Results of a retrospective study of the clinical efficacy and safety of insulin RinFast® in children with type 1 diabetes mellitus

Abstract

BACKGROUND: The relevance of the study is justified by the fact that in recent years, the original insulin preparations have been replaced with biosimilars in the regions of the Russian Federation, but there are currently few studies describing the use of insulin biosimilars in children with type 1 diabetes mellitus (DM1), both in domestic and foreign sources.AIM: To evaluate the efficacy and safety insulin therapy with RinFast® (GEROPHARM LLC, Russia) as bolus therapy in combination with long-acting insulin and as monotherapy in an insulin pump in children with DM1 in real clinical practice.MATERIALS AND METHODS: The dynamics of HbA1c after 3 and 6 months, the change in daily insulin requirements, the fre quency of episodes of postprandial hyper- and hypoglycemia, adverse reactions at injection sites, the number of patients who reached the target values of HbA1c in children with DM1 who received RinFast® at least 6 months after the original analogue of insulin aspart were evaluated.RESULTS: The study was conducted in 50 children with DM1 from 1 to 18 years old (average age 9.8±4.6 years), with a duration of DM1 of more than 1 year (average duration 3.5±2.1 years), who had glycated hemoglobin (HbA1c) at the beginning of follow-up of no more than 9.5% and received biosimilar RinFast® for at least 6 months after the transfer from the original analogue of insulin aspart. Basic bolus insulin therapy in 36 children was carried out using multiple injections of insulin (MII), in 14 — continuous supply of insulin (NPI) using an insulin pump. The study resulted in HbA1c levels comparable to the baseline 3 and 6 months after the start of therapy with the RinFast® biosimilar (p=0.05), no changes in the daily ­insulin ­requirement (p=0.05) and no increase in the frequency of episodes of postprandial hyper- (p=0.05) and hypoglycemia (p=0.05) and adverse events (p=0.05). High adherence to treatment with the RinFast® biosimilar was noted.CONCLUSION: The results obtained indicate the absence of a clinically significant deterioration in glycemic control indicators after the transfer of children with DM1 to therapy with the RinFast® biosimilar, which makes it possible to use it safely and effectively in this category of patients.