Evidence map›Paper›PMID 31819995›Full record

ArticleRheumatology (Oxford, England)2020

Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials.

Edward C Keystone, Harris A Ahmad, Yusuf Yazici, Martin J Bergman

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT00929864 phase3completednot on this map

A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

TypeinterventionalSponsorBristol-Myers SquibbRan2009 to 2012Enrolled869ConditionsRheumatoid ArthritisArmsAbatacept, Adalimumab
NCT01142726 phase3completednot on this map

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

TypeinterventionalSponsorBristol-Myers SquibbRan2010 to 2014Enrolled511ConditionsRheumatoid ArthritisArmsAbatacept, Methotrexate, Abatacept placebo, Methotrexate placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 2 countries.

Edward C KeystoneDepartment of Rheumatology, University of Toronto, Toronto, ON, Canada.
Harris A AhmadRheumatology, Bristol-Myers Squibb, Princeton, NJ.
Yusuf YaziciDepartment of Internal Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY.
Martin J BergmanDepartment of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.
Bristol-Myers Squibb (United States) · USDrexel University · USNew York University · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveData from two double-blind, randomized, Phase III studies were analysed to investigate the ability of Routine Assessment of Patient Index Data 3, DAS28 (CRP), modified (M)-DAS28 (CRP) and Simplified or Clinical Disease Activity Indices to predict structural damage progression in RA.

methodsThis post hoc analysis included data from the 2-year Abatacept vs adaliMumab comParison in bioLogic-naïvE RA subjects with background MTX (AMPLE) trial in biologic-naïve patients with active RA (<5 years) and an inadequate response to MTX, and the 12-month treatment period of the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) trial in MTX-naïve patients with early RA (⩽2 years) and poor prognostic indicators. Adjusted logistic regression analysis assessed the relationship between baseline disease activity and structural damage progression (defined as change from baseline greater than the smallest detectable change) at 12 and 24 months in AMPLE and 6 and 12 months in AVERT. Areas under the receiver operating characteristic curves for the impact of baseline disease activity on structural damage progression were calculated.

resultsAdjusted logistic regression analyses included all randomized and treated patients in AMPLE (N = 646) and those who received abatacept plus MTX or MTX monotherapy in AVERT (N = 235). Baseline Routine Assessment of Patient Index Data 3, DAS28 (CRP) and M-DAS28 (CRP) scores significantly predicted structural progression at months 12 and 24 in AMPLE (P < 0.05) and months 6 and 12 in AVERT (P < 0.01), and were stronger predictors than Simplified or Clinical Disease Activity Indices.

conclusionIn this post hoc analysis of two patient populations with RA, Routine Assessment of Patient Index Data 3, DAS28 (CRP) and M-DAS28 (CRP) were good at predicting structural damage.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov: NCT00929864 (AMPLE); NCT01142726 (AVERT).

Indexed as

AbataceptAdultAntirheumatic AgentsArthritis, RheumatoidDisease ProgressionDrug Therapy, CombinationFemaleHumansMagnetic Resonance ImagingMaleMethotrexateMiddle AgedRadiographyRemission InductionSeverity of Illness IndexTreatment OutcomeAbataceptAntirheumatic AgentsMethotrexateCDAIclinical trialcomposite indicesDAS28 (CRP)disease activityDMARDsM-DAS28 (CRP)RARAPID3SDAI

Identifiers

PMID31819995
PMCPMC7382603
OpenAlexW2994891320

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.