Evidence map›Paper›PMID 28133925›Full record

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

A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Giant Cell Arteritis.

Carol A Langford, David Cuthbertson, Steven R Ytterberg, Nader Khalidi, Paul A Monach, Simon Carette, Philip Seo, Larry W Moreland, Michael Weisman, Curry L Koening and 12 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 128 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
128citing papers in PubMed, 9 pooled it
36.4field-weighted citation impact, top 1% 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

128 citing papers in PubMed, 9 syntheses or guidelines pooled it, 383 citations in OpenAlex.

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68 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 13 institutions in 2 countries.

Carol A LangfordCleveland Clinic, Cleveland, Ohio.
David CuthbertsonUniversity of South Florida, Tampa.
Steven R YtterbergMayo Clinic, Rochester, Minnesota.
Nader KhalidiSt. Joseph's Hospital, McMaster University, Hamilton, Ontario, Canada.
Paul A MonachBoston University, Boston, Massachusetts.
Simon CaretteMount Sinai Hospital, Toronto, Ontario, Canada.
Philip SeoJohns Hopkins University, Baltimore, Maryland.
Larry W MorelandUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Michael WeismanCedars-Sinai Medical Center, Los Angeles, California.
Curry L KoeningUniversity of Utah, Salt Lake City.
Antoine G SreihUniversity of Pennsylvania, Philadelphia.
Robert SpieraHospital for Special Surgery, New York, New York.
Carol A McAlearUniversity of Pennsylvania, Philadelphia.
Kenneth J WarringtonMayo Clinic, Rochester, Minnesota.
Christian PagnouxMount Sinai Hospital, Toronto, Ontario, Canada.
Kathleen McKinnonUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Lindsy J ForbessCedars-Sinai Medical Center, Los Angeles, California.
Gary S HoffmanCleveland Clinic, Cleveland, Ohio.
Renée BorchinUniversity of South Florida, Tampa.
Jeffrey P KrischerUniversity of South Florida, Tampa.
Peter A MerkelUniversity of Pennsylvania, Philadelphia.
Vasculitis Clinical Research Consortium
University of South Florida · USCedars-Sinai Medical Center · USCleveland Clinic · USMayo Clinic · USMount Sinai Hospital · CAUniversity of Pennsylvania · USUniversity of Pittsburgh · USBoston University · USHospital for Special Surgery · USJohns Hopkins University · USPhiladelphia University · USSt. Joseph’s Healthcare Hamilton · CAUniversity of Utah · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
VCRC-VF FellowshipU54AR057319 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI MERKEL, PETER A · 2009 to 2020
$12.5M
VASCULITIS CLINICAL RESEARCH NETWORK (VCRN): RARE DISEASEU54RR019497 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI MERKEL, PETER A · 2003 to 2008
$6.1M
NCATS NIH HHS UL1 TR000439NCRR NIH HHS U54 RR019497NHLBI NIH HHS HHSN268200700003CNHLBI NIH HHS HHSN268200700006CNHLBI NIH HHS HHSN268200700036CNIAMS NIH HHS U54 AR057319
6 · The paper itself

Abstract

objectiveTo compare the efficacy of abatacept to that of placebo for the treatment of giant cell arteritis (GCA).

methodsIn this multicenter trial, patients with newly diagnosed or relapsing GCA were treated with abatacept 10 mg/kg intravenously on days 1, 15, and 29 and week 8, together with prednisone administered daily. At week 12, patients in remission underwent a double-blinded randomization to continue to receive abatacept monthly or switch to placebo. Patients in both study arms received a standardized prednisone taper, with discontinuation of prednisone at week 28. All patients remained on their randomized assignment until meeting criteria for early termination or until 12 months after enrollment of the last patient. The primary end point was duration of remission (relapse-free survival rate).

resultsForty-nine eligible patients with GCA were enrolled and treated with prednisone and abatacept; of these, 41 reached the week 12 randomization and underwent a blinded randomization to receive abatacept or placebo. Prednisone was tapered using a standardized schedule, reaching a daily dosage of 20 mg at week 12 with discontinuation in all patients at week 28. The relapse-free survival rate at 12 months was 48% for those receiving abatacept and 31% for those receiving placebo (P = 0.049). A longer median duration of remission was seen in those receiving abatacept compared to those receiving placebo (median duration 9.9 months versus 3.9 months; P = 0.023). There was no difference in the frequency or severity of adverse events, including infection, between the treatment arms.

conclusionIn patients with GCA, the addition of abatacept to a treatment regimen with prednisone reduced the risk of relapse and was not associated with a higher rate of toxicity compared to prednisone alone.

Indexed as

AbataceptAgedAged, 80 and overDouble-Blind MethodFemaleGiant Cell ArteritisHumansMaleMiddle AgedAbatacept

Identifiers

PMID28133925
PMCPMC5378642
OpenAlexW2581891606

What OpenQuestion holds

Textmetadata
LicenceTDM
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.