Evidence map›Paper›PMID 31174592›Full record

Observational studyArthritis research & therapy2019

Safety of abatacept compared with other biologic and conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: data from an observational study.

Gulsen Ozen, Sofia Pedro, Rebecca Schumacher, Teresa A Simon, Kaleb Michaud

Open access · goldAbstract readComparative StudyMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% 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

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

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  8. Immunosuppressants/Immunomodulators and Malignancy.Journal of clinical medicine · 2025
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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

5 authors at 4 institutions in 1 country.

Gulsen OzenUniversity of Nebraska Medical Center, Omaha, NE, USA.
Sofia PedroFORWARD, The National Databank for Rheumatic Diseases, Wichita, KS, USA.
Rebecca SchumacherFORWARD, The National Databank for Rheumatic Diseases, Wichita, KS, USA.
Teresa A SimonBristol-Myers Squibb, Princeton, NJ, USA.
Kaleb MichaudUniversity of Nebraska Medical Center, Omaha, NE, USA. kmichaud@unmc.edu.ORCID 0000-0002-5350-3934
The National Databank for Rheumatic Diseases · USBristol-Myers Squibb (United States) · USNebraska Medical Center · USUniversity of Nebraska Medical Center · US

Funding

Bristol-Myers Squibb NA
6 · The paper itself

Abstract

backgroundTo assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohort

methodsData were reviewed from patients (≥ 18 years) with RA who were registered with FORWARD, the National Databank for Rheumatic Diseases, and who initiated abatacept, other bDMARDs or csDMARDs between 2005 and 2015. Patients who switched treatment during the study could be allocated to more than one group. The incidence rates (IRs) by treatment were calculated for malignancies, hospitalized infections and autoimmune diseases identified by six monthly questionnaires and medical records. The hazard ratios (HRs) (95% confidence intervals [CIs]) for all outcomes with abatacept compared with other bDMARDs or csDMARDs were determined using marginal structural models adjusted for clinical confounders.

resultsIn the study sample, 1496 initiated abatacept, 3490 initiated another bDMARD and 1520 initiated a csDMARD. The risk of malignancies with abatacept was not statistically significant versus other bDMARDs (HR [95% CI)] 1.89 [0.93, 3.84]) or versus csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). Patients receiving abatacept versus other bDMARDs were at a lower risk of hospitalized infections (HR [95% CI] 0.37 [0.18, 0.75]); the risk versus csDMARDs was lower with wide CIs (HR [95% CI] 0.31 [0.09, 1.05]). The relative risks for psoriasis were similar between treatment groups (HR [95% CI] 1.46 [0.76, 2.81] and HR [95% CI] 2.05 [0.59, 7.16] for abatacept versus other bDMARDs and versus csDMARDS, respectively). The IR (95% CI) of severe infusion/injection reactions was lower with abatacept compared with other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively).

conclusionsIn this analysis, abatacept was well tolerated and did not result in an overall increased risk of malignancies, infections or autoimmune diseases compared with other bDMARDs or csDMARDs.

Indexed as

AbataceptAntirheumatic AgentsArthritis, RheumatoidBiological FactorsFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesRisk AssessmentRisk FactorsSurvival RateTime FactorsUnited StatesAbataceptAntirheumatic AgentsBiological FactorsAbataceptAutoimmune diseaseInfectionMalignancyObservationalRheumatoid arthritisSafety

Identifiers

PMID31174592
PMCPMC6555014
OpenAlexW2952905145

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.