Filgrastim versus TBO‐filgrastim to reduce the duration of neutropenia after autologous hematopoietic stem cell transplantation: TBO, or not TBO, that is the question

Abstract

After a hospital-wide formulary change resulted in the replacement of filgrastim with TBO-filgrastim for all on- and off-label indications, we performed a retrospective comparison of patients with myeloma receiving 200 mg/m(2) melphalan with autologous hematopoietic stem cell transplantation to see whether the type of growth factor used post-transplant made a difference. One hundred and eighty-two consecutive patients with myeloma were studied, 91 receiving filgrastim immediately prior to the change and 91 receiving TBO-filgrastim afterward. The CD34(+) cell dose was comparable, as were other characteristics. Although the overall time to neutrophil recovery was similar for both groups, early engraftment (≤ 12 d) occurred more often (p = 0.05), and late engraftment (≥ 14 d) less often (p = 0.09) in filgrastim-treated patients. The number of documented infections was significantly less in the TBO-filgrastim group. Day 100 mortality and hospital stay were similar for the two groups. These data indicate that there is no material difference between filgrastim and TBO-filgrastim in this clinical setting.

Ciprofloxacin vs levofloxacin for prophylaxis during hematopoietic stem‐cell transplantation

“…A 1‐day difference in engraftment was observed between treatment groups. TBO‐filgrastim, used during the levofloxacin treatment period, has been shown to delay engraftment compared to filgrastim, without compromising clinical outcomes or duration of hospital admission …”

Tbo-filgrastim versus filgrastim for stem cell mobilization and engraftment in autologous hematopoietic stem cell transplant patients: A retrospective review

“…There were no significant differences noted between any of the engraftment endpoints, demonstrating equivalence between the two products in supporting stem cell engraftment as shown in other retrospective observations. 11,12,15 In comparison to a retrospective review published in 2015 that showed significantly less documented infections in patients using tbo-filgrastim versus filgrastim for stem cell mobilization and engraftment, there was no difference in the number of infections documented per patient during this study. However, the filgrastim group had a larger number of positive blood cultures, gram positive bacterial cultures, and a larger number of documented clostridium difficile infections, while the tbo-filgrastim cohort had a larger number of confirmed respiratory infections and fungal infections.…”

“…This formulary change was based on the use of tbo-filgrastim as a biosimilar in the EU, a group of retrospective evidence demonstrating the safety and efficacy of tbo-filgrastim versus placebo and/or filgrastim, and the potential for significant cost savings by utilizing tbo-filgrastim. [11][12][13][14][15] This study compares the efficacy of tbo-filgrastim versus filgrastim for stem cell mobilization and stem cell engraftment in autologous HSCT recipients along with a financial analysis.…”

Conversion from Filgrastim to Tbo-filgrastim: Experience of a Large Health Care System

“…In addition, there is a growing body of evidence on the efficacy and safety of tbo-filgrastim in its off-label indications. 14,19,20 In 1 retrospective study conducted in a U.S. hospital among 185 patients diagnosed with lymphoma or plasma cell disorders undergoing G-CSF mobilization, there was no significant difference seen between filgrastim and tbo-filgrastim in the total collection of CD34(+) cells, which was the primary end point. Furthermore, no clinically meaningful differences were seen in secondary efficacy and safety end points.…”