The level of TNFα and IL6 in the blood plasma of patients with rheumatoid arthritis (RA) who received antiinflammatory therapy with methotrexate (MT) was significantly lower than in the patients without MT treatment. The level of caspase 6 and 9 gene transcripts in peripheral blood lymphocytes in patients with rheumatoid arthritic diagnosed for the first time and in patients with MT treatment were not significantly different. At the same time, the level of caspase 3 mRNA expression was significantly higher in the cells of the RA patients with MT therapy compared to the patients without MT therapy.
The emergence of new means of administering genetically-engineered biological drugs, such as an autoinjector (pen injector device), can positively affect the organizational aspects of treating patients with severe eosinophilic asthma (SA) who need biological therapy.The aim. To determine the place of a new delivery device for benralizumab (autoinjector, pen injector device) in the clinical practice of treating eosinophilic SA.Results. The expert council considered the results of the latest clinical studies and real practice data on the use of genetically-engineered biological drugs in the form of an autoinjector. The experts discussed the safety and efficacy of this delivery device and recommended considering the possibility of switching eosinophilic SA patients to self-administration of genetically-engineered biological drugs (autoinjector form) at home. This treatment tactic is especially relevant in the current epidemiological situation since it will reduce the risks of infection compared to planned medical care in inpatient or outpatient treatment settings and reduce the burden for healthcare workers.Conclusion. The practice of switching eosinophilic SA patients to self-administration of biologics in the form of an autoinjector (pen injector device) can improve the adherence to biological therapy and quality of life of this group of patients.
The Russian biotechnological company «BIOCAD» has designed a chimeric monoclonal antibody against CD20 (BCD-020, Acellbia®) that is a biosimilar of rituximab (RTM; MabThera®, F. Hoffmann-La Roche Ltd., Switzerland). In recent years, there has been evidence that RTM can be used at lower doses than those given in the standard recommendations and instructions for the use of this drug. This serves as the basis for the BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis) trial, the objective of which was to investigate the efficiency and safety of using Acellbia® (at a dose of 600 mg twice at a 2-week interval) as the first biological agent (BA) for methotrexate (MTX)-resistant active rheumatoid arthritis (RA). The investigation enrolled 159 patients aged 18 to 80 years with active RA. After 24 weeks 65.7 and 29.4% of patients achieved 20% improvement by the American College of Rheumatology (ACR) criteria in the Acellbia® + MTX and placebo (PL) + MTX groups, respectively (p<0.0001). The differences in the ACR20 response rate in the two groups were 36.3% (95% CI, 19.27–53.28%). There were significant differences between the groups in the ACR50 response rates: 28.4% and 5.9% (p=0.001) and in the ACR70 ones: 12.8% and only 2.0%, respectively (p=0.036). Analysis of all recorded adverse events (AE) frequency showed no significant differences between the patients in the study and control groups and demonstrates its equivalence with that of RTM (MabThera®); all the AE were expectable. It is noted that antibodies to RTM with binding and neutralizing activities had no impact on the efficiency and safety of therapy.
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