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Introduction: A number of studies uses severity of lung damage as a predictor of lung changes in the long-term period.Objective: To evaluate computed tomography (CT) findings in the long-term period after extremely severe lung damage (CT-4) caused by COVID-19 during different pandemic waves and compare those with clinical data.Materials and methods: The study included 51 patients (51.0% of them were women; age, 57 ± 12 years [95% CI, 53-60]) that were treated for COVID-19 with lung damage (CT-4) in O.M. Filatov City Clinical Hospital No. 15 (Moscow, Russian Federation) and gave their consent for examination after discharge. The patients underwent chest CT and dyspnea assessment (Medical Research Council [MRC] dyspnea scale) in the long-term period and were grouped based on the pandemic wave and dyspnea grade. Twelve patients from the first pandemic wave were examined 12.5 months after discharge; 13 patients from the second pandemic wave were examined in 6.5 months, and 26 patients from the third pandemic wave were examined in 8 months. The group with MRC dyspnea grade 0 included 19 patients, whereas 32 patients comprised the group with MRC dyspnea grades 1 and 2.Results: CT revealed changes in 50 (98.0%) of the examined patients, with fibrotic-like changes (88.2%), areas of consolidation (47.1%), and ground-glass opacity (13.7%) being the most common findings. All 3 patterns were equally common, regardless of the pandemic wave. No dyspnea higher than MRC grade 2 was observed. Fibrotic-like changes were found in 100.0% of the patients with MRC dyspnea grades 1 and 2, whereas they were detected only in 68.4% of the patients with MRC dyspnea grade 0, P = .002. The multivariate analysis showed that fibrotic-like changes were the only factor associated with dyspnea higher than grade 0.Conclusions: After extremely severe lung damage (CT-4) CT changes were present in almost all the patients. The study results highlight clinical significance of these changes and demonstrate the rehabilitation potential of this group.

The article presents the results of the three-year use of netakimab (NTK) in patients with ankylosing spondylitis (AS) as part of the phase III BCD-085-5/ASTERA study.Objective: to evaluate the long-term efficacy and safety of NTK over a three-year period in patients with active AS.Material and methods. BCD-085-5/ASTERA – double-blind, multicenter, randomized phase III clinical trial that enrolled patients with active AS (BASDAI ≥4) and a back pain intensity ≥4 on a numeric rating scale with inefficacy or intolerance of non-steroidal anti-inflammatory drugs or biologic drugs. A total of 228 patients were randomized in a 1:1 ratio and assigned to either the NTK group or the placebo/NTK group. Starting at week 16, patients who did not achieve ASAS20 (20% improvement according to ASAS criteria) received NTK 120 mg once every 2 weeks in an open-label regimen. Patients who achieved ASAS20 response at week 52 in the NTK group and week 68 in the placebo/NTK group continued to receive NTK (120 mg every 2 weeks) until week 156 in the NTK group and until week 172 in the placebo/NTK group.Results and discussion. Over the course of three years of NTK use, most patients experienced a sustained decline in AS activity (according to ASDAS-CRP, BASDAI) with sustained response (ASAS20/40, ASAS5/6) to therapy. Most adverse events reported were mild to moderate. 36.7% of patients had adverse events, which were mainly laboratory abnormalities, blood and lymphatic system abnormalities and infectious complications.Conclusion. The clinical effect of NTK was maintained in most patients with AS over a three-year period, with no significant loss of response. NTK was well tolerated and the safety profile remained favorable.

The article contains the data obtained during the 156-week follow-up of patients with ankylosing spondylitis (AS) in the ASTERA phase III study.Objective: to evaluate the effect impact of netakimab (NTK) on quality of life (QoL), back pain and work capacity in patients with active AS.Material and methods. The study enrolled 228 patients with active AS who were randomized 1:1 to receive NTK 120 mg or placebo. At week 52, patients in Group 1 (NTK) who achieved ASAS20 continued therapy (NTK at a dose of 120 mg once every 2 weeks) until week 156. Patients in Group 2 (placebo/NTK) received the study drug at a dose of 120 mg subcutaneously every 2 weeks from week 20 until week 68, after which the efficacy of therapy was determined (by achieving an ASAS20 response). Patients who achieved ASAS20 received treatment (NTK at a dose of 120 mg once every 2 weeks) until week 172.Results and discussion. Under NTK therapy, a significant improvement in QoL was observed in the assessment of the physical and psychological components of the SF-36 questionnaire, which was maintained during the three years of therapy: increase in indicator by 12.68±9.92; 13.27±10.14; 12.92±10.03; 14.10±10.35; 14.76±9.77 and 6.10±11.59; 5.50±11.82; 6.32±11.01; 5.87±11.45; 5.25±11.98 points at week 52, 76, 104, 128 and 156, respectively. During the extended therapy period, a reduction in the proportion of working hours missed for health reasons, an improvement in work capacity and work efficiency and an increase in daily activity were observed. Back pain (BASDAI question 2) and nocturnal back pain decreased steadily during the entire follow-up period compared to the screening values.Conclusion. NTK is an effective therapy for active AS that improves QoL scores, significantly reduces pain intensity and improves work productivity.

Relevance. Pentanedioic acid imidazolyl ethanamide (PAIE) has been used clinically as an antiviral agent for a long time, however, there is no information in the available literature concerning the dependence of PAIE pharmacokinetics on isoenzymes polymorphism of the cytochrome P450 system (CYP), as well as on the variability of pharmacokinetic parameters in humans. The aim of the study is to determine the main pharmacokinetic parameters of PAIE in healthy volunteers and to assess the contribution of polymorphism of CYP P450 isoenzymes to the variability of pharmacokinetic parameters.Material and methods. The study included 12 healthy volunteers (5 men and 7 women) of the Caucasian race, who took In[1]gavirin® at a dose of 180 mg (2 capsules of 90 mg) on an empty stomach during two dosing periods, separated by a 7-day washout period. Determination of PAIE concentration in blood plasma and urine samples was carried out by high-performance liquid chromatography–mass spectrometry. Polymorphism of CYP genes was analyzed using the polymerase chain re[1]action method in order to analyze the pharmacogenetic features of PAIE metabolism in volunteers during the study.Results. After oral administration, PAIE quickly reached the systemic circulation: the maximum concentration of 578.88±145.21 ng/ml was observed after about 2 hours. Pharmacokinetic parameters of PAIE did not show high intraindividual variability and did not depend on polymorphism of isoenzymes CYP1A1, CYP2C9, and CYP2D6. Within 48 hours after the administration of the studied drug, about half of the taken dose of PAIE was excreted in the urine unchanged, which indicates a significant contribution of the kidneys to the elimination of PAIE. The only adverse event registered in 1 volunteer was a clinically insignificant decrease in the level of leukocytes, which did not require medical intervention and was resolved without consequences.Conclusion. PAIE is characterized by predictable pharmacokinetics, low intraindividual variability of pharmacokinetic parameters, and a favorable safety profile.

Netakimab (NTK) is a humanized anti-interleukin-17A monoclonal antibody. To date, the drug has been approved to treat ankylosing spondylitis (AS), psoriatic arthritis, and plaque psoriasis. The paper gives the data obtained during 52-week follow-up of AS patients in the phase III ASTERA study.Objective: to study the efficacy and safety of NTK when used long in patients with active AS.Patients and methods. The investigation enrolled 228 patients with active AS, in whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective. The patients were randomized in a 1:1 ratio to receive NTK 120 mg or placebo. The drug was administered subcutaneously at weeks 0, 1, 2, and then once every 2 weeks. Patients who received placebo and achieved a 20% improvement according to the ASAS criteria (ASAS20) were excluded from the study at week 16. At this week, patients who took placebo and did not achieve an ASAS20 response were switched to subcutaneous NTK at 120 mg dose once every two weeks. The follow-up period was 52 weeks.Results and discussion. Patients with active AS who received NTK were more likely to respond to treatment than those who took placebo. The proportion of people who achieved 40% improvement (ASAS40) during treatment with NTK increased throughout the follow-up period and amounted to 80.7% at week 52. Positive changes were achieved in all used clinical and laboratory parameters of AS activity. There was also a decrease in inflammatory changes, as shown by magnetic resonance imaging (MRI). The adverse events (AEs) were mainly laboratory abnormalities and upper respiratory tract infections. Treatment-related AEs were recorded in no more than one third of patients and they were mild to moderate. Severe AEs were singular.Conclusion. Response to NTK therapy generates in the first weeks of drug use and increases throughout a year. The safety profile of NTK when used long is generally favorable.

Netakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A.Objective. The main objective of BCD-085-5/ASTERA study was to prove superiority of NTK over placebo and assess its’ safety in patients with active AS.Subjects and methods. BCD-085-5/ASTERA was a double-blind, multicenter, randomized, placebo-controlled, phase III study, which included 228 adult patients with active AS, persisting despite active treatment with NSAIDs. AS was considered active at BASDAI score ≥ 4.0. Patients were blindly randomized (1:1) to receive subcutaneous injections of NTK (120 mg) or placebo at weeks 0, 1, 2 and then every other week up to week 14. Starting from week 16 all patients from NTK group and patients from placebo group not achieving ASAS20 were switched to open label 120 mg NTK s/c once every two weeks. The total duration of treatment with NTK was 3 years.Results. Higher proportion of patients had ASAS40 response at week 16 (primary endpoint) in NTK arm compared to placebo (40,4 vs 2,6%, р

The paper presents the results of a double-blind (BCD-085-3/AILAS) phase II clinical trial of the original interleukin 17A (IL17A) inhibitor BCD-085 prescribed at different doses to patients with active ankylosing spondylitis (AS) and those of an extended (BCD-085-3ext/AILAS-II) trial characterizing the efficacy and safety of this drug when used for a year.The objective of the AILAS study is to determine the therapeutically effective and safe dose of BCD-085 in the treatment of active AS. The efficacy, safety, and immunogenicity of BCD-085 during its annual use were additionally evaluated in the extended trial.Subjects and methods. The investigation enrolled 89 patients diagnosed as having active (BASDAI scores >4.0; mean spinal pain scores >4.0) AS that met the 1984 New York classification criteria. After the end of the screening period, the patients were randomized at a ratio of 1:1:1:1 in one of four groups that received 40; 80 or 120 mg of BCD-085 subcutaneously or placebo on day 1 of weeks 0, 1, 2 and then once every two weeks up to week 12. The primary end point was the number of patients who achieved an ASAS20 response at week 16. The investigation evaluated the safety of the drug, by calculating the total incidence of adverse events (AEs) and serious AEs (SAEs) and the number of cases of premature therapy termination because of AEs.Results and discussion. An ASAS20 response at week 16 was achieved in 72.7% of patients receiving 40 mg of BCD-085, in 81.8% of those receiving 80 mg, in 90.9% of those receiving 120 mg, and in 42.9% of cases in the placebo group (p=0.004). The superiority of BCD-085 over placebo was proven for 80- and 120-mg doses. The fastest and most pronounced effect was observed in patients treated with 120 mg of BCD-085. In the extended study, an ASAS20 response at week 52 was recorded in 86.4% of patients. One or more AEs during the first 16 weeks of therapy were reported in 11 (50.0%) patients of the 40-mg group; in 6 (27.3%) of the 80 mg group; in 4 (18.2%) of the 120 mg group and in 7 (31.8%) of the placebo group (p=0.183). The frequency and spectrum of AEs did not significantly differ in patients who received placebo and BCD-085 in different doses. No SAE was recorded.Conclusion. Phase II study yielded data demonstrating the high efficacy and good tolerance of BCD-085 in the treatment of active AS. The best effect and optimal tolerance were demonstrated for a dose of 120 mg.

Aim. To study the diagnostic characteristics of the rapid test for qualitative simultaneous determination of cardiac fatty acid-binding protein (FABPs) and cardiac troponin I (cTnI) CARD-INFO 1+1 in patients with acute coronary syndrome (ACS).Material and methods. The study included 168 patients undergoing inpatient treatment after ACS, with typical anginal pain lasting at least 20 minutes occurred in the previous 1-24 hours. In addition to routine diagnostic procedures, on admission, we determined FABPs and cTnI concentrations using the high-quality immunochromatographic rapid test CARD-INFO 1 1 (OOO CARDIO-Plus, Russia).Results. The sensitivity of the CARD-INFO 1+1 rapid test was 88,1%, specificity — 89,8%, diagnostic accuracy — 88,7%. The indicators of the diagnostic effectiveness of CARD-INFO 1+1 test in patients with STE-ACS and NSTE-ACS did not significantly differ (p>0,05). The sensitivity of the rapid test reached a maximum in the period from 3 to 6 hours from the onset of pain. Compared with the determination of cTnI performed on admission to the hospital, a higher sensitivity of the CARD-INFO 1+1 test was revealed in patients with STE-ACS (87,7% vs 75,3%; p=0,044), in the first 1-3 hours after the beginning of clinical manifestations (86,8% vs 60,5%; p=0,041) and in the entire sample as a whole (88,1% vs 77,1%; p=0,033), with comparable specificity (89,8% and 93,2%, respectively; p=0,741).Conclusion. Qualitative immunochromatographic CARD-INFO 1+1 rapid test for the simultaneous determination of the content of FABPs and cTnI I is highly effective in the diagnosis of various forms of ACS. The highest diagnostic characteristics of the test were observed in patients in the early stages of the disease (the first 1-6 hours after the onset of pain). Carrying out the CARD-INFO 1+1 test revealed 12 MI cases more (11%) than the first determination of cTnI. Further studies will clarify the place of this technique in the modern algorithm for the management of patients with ACS and evaluate the possibility of using the rapid test in predicting the course of the disease.

In opinion the Expert council provides management tactics for patients with hypertriglyceridemia (HTG). It is demonstrated that HTG is a common condition in overweight patients and is an important component of residual risk. HTG creates additional conditions for the progression of atherosclerosis, so the level of triglycerides (TG) is recommended to be measured in patients with a high, very high and extremely high risk level. An indication for the appointment of drugs that reduce the concentration of TG is its level of more than 2,3 mmol/L. Statins are the agents of choice to reduce the risk of cardiovascular disease in high-risk patients with hypercholesterolemia and HTG. Fenofibrate is used to correct HTG, and in case of intolerance to it or when the target level of TG is not reached, omega-3 ethers of polyunsaturated fatty acids in a dose of 2-4 g/day are recommended. In patients with HTG with a TG level >5,6 mmol/L, fenofibrate is the agent of choice.

History of heart transplantation in combination with immunosuppressive therapy and acute viral respiratory infection overlay makes the patient difficult to manage. In case of COVID-19, the setting is complicated by unknown pathogenesis, including its effect on blood, coagulation system, and lung tissue. Current case report discusses the 60-year-old patient with a COVID-19 infection occurred in the immediate postoperative period after heart transplantation.

Aim. To evaluate diagnostic properties of qualitative tests for cardiac fraction of the fatty acid binding protein (cFABP) in patients hospitalized with suspected acute coronary syndrome (ACS), depending on glomerular filtration rate (GFR) level.Material and methods. Totally, 465 patients included, admitted with ACS within 24 hours from onset. All patients underwent cFABP test with immune chromatographic express tests “CardioFABP” (Novosibirsk, Russia) and/or “CARD-INFO” (Obninsk, Russia), as the levels of serum creatinine with further GFR calculation. Assessment of diagnostic characteristics was done by the values of specificity, sensitivity, and diagnostic correctness, as well as overall positive and negative test results according to GFR.Results. The analysis did not reveal significant difference in the number of positive and negative results of cFABP with the “CARD-INFO” (χ2=6,822, р=0,146), “CardioFABP” 10 ng/mL (χ2=4,968, р=0,291) and “CardioFABP” 15 ng/mL (χ2=8,673, р=0,07) in comparison by GFR. With coupled comparison, in the groups of patients by GFR there were differences in specificity for “CARD-INFO” (Fischer criteria =0,017, р˂0,05) and precision for “CardioFABP” (10 ng/mL) (χ2=5,793, р=0,017) in patients by GFR levels 60-90 and 30-59 mL/min/1,73 m2. For the other parameters of diagnostical efficacy there were no differences by GFR. In severe renal dysfunction (GFR ˂15 mL/min/1,73 m2) results of qualitative cFABP were false positive in 10 cases among 11 (90,9%).Conclusion. In patients hospitalized for suspected ACS, the results and diagnostic characteristics of the express-tests for cFABP “CARD-INFO” and “CardioFABP” depended mildly on GFR level with its values ≥15 mL/min/1,73 m2. Low number of patients with GFR ˂15 mL/min/1,73 m2 made not possible to acquire significant data on cFABP in this category of patients, however the data available make it not to apply the test in this category of patients.

The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable.

The article is on a clinical case of malignant arterial hypertension in predominant kidney damage in a young man with disease anamnesis lasting 17 years. Recent data on the disorder provided, aspects of its management complexity that do make to regard the problem far from solution.

In the clinical case, an individual approach is demonstrated to management of mechanical aortic valve thrombosis. The specifics of the case is in 12­13 weeks pregnancy of the patient, in aggressive antithrombotic therapy, absence of hemorrhagic complications and complications of the fetus.

The review presents recent studies demonstrating somatic shifts in psychological processes regarded as the risk factors for myocardial infarction: depression, stress, anxiety. Based upon a metaphorical term “a perfect storm”, inflammatory, immunological, neuro-humoral predisposing factors are presented, important for myocardial infarction development, as such shifts themselves, which are the somatic substrate for psychological states mediating myocardial infarction development through behavioral and biological risk factors: “sickness behavior”, “depression illness”. Both directions complete a vicious circle of psychosomatic changes. The emphasis is set on the importance of individual approach to rehabilitation and secondary prevention of myocardial infarction, as, from biopsychosocial point of view, the bottom-up and top-down psychosomatic links are unique for any patient.

Aim. To specify diagnostic characteristics of the test for qualitative measurement of the fatty acid binding protein, cardiac fraction (cFABP), in patients with suspected acute coronary syndrome (ACS) based on the subanalysis of ISPOLIN study.Material and methods. To the subanalysis, 592 patients included, admitted to inpatient institutions of 8 centers in 5 cities, with suspected ACS during 24 hours from the onset of clinical signs. At admittance, all patients underwent cFABP test in whole venous blood with immune chromatography express test “CardioFABP” (SPI “Biotest”, Novosibirsk, Russia) and level of cardiac troponin I by qualitative and quantitative methods. For both markers, the values were assessed of sensitivity, specificity, diagnostic accuracy, positive and negative predictive value in general, and various timing intervals from the moment of clinical ACS signs presentation and ECG changes.Results. During first 6 hours from the pain onset, cFABP test performed better than cTnI by sensitivity, diagnostic accuracy and negative predictive significane (p0,05). With the pain less than 3 hours and 3-6 hours, ROC areas for cFABP are better than those for cTnI. With the duration of clinical signs more than 6 hours, sensitivity and diagnostic accuracy were better than of cTnI. In anamnesis of the patients with false positive results of cFABP test there were kidney diseases and anemia. They also had GFR

Aim. To investigate on the clinical, anamnestic and laboratory-instrumental predictors of short term outcomes development in pulmonary thromboembolism (PTE).Material and methods. To the study, 136 patients included with the high and intermediate risk PTE confirmed by multispiral computed tomography. The endpoints were obstructive shock, fatal relapse, fatal outcome, necessity of resuscitation, urgent thrombolysis and hemodynamic support. Follow-up lasted for 30 days. Patients were selected to groups of complicated (n=44) and noncomplicated (n=92) course.Results. The predictors of adverse course of PTE were chronic heart failure of II stage (p=0,02), diabetes type 2 (p=000001), atrial fibrillation (p=0,001), permanent risk factor for PTE (p=0,002), syncope (p=0,02), positive test for the fatty acid binding cardiac protein (cFABP) (p=0,00001), troponin I positive test (p=0,02), heart rate ≥110 bpm (p=0,002), systolic BP ≤100 mmHg (p=0,00001), creatinine clearance ≤70 mL/min (p=0,0008). By the method of logistic regression a combination selected showing most predictive power, that includes heart rate ≥110 bpm, BP ≤100 mmHg, positive cFABP and diabetes. Upon the logistic regression coefficients the prediction score was formulated, named ROCky (Risk of Complications) that includes heart rate ≥110 bpm (1,5 points), BP ≤100 mmHg (2,5 pts), positive cFABP test (2 pts), diabetes type 2 (2,5 pts). The threshold estimated for prediction of combination endpoint ≥2,5 (Se 84%, Sp 75%), obstructive shock ≥3,5 (Se 83%, Sp 83%) and fatal outcome within 30 days ≥4,5 (Se 79%, Sp 82%). Combination of ≥2,5 points by ROCky and presence of echocardiographical signs of the right ventricle dysfunction showed more efficacy than the algorithm of European Society of Cardiology (2014) in the studied population of hemodynamically stable patients, for the obstructive shock, fatal relapse of PTE, fatal outcome and combination endpoint.Conclusion. The ROCky scale has demonstrated high efficacy in prediction of complications among hemodynamically stable patients and can be recommended for further investigation and implementation into clinical practice.

Aim. To assess the specifics of psychoemotional state of adult patients with non ST elevation acute coronary syndrome (NSTEACS) in 6 months post hospitalization.Material and methods. Totally, 101 patient included, with non-obstructive lesion of coronary flow. Groups were formed by gender: group 1 — 51 females, group 2 — 50 males. Mean age: women 50,5±4,7 y. o., men 46,7±6,8 y. o. Patients were also selected to subgroups by NSTEACS type: subgroup A — unstable angina (UA), subgroup B — myocardial infarction. Patients were questionned by phone in 6 months after discharge. The questionnaire included key points about health, emotional balance, physical activity and life quality.Results. There are gender differences in life quality constituents between men and women. In questions on general health state 6% of women replied that are not satisfied with their health, in men — 2%; satisfactorily graded their health state 27% of women and 38% of men, good — 47% and 46%, excellent — 20% and 14%, respectively. Pre-morbid physical activity at work was saved in 45% of men and 32% of women; active life style retained 47% of women and 42% of men. Men more often felt hopelessness (43% and 12%; p0,05) and were unsatisfied with their psychological state (31% and 6%; p0,05), however men noted loss of interest to former habits (13% и 22%; р>0,05). The specifics in subtypes of NSTEACS was also noted.Conclusion. Regardless an individuality of the meanings of life quality, experiences, coping, there is gender specifics, as specifics in NSTEACS subtype. The specifics can be included as a part of patient-centered work with post-ACS patients.

This article presents results from two clinical trials of infliximab biosimilar, BCD-055, including comparative data on the pharmacokinetics (PK), efficacy and safety of BCD-055 and innovator infliximab (IFX) in patients with ankylosing spondylitis (AS).Objective: The purpose of phase I clinical study ASART-1 was to evaluate the pharmacokinetic and safety profile of BCD-055 and to prove its equivalence with Remicade®, phase III study ASART-2 was conducted to evaluate the efficacy and tolerability of BCD-055 in comparison with Remicade® in patients with active AS.Patients and methods: Both studies were conducted as international multi-center randomized double-blind studies in direct comparison with innovator IFX. Inclusion and exclusion criteria, main examination methods, and drug regimens were the same in both trials. A total of 199 patients were enrolled in the studies. After the screening, the patients were stratified by CRP and BASDAI score, randomized (1:1 ratio in ASART-1; 2:1 ratio in ASART-2) into 2 arms and received BCD-055 or innovator IFX at a dose 5 mg/kg IV at 0, 2, 6 and then every 8 weeks (up to week 54). The primary endpoint for PK profile evaluation was the area under the concentration-time curve (AUC(0-tau)), maximum serum concentration of infliximab at steady state Cmax,ss. Efficacy was assessed by achieving ASAS20 at week 30, the endpoints for safety profile were the incidence of adverse events and serious adverse events during the maintenance-dosing phase and withdrawals from the study due to the safety reasons.Results: A total of 81 patients (ASART-1 study) were included in PK analysis, 199 patients were in efficacy and safety analysis. AUC(0-tau) value were 25,420,996.25±11,635,015.74 (ng/ml) Cmax,ss for BCD-055 and 26,114,705.71±12,102,376.9 (ng/ml)⋅h for INF innovator (p>0.05). Cmax,ss for BCD-055/Remicade® was 122,752 [99,401–151,553] ng/ml and 119,844 [98,120–132,772] ng/ml, respectively (p>0.05). ASAS20 was achieved at week 30 by 81.30% of the patients in the BCD-055 group, and 67.74% in the INF innovator group (p=0.061). The analysis of secondary endpoints (BASDAI, BASMI, BASFI, MASES, quality of life, chest excursion, and number of pathologically changed joints) showed no difference between the biosimilar and innovator groups. BCD-055 and innovator IFX showed highly similar safety profiles in both studies without cases of unexpected toxicity. The rates of AEs were equivalent for both drugs and were 48.48% and 58.21% of patients in the BCD-055 and Remicade®, respectively.Conclusion: BCD-055 is found to be equivalent in terms of PK, and showed the similarity in efficacy and safety profile compared with innovator IFX in patients with active AS.

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

Aim. Life quality is an integral parameter of medical care efficacy. In incomplete revascularization after myocardial infarction the quality of life might change in relevance with the severity of residual lesion. The study is done with an aim to reveal the specifics of patients life quality in such clinical situation.Material and methods. The investigation of 100 patients is done (mean age 63±0,9 y.o.) with acute ST-elevation myocardial infarction and incomplete revascularization, of those 20 underwent delayed surgery (percutaneous or bypass) — group 1; 54 had no further surgery (group 2); and 26 did not have primary revascularization — group 3. Life quality was assessed with the Medical Outcomes SF-36. The test was performed in 12 months after index event.Results. Life quality of group 1 patients changes significantly after revascularization towards improvement of physical and psychological health components. Life quality parameters in the group 1 remain high, about a “full” health. In group 2 and 3 patients there is restriction of social contacts, decrease of communicating due to worse physical and emotional conditions.Conclusion. After delayed revascularization, comparing to its absence or intervention only on infarct-related artery, the parameters of life quality post-MI are significantly better.

The article focuses on the comparative analysis of tactics of the rational complete and incomplete revascularizations in patients with ST elevation myocardial infarction and angina, underwent multivessel stenting and coronary bypass grafting.Patients with diffuse atherosclerotic lesion of coronary arteries are one of the most strenuous kinds of patients. The demand for revascularization of high in this group and, by the data of several authors, is up to 70% among all surgeries. This origins from the changes in demographics (population ageing) as the manifest of ischemic disease in younger age that further presents with the worse morphological substrate. The problem of optimal tactics choice (coronary bypass, endovascular revascularization, conservative strategy) of diffuse coronary atherosclerosis is still of the main topics in discussion and controversy in science.

The article focuses on the form of ethical controversy of the new drugs studies on humans. The issue is at its most importance in early phases of clinical trials that resemble an experiment, therefore requiring specific regulation. Has the difficulties been resolved, that are related to ethical aspects of human participants in new drugs investigation? Are not there any aspects that require thorough interdisciplinary workout, but being covered by strict regulation? Authors try to answer these questions taking into account a biosocial nature of the object of investigations.

Aim. To compare two approaches to warfarin dosage formulation: the standard and with the clinical algorithm.Material and methods. As an approach to warfarin dosage, we have used the method that included clinical properties of the patients. Into the group of the studied approach (intervention group), we randomized 31 person, into the standard approach group (controls) — 29 persons with a variety of indications for vitamin K antagonists treatment. Target diapason of International Normalized Ratio (INR) for all the patients was 2,0 to 3,0.Results. A stable target INR in both groups was reached during hospitalization just in a small part of the patients: 19,4% in intervention group and 17,2% in controls. The patients from intervention group reached stable INR by 6,8 days in average, that is almost two times faster than controls, who had their target INR by 12,4 day in average (p

The article focuses on new data on trimetazidine MB cytoprotection studies. The data provided on novel mechanisms of its effect including systemic action not related to myocardium. The results of epidemiological studies and meta-analysis are provided that confirm safety and efficacy of the medication in ischemic heart disease and chronic heart failure.

Aim. To study the rate of chronic glomerulonephritis progression when added by anemia and cardiovascular disease (CVD). Subjects and methods. 231 patients (133 men and 98 women) with predialysis chronic glomerulonephritis (CGN) were examined. The patients’ mean age of was 35.8±11.8 years; the disease duration was 1 to 17 years. The disease onset was the date when urinalysis showed evidence of persistent proteinuria and (or) hematuria. Besides, the time when anemia developed and the clinical and instrumental signs of CVD appeared was taken as the initial reference point; the time when end-stage renal failure was diagnosed was taken to be the endpoint. Red blood cell counts with the inclusion of its indices, hemoglobin concentration, hematocrit values, daily proteinuria values, and glomerular filtration rate were analyzed. The biochemical parameters included the concentrations of electrolytes, creatinine, fibrinogen, iron, cholesterol, total protein and C-reactive protein (CRP). Electrocardiography and echocardiography, bicycle ergometry and 24-hour ECG monitoring were used to detect CVD. Results. The presence of anemia and CVD in patients with predialysis CGN versus those without anemia and CVD was associated with an increase in the concentrations of CRP [36.2 and 12.6%; respectively; (p

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