Abstract
BackgroundTo ascertain the efficacy, safety, and immunogenicity from existing evidence via conducting a meta-analysis of randomized controlled trials between biosimilar and originator insulins.MethodsThe PubMed, Cochrane Library, EMBASE, and ClinicalTrails.gov were searched to identify head-to-head randomized controlled trials (RCTs) that directly compare the efficacy and safety of biosimilar insulin and its originator. Efficacy was assessed by change of HbA1C, fasting plasma glucose (laboratory or self-monitoring of blood glucose (SMBG)), and change all mean of 7 points- or 8 points- SMBG. Safety was assessed by change in proportion hypoglycemia and serious hypoglycemia. The occurrence of anti-insulin antibodies (AIAs) was also evaluated.ResultsFourteen RCTs with 6188 patients from different countries were included. Data were pooled using a random-effects model and were expressed as the mean difference (MD), odds ratio (OR), and 95% confidence interval (CI). In efficacy, Insulin biosimilar products showed similar in change of HbA1C at weeks 26 and 52, the MD were 0.03 (95% CI − 0.02 to 0.07, p = 0.28), and 0.05 (95% CI − 0.05 to 0.15, p = 0.36), respectively. The proportion of HbA1C less than 7% at endpoint, the OR were 1.04 (95% CI 0.89 to 1.20, p = 0.64). The change of fasting plasma glucose (laboratory or SMBG) mmol/L in 24–52 weeks and change all mean of 7 points−/8 points- SMBG mmol/L in 24–52 weeks, the MD were 0.02 (95% CI − 0.20 to 0.24, p = 0.87) and − 0.34 (95% CI − 1.35 to 0.67, p = 0.51), respectively. In occurrence of hypoglycemia (≥ 1 events) and severe hypoglycemia, the OR were 0.96 (95% CI 0.85 to 1.09, p = 0.52) and 1.06 (95% CI 0.85 to 1.31, p = 0.62). The AIA was 1.02 (95% CI 0.90 to 1.16, p = 0.76). Analysis stratified by type of diabetes and duration of insulin. There was no significant difference between the biosimilar and their reference group in a different type of diabetes and different duration of insulin.ConclusionsInsulin biosimilar showed comparable characteristics with the reference drug in terms of efficacy, safety, immunogenicity, through comprehensive and specific conventional meta-analysis.
Highlights
To ascertain the efficacy, safety, and immunogenicity from existing evidence via conducting a metaanalysis of randomized controlled trials between biosimilar and originator insulins
Study characteristics A total of 196 records were screened and 89 full-text articles were assessed for eligibility
All the studies reported the outcome of efficacy and safety and eleven of them reported immunogenicity [19, 20, 22,23,24,25,26,27,28,29,30]
Summary
Safety, and immunogenicity from existing evidence via conducting a metaanalysis of randomized controlled trials between biosimilar and originator insulins. The management of patients living with type 1 and type 2 diabetics, and their complications, such as cardiovascular. The global costs of diabetes and its consequences are large and will substantially increase [4]. Good glycemic control is the goal of diabetes treatment and prevents cardiovascular complications and reduces mortality [5, 6]. Patients living with type 1 diabetes must use insulin. If patients living with type 2 diabetes, medications include oral medications to control it, while others may need insulin. Insulins biosimilar has expanded treatment options for diabetes and can potentially reduce medical costs, especially in low- and middle-income countries. The notable cost-effectiveness impact of a biosimilar is the potential for healthcare budgetary redistribution, decrease financial barriers and increase patient access to biological therapies [7, 8]. The results in clinical trials are consistent, when the number of samples increases, it may cause differences or differences in certain subgroups
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