Biosimilar eculizumab for the treatment of pregnancy associated atypical hemolytic uremic syndrome: a retrospective comparative study

Korotchaeva Y.V.: Sechenov University, Moscow

Kozlovskaya N.L.: Eramishancev City Clinical Hospital, Moscow

Kirsanova T.V.: Kulakov Scientific Research Medical Center for Obstetrics, Gynecology and Perinatology

Balakireva A.I.: Lomonosov Moscow State University

Shifman E.M.: Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia

Moiseev S.: Tareev Clinic of Internal Diseases, Sechenov First Moscow State Medical University, Moscow, Russia

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Summary

Aim

To compare the efficacy and safety profile of the original and biosimilar eculizumab in the treatment of pregnancy associated atypical hemolytic uremic syndrome (p-aHUS).

Material and methods

In a retrospective multicenter observational study, we enrolled 74 females (age 15 to 44 years) with p-aHUS treated with the original eculizumab (n=41) or its biosimilar (n=33) in addition to plasma therapy. Eculizumab was administered at a dose of 900 mg intravenously every week for the first 4 weeks (induction) and at a dose of 1,200 mg for the fifth week, followed by 1,200 mg every two weeks (maintenance). The primary endpoint was the combination of death from all causes and end-stage renal disease, whereas the secondary endpoints included death from all causes, normalization of blood platelet count and serum LDH activity (hematologic response) and changes in renal function in surviving patients.

Results

The baseline demographic and clinical characteristics, including the severity of thrombotic microangiopathy (TMA), were similar across the patients treated with the original and biosimilar eculizumab. Most patients from the two groups required treatment with hemodialysis within the first few days after the onset of TMA (90.2% and 84.8%, respectively) and presented with various extrarenal manifestations (92.7% and 96.9%). The hematologic response to eculizumab was achieved in all surviving patients treated both with the reference and biosimilar products. The occurrence of the primary endpoint was similar in the two groups of patients (19.5% and 18.1%, respectively). The mortality rate from multiple organ failure was also similar (7.3% and 3.0, respectively). In both groups of patients, early treatment with eculizumab initiated within one week after disease onset was the most effective and allowed to avoid death and to achieve recovery of kidney function. Discontinuation of eculizumab due to adverse reactions was not reported.

Conclusion

In patients with p-aHUS, biosimilar eculizumab (Elizaria) was as effective and safe as a reference product (Soliris).

Key words

Pregnancy associated atypical hemolytic uremic syndrome, pregnancy, thrombotic microangiopathy.