Comparison of biosimilar Tigerase and Pulmozyme in long-term symptomatic therapy of patients with cystic fibrosis and severe pulmonary impairment (subgroup analysis of a Phase III randomized open-label clinical trial (NCT04468100))

Autor: Elena L. Amelina, Stanislav A. Krasovsky, Nina E. Akhtyamova-Givirovskaya, Nataliya Yu. Kashirskaya, Diana I. Abdulganieva, Irina K. Asherova, Ilya E. Zilber, Liliya S. Kozyreva, Lubov M. Kudelya, Natalya D. Ponomareva, Nataliya P. Revel-Muroz, Elena M. Reutskaya, Tatiana A. Stepanenko, Gulnara N. Seitova, Olga P. Ukhanova, Olga V. Magnitskaya, Dmitry A. Kudlay, Oksana A. Markova, Elena V. Gapchenko
Rok vydání: 2021
Předmět:
Lung Diseases
Male
Cystic Fibrosis
Pulmonology
Physiology
Epidemiology
Drug research and development
Biochemistry
Russia
Geographical Locations
Medical Conditions
Clinical trials
Immune Physiology
Forced Expiratory Volume
Medicine and Health Sciences
Prospective Studies
Lung
Expectorants
Immune System Proteins
Deoxyribonucleases
Multidisciplinary
Pharmaceutics
Middle Aged
Recombinant Proteins
Phase III clinical investigation
Europe
Genetic Diseases
Research Design
Mucociliary Clearance
Medicine
Female
Research Article
Adult
Asia
Clinical Research Design
Science
Immunology
Autosomal Recessive Diseases
Drug Therapy
Deoxyribonuclease I
Humans
Antigens
Biosimilar Pharmaceuticals
Clinical Genetics
Pharmacology
Biology and Life Sciences
Proteins
Fibrosis
Research and analysis methods
Clinical medicine
People and Places
Adverse Events
Receptor Antagonist Therapy
Developmental Biology
Zdroj: PLoS ONE, Vol 16, Iss 12, p e0261410 (2021)
PLoS ONE
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0261410
Popis: 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.
Databáze: OpenAIRE
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