Evidence map›Paper›PMID 31528843›Full record

ArticleRheumatology advances in practice2019

Integrated safety profile of atacicept: an analysis of pooled data from the atacicept clinical trial programme.

Caroline Gordon, Roberto Bassi, Peter Chang, Amy Kao, David Jayne, David Wofsy, Patricia Fleuranceau-Morel

Abstract read
In one paragraph

Article in Rheumatology advances in practice, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

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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

7 authors.

Caroline GordonRheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.
Roberto BassiEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
Peter ChangEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
Amy KaoEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
David JayneDepartment of Medicine, University of Cambridge, Cambridge, UK.
David WofsyRussell/Engleman Rheumatology Research Center, University of California, San Francisco, CA, USA.
Patricia Fleuranceau-MorelEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo characterize the overall safety profile of atacicept, we conducted an integrated analysis of pooled safety data from all 17 clinical studies to date.

methodsThree data sets were used to investigate safety endpoints: a double-blind placebo-controlled set (

resultsOf 1568 patients in the double-blind placebo-controlled-set, 30.8% received placebo, and 8.2, 24.5 and 36.5% received atacicept 25, 75 and 150 mg, respectively. Treatment-emergent adverse event (TEAE) rates (adjusted by treatment-exposure) were generally higher with atacicept

conclusionThe results of this integrated safety analysis support further development and evaluation of atacicept in selected patients for whom potential benefits might outweigh risks.

Indexed as

adverse eventsataciceptautoimmune diseasesB-cell targetingclinical trialssafetysystemic lupus erythematosus

Identifiers

PMID31528843
PMCPMC6735746

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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.