective: to analyze the clinical features of the inpatient population with AS in relation to their HLA-B27 status. Material and methods. Cross sectional study of 200 consecutive AS patients admitted to the rheumatology department of the V.A. Nasonova Research Institute of Rheumatology. All patients underwent standard clinical examination recommended for assessment of AS activity and functional status. The levels of transaminases, uric acid, urea, creatinine, interleukin (IL) 6 and IL17 in blood serum were also examined. Results and discussion. HLA-B27 was detected in 166 (83 %) of 200 patients with AS (in 89.8 % of men and in 73.2 % of women; p = 0.003). Among HLA-B27 positive patients with AS, 63.9 % were men, and among HLA-B27 negative patients, 35.3 % were men (p = 0.002). The mean age of AS onset was 5 years higher in HLA-B27-negative patients, and the disease was about 2 times less likely to occur in childhood in them. Syndesmophytes were detected in 25 % of HLA-B27 positive patients and in 15 % of patients who did not have this antigen (p &gt; 0.05). Syndesmophytes were found in 31.1 % of HLA-B27 positive and 25 % of HLA-B27 negative men. 15 % of women with HLA-B27 and 9 % of women without this antigen had syndesmophytes (p = 0.022). Inflammatory bowel disease was more common in HLA-B27-negative patients, whereas uveitis and psoriasis were less common. Activity rates and incidence of arthritis and enthesitis were similar in HLA-B27 positive and negative patients. Serum concentration of IL17 was six times higher in HLA-B27 negative patients than in HLA-B27 positive patients (p = 0.012). Conclusion. In the Russia’s AS patient population there are associations with HLA-B27, characteristic for most ethnic groups (e. g., earlier onset of the disease) and associations not found in all ethnic groups (e. g., a more severe course, a higher incidence of arthritis and enthesitis). In addition, the concentration of IL17 in the blood serum of HLA-B27 negative patients was six times higher than that of HLA-B27 positive patients. This may indicate non-canonical mechanisms of pathogenesis of AS that develop in the absence of the HLA-B27 gene, which requires further research.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136037635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term results of therapy with sequential use of rituximab and belimumab in patients with systemic lupus erythematosus","authors":"S. K. Solovyev, A. A. Mesnyankina, E. A. Aseeva, N. Yu. Nikishina","doi":"10.14412/1996-7012-2023-5-22-28","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-22-28","url":null,"abstract":"Objective: To evaluate the efficacy of combination therapy with rituximab (RTM) and belimumab (BLM) in patients with systemic lupus erythematosus (SLE) during long-term follow-up. Material and methods. Twelve patients with definite high- and moderate activity SLE were included in the study. Nine of them had skin and joint manifestations, and the others had renal, peripheral nervous system involvement, and vasculitis. Patients received RTM at a dose of 500–2000 mg with premedication with 6-methylprednisolone and then BLM according to the standard regimen of 10 mg/kg once a month. Patients were divided into two groups according to the timing of assessment of long-term outcomes. In the 1 st group, data were evaluated after 7–9 years (n = 4), and in the 2 nd group – after 2–4 years (n = 8) after the prescription of biologic disease-modifying antirheumatic drugs (bDMARDs). Efficacy and tolerability of therapy, SLE activity, and dose of oral glucocorticoids (GC) were evaluated. Results and discussion. Against the background of combination therapy, clinical and immunological response was achieved in 11 of 12 patients after one year (median SLEDAI-2K at baseline – 10 [9.5; 14.5] points, 6 and 12 months after administratrion of BLM – 4 [2; 6] points). When bDMARDs were prescribed in the first two years of the disease, patients responded better to therapy and showed more significant positive dynamics in clinical and laboratory parameters. Subsequently, BLM therapy was limited to an average of 2 years, during which a stable remission was achieved. Prescribing bDMARDs allowed GC to be used as initial therapy in an exacerbation of SLE in medium and low doses (subsequently further reduced). Clinical remission was achieved and maintained in 7 patients, exacerbation at different time points after discontinuation of bDMARDs occurred in 3 patients, efficacy waned in one patient, and no result was achieved with combination therapy in another patient. Conclusion. The most pronounced positive result can be expected when a bDMARDs are prescribed as early as possible after diagnosis of SLE (in the first 2 years of the disease). It is advisable to administer BLM infusions as recommended once a month without long breaks between injections for at least 2 years and to continue until a durable effect is achieved. The use of low-dose GC and its discontinuation is an achievable goal, but careful monitoring of patients is needed to detect early symptoms of exacerbation.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of long-term use of low molecular weight heparins in patients with systemic lupus erythematosus and antiphospholipid syndrome","authors":"N. V. Seredavkina, F. A. Cheldieva, A. A. Shumilova, T. M. Reshetnyak","doi":"10.14412/1996-7012-2023-5-15-21","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-15-21","url":null,"abstract":"To date, the management of patients with antiphospholipid syndrome (APS) with ineffectiveness and/or intolerance to vitamin K antagonists and direct oral anticoagulants remains controversial. One of the treatment strategies is the administration of low molecular weight heparins (LMWH) over a long period of time. Objective: to evaluate the efefficacy and safety of long-term treatment with LMWH in patients with APS. Material and methods. The study included 15 patients (13 women and 2 men) with APS. In 2 of them APS was isolated, in 12 it was combined with systemic lupus erythematosus (SLE), and in 1 – with SLE and psoriatic arthritis. The mean age of patients was 44 ± 12 years, and the mean duration of disease was 12 [6; 18] years. All patients were repeatedly examined in the V. A. Nasonova Research Institute of Rheumatology during hospitalizations and continued outpatient care in the clinical diagnostic center of the Institute. Results and discussion. Ten (67 %) patients received nadroparin, 5 (33 %) patients received enoxaparin. The median duration of therapy was 4 [1; 10] years. Indications for the use of LMWH were inefficacy and intolerance of oral anticoagulants (n = 12, 100 %) and vascular involvement such as thromboangiitis obliterans with the development of chronic arterial insufficiency, ulcers and necrosis of the toes (n = 6, 40 %). During therapy, 13 (86 %) of 15 patients showed clinical improvement: healing of ulcers and necrosis, reduction in the stage of arterial insufficiency, recanalization of venous blood clots. During the entire treatment period with LMWH, one patient experienced a relapse of thrombosis due to an insufficient dose of the drug. No hemorrhagic complications occurred in any case. Other adverse events, including elevated liver aminotransferases, osteoporosis, and thrombocytopenia, were also not observed. Conclusion. The results obtained suggest that long-term therapy with LMWH may be safe and effective in patients with APS.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dance therapy as a method of rehabilitation in rheumatic diseases","authors":"E. V. Matyanova, E. Yu. Polishchuk, O. V. Kondrasheva, A. E. Karateev, A. M. Lila","doi":"10.14412/1996-7012-2023-5-7-14","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-7-14","url":null,"abstract":"A dance is considered from the perspective of art therapy, psychotherapy and kinesiotherapy as a component of therapeutic exercises. Previous experience with dance therapy in various rheumatic diseases is presented, and a theoretical rationale for adapting new dance styles for the purposes of complex non-drug treatment of rheumatologic patients is provided.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamics of global longitudinal strain of the left ventricular myocardium and blood biomarker levels in patients with rheumatoid arthritis treated with biologic disease-modifying antirheumatic drugs or Janus kinase inhibitors","authors":"Yu. N. Gorbunova, I. G. Kirillova, T. V. Popkova, M. E. Diatroptov, T. I. Nevretdinov, A. M. Lila","doi":"10.14412/1996-7012-2023-5-36-42","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-36-42","url":null,"abstract":"Objective: to study the dynamics of global longitudinal myocardial strain (GLS) using echocardiography (speckle tracking method) and blood biomarker levels (NT -proBNP, soluble ST2, sST2) in RA patients against a background of 12 months of therapy with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi). Material and methods. The study included 50 patients with RA (ACR/EULAR criteria, 2010): 84 % were women, median age 51.0 [40.0; 59.0] years, median duration of RA was 4.5 [3.0; 14.0] years, median DAS28 5.7 [5.2; 6.4] points. 78 % of patients were positive for IgM rheumatoid factor, 66 % for antibodies to cyclic citrullinated peptide. At the time of inclusion in the study, 38% of patients were receiving methotrexate, 38 % – leflunomide, 10 % – sulfasalazine, 12 % – hydroxychloroquine, 70 % – glucocorticoids, 82 % – nonsteroidal anti-inflammatory drugs. 60 % of patients with RA had a history of inadequate efficacy of two or more DMARDs. After examination, all patients were prescribed bDMARDs or JAKi. TNF-α inhibitors were given to 38% of patients, anti-B-cell therapy – to 50% of patients, IL-6 inhibitors – to 4%, T-lymphocyte costimulation blockers – to 2 %, JAKi – to 6 % of RA patients. All patients with RA were examined before administration of bDMARDs and in dynamics after 12 months of treatment. Echocardiography was performed – tissue Dopplerography and evaluation by speckle tracking method of left ventricular myocardium GLS (GLD LVM); in blood serum the levels of NT-proBNP, sST2 were determined. The normal range for NT-proBNP was less than 125 pg/ml, and for sST2 less than 17.65 ng/ml. The control group consisted of 20 healthy subjects who were comparable in sex and age. RA patients and subjects in the control group had no cardiovascular disease. Results and discussion. After 12 months of bDMARDs therapy, GLS LVM increased and the frequency of reduced GLS LVM decreased by 47 % (p < 0.05). The indexed end-systolic volume of the left atrium also decreased. RA patients had higher values of NT-proBNP and sST2 compared to the control group (p < 0.05). The variations of NT-proBNP level in blood serum of RA patients after 12 months of therapy were statistically insignificant (p = 0.5). The level of sST2 in the serum of patients with RA decreased significantly after 12 months of therapy compared to baseline (p < 0.01). Direct correlations were found between the delta (Δ) of the level of sST2 and ΔDAS28, the level of ΔsST2 and ΔCRP, and ΔACCP. After 12 months of therapy, RA patients with persistent moderate/high disease activity had higher levels of systolic blood pressure and serum levels of NT-proBNP, lower left ventricular (LV) ejection fraction (LVEF) and GLS LVM than patients who had remission/low RA activity. There were no differences between groups in LVEF, LV size, LV myocardial mass index, and NT-proBNP levels. Negative correlations were observed between ΔGLD LVM and ΔESR and ΔsST2. Conclusion. In pat","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"77 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of IRF5 (rs2004640), STAT4 (rs7574865), and TNFAIP3 (rs6920220, rs2230926) gene polymorphisms with primary Sjögren's syndrome and its complication, MALT-lymphoma","authors":"I. A. Guseva, A. V. Torgashina, J. I. Khvan, M. Yu. Krylov, E. Yu. Samarkina, N. V. Konovalova, D. A. Varlamov","doi":"10.14412/1996-7012-2023-5-29-35","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-5-29-35","url":null,"abstract":"In recent years, more and more data have emerged confirming the contribution of non-HLA genetic markers to the predisposition to thedevelopment of Sjögren's syndrome (SS) and its severe complication, MALT-lymphoma. Objective: to study the association of polymorphisms of IRF5 (rs2004640), STAT4 (rs7574865), and TNFAIP3 (rs6920220, rs2230926) genes with predisposition to the development of SS and MALT-lymphoma. Materials and methods. The study included 80 patients with SS and 103 individuals in the control group. Sixteen patients were diagnosed with MALT-lymphoma. Genotyping of polymorphisms of IRF5 (rs2004640), STAT4 (rs7574865), TNFAIP3 (rs6920220, rs2230926) genes was performed by real-time polymerase chain reaction using original allele-specific probes labeled with different fluorescent labels. Results and discussion. The distribution of genotypes and alleles of the STAT4 gene differed statistically significantly in the study and control groups of patients (p = 0.0005 and p = 0.0001, respectively). The presence of the homozygous TT genotype increased the risk of developing SS more than eightfold compared to TG+GG genotypes (odds ratio, OR=8.2; 95 % confidence interval, CI 2.5–30.0; p=0.0001)]. The polymorphism of the TNFAIP3 rs2230926 gene was also associated with the risk of developing SS: the presence of the TG genotype significantly increased the probability of developing SS compared to the TT genotype (OR 6.4; 95% CI 1.2–44.3; p = 0.01). The development of MALT-lymphoma was associated with the rs6920220 polymorphism of the TNFAIP3 gene. In 10 out of 16 patients with MALT-lymphoma (62.5 %) at least one minor A allele (AA+GA) was detected, while in patients without MALT-lymphoma only in 32.8 % of patients at least one minor A allele was detected (OR=3.4, CI 1.1–10.7; p=0.03). In addition, a correlation was found between the rs7574865 TT genotype of the STAT4 gene and the risk of developing severe leukopenia in SS, which was significantly more frequent in carriers of the TT genotype than in individuals with the GG + GT genotype (OR 4.9; 95 % CI 1.7–14.4; p = 0.004). Polymorphism of the IRF5 gene (rs2004640) was not associated with risk of developing SS or with clinical manifestations of the disease. Conclusion. Polymorphisms rs7574865 of STAT4 gene, rs6920220, rs2230926 of TNFAIP3 gene are associated either with the risk of developing SS or with severe complications of the disease, MALT-lymphoma and leukopenia.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136182335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Olokizumab, a monoclonal antibody against interleukin-6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by tumour necrosis factor inhibitor therapy: efficacy and safety results of a randomised controlled phase III study","authors":"E. Feist, S. Fatenejad, S. Grishin, E. Korneva, M.E. Luggen, E. Nasonov, M. Samsonov, J.S. Smolen, R.M. Fleischmann","doi":"10.14412/1996-7012-2023-2-23-36","DOIUrl":"https://doi.org/10.14412/1996-7012-2023-2-23-36","url":null,"abstract":"Objectives To assess the efficacy and safety of olokizumab (OKZ), a monoclonal antibody against the interleukin-6 (IL-6) cytokine, versus placebo (PBO) in patients with prior inadequate response to tumour necrosis factor inhibitors (TNFi-IRs). Methods In this 24-week multicentre, placebo-controlled, double-blind study, the patients were randomised in a 2:2:1 ratio to receive subcutaneously administered OKZ 64 mg once every 2 weeks (q2w), OKZ 64 mg once every 4 weeks (q4w) or PBO plus methotrexate. At week 16, the patients on PBO were randomised to receive either OKZ regime. The primary endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. Disease Activity Score 28-joint count C-reactive protein (DAS28 (CRP)) <3.2 at week 12 was the major secondary efficacy endpoint. Safety and immunogenicity were assessed. Results In 368 patients randomised, ACR20 response rates were 60.9% in OKZ q2w, 59.6% in OKZ q4w and 40.6% in PBO (p<0.01 for both comparisons). Achievement of DAS28 (CRP) <3.2 was significantly different, favouring the OKZ arms. Improvements in efficacy and patientreported outcomes were maintained throughout 24 weeks and were noted after week 16 in patients who switched from PBO.Dose-related treatment-emergent serious adverse events were 7% in OKZ q2w, 3.2% in OKZ q4w and none in the PBO group. Conclusions Direct inhibition of IL-6 with OKZ resulted in significant improvements in the signs and symptoms of rheumatoid arthritis compared with PBO in TNFi-IR patients with a similar safety profile as observed for monoclonal antibodies to the IL-6 receptor.","PeriodicalId":270571,"journal":{"name":"Sovremennaâ Revmatologiâ","volume":"163 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135415163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}