Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

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Trulicity® (dulaglutid): Antikroppar

En liten del av patienterna (1,6 %) utvecklade antikroppar mot Trulicity (dulaglutid). Minskningarna av HbA1c var liknande hos patienter med GADA+ och GADA-

Detailed Information

In 9 phase 2 and phase 3 clinical studies, treatment with dulaglutide was associated with a 1.6% incidence of treatment emergent dulaglutide anti-drug antibodies (Table 1. Incidence of Anti-Drug Antibodies Across 9 Phase 2 and Phase 3 Studies in Patients Treated With Dulaglutide), indicating that the structural modifications in the GLP-1 and modified IgG4 parts of the dulaglutide molecule, together with high homology with native GLP-1 and native IgG4, minimise the risk of immune response against dulaglutide. 1,2

Patients with dulaglutide anti‑drug antibodies generally had low titres, and although the number of patients developing dulaglutide anti‑drug antibodies was low, examination of the phase III data revealed no clear impact of dulaglutide anti‑drug antibodies on changes in HbA1c.1


 

None of the patients with systemic hypersensitivity developed dulaglutide anti‑drug antibodies.1

Table 1. Incidence of Anti-Drug Antibodies Across 9 Phase 2 and Phase 3 Studies in Patients Treated With Dulaglutide2

Incidence of Anti-Drug Antibodies in Patients Treated With Dulaglutide (N=4006)

Patients with dulaglutide anti-drug antibodies

Dulaglutide-neutralizing antibodies

Antibodies against native glucagon-like peptide-1

64 (1.6)

34 (0.9)

36 (0.9)

Data presented as number of patients (percentage of overall population).

References

1. Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Milicevic Z, Anglin G, Harper K, et al. Low incidence of anti-drug antibodies in patients with type 2 diabetes treated with once-weekly glucagon-like peptide-1 receptor agonist dulaglutide. Diabetes Obes Metab. 2016;18(5):533-536. http://onlinelibrary.wiley.com/doi/10.1111/dom.12640/full

Datum fӧr senaste ӧversyn 2017 M09 26

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