scholarly journals USE OF GENETICALLY ENGINEERED BIOLOGICAL DRUGS FOR RHEUMATOID ARTHRITIS IN THE RUSSIAN FEDERATION

2012 ◽  
Vol 0 (6) ◽  
pp. 10
Author(s):  
Rimma Mikhailovna Balabanova ◽  
V N Amirdzhanova ◽  
E L Nasonov
Keyword(s):  
Rheumatoid Arthritis ◽  
Russian Federation ◽  
Genetically Engineered ◽  
Biological Drugs ◽  
The Russian Federation

scholarly journals The use of biosimilars as a new approach to the treatment of rheumatoid arthritis

2021 ◽  
pp. 112-121
Author(s):  
N. V. Chichasova ◽  
A. M. Lila
Keyword(s):  
Rheumatoid Arthritis ◽  
Russian Federation ◽  
Clinical Effectiveness ◽  
Study Data ◽  
Inadequate Response ◽  
Triple Combination ◽  
Biological Drugs ◽  
Double Blind ◽  
The Russian Federation ◽  
Hands And Feet

The article discusses various options for the management of patients with rheumatoid arthritis (RA) in accordance with modern foreign and domestic recommendations. Data on the possibility of achieving an effect on the background of monotherapy with methotrexate (MT) are presented and options for more active therapy are discussed. The authors compare the effectiveness of sequential change of basic anti-inflammatory drugs (DMARDs), sequential addition of DMARDs to MT, treatment with a triple combination of DMARDs with an inadequate response to MT or in the debut of therapy, combination of DMARDs and biological drugs. According to the study data, in cohorts of patients with equal clinical effectiveness of the triple combination of DMARDs and the combination of DMARDs with biological drugs, however, the severity of the progression of destruction in the joints of the hands and feet is less when using biological agents. It was noted that the evaluation of the effectiveness of the double / triple combination of DMARDs was carried out in open observational studies, which has less evidence value than randomized controlled double-blind placebo-controlled trials (RCTs) for the assessment of biological drugs. Despite the importance of implementing biological drugs in clinical practice, their high cost limits their use by patients. Registration in the Russian Federation of the first biosimilar of etanercept (ETN) - the drug Erelzi is important for the treatment of patients with RA. The article describes the advantages of original ETN (tumor necrosis factor ainhibitor - iFNO a) over other iFNO a, which are monoclonal antibodies to this cytokine. The article presents data on the equivalence of the ETN biosimilar registered in the Russian Federation (Erelzi) with the original ETN in terms of clinical efficacy, safety and immunogenicity. The comparability of drugs in terms of the frequency of adverse events was demonstrated. It is shown that switching from the original ETN to its biosimilar allows you to maintain the effect, not accompanied by an increase in the frequency of intolerance or immunogenicity. It is indicated that Erelzi is registered in the Russian Federation for the treatment of RA, various variants of axial spondylitis, psoriatic arthritis, psoriasis and juvenile idiopathic arthritis.

scholarly journals THU0206 А VERY EARLY (7-28 DAYS) RESPONSE ON JAK INHIBITOR TOFACITINIB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: EFFECT ON PAIN AND CENTRAL SENSITIZATION.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 327.3-327
Author(s):  
A. Karateev ◽  
E. Filatova ◽  
E. Pogozheva ◽  
V. Amirdzhanova ◽  
E. Nasonov ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Central Sensitization ◽  
Early Time ◽  
National Registry ◽  
Genetically Engineered ◽  
Pain Severity ◽  
Signal Pathways ◽  
Jak Inhibitor ◽  
Jak Inhibitors ◽  
Biological Drugs

Background:The presence of central sensitization (CS) significantly burdens the course of rheumatoid arthritis (RA). JAK inhibitors block intracellular signal pathways including the ones responsible for synthesis of mediators and cytokines causing pain and CS. The application of JAK inhibitors is supposed to relieve pain and reduce CS severity promptly.Objectives:To evaluate JAK inhibitor effect on pain and signs of CS in patients with active RA 7 and 28 days after the start of therapy.Methods:Study group included 39 patients with RA, their age was 50.9±11.1, 79.5% of women, 89.7% of RF “+”, DAS28 5.8±0.6, receiving DMARDs (methotrexate 82.0% and leflunomide 18.0%), who were administered with tofacitinib 5 mg 2 times a day due to inefficiency or intolerance of genetically engineered biological drugs. There were assessed the pain severity using Brief pain inventory (BPI) questionnaire, the presence of neuropathic pain component (NPC) using PainDETECT questionnaire and signs of CS using Central Sensitisation Inventory (CSI) questionnaire at early time after tofacitinib administration.Results:Patients initially experienced a severe pain – 5.72±2.21 according to the visual analogue scale (VAS), 53.8% had signs of central sensitization (CSI ≥ 40), 17.9% had NPC (PainDETECT ≥18). 7 days after tofacitinib intake there was statistically reliable reduction of pain severity – up to 4.37±2.2 (р=0.01), pain decrease of 29.4±17.9% (BPI), NCP – PainDETECT from 12.9±5.5 to 10.6±5.6 (р=0.047) and CS – CSI from 43.1±12.8 to 35.9±11.2 (р=0.01). The effect had increased after 28 days: pain level (VAS) was 2.84±1.57 (р=0.000), pain decrease of 43.6±29.6% (BPI), PainDETECT 29.8±12.4 (р=0.000), CSI 26.4±13.9 (р=0.000).During this period there were no serious adverse reactions.Conclusion:The application of JAK inhibitor tofacitinib allows to reach a fast analgesic effect, also due to impact on CS and NCP.Source: National Registry patients with RADisclosure of Interests: :Andrey Karateev: None declared, Ekaterina Filatova: None declared, Elena Pogozheva: None declared, Vera Amirdzhanova: None declared, Evgeny Nasonov: None declared, Alexander Lila: None declared, V Mazurov: None declared, N Lapkina: None declared, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Tatiana Salnikova: None declared, Ruzana Samigullina: None declared, Diana Chakieva: None declared, Irina Marusenko: None declared, Olga Semagina: None declared, Marina Semchenkova: None declared

scholarly journals RHEUMATOID ARTHRITIS IN THE RUSSIAN FEDERATION ACCORDING TO RUSSIAN ARTHRITIS REGISTRY DATA (COMMUNICATION I)

2016 ◽  
Vol 54 ◽  
pp. 50-62
Author(s):  
E. L. Nasonov ◽  
D. E. Karateev ◽  
A. M. Satybaldyev ◽  
E. L. Luchikhina ◽  
G. V. Lukina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Russian Federation ◽  
Data Communication ◽  
Registry Data ◽  
The Russian Federation

scholarly journals RHEUMATOID ARTHRITIS IN THE RUSSIAN FEDERATION ACCORDING TO RUSSIAN ARTHRITIS REGISTRY DATA (COMMUNICATION I)

2015 ◽  
Vol 53 (5) ◽  
pp. 472-484 ◽  
Author(s):  
E. L. Nasonov ◽  
D. E. Karateev ◽  
A. M. Satybaldyev ◽  
E. L. Luchikhina ◽  
G. V. Lukina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Russian Federation ◽  
Data Communication ◽  
Registry Data ◽  
The Russian Federation

scholarly journals Rheumatoid arthritis in the Russian Federation: sociological aspekts

2019 ◽  
Vol 14 (2) ◽  
Author(s):  
Andrey Reshetnikov ◽  
Nadejda Prisyazhnaya ◽  
Sergey Pavlov ◽  
Nadejda Vyatkina ◽  
Elena Marochkina
Keyword(s):  
Rheumatoid Arthritis ◽  
Russian Federation ◽  
The Russian Federation

Possibilities of personalized approach to genetically engineered biological therapy of rheumatoid arthritis

2021 ◽  
pp. 35-40
Author(s):  
L. N. Shilova ◽  
S. S. Spitsina
Keyword(s):  
Rheumatoid Arthritis ◽  
Biological Therapy ◽  
Predictive Biomarkers ◽  
Empirical Therapy ◽  
Pathological Process ◽  
Genetically Engineered ◽  
Patient Centered ◽  
Biological Drugs ◽  
Potential Association ◽  
Personalized Approach

Rheumatoid arthritis is the most common rheumatic disease characterized by damage to the synovium, progressive destruction of cartilage and bone tissue. As a result of the establishment of the biological role of cytokines, it became possible to intervene in the main links of the pathogenesis of the disease, which led to inhibition of the main pathological process in RA – autoimmune inflammation.The aim. To consider the possibilities of optimizing the biological therapy of rheumatoid arthritis by identifying predictors of anti-inflammatory efficacy among clinical and laboratory markers.Basic provisions. Despite the success of genetically engineered biological drugs in the treatment of inflammatory arthritis, due to the lack of predictive biomarkers, the use of a trial and error approach, empirical therapy, is inevitable, which does not always lead to satisfactory results. The study of the main biomarkers of RA provides new insights into their potential association with various clinical phenotypes.Conclusion. This patient-centered approach offers the prospect of improving treatment outcomes through the use of specific drugs in certain patient groups.

scholarly journals Pilot Project «All-Russian Registry of Patients with Severe Bronchial Asthma.» The First Results in a Children’s Group of Patients (Moscow’s Observation Program)

2017 ◽  
Vol 14 (2) ◽  
pp. 80-86 ◽  
Author(s):  
Leyla S. Namazova-Baranova ◽  
Elena A. Vishneva ◽  
Elena Dobrynina ◽  
Anna A. Alekseeva ◽  
Andrey S. Belevskiy ◽  
...  
Keyword(s):  
Bronchial Asthma ◽  
Russian Federation ◽  
Professional Associations ◽  
Pilot Project ◽  
Genetically Engineered ◽  
Federal State ◽  
Public Organization ◽  
Observation Program ◽  
First Results ◽  
The Russian Federation

The article presents the first results of the pilot observation program «The All-Russian Severe Asthma Patient Registry» which was started in Moscow. Objectives. The objective of this initiative is the accumulation of clinical data on patients with severe bronchial asthma in the Russian Federation. Methods. The chosen method was a registry, the rights holders of which were 3 professional associations — Interregional Public Organization «Russian Respiratory Society», Public Organization «Union of Pediatricians of Russia», All-Russian Public Organization «Association of Allergologists and Clinical Immunologists». Results. The results of the pilot project are presented by the data analysis of electronic case report forms of 36 children (totally, the project included 100 patients, 64 adults and 36 children) enrolled in the program from June to December 2016. Using the registry, a detailed analysis of the clinical characteristics of a group of children with severe atopic bronchial asthma was carried out, the results of a pharmacoepidemiological evaluation of therapy were given. Obtained by the researchers, a high frequency of the assignment of a genetically engineered biologic drug of omalizumab meets the international recommendations but does not reflect the all-Russian reality and can be explained by inclusion in the registry of pediatric patients observed only in the Federal State Autonomous Institution «National Scientific and Practical Center of Children’s Health» of the Ministry of Health of the Russian Federation. Conclusion. To determine true indicators that characterize bronchial asthma in children in the Russian Federation it is necessary, undoubtedly, to expand the geography of project participants.

Selected problems in the use of genetic engineering biological therapy in patients with rheumatoid arthritis

2021 ◽  
Vol 6 (4) ◽  
pp. 36-39
Author(s):  
K. Leonova
Keyword(s):  
Rheumatoid Arthritis ◽  
Biological Therapy ◽  
Pharmacological Therapy ◽  
Genetically Engineered ◽  
Biological Drugs ◽  
Inflammatory Drugs ◽  
The Moment ◽  
Attending Physician

Rheumatoid arthritis, like any chronic non-infectious disease, requires constant pharmacological therapy and monitoring of treatment. To relieve exacerbation, maintain long-term remission and improve the quality of life of patients, basic anti-inflammatory drugs are used, which have passed many years of testing for efficacy and safety and are available for patients. But there is a group of drugs that have appeared relatively recently - genetically engineered biological drugs. At the moment, their use is somewhat limited due to the presence of a number of problems. With the accumulation of data on the study of the safety of genetically engineered drugs in the treatment of rheumatoid arthritis, it will be possible to solve many practical issues that arise in the attending physician during the supervision of patients.

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