Introduction The objective of this study was to demonstrate that BCD-057 is similar to innovator adalimumab (iADA) in terms of efficacy, safety, and pharmacokinetics in steady state in the target population of patients with moderate to severe plaque psoriasis (NCT02762955). Methods Patients were randomized in 1:1 ratio to receive 80 mg of BCD-057 or iADA at week 0 and 40 mg thereafter every other week from week 1. At week 24 patients from iADA group were re-randomized (1:1) to continue iADA or to be switched to BCD-057. The primary efficacy endpoint was 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75), secondary endpoints included PASI percent improvement and relative change in affected Body Surface Area (BSA) from baseline at weeks 16, 24, 33, and 55. Safety was assessed through monitoring of adverse events (AEs) and antidrug antibodies. Pharmacokinetics was evaluated at steady state. Results Overall, 346 adult patients were included in the study (174/172 patients in BCD-057/iADA arms, respectively). At week 16 PASI 75 was achieved by 60.34% and 63.37% of patients in BCD-057 and iADA arms, respectively (p = 0.5622). Bounds of the calculated 95% confidence interval (CI) for the difference between PASI 75 responses in arms [-13.26%; 7.2%] fall within the equivalence margin [-15% to 15%] demonstrating equivalent efficacy of BCD-057 and iADA. At week 55 81.61%, 85.56%, and 80.49% of patients in BCD-057, iADA and iADA/BCD-057 arms achieved PASI 75. Comparison of the secondary endpoints did not show significant differences between arms. A comparable pharmacokinetics was shown at steady state. Safety profiles and proportions of patients with antidrug antibodies were similar between arms. The switch from the iADA to BCD-057 did not affect the immunogenicity profile. Conclusion Obtained data demonstrate that BCD-057 and iADA are highly similar in clinical efficacy, pharmacokinetics, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

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The article describes a case of late diagnostics of tertiary syphilis affecting the musculoskeletal system in a patient who was under long-term supervision with a district general practitioner and who was diagnosed with thrombophlebitis. The diagnosis was verified only after the autotomy of the right lower leg

BACKGROUND: Since the beginning of the pandemic of a new coronavirus infection, preventive measures aimed at combating the spread of the pathogen, preventing the development of severe forms of infection and deaths have been improved. Despite the absence of a legally established generally accepted post-vaccination protective value of antibodies to coronavirus, the study of the presence of antibodies and the determination of their amount in the blood serum of the vaccinated population continues. AIM: The aim of the study is to present the results of the study of humoral immunity to SARS COV-2 in medical organizations. MATERIALS AND METHODS: The study involved employees of medical organizations of the State Autonomous Health Institution "Republican Clinical Dermatovenerologic Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor A.G. Ge" in Kazan and the State Autonomous Health Institution "City Polyclinic No. 3" in Naberezhnye Chelny in the number of 393 people who were vaccinated with the two-component vaccine GamCovidVac (Sputnik V), after which a sufficient amount of time has passed for the formation of an immune response: more than 21 days. The blood sera of 393 people (including 350 women) were examined for the determination of specific IgG to SARS-CoV-2 by enzyme immunoassay using the Vector-Best kit (Novosibirsk, Russia). Statistical analysis was carried out using the StatTech v. 2.8.8 (developer - Stattech LLC, Russia). RESULTS: The median of the age of the subjects was 47 years (Q1 - Q3:39-59). The mean antibody titer level was 570 BAU/ml (Q1 Q3:128-1150). A correlation analysis of the relationship between titer levels and age at the time of vaccination was performed, according to the results of which a weak direct relationship was established, and when assessing the dependence of antibody titer levels on the duration of vaccination after the second component at the time of checking the titers, there was no connection. CONCLUSIONS: The ongoing pandemic of a new coronavirus infection with the emergence of new forms of the disease caused by other strains of the virus, the improvement of prevention methods, requires constant monitoring of the epidemiological situation with the study of the effectiveness of vaccines, including at the cellular level.

The paper gives the results of the phase III clinical trial of adalimumab (ADA) biosimilar, (BCD-057) (BIOCAD, Russia), which demonstrate the clinical equivalence of the biosimilar to the ADA innovator Humira® in patients with moderate and severe psoriasis.Objective. The BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial of the efficacy and safety of BCD-057 (International Nonproprietary Name (INN): adalimumab, ZAO «BIOCARD», Russia) versus Himura® (INN: adalimumab (OOO «Abbvie») in patients with plaque psoriasis aims to prove the equivalent pharmacokinetics, efficacy, safety, and immunogenicity of these medicines in both direct parallel comparison and subsequent switching from innovator to biosimilar.Patients and methods. The investigation enrolled 346 adult patients diagnosed with moderate to severe plaque psoriasis lasting at least 6 months. After screening, the patients were randomized in a 1:1 ratio into BCD-057 or Humira® groups. At week 24, the patients taking Humira® were re-randomized 1:1 into a group to continue treatment with the ADA innovator or into that to switch to BCD-057. The primary efficacy endpoint was to estimate the proportion of patients who had achieved a 75% improvement in Psoriasis Area and Severity Index (PASI75) at week 16. The secondary endpoints included the assessment of the time course of changes in the skin, nails, degree of itching, and quality of life at weeks 16 and 24. Safety was evaluated from the incidence of treatment-associated adverse events (AEs), cases of severe toxicity (grades 3–4 AEs according to the Common Terminology Criteria Adverse Event (CTCAE) 4.03), cases of early patient withdrawal due to AEs, as well as cases of toxicity potentially associated with the use of tumor necrosis factor-α inhibitors. Immunogenicity was determined using the validated test of patient serum samples for binding antibodies (BAb) and neutralizing antibodies.Results and discussion. The per-protocol population for efficacy evaluation included 342 patients. At week 16, the primary endpoint of PASI75 was shown to be achieved by 62.5% (105/168) and 66.46% (109/164) of the patients in the BCD-057 and Himura® groups, respectively; p=0.45). The difference between the groups in PASI75 responses was 3.22% with 95% confidence interval [-14.25%; 6.32%]. The analysis of additional endpoints revealed no significant differences in the efficacy of the biosimilar and innovator. During 24 weeks of the investigation, treatment-associated AEs were recorded in 31.03 and 25.58% of the patients in the BCD-057 and Humira® groups, respectively (p=0.31). The proportion of patients with BAb detected at 16 weeks of the investigation was 25.44 and 24.07% in the BCD-057 and Humira® groups, respectively (p=0.87).Conclusion. The investigation provided convincing clinical evidence for of the equivalent efficacy, safety, and immunogenicity of BCD-057 and Humira®.