Evidence map›Paper›PMID 32335844›Full record

Trial reportJournal of pharmacokinetics and pharmacodynamics2020

A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus.

Sonja Hartmann, Konstantinos Biliouris, Himanshu Naik, Dania Rabah, Lauren Stevenson, Chase Shen, Ivan A Nestorov, Lawrence J Lesko, Mirjam N Trame

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of pharmacokinetics and pharmacodynamics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Type I Interferon Production of Plasmacytoid Dendritic Cells under Control.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Sonja HartmannDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, FL, USA.
Konstantinos BiliourisDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, FL, USA.
Himanshu NaikBiogen Inc., 225 Binney Street, Cambridge, MA, 02142, USA. himanshu.naik@biogen.com.
Dania RabahBiogen Inc., 225 Binney Street, Cambridge, MA, 02142, USA.
Lauren StevensonImmunologix Laboratories, Tampa, FL, USA.
Chase ShenBiogen Inc., 225 Binney Street, Cambridge, MA, 02142, USA.
Ivan A NestorovBiogen Inc., 225 Binney Street, Cambridge, MA, 02142, USA.
Lawrence J LeskoDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, FL, USA.
Mirjam N TrameDepartment of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A population pharmacokinetic/pharmacodynamic (popPK/PD) model for BIIB059 (anti-blood dendritic cell antigen 2 [anti-BDCA2]), a humanized immunoglobulin G1 monoclonal antibody currently under development for the treatment of SLE and CLE, is presented. BIIB059 binds BDCA2, a plasmacytoid dendritic cell (pDC)-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. Phase 1 PK and PD data of healthy adult volunteers (HV, n = 87) and SLE subjects (n = 22) were utilized for the development of the popPK/PD model. The data included single and multiple dosing of intravenous and subcutaneous BIIB059. BDCA2 internalization (PD marker) was measured for all subjects by monitoring reduction of BDCA2 on pDC cell surface and used for development of the popPD model. A two-compartment popPK model with linear plus non-linear elimination was found to best describe BIIB059 PK. BDCA2 levels were best captured using an indirect response model with stimulation of the elimination of BDCA2. Clearance in SLE subjects was 25% higher compared to HV (6.87 vs 5.52 mL/h). Bodyweight was identified as only other covariate on clearance and central volume. The estimates of EC

Indexed as

Models, BiologicalAdministration, IntravenousAdultAgedAntibodies, Monoclonal, HumanizedArea Under CurveBiological AvailabilityDose-Response Relationship, DrugDrug Administration ScheduleFemaleHalf-LifeHumansInjections, SubcutaneousLectins, C-TypeLupus Erythematosus, CutaneousLupus Erythematosus, SystemicAntibodies, Monoclonal, HumanizedCLEC4C protein, humanLectins, C-TypeMembrane GlycoproteinsReceptors, ImmunologicCutaneous lupus erythematosusDrug developmentMonoclonal antibodyPopulation PK/PD modelSystemic lupus erythematosus

Identifiers

PMID32335844

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.