Nephron · 2026
Long-Term Therapy with Eculizumab Biosimilar in Patients with Atypical Haemolytic Uraemic Syndrome: Outcomes of a Prospective Observational Study.
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Kotenko Oleg, Kozlovskaya Natalia, Emirova Khadizha, Muzurov Alexander, Moiseev Sergey, Konakova Irina, Shavkin Aleksey, Makarova Tamara, Gazizulina Maria, Vinogradov Vladimir, Ivanova Ekaterina, Demyanova Kseniya, Korotchaeva Yulia, Proshina Tatiana, Melnikova Yulia, Рoladova Lyudmila, Mazur Yulia, Markova Oksana, Borozinets Anton
Аннотация
BACKGROUND: The objective of a multicentre, prospective, observational study of an eculizumab biosimilar (Elizaria®) was to analyse the efficacy and safety of long-term complement inhibitor therapy in patients with atypical haemolytic uraemic syndrome (aHUS).
MATERIALS AND METHODS: The study included 50 patients aged 1-55 years, with 42% of them under the age of 18. The patients received the eculizumab biosimilar in routine clinical practice within 56 weeks; 19 patients (38%) had been treated with eculizumab prior to enrolment, whereas 31 patients (62%) were naive to complement inhibitors.
RESULTS: By the end of the study, an increase in platelet count of 39.48 ± 21.7 × 109/L and 33.61 ± 24.06 × 109/L was reported in treatment-naive and treatment-experienced patients, respectively. By the end of the study, 96% of treatment-experienced patients and 100% of treatment-naive patients had normal platelet counts. The mean LDH activity did not change significantly, with levels of 253.84 ± 122.22 U/L registered at screening and 245.24 ± 93.52 U/L at the end of the study. In total, 39 patients (77.6%) at week 21 and 40 patients (80%) at week 52 had no thrombotic microangiopathy (TMA) events. During the study, the proportion of patients with a complete TMA response increased significantly, rising to 8% (p = 0.046). The proportion of patients with an estimated glomerular filtration rate improvement of 15 mL/min/1.73 m2 and more at week 52 was 12%. During the safety assessment, 63 adverse events not related to the investigational medicinal product were reported.
CONCLUSION: Long-term complement inhibitor therapy with the eculizumab biosimilar in patients with aHUS has demonstrated a stable effect, a favourable safety profile, and low immunogenicity.
MATERIALS AND METHODS: The study included 50 patients aged 1-55 years, with 42% of them under the age of 18. The patients received the eculizumab biosimilar in routine clinical practice within 56 weeks; 19 patients (38%) had been treated with eculizumab prior to enrolment, whereas 31 patients (62%) were naive to complement inhibitors.
RESULTS: By the end of the study, an increase in platelet count of 39.48 ± 21.7 × 109/L and 33.61 ± 24.06 × 109/L was reported in treatment-naive and treatment-experienced patients, respectively. By the end of the study, 96% of treatment-experienced patients and 100% of treatment-naive patients had normal platelet counts. The mean LDH activity did not change significantly, with levels of 253.84 ± 122.22 U/L registered at screening and 245.24 ± 93.52 U/L at the end of the study. In total, 39 patients (77.6%) at week 21 and 40 patients (80%) at week 52 had no thrombotic microangiopathy (TMA) events. During the study, the proportion of patients with a complete TMA response increased significantly, rising to 8% (p = 0.046). The proportion of patients with an estimated glomerular filtration rate improvement of 15 mL/min/1.73 m2 and more at week 52 was 12%. During the safety assessment, 63 adverse events not related to the investigational medicinal product were reported.
CONCLUSION: Long-term complement inhibitor therapy with the eculizumab biosimilar in patients with aHUS has demonstrated a stable effect, a favourable safety profile, and low immunogenicity.