A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha

Barakhoeva, Z.; Vovk, L.; Fetisova, Y.; Marilova, N.; Ovchinnikova, M.; MarinaTischenko; Scherbatyuk, Y.; Kolotovkina, A.; Miskun, A.; Kasyanova, G.; TatyanaTeterina; Zorina, I.; Belousova, N.; Morozova, E.; Yakovenko, S.; Apryshko, V.; Sichinava, L.; Shalinа, R.; Polzikov, M.

Авторы: Zarema Barakhoeva, Lyudmila Vovk, Yulia Fetisova, Nina Marilova, Maria Ovchinnikova, MarinaTischenko, Yulia Scherbatyuk, Alexandra Kolotovkina, Anna Miskun, Galina Kasyanova, TatyanaTeterina, Irina Zorina, Nadezhda Belousova, Ekaterina Morozova, Sergey Yakovenko, Valentina Apryshko, Lali Sichinava, Raisa Shalinа, Mikhail Polzikov
Журнал: European Journal of Obstetrics, Gynecology and Reproductive Biology
Том: 241
Год издания: 2019
Издательство: Elsevier BV
Местоположение издательства: Netherlands
Первая страница: 6
Последняя страница: 12
DOI: 10.1016/j.ejogrb.2019.07.032
Аннотация: Objective The aim of the present study was to investigate the therapeutic equivalence between the follitropin alpha biosimilar and the reference medication in women undergoing assisted reproductive technologies (ART). Study design This multicenter, randomized (1:1), embryologist-blinded, parallel-group, comparative phase III study involved 110 women aged 20–35 years old with tubal and/or male factors of infertility. All of the subjects underwent controlled ovarian hyperstimulation (COH) using a gonadotropin-releasing hormone antagonist (GnRH-ant) protocol. Over the 5-day fixed-dose regimen, the women received 150 IU/day of follitropin alpha biosimilar (n = 55) or original follitropin alpha (n = 55), followed by dose adaptation. The primary endpoint for assessing the therapeutic equivalence was the number of retrieved oocytes using a pre-determined clinical equivalence margin of ± 3.4 oocytes. Results Similar numbers of oocytes were retrieved in both groups: 12.16 ± 7.28 in the follitropin alpha biosimilar group and 11.62 ± 6.29 in the original follitropin alpha group, with mean difference of 0.546 ± 1.297 oocytes (95% confidence interval [CI]: -2.026, 3.116), p = 0.002 (intention-to-treat [ITT] population). Additionally, no statistically significant differences were found for secondary endpoints: the onset of biochemical (34.7% and 36.7%, p = 0.883), clinical pregnancy (26.5% and 32.7%, p = 0.507), delivery (26.5% and 24.5%, p = 0.817) and take-home baby rate (28.6% and 26.5%, p = 0.816) for the follitropin biosimilar and original follitropin groups (per-protocol [PP] population). Ovarian hyperstimulation syndrome was observed in subjects with a positive pregnancy test in 0% and 3.64% of cases and after triggering ovulation in 7.27% and 3.64% for the follitropin biosimilar and original follitropin groups, respectively. Conclusions This study demonstrated similar therapeutic equivalence and safety profiles between the follitropin alpha biosimilar and the reference follitropin in women who underwent COH in GnRH-ant cycles.
Добавил в систему: Яковенко Сергей Александрович

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