Low immunogenicity of insulin efsitora alfa in participants with type 1 and type 2 diabetes mellitus
Authors' conclusion
Efsitora caused an immunogenic response in up to 3.0% of participants with T1DM and T2DM. Descriptive analysis indicates that the immunogenicity of efsitora did not noticeably impact its pharmacokinetics, efficacy or safety. The molecular design of efsitora may contribute to its low immunogenicity.
Study context
- Population
- Participants with T1D and T2D treated with once-weekly basal insulin efsitora in 5 phase 3 clinical trials5 phase 3 trials
- Participants
- 341 vs 1,861
- Comparison
- T1DM vs T2DM
- T1DMn = 341
- T2DMn = 1,861
- Outcome
- Incidence of treatment-emergent antidrug antibodies (TE ADA)
Methodological detailsdescriptive analysis
- Descriptive analysis
Pooled result
As reported in the abstract
Developed TE ADA
Further pooled results
| Outcome | T2DM |
|---|---|
| Cross-reactive antibodies to native insulin; neutralising antibodies against efsitora and native insulin | |
| Cross-reactive to native insulin | 1.7% |
| Neutralising against efsitora | 1.1% |
| Neutralising against native insulin | 0.8% |
Cross-reactive antibodies to native insulin; neutralising antibodies against efsitora and native insulin
- Not observed in T1DM
Maximum ADA titres
- Range
- 1:40 to 1:81 920
- Median
- 1:80
Clearance of efsitora (PK)
- Similar between baseline ADA+ and ADA- groups
HbA1c reduction by TE ADA status · primary endpoint of trials
- TE ADA status did not significantly affect HbA1c reduction
Safety
- TE ADA status did not cause hypersensitivity or injection site reactions
Original publication
Low immunogenicity of insulin efsitora alfa in participants with type 1 and type 2 diabetes mellitus. Diabetes Obes Metab. Published 4 December 2025. doi:10.
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