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Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease
Kumar Kandadi Muralidharan, Xiao Tong, Kenneth G. Kowalski, Raj Rajagovindan, Lin Lin, Samantha Budd Haberlain, Ivan Nestorov. CPT: Pharmacometrics & Systems Pharmacology, 2021-10-26
Topic: Drug trials: efficacy and safety
Aducanumab is a human immunoglobulin G1 anti‐amyloid beta (Aβ) antibody currently being evaluated for potential treatment of patients with early Alzheimer’s disease. This paper describes the relationship between the population pharmacokinetics (PopPKs) and pharmacokinetics‐pharmacodynamics (PKs‐PDs) of aducanumab using data from phase I to III clinical studies, with standard uptake value ratio (SUVR) used as a PD marker. Across clinical studies, aducanumab was administered intravenously either as a single dose ranging from 0.3 to 60 mg/kg or as multiple doses of 1, 3, 6, or 10 mg/kg every 4 weeks. A titration regimen with maintenance doses of 3, 6, or 10 mg/kg was also evaluated. Aducanumab PK was characterized with a two‐compartment model with first‐order elimination. No nonlinearities in PKs were observed. The PopPK‐PD model was developed using a sequential estimation approach. The time course of amyloid plaques, as expressed by composite SUVR measured using positron emission tomography, was described using an indirect response model with drug effect stimulating the elimination of SUVR. None of the identified covariates on PK and the PopPK‐PD model were clinically relevant. The PopPK‐PD model showed that magnitude, duration, and consistency of dosing are important factors determining the degree of Aβ removal. The intrinsic pharmacology of aducanumab remained consistent across studies.
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APA 7th
Muralidharan, K. K., Tong, X., Kowalski, K. G., Rajagovindan, R., Lin, L., Haberlain, S. B., et al. (2021). Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease. CPT: Pharmacometrics & Systems Pharmacology. https://doi.org/10.1002/psp4.12728
Vancouver
Muralidharan KK, Tong X, Kowalski KG, Rajagovindan R, Lin L, Haberlain SB, et al. Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease. CPT: Pharmacometrics & Systems Pharmacology. 2021. doi:10.1002/psp4.12728.
BibTeX
@article{muralidharan2021-098ca6fa,
author = {Muralidharan, Kumar Kandadi and Tong, Xiao and Kowalski, Kenneth G. and Rajagovindan, Raj and Lin, Lin and Haberlain, Samantha Budd and Nestorov, Ivan},
title = {{Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease}},
journal = {CPT: Pharmacometrics \& Systems Pharmacology},
year = {2021},
doi = {10.1002/psp4.12728},
url = {https://doi.org/10.1002/psp4.12728}
}
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Key findings
- The PopPK‐PD model showed that magnitude, duration, and consistency of dosing are important factors determining the degree of Aβ removal.
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Study details
- Evidence strengthLow
How this study scored 39/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 22 of the 56 points we could judge it on, which is 39 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (CPT: Pharmacometrics & Systems Pharmacology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 22 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 22 of the 56 points we could judge it on is 39 out of 100. |
| Total | 39 / 100 | — |
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