You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Kisunla ® (donanemab-azbt) injection, for intravenous infusion
350 mg/20 mL (17.5 mg/mL)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Do antidrug antibodies affect the efficacy of Kisunla® (donanemab-azbt)?
Amyloid plaque reduction and clinical efficacy outcomes were found irrespective of anti-drug antibodies.
See important safety information, including boxed warning, in the attached prescribing information.
Effect of Immunogenicity on Clinical Efficacy
A pharmacokinetic and pharmacodynamic (PK/PD) model and repeated-measures model evaluated the effect of antidrug antibody (ADA) titer on
- the rate of disease progression, as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS) and Clinical Dementia Rating scale-Sum of Boxes (CDR-SB), and
- reduction in amyloid plaque.1
Among participants treated with donanemab in placebo-controlled studies who developed ADA, mean donanemab serum trough concentrations at various time points were lower than in participants who had not developed ADA.2
No Association Between Presence of ADA and Clinical Efficacy of Donanemab
Both the PK/PD model and the repeated-measures model demonstrated that, irrespective of ADA titer, no association was observed between the presence of ADA and the clinical efficacy of donanemab.1 ADA testing is not part of the routine assessments described in the product labeling, and healthcare providers should follow the approved prescribing information for patient monitoring and management.2 The low-, medium-, and high-titer categories in the donanemab program were study-specific analytical groupings and are not universal ADA cutoffs applicable across biologics.
Reduction in Amyloid Plaque Not Impacted by ADA Titer
Although donanemab exposure decreased with increasing ADA titer, the majority of participants maintained average donanemab concentrations above the median threshold concentration (15.2 μg/mL) associated with amyloid plaque reduction throughout the dosing interval.1 This analysis was completed in a study setting, where ADA were assessed using validated sponsor-specific immunogenicity assays performed in approved laboratories.
Participants with high ADA titers showed less reduction in amyloid plaque compared to participants with low ADA titers, with the least squares mean change from baseline to week 76 being
- −89.8 in the lower titer group
- −88.4 in the middle titer group
- −74.8 in the upper titer group, and
- −0.7 in the placebo group (p<.001 for all titer levels).1
There were no identified clinically significant effects of ADA on the efficacy of donanemab over the treatment duration of 18 months.1,2
Enclosed Prescribing Information
KISUNLA® (donanemab-azbt) injection, for intravenous use, Lilly
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
- Mullins GR, Ardayfio P, Gueorguieva I, et al. Donanemab immunogenicity in participants with early symptomatic Alzheimer’s disease. Alzheimer’s Dement (N Y). 2025;11(3):e70149. https://doi.org/10.1002/trc2.70149
- Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
Date of Last Review: July 22, 2026