Lower Pain Scores With Biosimilar Pegfilgrastim After Pediatric Stem Cell Transplant

Allogenic hematopoietic stem cell transplantation (allo-HSCT), used to treat hematologic malignancies, some metabolic diseases, and immunologic deficiency, can be aided by treatment with granulocyte-colony stimulating factor (G-CSF) therapies. G-CSFs—including filgrastim and the longer-acting pegfilgrastim—can promote hematopoiesis, accelerate immune reconstruction, and reduce the duration of febrile neutropenia.

A recent retrospective analysis compared experience with Chinese-licensed biosimilar pegfilgrastim (manufactured by Qilu Pharmaceutical) and biosimilar filgrastim (manufactured by Kyowa Hakko Kirin) products in treating pediatric patients.

The patients (n = 86), all of whom received allo-HSCT at a single center between 2014 and 2017, had thalassemia major, aplastic anemia, leukemia, and mucopolysaccharidosis. In total, 53 of the patients were treated with pegfilgrastim, and 33 were treated with filgrastim; in both groups, G-CSF was administered 5 days after allo-HSCT. Patients were followed for at least 3 months.

Read more about biosimilar G-CSF agents and stem cell transplantation.

There was no significant difference observed between the patients receiving pegfilgrastim and those receiving filgrastim in terms of time to neutrophil recovery, time to platelet recovery, white blood cell count, or neutrophil percentage. There were also no significant differences between the 2 groups in the incidence of fever for unknown reasons or transplantation-related complications.

However, there was a significant difference observed in pain scores between the 2 groups using the visual analogue scale (and the modified Flacc scale for infants); the pain score was 3.06 (standard deviation [SD], 0.41) for the pegfilgrastim group and 25.18 (SD, 6.22) for the filgrastim group (P <.001). The authors suggest that the patients who received a single dose of pegfilgrastim—versus an average of 9.78 (SD, 2.36) doses of filgrastim&mdash;had a less injection-related pain and therefore a lower psychological burden associated with G-CSF treatment.

Additionally, total hospitalization costs were higher for the filgrastim group than for the pegfilgrastim group, though the difference was not statistically significant. The authors indicate that increased pain and higher psychological burden in the filgrastim group may have led to lower compliance with G-CSF treatment.

While the authors note that the long-term effects of using pegfilgrastim versus filgrastim after allo-HSCT need to be investigated, and that larger, multi-center, randomized controlled trials will be needed, their research has “encouraging findings” that support the use of pegfilgrastim in this setting.

Reference

Ye Q, Jiang H, Jiang H. A comparison of the effect of xinruibai versus filgrastim on hematopoietic reconstruction after allogeneic hematopoietic stem cell transplantation. Ital J Pediatr. 2018;44(1): 63. doi: 10.1186/s13052-018-0482-0.