Tirzepatide Immunogenicity on Pharmacokinetics, Efficacy, and Safety: Analysis of Data From Phase 3 Studies
Authors' conclusion
Immunogenicity did not affect TZP pharmacokinetics or efficacy. The majority of hypersensitivity or injection site reactions experienced by TE ADA+ patients were mild to moderate in severity.
Study context
- Population
- Antidrug antibodies (ADA)-evaluable tirzepatide (TZP)-treated patients with T2D (TZP 5, 10 or 15 mg) in SURPASS-1 to −5, Japan-Mono and Japan-Combo
- Participants
- 5,025 patients7 phase 3 trials
- Comparison
- Treatment-emergent (TE) ADA+ vs TE ADA- TZP-treated patients
- Outcome
- Incidence of TE ADA and their effect on pharmacokinetics, efficacy and safety
- Follow-up
- Week 40 (SURPASS-1, −2, −5) or week 52 (SURPASS-3, −4, Japan-Mono, Japan-Combo)
Methodological detailsSURPASS programme, post hoc immunogenicity analysis
- SURPASS programme
- Post hoc immunogenicity analysis
Pooled result
As reported in the abstract
TE ADA incidence
- TE ADA developed in TZP-treated patients
- 51.1%
- Maximum ADA titers among TE ADA+ patients
- 1:20 to 1: 81 920
- Neutralizing antibodies (NAb) against TZP activity on GIP receptor
- 1.9%
- NAb against TZP activity on GLP-1 receptor
- 2.1%
- Cross-reactive NAb against nGIP or nGLP-1
- Less than 1.0%
Further pooled results
Pharmacokinetics and efficacy by immunogenicity
- TE ADA status, ADA titer and NAb status had no effect on TZP pharmacokinetics or efficacy
Safety
- More TE ADA+ than TE ADA- patients had hypersensitivity or injection site reactions
- Most reactions nonserious and nonsevere; most occurred and/or resolved irrespective of TE ADA status or titer
Original publication
Tirzepatide Immunogenicity on Pharmacokinetics, Efficacy, and Safety: Analysis of Data From Phase 3 Studies. J Clin Endocrinol Metab. Published 13 September 2023. doi:10.
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