Omalizumab biosimilar corresponds to the reference medicine in children with severe allergic asthma

P043, an anomalizumab biosimilar, was found to be equivalent to the reference drug omalizumab in reducing exacerbations and treating asthma, with no significant differences in efficacy and safety parameters.¹

“Allergic asthma imposes a significant burden on quality of life. A significant proportion of patients with moderate to severe allergic asthma require omalizumab, a monoclonal antibody against immunoglobulin E, as adjunctive therapy… This life-threatening condition requires affordable and effective treatment options, which warrants a clinical equivalence trial for a new biosimilar of omalizumab compared to the originator,” wrote principal investigator Mostafa Ghanei, MD, professor at the Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran, and colleagues.¹

Ghanei and colleagues analyzed data from 256 participants with uncontrolled moderate to severe allergic asthma enrolled in a randomized, multicenter, double-blind, two-arm, parallel-group Phase 3 clinical equivalence trial (NCT05813470). Participants were randomized to receive either P043 or omalizumab at doses ranging from 150 to 375 mg, based on pretreatment serum total IgE levels (IU/mL) and body weight (kg), every 2 or 4 weeks for 28 weeks.¹

The researchers found that the P043 cohort had an exacerbation rate of 0.150 (95% CI 0.079-0.220) and the omalizumab cohort had an exacerbation rate of 0.190 (95% CI 0.079-0.220; per protocol). The least squared mean differences in predicted forced expiratory volume in the first second (FEV1) were -2.51% (95% CI -7.17-2.15; P = .29) before using a bronchodilator and -3.87% (95% CI: -8.79-1.04; P = .12) after using a bronchodilator.¹

In the P043 group, mean Asthma Control Test (ACT) scores at screening were 10.62 (standard deviation [SD]2.93) and 20.93 (SD 4.26) at the final visit. In the omalizumab group, mean ACT values ​​were 11.09 (SD 2.75) at screening and 20.46 (SD 5.11) at the final visit.¹

Regarding safety, Ghanei and colleagues found that a total of 288 adverse events (AEs) occurred among the enrolled participants. The most common AEs were dyspnea and headache. There were no significant differences in the overall incidence of AEs between the omalizumab and P043 cohorts (P = .62) and serious AEs (P = .07). There was no evidence of antibodies to the drug.

“Because asthma is a chronic disease, ensuring an acceptable safety profile for any treatment is imperative,” concluded Ghanei and colleagues.¹ “The results of this study suggest that P043, an omalizumab biosimilar, can be used as an add-on treatment for patients with uncontrolled moderate to severe allergic asthma.”

Other recent research on asthma has found that treating children aged 6 to 11 years with uncontrolled moderate to severe type 2 asthma with dupilumab for up to two years resulted in a reduction in exacerbation rates and improvements in lung function, according to new findings from the largest dose cohort in the VOYAGE and EXCURSION pediatric trials.²

Dupilumab significantly reduced the annual exacerbation rate and improved ppFEV1 in the 158 children who were treated continuously with the drug for up to 2 years. The 85 children who initially received placebo in the EXCURSION study and then switched to 200 mg dupilumab every 2 weeks experienced comparable reductions in severe asthma exacerbations and ppFEV1 improvements observed in the study.²

REFERENCES
1. Ghanei M, Ghalebaghi ​​​​B, Sami R, et al. Efficacy and safety of a proposed omalizumab biosimilar compared with the reference product in the treatment of uncontrolled moderate to severe allergic asthma: a multicenter, randomized, double-blind, phase III clinical equivalence trial. Front Immunol. 2024;15:1425906. doi:10.3389/fimmu.2024.1425906
2.Phipatanakul W, Vogelberg C, Bacharier LB, et al. Dupilumab 200 mg was effective for up to 2 years in children (6–11 years) with moderate to severe asthma: open-label extension study EXCURSION. Pediatric Pulmonol. 2024; 1-8. doi:10.1002/ppul.27167.