The article discusses the results of a phase III clinical trial to compare the pharmacokinetics, efficacy and safety of the biosimilar medicinal product Tigerase® (dornase alpha) (Generium JSC, Russia) and the reference medicinal product Pulmozyme® (F.Hoffmann-La Roche Ltd, Switzerland) with the purpose of establishing their comparability for symptomatic treatment of patients with cystic fibrosis (CF).Methods. The study included 100 patients aged 18 years and older with a confirmed diagnosis of CF, who were divided into two groups by stratified randomization in a ratio of 1 : 1 based on the initial level of FEV1 (40–60% or > 60–100% from due value). Tigerase® or Pulmozyme® were used in a dose of 2.5 mg daily, once a day in the form of inhalations using a jet nebulizer compressor for 24 weeks.Results and discussion: The analysis of the data regarding the primary efficacy endpoint – changes in FEV1 – showed that in both groups (FAS population (Full analyses set) and PP population (Per protocol)), similar changes in FEV1 were observed. The average value of changes in FEV1 after 24 weeks of treatment compared with the initial level in the FAS population was –1.3% ± 9.8 % (95% CI (–4.1; 1.6)) in Group I (Tigerase®) and –1.9% ± 10.0% (95% CI (–4.7; 1.0)) in Group II (Pulmozyme®). The point estimate for the intergroup difference in changes in FEV1 (Group I – Group II) was 0.6%. The calculated 95% CI for the difference in changes in FEV1 in the FAS population was (–3.3; 4.6%]. In both populations studied, the intergroup difference in changes in FEV1 did not exceed 6%. During long-term treatment of patients with CF, no statistically significant differences were found in terms of efficacy (changes in FEV1 and FVC; number of exacerbations of chronic pulmonary disease and the number of days before its development; change in body weight; quality of life) between medicinal products in both studied populations (FAS and PP).Conciusion. A safety analysis demonstrated the comparability of medicinal products in terms of the incidence of adverse events. The frequency of detection of antibodies to dornase alpha during the study was similar in the treatment groups; the formation of antibodies did not lead to a decrease in the efficacy and safety of therapy.
Информация об авторах Мусин Ильдар Наилевич, к.т.н., заведующий кафедрой медицинской инженерии Казанского национального исследовательского технологического университета, г. Казань. 420015, г. Казань, ул. К.Маркса, 68. Тел.: (843) 2314383.
Fifty-two patients with chronic obstructive pulmonary disease (COPD) aged 44 to 71 yrs were examined. Of them, 26 ones suffered from type 2 diabetes mellitus (DM). We established that in patients with concomitant DM, COPD has more severe course with more advanced respiratory failure and chronic cor pulmonale and more frequent exacerbations. COPD patients with concomitant DM more often have co-morbidity, such as obesity, ischemic heart disease, chronic heart failure. Co-morbidity of COLD and DM requires more extensive pharmacotherapy.
Background Patients with cystic fibrosis (CF) need costly medical care and adequate therapy with expensive medicinal products. Tigerase® is the first biosimilar of dornase alfa, developed by the lead Russian biotechnology company GENERIUM. The aim of the manuscript to present post hoc sub-analysis of patients’ data with cystic fibrosis and severe pulmonary impairment of a larger comparative study (phase III open label, prospective, multi-centre, randomized study (NCT04468100)) of a generic version of recombinant human DNase Tigerase® to the only comparable drug, Pulmozyme® Methods In the analyses included subgroup of 46 severe pulmonary impairment patients with baseline FEV1 level 40–60% of predicted (23 patients in each treatment group) out of 100 patients registered in the study phase III open label, prospective, multi-center, randomized study (NCT04468100), and compared efficacy endpoints (FEV1, FVC, number and time of exacerbations, body weight, St.George’s Respiratory Questionnaire) as well as safety parameters (AEs, SAEs, anti-drug antibody) within 24 treatment weeks. Results All outcomes were comparable among the studied groups. In the efficacy dataset, the similar mean FEV1 and mean FVC changes for 24 weeks of both treatment groups were observed. The groups were also comparable in safety, all the secondary efficacy parameters and immunogenicity. Conclusions The findings from this study support the clinical Tigerase® biosimilarity to Pulmozyme® administered in CF patients with severe impairment of pulmonary function.
2 Altai Regional Clinical Hospital, 656024, Barnaul, RussiaThe aim of this study was to evaluate presepsin to improve diagnosis of severe pneumonia, sepsis in patients on hemodialysis. Material and methods. 62 patients with severe pneumonia, sepsis, chronic glomerulonephritis and nephropathy aged from 17 to 77 years were examined. Among them were 19 patients who received hemodialysis. These patients have been investigated for the level of the presepsin. Presepsin level was quantified on immunohemilyuministsentny analyzer Pathfast (Mitsubishi Chemical Medience Corporation, Japan) in pg/ml.Results. Рresepsin at the group of patients with severe pneumonia who received hemodialysis was 6587.9 ± 2011.09 pg/ml (n = 7), рresepsin at the group of patients with pneumogenic sepsis who received hemodialysis was 6931.1 ± 820.46 pg/ml (n = 7). Рresepsin at the group of patients with chronic glomerulonephritis and nephropathy who received hemodialysis was 1693.0 ± 248.24 pg/ml (n = 5). There was no difference between the presepsin level at the groups of patients with severe pneumonia, pneumogenic sepsis who received hemodialysis. The presepsin at the group of patients with severe pneumonia, pneumogenic sepsis who received hemodialysis was above the the level of presepsin at the group of patients with chronic glomerulonephritis and nephropathy who received hemodialysis.Conclusion. The high level of presepsin is an indication of an active infectious disease and the effect of hemodialysis.
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