In:
PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 12 ( 2021-12-23), p. e0261410-
Abstract:
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 FEV 1 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 (FEV 1 , 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 FEV 1 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.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0261410
DOI:
10.1371/journal.pone.0261410.g001
DOI:
10.1371/journal.pone.0261410.g002
DOI:
10.1371/journal.pone.0261410.t001
DOI:
10.1371/journal.pone.0261410.t002
DOI:
10.1371/journal.pone.0261410.t003
DOI:
10.1371/journal.pone.0261410.t004
DOI:
10.1371/journal.pone.0261410.t005
DOI:
10.1371/journal.pone.0261410.s001
DOI:
10.1371/journal.pone.0261410.s002
DOI:
10.1371/journal.pone.0261410.s003
DOI:
10.1371/journal.pone.0261410.s004
DOI:
10.1371/journal.pone.0261410.r001
DOI:
10.1371/journal.pone.0261410.r002
DOI:
10.1371/journal.pone.0261410.r003
DOI:
10.1371/journal.pone.0261410.r004
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2267670-3
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