Evidence map›Paper›PMID 28118537›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2017

Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus.

Victoria P Werth, David Fiorentino, Barbara A Sullivan, Michael J Boedigheimer, Kit Chiu, Christine Wang, Gregory E Arnold, Michael A Damore, Jeannette Bigler, Andrew A Welcher and 3 more

Open access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% 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

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Evolving role of CD8Frontiers in immunology · 2026
    Review
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  9. Article
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  16. IFN-γ, should not be ignored in SLE.Frontiers in immunology · 2022
    Review
  17. Review
  18. Advances in therapeutic targets-related study on systemic lupus erythematosus.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2021
    Article
  19. Review
  20. 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

13 authors at 3 institutions in 1 country.

Victoria P WerthUniversity of Pennsylvania and Corporal Michael J. Crescenz Veterans Administration Medical Center, Philadelphia, Pennsylvania.
David FiorentinoStanford University, Palo Alto, California.
Barbara A SullivanAmgen Inc., Thousand Oaks, California.
Michael J BoedigheimerAmgen Inc., Thousand Oaks, California.
Kit ChiuAmgen Inc., Thousand Oaks, California.
Christine WangAmgen Inc., Thousand Oaks, California.
Gregory E ArnoldAmgen Inc., Thousand Oaks, California.
Michael A DamoreAmgen Inc., Thousand Oaks, California.
Jeannette BiglerAmgen, Inc., Seattle, Washington.
Andrew A WelcherAmgen Inc., Thousand Oaks, California.
Chris B RussellAmgen, Inc., Seattle, Washington.
David A MartinAmgen, Inc., Seattle, Washington.
James B ChungAmgen Inc., Thousand Oaks, California.
Amgen (United States) · USPalo Alto University · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInterferon-γ (IFNγ) is implicated in the pathogenesis of discoid lupus erythematosus (DLE). This study sought to evaluate a single dose of AMG 811, an anti-IFNγ antibody, in patients with DLE.

methodsThe study was designed as a phase I randomized, double-blind, placebo-controlled crossover study of the pharmacodynamics, safety, and clinical efficacy of AMG 811 in patients with DLE. Patients received a single subcutaneous dose of AMG 811 (180 mg) or placebo. The patients in sequence 1 received AMG 811 followed by placebo, while those in sequence 2 received placebo followed by AMG 811. Pharmacodynamic end points included global transcriptional analyses of lesional and nonlesional skin, IFNγ blockade signature (IGBS) transcriptional scores in the skin and blood, keratinocyte IFNγ RNA scores, and serum levels of CXCL10 protein. Additional end points were efficacy outcome measures, including the Cutaneous Lupus Erythematosus Disease Area and Severity Index, and safety outcome measures.

resultsSixteen patients with DLE were enrolled in the study (9 in sequence 1 and 7 in sequence 2). AMG 811 treatment reduced the IGBS score (which was elevated in DLE patients at baseline) in both the blood and lesional skin. The keratinocyte IFNγ RNA score was not affected by administration of AMG 811. Serum CXCL10 protein levels (which were elevated in the blood of DLE patients) were reduced with AMG 811 treatment. The AMG 811 treatment was well tolerated but did not lead to statistically significant improvements in any of the efficacy outcome measures.

conclusionAMG 811 treatment led to changes in IFNγ-associated biomarkers and was well tolerated, but no significant clinical benefit was observed in patients with DLE.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChemokine CXCL10Cross-Over StudiesDouble-Blind MethodFemaleHumansImmunosuppressive AgentsInterferon-gammaLupus Erythematosus, DiscoidMaleMiddle AgedRNA, MessengerTreatment OutcomeAMG 811Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedChemokine CXCL10CXCL10 protein, humanImmunosuppressive AgentsInterferon-gammaRNA, Messenger

Identifiers

PMID28118537
PMCPMC5434930
OpenAlexW2786317321

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.