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The following is a summary of “Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria,” published in the August 2024 issue of Hematology by Kulasekararaj et al.
The ABP 959 is a biosimilar to the eculizumab reference product (RP), approved for treating patients with paroxysmal nocturnal hemoglobinuria (PNH).
Researchers conducted a retrospective study evaluating the clinical similarity of ABP 959 in comparison with eculizumab RP.
They divided eculizumab RP-treated patients with PNH into 1 of 2 sequences, ABP 959/eculizumab RP or eculizumab RP/ABP 959. The ABP 959’s efficacy was addressed by measuring control of intravascular hemolysis with lactate dehydrogenase (LDH) and the time-adjusted area under the effect curve of LDH. Secondary outcomes were evaluated, including safety, pharmacokinetics, and immunogenicity 42 patients were selected, 20 in the ABP 959/eculizumab RP group and 22 in the eculizumab RP/ABP 959 cohort within 25 centers.
The results showed efficacy similarity was observed by a ratio of geometric least squares means of LDH (ABP 959/eculizumab RP) of 1.0628, with a one-sided 97.5% upper CI of 1.1576 at week 27. Additionally, the geometric mean ratio of the time-adjusted area under the effect curve of LDH (ABP 959 vs. eculizumab RP) was 0.981, with a 90% CI of 0.9403–1.0239 from week 13 to 27, week 39 to 53, and week 65 to 79. All secondary efficacy endpoints were comparable between treatment cohorts, and no new safety concerns were identified.
The results showed patients with PNH and previously demonstrated the similarity of analytical, nonclinical, and clinical pharmacokinetics and pharmacodynamics in healthy volunteers, supported by no clinical differences between ABP 959 and eculizumab RP.
Source: onlinelibrary.wiley.com/doi/full/10.1002/ajh.27456
