Evidence map›Paper›PMID 26473625›Full record

Trial reportArthritis care & research2016

Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis.

Roy Fleischmann, Michael E Weinblatt, Michael Schiff, Dinesh Khanna, Michael A Maldonado, Anagha Nadkarni, Daniel E Furst

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

Trial report in Arthritis care & research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 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

7 authors at 6 institutions in 1 country.

Roy FleischmannUniversity of Texas Southwestern Medical Center, Dallas.
Michael E WeinblattBrigham and Women's Hospital, Boston, Massachusetts.
Michael SchiffUniversity of Colorado, Denver.
Dinesh KhannaDinesh Khanna, MD: University of Michigan, Ann Arbor.
Michael A MaldonadoBristol-Myers Squibb, Princeton, New Jersey.
Anagha NadkarniBristol-Myers Squibb, Princeton, New Jersey.
Daniel E FurstUniversity of California at Los Angeles.
Bristol-Myers Squibb (United States) · USBrigham and Women's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity of California, Los Angeles · USUniversity of Colorado Denver · USUniversity of Michigan–Ann Arbor · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo report 2-year patient-reported outcomes (PROs) from the head-to-head Abatacept versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate (MTX) (AMPLE) trial.

methodsAMPLE was a phase IIIb, randomized, investigator-blinded trial. Biologic-naive patients with rheumatoid arthritis (RA) and an inadequate response to MTX were randomized to subcutaneous (SC) abatacept (125 mg/week) or adalimumab (40 mg every 2 weeks) with background MTX. PROs (pain, fatigue, ability to perform work, and ability to perform daily activities) were compared up to year 2 for patients in each treatment group, as well as those who achieved low disease activity at both years 1 and 2 (responders) and those who did not (nonresponders).

resultsA total of 646 patients were randomized and treated with SC abatacept (n = 318) or adalimumab (n = 328). Baseline characteristics were balanced between the 2 treatment arms. Comparable improvements in PROs were observed in the abatacept and adalimumab groups over 2 years, with both groups achieving clinically meaningful improvements in PROs from baseline. At year 2, fatigue improved by 23.4 mm and 21.5 mm on a 100-mm visual analog scale with abatacept and adalimumab, respectively. Clinical responders achieved greater improvements in PROs than nonresponders.

conclusionIn biologic-naive patients with active RA, despite prior MTX, treatment with SC abatacept or adalimumab with background MTX resulted in comparable improvements in PROs, which were highly correlated with physician-reported clinical response end points.

Indexed as

AbataceptAdalimumabAdultAgedAntirheumatic AgentsArthritis, RheumatoidFemaleHumansInjections, SubcutaneousMaleMiddle AgedPatient Reported Outcome MeasuresTreatment OutcomeAbataceptAdalimumabAntirheumatic Agents

Identifiers

PMID26473625
PMCPMC5094537
OpenAlexW2224441789

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.