Efficacy and safety of a proposed omalizumab biosimilar compared to the reference product in the management of uncontrolled moderate-to-severe allergic asthma: a multicenter, phase III, randomized, double-blind, equivalency clinical trial.
IgE
allergic
asthma
biosimilar
omalizumab
Journal
Frontiers in immunology
ISSN: 1664-3224
Titre abrégé: Front Immunol
Pays: Switzerland
ID NLM: 101560960
Informations de publication
Date de publication:
2024
2024
Historique:
received:
30
04
2024
accepted:
25
06
2024
medline:
13
8
2024
pubmed:
13
8
2024
entrez:
13
8
2024
Statut:
epublish
Résumé
Allergic asthma has a considerable burden on the quality of life. A significant portion of moderate-to-severe allergic asthma patients need omalizumab, an anti-immunoglobulin-E monoclonal antibody, as an add-on therapy. In this phase III clinical trial P043 (Zerafil Exacerbation rates, Asthma Control Test (ACT) results, spirometry measurements, immunogenicity, and safety were evaluated. Each subject received either medication with a dose ranging from 150 to 375 mg based on pre-treatment serum total IgE level (IU/mL) and body weight (kg) every two or four weeks for a duration of 28 weeks. Exacerbation rates were 0.150 (CI: 0.079-0.220) in the P043 group, and 0.190 (CI: 0.110-0.270) in the omalizumab group (per-protocol). The least squares mean differences of predicted Forced Expiratory Volume in the First second (FEV P043 was equivalent to omalizumab in the management of asthma in reduction of exacerbations. There was no significant difference in other efficacy and safety parameters. www.clinicaltrials.gov (NCT05813470) and www.IRCT.ir (IRCT20150303021315N20).
Sections du résumé
Background and aims
UNASSIGNED
Allergic asthma has a considerable burden on the quality of life. A significant portion of moderate-to-severe allergic asthma patients need omalizumab, an anti-immunoglobulin-E monoclonal antibody, as an add-on therapy. In this phase III clinical trial P043 (Zerafil
Methods
UNASSIGNED
Exacerbation rates, Asthma Control Test (ACT) results, spirometry measurements, immunogenicity, and safety were evaluated. Each subject received either medication with a dose ranging from 150 to 375 mg based on pre-treatment serum total IgE level (IU/mL) and body weight (kg) every two or four weeks for a duration of 28 weeks.
Results
UNASSIGNED
Exacerbation rates were 0.150 (CI: 0.079-0.220) in the P043 group, and 0.190 (CI: 0.110-0.270) in the omalizumab group (per-protocol). The least squares mean differences of predicted Forced Expiratory Volume in the First second (FEV
Conclusion
UNASSIGNED
P043 was equivalent to omalizumab in the management of asthma in reduction of exacerbations. There was no significant difference in other efficacy and safety parameters.
Clinical trial registration
UNASSIGNED
www.clinicaltrials.gov (NCT05813470) and www.IRCT.ir (IRCT20150303021315N20).
Identifiants
pubmed: 39136011
doi: 10.3389/fimmu.2024.1425906
pmc: PMC11317399
doi:
Substances chimiques
Omalizumab
2P471X1Z11
Anti-Asthmatic Agents
0
Biosimilar Pharmaceuticals
0
Immunoglobulin E
37341-29-0
Banques de données
ClinicalTrials.gov
['NCT05813470']
Types de publication
Journal Article
Clinical Trial, Phase III
Randomized Controlled Trial
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1425906Informations de copyright
Copyright © 2024 Ghanei, Ghalebaghi, Sami, Torabizadeh, Mirsadraee, Amra, Tavakol, Raji, Fallahpour, Kiani, Abedini, Jabbari Azad, Mahdaviani, Attaran, Samet, Tavana, Haddadzadeh shoushtari, Nazari, AghaeiMeybodi, Fazlollahi, Ghasemi, Sabzvari, Kafi and Idani.
Déclaration de conflit d'intérêts
Author BG has received educational grants from AstraZeneca, Abidi, and Sanofi. Author MM has received research grants from Koushan Pharmed. Authors HR and DA have received research grants from AstraZeneca. Author MF has received research grants from Abidi. Author AK has received lecture honorarium from AstraZeneca. Author FJ has received research grants from Zist Takhmir and Vitabiotics. Author ST has received travel supports to attend scientific meetings from Novartis, GSK, and AstraZeneca. Author MH has collaborated with Jaber-ebne-hayyan. Author MRF has collaborated with Pooyesh darou. Author HK is the head of the medical department of Orchid Pharmed Company; which is in collaboration with CinnaGen company with respect to conducting clinical trials. Author AS is a member of CinnaGen medical biotechnology research center, which collaborates with universities and researchers all over the world with regards to research and development of medications and health issues. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. This study was supported by CinnaGen Company by grant number of 701/373. The sponsor also had participated in the conduction of the study.