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

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.

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POPULATION REGISTRIES OF NON-COMMUNICABLE DISEASES IN THE RUSSIAN FEDERATION

Hygiene and Sanitation ◽

10.18821/0016-9900-2019-98-12-1432-1436 ◽

2019 ◽

Vol 98 (12) ◽

pp. 1432-1436

Author(s):

Tatiana N. Unguryanu

Keyword(s):

Russian Federation ◽

Skin Diseases ◽

Epidemiological Studies ◽

Registry Data ◽

Large Sample Size ◽

Confounding Factors ◽

Birth Registry ◽

Organizational Goals ◽

The Russian Federation ◽

Assess Quality

Population registries consolidate information about cases of disease among the geographically limited population at the national, regional or municipal levels. The main tasks of registries are to monitor the levels of prevalence, to study risk factors, and to evaluate effectiveness of therapeutic or preventive measures. Currently, in the Russian Federation there is a lot of federal registries of various such diseases, like diabetes, cancer, congenital malformations, chronic skin diseases, cardiovascular diseases, bronchial asthma, orphan diseases, and others. These registries allow obtaining the necessary information about the prevalence, clinical course of disease, its complications, associated conditions, socio-demographic characteristics of patients, effect of a particular treatment on the course and outcomes of the disease.The article provides information about cancer registry, county birth registry and injury registry in the Arkhangelsk region. The advantages and limitations of population registries for epidemiological studies are given. Using registries in epidemiological studies is based on complete data collection, saving resources, taking into account confounding factors that are accessible to entire population. Register-based research has a large sample size, which makes it possible to study rare exposures and outcomes. The long collection of information in time allows studying diseases with a long latent period after exposure. The limitations of the registry data for epidemiological study include the fact that data is collected by the registrar and not by the researcher. The registries don’t contain information about specific confounding factors, which doesn’t allow correcting them. It is difficult to assess quality of registry data, as there is no “gold standard” for the comparement with the registry database The exchange of data between registries should be promising, as it will combine efforts to achieve common scientific and organizational goals.

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harmacoeconomic feasibility of using the drug upadacitinib in patients with rheumatoid arthritis in the healthcare system of the Russian Federation

Kachestvennaya klinicheskaya praktika ◽

10.37489/2588-0519-2020-3-40-51 ◽

2020 ◽

pp. 40-51

Author(s):

A. M. Lila ◽

S. K. Zyryanov ◽

I. N. Dyakov

Keyword(s):

Rheumatoid Arthritis ◽

Sensitivity Analysis ◽

Healthcare System ◽

Russian Federation ◽

Impact Analysis ◽

Pharmacoeconomic Analysis ◽

Indirect Comparison ◽

Analysis Data ◽

The Russian Federation ◽

The Impact

Aim. To assess the pharmacoeconomic feasibility of including the drug upadacitinib in restrictive lists and government funding programs to provide patients with rheumatoid arthritis.Materials and methods. Study Design — Retrospective Analysisof Literary Data. Pharmacoeconomic analysis methods — indirect comparison, clinical-economic analysis (cost-effectiveness analysis) using sensitivity analysis; budget impact analysis using sensitivity analysis. Data on the effectiveness of the analyzed drugs are taken from publications on clinical studies of the compared drugs; on the cost of drugs — the state register of marginal selling prices, data of the manufacturer’s company.Results. According to the results of indirect comparison, with respect to the frequency of achievement of the DAS28 test (CRP) <2.6, the effectiveness of the preparations tofacitinib and baricitinib does not significantly differ — OR = 1.275 (0.842; 1.931). At the same time, the preparation upadacitinib allows to achieve this indicator reliably more effective than the baricitinib — OR = 1.529 (1.021; 2.292) and tofacitinib — OR = 1.95 (1.285; 2.960). Costs for the use of upadacitinib against the background of methotrexate for 52 weeks will amount to 654 983.88 rubles, and will require 4.7 % less costs than the use of tofacitinib or baricitinib against the background of the use of methotrexate (687 217.53 rubles). In an indirect comparison of upadacitinib-baricitinib through the general comparator adalimumab, the effectiveness of upadacitinib with respect to the frequency of achievement of DAS28-CRP <2.6 turned out to be higher than baricitinib per 32.3 %. With indirect comparison of upadacitinib-tofacitinib under the same conditions, the efficiency of upadacitinib is 57.7 % higher than that of tofacitinib. Analysis of the impact on the budget showed that with the inclusion of the drug upadacitinib in the lists of VED and ONLS and a gradual increase in the proportion of patients, receiving upadacitinib instead of tofacitinib and baricitinib in the 1st year before 15 %, in the 2nd year — 30 %, in the 3rd year — 45 % for the group of 2.318 patients for 3 years, the reduction in the budget burden will be 1.4 % or 62.8 million rubles. With the provision of upadacitinib, 100 % of patients from the first year, the budget burden for 3 years will decrease by 4.7 % or 213.1 million rubles in comparison with the current regime.Conclusion. tte drug upadacitinib at a lower course cost has greater effectiveness in achieving clinical remission according to the indicator DAS28-CRP (<2.6), and therefore its use in the conditions of the healthcare system of the Russian Federation for the treatment of patients with rheumatoid arthritis is pharmacoeconomic and expedient.

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