Results of a 12-Week Open-Label, Non-Interventional Study of the Efficacy and Safety of Olokizumab Therapy in Patients with Rheumatoid Arthritis after Switching from Anti-B-Cell Therapy during the SARS-CoV-2 Pandemic.

ABSTTACT: -The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic disease-modifying antirheumatic drugs (DMARDs) and genetically engineered biological drugs (biological DMARDs, or biologics) on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biologics and to search for alternative therapy programs to maintain control over disease activity. PURPOSE OF THE STUDY: The purpose of the study was to evaluate the efficacy and safety of the drug Artlegia® (olokizumab), solution for subcutaneous injection, 160 mg/ml-0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheumatoid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic. MATERIALS AND METHODS: The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000-500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. On weeks 0, 4, 8, and 12 after the switch, the severity of pain was assessed on the VAS scale, the number of tender and swollen joints (TJC28 and SJC28), the level of acute-phase inflammation markers, the DAS28 (disease activity score), ESR, CRP, CDAI (clinical activity index), and the functional state index HAQ (Health Assessment Questionnaire) were determined, as well as the safety profile of therapy was assessed. RESULTS: Data analysis was performed using median values (Me) were used for data analysis. A significant decrease in TJC28 was detected after 8 and 12 weeks of treatment with olokizumab (Artlegia®) (Me baseline = 10, Me 8 weeks = 4, Me 12 weeks = 4, p < 0.05) and a decrease in TSC28 was detected after 4, 8, and 12 weeks of treatment (Me baseline = 9, Me 4 weeks = 3.5, Me 8 weeks = 2.5, Me 12 weeks = 2.0, p < 0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me4 weeks = 21, Me4 weeks = 1, p < 0.05, ESR: Mesno = 31, Me4 weeks = 7, p < 0.05). Positive dynamics persisted on 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0; ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by week 4 became within the normal range, regardless of the initial values. All activity indices improved from week 4 in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22, p < 0.05; DAS28CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45, p < 0.05; CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0, p < 0.05. All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by week 12 of the study: Me baseline = 1.62, Me 12 weeks = 1.31, p < 0.05. CONCLUSIONS: The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.

[Mental disorders and personality characteristics of patients with polycystic ovary syndrome]. / Psikhicheskie rasstroistva i lichnostnye osobennosti u patsientok s sindromom polikistoznykh yaichnikov.

OBJECTIVE: To study the frequency and clinical manifestations of mental disorders in women with polycystic ovary syndrome (PCOS), to describe the personality characteristics and basic behavioral styles of these patients. MATERIAL AND METHODS: One hundred and sixteen women with PCOS were examined, the average age was 26.9±4.1 years. The diagnosis of PCOS was verified by a gynecologist based on the ESHRE/ASRM criteria, the qualification of the mental state was carried out by a psychiatrist based on the ICD-10 criteria. MMPI and 16-PF were used to assess personality characteristics. RESULTS: Mental disorders were diagnosed in 76 (65.5%) patients. Generalized anxiety disorder (26.7%), recurrent depression (19.8%) and bipolar affective disorder (14.7%) were prevailed. A psychological study of the PCOS patients identified four main behavioral styles: anxiety-depressive (n=18, 22.5%), masculine (n=18, 22.5%), hyperthymic (n=25, 31.3%) and sensitive (n=19, 23.7%). Anxiety-depressive and sensitive styles were most frequently combined with mental disorders. CONCLUSION: Women with PCOS have an increased risk of developing mental disorders, which indicates the need to connect psychological and psychiatric support to their medical management.

SURGICALLY ASSISTED RAPID MAXILLARY EXPANSION: RETROSPECTIVE ANALYSIS OF COMPLICATIONS 2012-2017.

Surgically assisted rapid maxillary expansion (SARME) is a common technique developed to treat skeletally mature patients with transverse maxillary deficiency. Although SARME is supposed to be a relatively safe procedure, it is not completely free of complications. The purpose of this study was to reveal the most typical postoperative SARME complications. Retrospective evaluation of the clinical cases of 665 patients (247 males and 418 females, mean age 25,3 years) with the diagnosis of maxillary transverse deficiency, who underwent SARME in period between 2012 and 2017 at the Clinical Center of Maxillofacial, Plastic Surgery and Dentistry, Moscow. According to the results of the research, the most typical complications of SARME are paresthesia of the infraorbital nerve branches and nasopalatine nerve (198/665), distraction device dislocation (61/665), inflammation in the distraction device area (57/665), insufficient expansion of the maxilla (42/665), asymmetric expansion (27/665). The number of complications revealed indicates that SARME is an operation associated with the risks of postoperative complications. Careful treatment planning, following the operation protocol and performing the minimally invasive access can help to avoid the majority of complications.

Flavonoids from the Genus Astragalus: Phytochemistry and Biological Activity.

Flavonoids, the most common plant polyphenols are widely distributed in every species and possess a broad range of pharmacological activities. The genus Astragalus is the largest in the Fabaceae family with more than 2,500 species spread. They are known to contain different metabolites such as flavonoids, saponins, and polysaccharides. Plants from the genus have been used in the traditional medicine of many countries for centuries. This paper is focused on the large group of flavonoid compounds. Details on structure as well as information about the pharmacological properties of flavonoids, isolated from Astragalus species have been discussed. This review is based on publications until the first half of 2014 and includes also the results from our phytochemical investigations of the genus.