There are results of a comparative phase III clinical study on the efficiency and safety of the biosimilar drug Genolar ® (Generium JSC, Russia) and the reference drug Xolair ® (Novartis Pharma AG, Switzerland) ((NCT04607629). The study is aimed to establish the clinical equivalence of the compared drugs for additional therapy of patients with moderate and severe bronchial asthma (BA) are considered in the article. Methods. The study enrolled 191 patients aged 18 to 75 years with a moderate to severe atopic asthma for ≥ 1 year, the symptoms of which were insufficiently controlled by therapy corresponding to the 4 th stage of treatment (GINA, 2017) for ≥ 2 months before the screening. Patients were divided into the two groups in a ratio of 2 : 1 with the block randomization. 127 patients of the Group 1 were administered Genolar ® for 52 weeks ± 3 days; 64 patients of the Group 2 were administered Xolair ® for 26 weeks ± 3 days. The dose and frequency of the compared drugs administration were determined based both the initial IgE concentration (IU/mL) measured before treatment and the current body weight (kg) of the patient. The recommended omalizumab dose was 75 to 600 mg once every 2 or 4 weeks. The primary efficacy endpoint was the patients' percentage with a physician evaluation of "excellent" or "good" on the Global Evaluation of Treatment Effectiveness (GETE) scale after 26 weeks of comparative treatment. Results. According to the data analysis results, the patients' proportion with a GETE score of "excellent" or "good" after 26 weeks of therapy were no statistically significant differences between the groups in both investigated populations (PP-population (per protocol) and FAS-population (full analyses set)) (p > 0.05). Primary efficacy endpoint data analysis showed that the patients' proportion of the PP population with a GETE score of "excellent" or "good" was 57.4% of the Group 1 and 45.2% of the Group 2 (p = 0.132). The calculated one-sided 95% CI in order to test the study statistical hypothesis showed that the investigated drug Genolar ® (Generium JSC, Russia) is "non-inferior" than the reference drug. The PP population onesided 95% CI was from -0.5 to 25.0% (p = 0.116), the FAS population one was from -1.1 to 24.2% (p = 0.134). According to the safety analysis results, the comparability of the investigated and reference drugs in terms of the frequency of the adverse events was demonstrated. The analysis results of the anti-drug antibodies to omalizumab detection revealed the antibody production absence in response to the administration of the studied drugs. Conclusion. The clinical study results have proved the equivalence of the biological analogue Genolar ® (Generium JSC, Russia) and the reference drug Xolair ® (Novartis Pharma AG, Switzerland).
Post-COVID syndrome develops after COVID-19 (COronaVIrus Disease 2019) and leads to cumulative effects in the form of shortness of breath and impaired lung function. Notably, patients with airway inflammation and COVID-19 were found to have increased concentrations of hyaluronic acid (HA). Since bovhyaluronidase azoximer (Longidase®) catalyzes the hydrolysis of HA, this drug has the potential to reduce HA levels and improve lung function in patients with post-COVID syndrome.The aim of the DISSOLVE trial, which was conducted early in the pandemic, was to investigate the efficacy and safety of bovhyaluronidase azoximer in patients with symptoms associated with post-COVID syndrome.Methods. An open, prospective, controlled, comparative, multicenter clinical trial (NCT04645368) included adult patients (n = 160) who had post-COVID syndrome. Patients in the treatment group (n = 81) received bovhyaluronidase azoximer, and individuals in the control group (n = 79) were followed up without intervention. The study included physical examination, evaluation of forced vital capacity (FVC), assessment of dyspnea with the Modified Medical Research Council Dyspnea Scale (mMRC), 6-minute walking test, and pulse oximetry. These indicators were measured on 3 visits, at days 1 (baseline), 75, and 180. In addition, the number of patients who experienced adverse events and serious adverse events were recorded.Results. Baseline patient characteristics in the treatment group and the control group were similar. In the treatment group, there was a statistically significant reduction in residual pulmonary abnormalities after visit 2 (day 75) and visit 3 (day 180). In addition, FVC, pulse oximetry values, and functional exercise tolerance increased statistically significantly at days 75 and 180 compared to baseline. The mMRC scores for dyspnea decreased statistically significantly in the treatment group over 75 days. The safety profile of the drug was reported to be favorable throughout the study. Conclusion. Treatment with bovhyaluronidase azoximer in patients with post-COVID syndrome showed improvement in FVC, pulse oximetry, functional exercise tolerance, and mMRC dyspnea.
На основе крупного российского мультицентрового исследования проведен анализ эффективности и приверженности терапии формотеролом (Форадил Аэролайзер) у пациентов с хронической обструктивной болезнью легких (ХОБЛ) с разными стадиями по классификации GOLD, и особое внимание было уделено больным со II стадией ХОБЛ. Из 1 603 больных ХОБЛ, включенных в иссле- дование, 63,3 % - имели II, 33,5 % - III, 3,3 % - IV стадию. Во всех подгруппах пациентов с ХОБЛ терапия формотеролом привела к достоверному и клинически значимому росту объема форсированного выдоха за 1-ю с - ОФВ1 ( p < 0,001) (у больных со II стадией - около 20 %). По абсолютному среднему приросту дистанции в тесте с 6-минутной ходьбой больные разных стадий практически не различались (прирост - 74, 76 и 64 м для пациентов со II, III и IV стадей ХОБЛ соответственно). Во всех подгруппах больных ХОБЛ было отмечено статистически значимое снижение частоты использования бронходилататора короткого действия: в среднем на 2,5; 2,4 и 5,9 ингаляций в неделю для больных II, III и IV стадии ХОБЛ соответственно. На фоне терапии формотеролом во всех подгруппах больных ХОБЛ продемонстрировано статистически значимое снижение всех видов обострений ХОБЛ ( p < 0,001). Средний прирост суммарного балла по шкале EQ-5D у больных со II, III и IV стадиями ХОБЛ составил 0,28; 0,39 и 0,52 баллов соответственно. Таким образом, длительная поддерживающая терапия формотеролом эффективна у больных с разными стадиями ХОБЛ, в т. ч. со II стадией ХОБЛ. Полученные данные являются убедительным основанием для стартовой терапии формотеролом больных ХОБЛ среднетяжелого течения.
The aim of this study was to analyze the rationality of antibiotics administration and choice in patients with different respiratory diseases referred from outpatient departments to the city diagnostic center № 1 at Saint Petersburg. Two hundred and thirty five outpatient medical histories were analyzed. We revealed cases of unreasonable (in patients with bronchial asthma and exogenous allergic alveolitis) and irrational antibiotic administration (rare administration of inhibitor protected aminopenicillins, cefuroxime axetil, respiratory quinolones; use of aminoglycozides, co trimoxazolе and tetracyclines in therapeutic patients). Elderly and senile age, smoking and post tuberculotic lung pathology provided lingering pneumonia course. Eighteen patients with uncomplicated pneumonia (including lingering variants), exacerbation of chronic bronchitis and bronchiectasis were successfully treated by sparfloxacin.
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