AI Article Synopsis
- The study aimed to compare the efficacy, safety, and immunogenicity of a new treatment (P043) for allergic asthma with the established drug, Xolair (omalizumab), focusing on the rate of asthma exacerbations.
- Over a 28-week trial with 256 participants, results showed that both treatments had similar rates of exacerbations, asthma control test scores, and spirometry measurements, indicating that P043 is as effective as omalizumab.
- Adverse events reported were comparable between both groups, with common issues being dyspnea and headache, and no significant issues with drug safety or immunogenicity observed for either treatment.
Article 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 (FEV) 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).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11317399 | PMC |
| http://dx.doi.org/10.3389/fimmu.2024.1425906 | DOI Listing |
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