Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/µL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting.

Suppressive ability of defatted rice bran against lipid oxidation in cookies containing iron.

Cookies containing iron, defatted rice bran, and several oils were prepared, and their oxidative stability evaluated. Oxidation was suppressed by the defatted rice bran, but a limit to the suppressive effect was observed. The maximum peroxide values obtained with defatted rice bran were low, and similar, regardless of the degree of unsaturation of the oils. A chemical analysis suggested that proteins and polyphenols in the defatted rice bran contributed to the suppressive effect. Cookies without the defatted rice bran showed decreasing maximum peroxide value as the relative humidity increased. No such dependence was observed for the cookies containing defatted rice bran. The water sorption isotherm of defatted rice bran indicated that the weak dependence was due to low water sorption.