COVID-19 is a contagious multisystem inflammatory disease caused by a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We studied the efficacy of Aprotinin (nonspecific serine proteases inhibitor) in combination with Avifavir^® or Hydroxychloroquine (HCQ) drugs, which are recommended by the Russian Ministry of Health for the treatment therapy of moderate COVID-19 patients. This prospective single-center study included participants with moderate COVID-19-related pneumonia, laboratory-confirmed SARS-CoV-2, and admitted to the hospitals. Patients received combinations of intravenous (IV) Aprotinin (1,000,000 KIU daily, 3 days) and HCQ (cohort 1), inhalation (inh) treatment with Aprotinin (625 KIU four times per day, 5 days) and HCQ (cohort 2) or IV Aprotinin (1,000,000 KIU daily for 5 days) and Avifavir (cohort 3). In cohorts 1–3, the combination therapy showed 100% efficacy in preventing the transfer of patients (n = 30) to the intensive care unit (ICU). The effect of the combination therapy in cohort 3 was the most prominent, and the median time to SARS-CoV-2 elimination was 3.5 days (IQR 3.0–4.0), normalization of the CRP concentration was 3.5 days (IQR 3–5), of the D-dimer concentration was 5 days (IQR 4 to 5); body temperature was 1 day (IQR 1–3), improvement in clinical status or discharge from the hospital was 5 days (IQR 5–5), and improvement in lung lesions of patients on 14 day was 100%.

Aim. To evaluate the long-term safety and efficacy of goflkicept treatment in patients with idiopathic recurrent pericarditis (IRP). Materials and methods. This report presents the interim analysis of an ongoing open-label extension (OLE) clinical trial of goflkicept in patients with IRP (NCT 05673902), as a continuation of the core study (NCT04692766). The study assessed the frequency of pericarditis recurrence, time to recurrence after 12 and 60 weeks of goflkicept therapy, changes in C-reactive protein level, chest pain intensity, pericardial effusion size, and adverse events (AEs). Results. All patients remained in clinical-laboratory remission during the 60 weeks of goflkicept treatment. The recurrence frequency was 31.3% (5/16) after 60 weeks and 90% (9/10) after 12 weeks of goflkicept treatment (p0.001). A total of 64 AEs were reported in 16 patients (94.1%), mostly of mild to moderate severity. The most common AEs were infections, occurring in 11 patients (64.7%). Nine serious adverse events were reported in 5 patients, none of which were considered drug-related. There were no deaths. Conclusion. Long-term goflkicept therapy resulted in a significant reduction in the risk of recurrence and prolonged remission without an increase in adverse events.

In May 2020 the Russian Ministry of Health granted fast-track marketing authorization to RNA polymerase inhibitor AVIFAVIR (favipiravir) for the treatment of COVID-19 patients. In the pilot stage of Phase II/III clinical trial, AVIFAVIR enabled SARS-CoV-2 viral clearance in 62.5% of patients within 4 days, and was safe and well-tolerated.

The development of cardiovascular disorders associated with atherosclerotic vascular lesions is a common complication of autoimmune rheumatic diseases (AIRDs), leading to a life expectancy decrease. Rheumatoid arthritis (RA) has a special place among the AIRDs, and the incidence of atherosclerotic vascular disease is 1.5-fold higher than in the general population, which is comparable to type 2 diabetes mellitus. This difference is due to the shared immunopathogenetic mechanisms of RA and atherosclerosis. The aim of the study was to identify predictors of cardiovascular adverse events (CAE) during therapy with the interleukin 6 (IL-6) inhibitor olokizumab (OKZ) and to evaluate the cardioprotective potential of this monoclonal antibody. In a pooled retrospective analysis of data from randomized and open-label, long-term clinical trials of the OKZ efficacy in patients with RA, we evaluated the effects of OKZ therapy on the incidence of CAE and the following lipid profile parameters: apolipoprotein B (ApoB), apolipoprotein A1 (ApoA1), lipoprotein-a (Lp(a)), adiponectin, homocysteine, and albumin. During treatment with OKZ, an increased risk of CAE was independently associated with age over 60 years (hazard ratio (HR) – 1.59; 95% confidence interval (95% CI): 1.12–2.26), elevated (>30) body mass index (HR=1.75; 95% CI: 1.26–2.45), hypertention (HR=2.44; 95% CI: 1.46–4.06) and ApoA1 (>2.25 g/L) (OR=2.23; 95% CI: 1.05–4.72). During treatment with OKZ, an increase in adiponectin levels, a decrease in homocysteine, Lp(a), and no changes of the ApoB/ApoA1 ratio were noted. Favorable dynamics of cardiovascular risk biomarkers in patients receiving active therapy compared to placebo indicate a likely positive effect of OKZ on the cardiovascular system.

Objective. To evaluate the pharmacokinetics (PK), efficacy, and safety of the direct interleukin-6 inhibitor olokizumab (OKZ) when used in adolescent patients with active juvenile idiopathic polyarthritis (JIA), with ineffectiveness or intolerance to methotrexate. Patients and methods. The results of OKZ therapy at a dose of 64 mg every 4 weeks during 24 weeks of the open-label study were analysed. The parameters of PK, efficacy, dynamics of serum concentration of C-reactive protein (CRP), adverse events (AEs) were evaluated. Results. Sixteen patients were included in the study, of whom 13 (81.2%) received OKZ therapy up to and including week 24. The PK profile was consistent with that of adults with rheumatoid arthritis. By week 16, 12 (80%) patients achieved an ACRpedi30 response, 11 (73.3%) achieved ACRpedi50, inactive disease was achieved by 2 (13.3%) patients. The response was maintained until week 24. There were no exacerbations of pJIA. Patients with baseline CRP values >10 mg/L and in the subgroup naive to biologic anti-rheumatic drugs had a trend towards a higher response (p > 0.05). Twenty-three AEs were reported in 12 (75.0%) patients, all of mild to moderate severity, with infections being the most frequent AE in 6 (37.5%) patients. No serious AEs or deaths were reported. Conclusion. Treatment with OKZ demonstrated a reduction in pJIA activity and good tolerability. The safety profile was consistent with that of interleukin-6 blockers, and the OKZ PK was consistent with that of adults with rheumatoid arthritis. Key words: juvenile idiopathic arthritis, genetically engineered biological drugs, interleukin-6 inhibitor, olokizumab, clinical

Olokizumab (OKZ) is a monoclonal antibody that binds interleukin 6 in the blood plasma, thereby exerting a pronounced anti-inflammatory effect in rheumatoid arthritis (RA). In addition to its effect on RA disease activity, OKZ significantly reduces the severity of key RA symptoms, which are referred to as patient-reported outcomes (PROs). The aim – to evaluate the effect of olokizumab on patient-reported outcomes using data from a meta-analysis of randomized controlled trials (RCTs) and observational studies. Materials and methods : We searched PubMed, Web of Science, Scopus, Cochrane, and eLibrary for publications from January 2014 to June 2025 using the keywords “olokizumab”, “rheumatoid arthritis”, and “patient-reported outcomes”: pain, PtGA, HAQ-DI, and FACIT-F. A meta-analysis was then conducted of a series of studies that met the selection criteria. In addition to the effect of OKZ on RA disease activity, it also examined its effect on PROs: pain (visual analog scale, 0–100 numeric rating scale), patient global assessment (PtGA), functional impairment (HAQ-DI (Health Assessment Questionnaire – Disability Index)), and fatigue (FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue)). The efficacy of OKZ in the most commonly used regimen – subcutaneous injections of 64 mg every 4 weeks – was assessed. Results . Five phase II–III RCTs and four observational studies in real-world clinical practice (n=3013) were selected for the meta-analysis. According to the data obtained, significant positive dynamics in PROs were observed after 12 and 24 weeks from the start of therapy with OKZ treatment. Thus, pain dynamics by 24 weeks (mean difference) was –33.29 (95% confidential interval (95% CI): –39.53; –27.07), PtGA dynamics at 24 weeks was –28.62 (95% CI: –33.87; –23.37), HAQ-DI dynamics at 12 weeks was –0.24 (95% CI: –0.35; –0.13), and FACIT-F at 24 weeks was 8.80 (95% CI: 5.81; 11.79). The data obtained had moderate to high heterogeneity (I2 index >25%). The dynamics of PROs in RCTs and observational studies were unidirectional and similar. Conclusion. OKZ has a significant positive effect on PROs in RA. OKZ can be considered as an effective treatment for patients with RA, chronic pain, and fatigue.