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

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 Publisher Pubmed

Ghanei M¹ ; Ghalebaghi B² ; Sami R³ ; Torabizadeh M⁴ ; Mirsadraee M⁵ ; Amra B⁶ ; Tavakol M⁷ ; Raji H⁸ ; Fallahpour M⁹ ; Kiani A¹⁰ ; Abedini A¹¹ ; Jabbari Azad F¹² ; Mahdaviani SA¹³ ; Attaran D¹⁴ Show All Authors

Ghanei M¹
Ghalebaghi B²
Sami R³
Torabizadeh M⁴
Mirsadraee M⁵
Amra B⁶
Tavakol M⁷
Raji H⁸
Fallahpour M⁹
Kiani A¹⁰
Abedini A¹¹
Jabbari Azad F¹²
Mahdaviani SA¹³
Attaran D¹⁴
Samet M¹⁵
Tavana S¹⁶
Haddadzadeh Shoushtari M¹⁷
Nazari J¹⁸
Aghaeimeybodi F¹⁵
Fazlollahi MR¹⁹
Ghasemi R²⁰
Sabzvari A²¹
Kafi H²²
Idani E²³

Show Affiliations

1. Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
2. Ear, Nose, Throat and Head and Neck Surgery Research Center, Iran University of Medical Sciences, Tehran, Iran
3. Department of Internal Medicine, School of Medicine, Khorshid Hospital, Isfahan University of Medical Sciences, Isfahan, Iran
4. Golestan Hospital Clinical Research Development Unit, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
5. Department of Internal Medicine, Islamic Azad University, Mashhad, Iran
6. Bamdad Respiratory and Sleep Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
7. Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran
8. Department of Internal Medicine, Air Pollution and Respiratory Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
9. Allergy Department, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran
10. Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran
11. Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran
12. Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
13. Pediatric Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
14. Respiratory & Critical Care Division, Mashhad University of Medical Sciences, Mashhad, Iran
15. Department of Internal Medicine, Division of Pulmonology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
16. Department of Pulmonary Medicine, Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
17. Air Pollution and Respiratory Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
18. Lung Department, Ebnesina Hospital, Tehran, Iran
19. Immunology, Asthma and Allergy Research Institute, Tehran University of Medical Sciences, Tehran, Iran
20. Eisabne Maryam Hospital, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran
21. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran
22. Medical Department, Orchid Pharmed Company, Tehran, Iran
23. Pulmonary Rehabilitation Research Center (PRRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran

Source: Frontiers in Immunology Published:2024

Abstract

Background and aims: 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®, CinnaGen, Iran) efficacy, safety, and immunogenicity were compared with Xolair® (the originator omalizumab). The primary outcome was the rate of protocol-defined asthma exacerbations. Methods: 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: 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 (FEV1) were -2.51% (CI: -7.17-2.15, P=0.29) and -3.87% (CI: -8.79-1.04, P=0.12), pre- and post-bronchodilator use. The mean ± SD of ACT scores at the screening and the last visit were 10.62 ± 2.93 and 20.93 ± 4.26 in P043 and 11.09 ± 2.75 and 20.46 ± 5.11 in the omalizumab group. A total of 288 adverse events were reported for the 256 enrolled participants. Among all, “dyspnea” and “headache” were the most reported ones. The overall incidence of adverse events (P=0.62) and serious adverse events (P=0.07) had no significant differences between the two groups. None of the samples were positive for anti-drug antibodies. Conclusion: 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: www.clinicaltrials.gov (NCT05813470) and www.IRCT.ir (IRCT20150303021315N20). 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.

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Style	Citing Format
MLA	Ghanei M, et al.. "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." Frontiers in Immunology, vol. 15, no. , 2024, pp. -.
APA	Ghanei M, Ghalebaghi B, Sami R, Torabizadeh M, Mirsadraee M, Amra B, Tavakol M, Raji H, Fallahpour M, Kiani A, Abedini A, Jabbari Azad F, Mahdaviani SA, Attaran D, Samet M, Tavana S, Haddadzadeh Shoushtari M, Nazari J, Aghaeimeybodi F, ... Idani E (2024). 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. Frontiers in Immunology, 15(), -.
Chicago	Ghanei M, Ghalebaghi B, Sami R, Torabizadeh M, Mirsadraee M, Amra B, Tavakol M, et al.. "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." Frontiers in Immunology 15, no. (2024): -.
Harvard	Ghanei M et al. (2024) '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', Frontiers in Immunology, 15(), pp. -.
Vancouver	Ghanei M, Ghalebaghi B, Sami R, Torabizadeh M, Mirsadraee M, Amra B, et al.. 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. Frontiers in Immunology. 2024;15():-.
BibTex	@article{ author = {Ghanei M and Ghalebaghi B and Sami R and Torabizadeh M and Mirsadraee M and Amra B and Tavakol M and Raji H and Fallahpour M and Kiani A and Abedini A and Jabbari Azad F and Mahdaviani SA and Attaran D and Samet M and Tavana S and Haddadzadeh Shoushtari M and Nazari J and Aghaeimeybodi F and Fazlollahi MR and Ghasemi R and Sabzvari A and Kafi H and Idani E}, title = {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}, journal = {Frontiers in Immunology}, volume = {15}, number = {}, pages = {-}, year = {2024} }
RIS	TY - JOUR AU - Ghanei M AU - Ghalebaghi B AU - Sami R AU - Torabizadeh M AU - Mirsadraee M AU - Amra B AU - Tavakol M AU - Raji H AU - Fallahpour M AU - Kiani A AU - Abedini A AU - Jabbari Azad F AU - Mahdaviani SA AU - Attaran D AU - Samet M AU - Tavana S AU - Haddadzadeh Shoushtari M AU - Nazari J AU - Aghaeimeybodi F AU - Fazlollahi MR AU - Ghasemi R AU - Sabzvari A AU - Kafi H AU - Idani E TI - 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 JO - Frontiers in Immunology VL - 15 IS - SP - EP - PY - 2024 ER -

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