Abasaglar ® (insulin glargin)

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Abasaglar® (insulin glargin): Överkänslighetsreaktioner

I ELEMENT fas 3-studier var incidensen av allergiska händelser och reaktioner på injektionsstället likartade mellan Abasaglar- och Lantusbehandlade grupper.

Detailed Information

In 3 phase 3 studies, ELEMENT-1, ELEMENT-2, and ELEMENT-5, the efficacy and safety of Abasaglar was compared with Lantus in the treatment of patients with T1DM or T2DM.1-4

In the ELEMENT-1, ELEMENT-2, and ELEMENT-5 studies, the incidences of allergic events and injection site reactions were similar between treatment groups (Table 1). Allergic events

  • were predominantly mild or moderate in severity, and

  • did not result in discontinuation excepted in ELEMENT-5 study where 1 patient treated with Abasaglar discontinued due to hypersensitivity reaction, which was moderate in severity.1,2,4

Pain was the most commonly reported injection site reaction and was primarily reported as mild to moderate in severity (Table 1).1-4  

Table 1. Allergic Events and Injection Site Reaction in ELEMENT-1, ELEMENT-2, and ELEMENT-5 Studies

Assessment, n (%)a

Abasaglar
(n=268)

Lantus
(n=267)

Abasaglar
(n=376)

Lantus
(n=380)

Abasaglar
(n=249)

Lantus
(n=244)

ELEMENT-1b1

ELEMENT-2c2

ELEMENT-5d3,4

Special topic assessment of allergic events

20 (8)

11 (4)

21 (6)

27 (7)

10 (4)

15 (6)

Dermatitis, pruritus, rash, othere

7 (3)

4 (2)

8 (2)

12 (3)

3 (1)

3 (1)

Arthralgia, arthritis, periarthritis

4 (2)

5 (2)

7 (2)

9 (2)

3 (1)

8 (3)

Injection sitef

6 (2)

2 (1)

5 (1)

4 (1)

6 (2)

9 (4)

Hypersensitivity

1 (<1)

1 (<1)

NR

NR

1 (<1)

1 (<1)

Allergic respiratory symptom, asthma, nasal edema

2 (1)

0 (0)

3 (1)

5 (1)

1 (<1)g

1 (<1)g

Injection site reactionh

7 (3)

3 (1)

13 (4)

11 (3)

6 (2)

9 (4)

Pain

6 (2)

2 (1)

10 (3)

5 (1)

2 (<1)

7 (3)

Pruritus

2 (1)

1 (<1)

4 (1)

4 (1)

2 (<1)

1 (<1)

Rash

2 (1)

1 (<1)

3 (1)

3 (1)

2 (<1)

1 (<1)

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 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; NR = not reported.

a Patients may be counted in more than 1 category.

b p>.05 for all treatment comparisons. Treatment comparisons were not performed if there were less than 4 patients with events.

c p>.05 for all treatment comparisons with the exception of injection site reactions as treatment comparisons were not performed.

d p>.05 for all treatment comparisons.

e Angioedema, macular rash, papular rash, photosensitivity reaction, pruritic rash, urticaria, vesicular rash.

f Induration, nodule, pruritus, reaction, swelling.

g Respiratory (asthma), thoracic and mediastinal disorders.

h Patient questionnaires.

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. Pollom RK, Lacaya LB, Ilag LL. Efficacy and safety between insulin glargine products (LY2963016 and Lantus®) in patients with T2DM: the ELEMENT 5 study [abstract]. Diabetes. 2017;66(suppl 1):A249. https://doi.org/10.2337/db17-890-1488

4. 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 M06 06


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