Abasaglar ® (insulin glargin)

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Abasaglar® (insulin glargin): Immunogenicitet i fas 3-studier

I fas 3-studierna hade majoriteten av patienterna inga detekterbara antikroppar eller förändringar i den totala insulinantikroppsnivån.

Detailed Information

The development of antibody responses to insulin glargine differs in patients with T1DM compared with patients with T2DM. In phase 3 studies, the immunogenicity of Abasaglar was studied separately and compared with that of Lantus.1,2

In the main phase 3 studies, a greater proportion of patients with T1DM in the ELEMENT-1 study showed detectable antibodies to insulin glargine at baseline compared with patients with T2DM in the ELEMENT-2 study.1,2  This autoimmune condition has been previously described.3,4

In the phase 3 studies, ELEMENT-1, ELEMENT-2, and ELEMENT-5, antibody levels (percent binding) were similar between both treatment groups with no significant differences at any visit in the total study population.1,2,5

In the ELEMENT-1, ELEMENT-2, and ELEMENT-5 studies, the incidence of detectable antibodies and the median insulin antibody binding were similar between treatment groups (Table 1. Incidences of Detectable Antibodies and Percent Insulin Antibody Binding in the ELEMENT-1, ELEMENT-2, and ELEMENT-5 Studies   ).1,2,5

Table 1. Incidences of Detectable Antibodies and Percent Insulin Antibody Binding in the ELEMENT-1, ELEMENT-2, and ELEMENT-5 Studies1,2,5

Assessmenta

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Abasaglar
(n=234)

Lantus
(n=239)

ELEMENT-1

ELEMENT-2

ELEMENT-5

Incidence of detectable antibodies, n (%)b   

24 weeks

80 (30)

90 (34)

56 (15)

40 (11)

68 (29)

66 (28)

52 weeks

107 (40)

105 (39)

N/A

N/A

N/A

N/A

Percent insulin antibody binding, medianc

24 weeks

1.17

1.10

1.07

0.65

1.76

0.81

52 weeks

0.92

0.89

N/A

N/A

N/A

N/A

Abbreviations: Abasaglar = Abasaglar® (insulin glargine) 100 units/mL; ELEMENT-1 = a prospEctive, randomized, open-LabEl coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult patiENTs with type 1 diabetes mellitus; ELEMENT-2 = a prospEctive, randomized, doubLE-blind coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus; ELEMENT-5 = a study of LY2963016 compared to LANTUS® in adult participants with type 2 diabetes mellitus; Lantus = Lantus® (insulin glargine) 100 units/mL; LOCF = last observation carried forward; N/A = not applicable.

a p>.05 for all within-study treatment comparisons.

b Data represents overall 24- and 52-week study periods and not LOCF.

c Data represents LOCF.

References

1. Blevins TC, Dahl D, Rosenstock J, et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab. 2015;17(8):726-733. http://dx.doi.org/10.1111/dom.12496

2. Rosenstock J, Hollander P, Bhargava A, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab. 2015;17(8):734-741. http://dx.doi.org/10.1111/dom.12482

3. Eibl N, Spatz M, Fischer GF et al. Impaired primary immune response in type-1 diabetes: results from a controlled vaccination study. Clin Immunol 2002; 103:249–259. http://dx.doi.org/10.1006/clim.2002.5220

4. Centers for Disease Control and Prevention. National diabetes fact sheet. 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed May 28, 2018.

5. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

ELEMENT-1 = a prospEctive, randomized, open-LabEl coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult patiENTs with type 1 diabetes mellitus

ELEMENT-2 = a prospEctive, randomized, doubLE-blind coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus

ELEMENT-5 = a prospEctive, randomized, open-LabEl coMparison of a long-acting basal insulin analog LY2963016 to Lantus® in adult patiENTs with type 2 diabetes mellitus

Lantus = Lantus® (insulin glargine) 100 units/mL

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2018 M05 28

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