Evidence map›Paper›PMID 35352835›Full record

ArticleJournal of clinical pharmacology2022

Relationship Between Anifrolumab Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Moderate to Severe Systemic Lupus Erythematosus.

Yen Lin Chia, Raj Tummala, Tu H Mai, Tomas Rouse, Katie Streicher, Wendy I White, Eric F Morand, Richard A Furie

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
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

8 citing papers in PubMed, 12 citations in OpenAlex.

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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

8 authors at 5 institutions in 5 countries.

Yen Lin ChiaBioPharmaceuticals R&D, AstraZeneca US, South San Francisco, California, USA.
Raj TummalaBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, Maryland, USA.
Tu H MaiBioPharmaceuticals R&D, AstraZeneca US, South San Francisco, California, USA.
Tomas RouseBioPharmaceuticals R&D, AstraZeneca R&D, Gothenburg, Sweden.
Katie StreicherBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, Maryland, USA.
Wendy I WhiteBioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, Maryland, USA.
Eric F MorandCentre for Inflammatory Disease Monash Health, Monash University, Melbourne, Victoria, Australia.
Richard A FurieDivision of Rheumatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, New York, USA.
AstraZeneca (United States) · USAstraZeneca (Australia) · AUAstraZeneca (Italy) · ITMonash University · AUNorthwell Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed to elucidate the pharmacokinetic/pharmacodynamic and pharmacodynamic/efficacy relationships of anifrolumab, a type I interferon receptor antibody, in patients with moderate to severe systemic lupus erythematosus. Data were pooled from the randomized, 52-week, placebo-controlled TULIP-1 and TULIP-2 trials of intravenous anifrolumab (150 mg/300 mg, every 4 weeks for 48 weeks). Pharmacodynamic neutralization was measured with a 21-gene type I interferon gene signature (21-IFNGS) in patients with high IFNGS. The pharmacokinetic/pharmacodynamic relationship was analyzed graphically and modeled with a nonlinear mixed-effects model. British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates were compared across 21-IFNGS neutralization quartiles. Overall, 819 patients received ≥1 dose of anifrolumab or placebo, of whom 676 were IFNGS high. Over 52 weeks, higher average anifrolumab serum concentrations were associated with increased median 21-IFNGS neutralization, which was rapid and sustained with anifrolumab 300 mg (>80%, weeks 12-52), lower and delayed with anifrolumab 150 mg (>50%, week 52), and minimal with placebo. The proportion of patients with week 24 anifrolumab trough concentration exceeding the IC

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicHumansSeverity of Illness IndexTreatment OutcomeanifrolumabAntibodies, Monoclonal, Humanizedanifrolumabinterferonpharmacodynamicspharmacokineticssystemic lupus erythematosus (SLE)

Identifiers

PMID35352835
PMCPMC9545691
OpenAlexW4221022947

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.