Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab.

Autor: Kulagin AD; RM Gorbacheva Research Institute, Pavlov University, 6/8 L'va Tolstogo St, Saint Petersburg, 197022, Russia. kulagingem@rambler.ru., Ptushkin VV; Botkin Moscow City Clinical Hospital, Moscow, Russia., Lukina EA; National Medical Research Center for Hematology, Moscow, Russia., Davydkin IL; Samara State Medical University, Samara, Russia., Korobkin AV; Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russia., Shamrai VS; Rostov Regional Clinical Hospital, Rostov-on-Don, Russia., Konstantinova TS; Sverdlovsk Regional Clinical Hospital No. 1, Yekaterinburg, Russia., Kaporskaya TS; Irkutsk Regional Clinical Hospital, Irkutsk, Russia., Mitina TA; Moscow Regional Clinical Research Institute Named After M.F. Vladimirsky, Moscow, Russia., Ksenzova TI; Tyumen Regional Clinical Hospital No. 1, Tyumen, Russia., Zuev EV; JSC GENERIUM, Volginsky Settlement, Vladimir Region, Russia., Markova OA; JSC GENERIUM, Volginsky Settlement, Vladimir Region, Russia., Gapchenko EV; JSC GENERIUM, Volginsky Settlement, Vladimir Region, Russia., Kudlay DA; JSC GENERIUM, Volginsky Settlement, Vladimir Region, Russia.; I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
Jazyk: angličtina
Zdroj: Annals of hematology [Ann Hematol] 2021 Nov; Vol. 100 (11), pp. 2689-2698. Date of Electronic Publication: 2021 Aug 16.
DOI: 10.1007/s00277-021-04624-7
Abstrakt: Currently, eculizumab is the main effective treatment for paroxysmal nocturnal hemoglobinuria (PNH). The aim of this randomized multicenter noninferiority study was to evaluate the efficacy and safety of the Biosimilar (Elizaria) in comparison with the Originator (Soliris) in patients with PNH. Biosimilar and Originator were administered at a dose of 600 mg weekly for 4 weeks at the initial stage in naive patients, as well as for maintenance therapy at a dose of 900 mg every 2 weeks in all patients. The primary endpoint was a comparative assessment of hemolytic activity based on the area under the lactate dehydrogenase (LDH) concentration-time curve during the maintenance therapy. Thirty-two (32) patients were randomized for therapy with Biosimilar (n = 16) or Originator (n = 16). The mean values of LDH concentration-time curve were similar in both treatment groups without statistically significant differences (p > 0.05). Evaluation of secondary endpoints has shown no statistically significant differences between the groups. Safety values were comparable in both treatment groups. The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056.
(© 2021. The Author(s).)
Databáze: MEDLINE
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