Comparative efficacy of the original and biosimilar eculizumab in the treatment of obstetric atypical hemolytic-uremic syndrome

Korotchaeva Y.V.: Sechenov University, Moscow

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

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

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Summary

Obstetric atypical hemolytic-uremic syndrome (aHUS) is an emergency with an unfavorable prognosis. The implementation of the complement-blocking drug Eculizumab into clinical practice significantly improved prognosis of patients with obstetric aHUS. In 2019, the first biosimilar of Eculizumab was developed in Russia by GENERIUM.

Aim

In a retrospective study, we compared the efficacy of the original and biosimilar eculizumab in the treatment of obstetric aHUS.

Material and methods

We recruited 50 patients with obstetric aHUS; 41 of them were treated with the original eculizumab, and 9 patients with biosimilar eculizumab. Eighteen of 41 patients initially treated with the original eculizumab were switched to biosimilar in 2019.

Results

Patients in the two groups initially did not differ in age, obstetric history, the number of previous complement activating conditions and the clinical and laboratory parameters in the acute phase of the disease. Kidney function recovered completely in 80.5% and 88.9% of patients who were treated with the original and biosimilar eculizumab, respectively, whereas 12.2% and 11.1% of patients from the two groups remained dialysis-dependent. In both groups, the renal outcome was better with the early initiation of therapy (within 2 weeks from the onset of the disease) (odds ratio 11.6, 95% confidence interval 1.73; 78.43). Hematological parameters normalized in all surviving patients. None of 18 patients who switched from the original eculizumab to biosimilar had a recurrence of thrombotic microangiopathy.

Conclusion

Our results confirmed the similar efficacy of the original and biosimilar eculizumab in the treatment of obstetric aHUS, both for relief of an acute episode of thrombotic microangiopathy and for prevention of aHUS relapse.

Key words

Obstetric atypical hemolytic-uremic syndrome, pregnancy, thrombotic microangiopathy, eculizumab, Elizaria, Soliris