Medical security and efficacy of “filgrastim biosimilar 2” in Japanese sufferers in a post-marketing surveillance research.
J Infect Chemother. 2018 Feb 02;:
Authors: Tamura Ok, Hashimoto Ok, Nishikawa Ok
We performed a post-marketing surveillance to judge the protection and efficacy of TKN732, authorized as “filgrastim biosimilar 2”, in Japanese sufferers who developed neutropenia in the midst of most cancers chemotherapy or hematopoietic stem cell transplantation. A complete of 653 sufferers have been registered in the course of the 2-year enrollment interval ranging from Could 2013, and 627 and 614 sufferers have been eligible for security and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adversarial drug reactions have been reported in 33 sufferers (5.26%). Again ache was most incessantly noticed and reported in 20 sufferers (three.19%), adopted by pyrexia (1.28%) and bone ache (zero.96%). Danger components for adversarial reactions recognized by logistic regression analyses have been youthful age, presence of previous medical historical past, and decrease whole dose on the onset of adversarial reactions. Among the many 576 most cancers sufferers who developed Grade 2-Four neutropenia after chemotherapy, restoration to Grade 1/zero was reported in 553 sufferers (96%) following filgrastim biosimilar 2 therapy. The median length of neutrophil counts beneath 1500/?L was 5 days. As well as, all 11 sufferers who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this research confirmed that filgrastim biosimilar 2 has an analogous security profile and comparable results to the unique G-CSF product in the actual world medical setting.
PMID: 29398477 [PubMed – as supplied by publisher]