Evidence map›Paper›PMID 37932010›Full record

SynthesisAnnals of the rheumatic diseases2024

Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies.

Teresa A Simon, Lixian Dong, Samy Suissa, Kaleb Michaud, Sofia Pedro, Marc Hochberg, Maarten Boers, Johan Askling, Thomas Frisell, Anja Strangfeld and 4 more

Open access · hybridAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in Annals of the rheumatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 5% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
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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

14 authors at 8 institutions in 5 countries.

Teresa A SimonGlobal Pharmacovigilance and Epidemiology, Bristol Myers Squibb, Princeton, New Jersey, USA.
Lixian DongGlobal Pharmacovigilance and Epidemiology, Bristol Myers Squibb, Princeton, New Jersey, USA.
Samy SuissaDepartment of Epidemiology and Biostatistics, McGill University, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0002-1281-5296
Kaleb MichaudInternal Medicine, Division of Rheumatology, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Sofia PedroFORWARD, The National Databank for Rheumatic Diseases, Wichita, Kansas, USA.
Marc HochbergDepartment of Medicine, University of Maryland, School of Medicine, Baltimore, Maryland, USA.
Maarten BoersDepartment of Epidemiology and Data Science, Amsterdam UMC - Vrije Universiteit, Amsterdam, The Netherlands.
Johan AsklingRheumatology, Theme Inflammation and Ageing, Karolinska University Hospital, Stockholm, Sweden.ORCID http://orcid.org/0000-0003-0433-0616
Thomas FrisellClinical Epidemiology Division, Karolinska Institutet, Stockholm, Sweden.ORCID http://orcid.org/0000-0002-5735-9626
Anja StrangfeldEpidemiology and Health Services Research, German Rheumatism Research Center, Berlin, Germany.ORCID http://orcid.org/0000-0002-6233-022X
Yvette MeissnerEpidemiology and Health Services Research, German Rheumatism Research Center, Berlin, Germany.ORCID http://orcid.org/0000-0003-0147-4112
Vadim KhaychukUS Medical Immunology and Fibrosis, Bristol Myers Squibb, Princeton, New Jersey, USA.
Alyssa DominiqueGlobal Pharmacovigilance and Epidemiology, Bristol Myers Squibb, Princeton, New Jersey, USA.
Michael A MaldonadoI&F R&D, Bristol Myers Squibb Co, Princeton, New Jersey, USA michael.maldonado@bms.com.ORCID http://orcid.org/0009-0007-4391-2324
Bristol-Myers Squibb (United States) · USGerman Rheumatism Research Centre · DEThe National Databank for Rheumatic Diseases · USAmsterdam University Medical Centers · NLKarolinska Institutet · SEKarolinska University Hospital · SEMcGill University · CAUniversity of Maryland, Baltimore · US

Funding

University of Maryland Claude D. Pepper Older Americans Independence Center (UM-OAIC)P30AG028747 · NIA · UNIVERSITY OF MARYLAND BALTIMORE · PI Stephen L. Seliger · 2006 to 2026
$28.9M
NIA NIH HHS P30 AG028747
6 · The paper itself

Abstract

objectivesThis study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA).

methodsThis evaluation included 16 abatacept RA clinical trials and 6 observational studies. NMSC incidence rates (IRs)/1000 patient-years (p-y) of exposure were compared between patients treated with abatacept versus placebo, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biological/targeted synthetic (b/ts)DMARDs. For observational studies, a random-effects model was used to pool rate ratios (RRs).

results~49 000 patients receiving abatacept were analysed from clinical trials (~7000) and observational studies (~42 000). In randomised trials (n=4138; median abatacept exposure, 12 (range 2-30) months), NMSC IRs (95% CIs) were not significantly different for abatacept (6.0 (3.3 to 10.0)) and placebo (4.0 (1.3 to 9.3)) and remained stable throughout the long-term, open-label period (median cumulative exposure, 28 (range 2-130 months); 21 335 p-y of exposure (7044 patients over 3 years)). For registry databases, NMSC IRs/1000 p-y were 5-12 (abatacept), 1.6-10 (csDMARDs) and 3-8 (other b/tsDMARDs). Claims database IRs were 19-22 (abatacept), 15-18 (csDMARDs) and 14-17 (other b/tsDMARDs). Pooled RRs (95% CIs) from observational studies for NMSC in patients receiving abatacept were 1.84 (1.00 to 3.37) vs csDMARDs and 1.11 (0.98 to 1.26) vs other b/tsDMARDs.

conclusionsConsistent with the warnings and precautions of the abatacept label, this analysis suggests a potential increase in NMSC risk with abatacept use compared with csDMARDs. No significant increase was observed compared with b/tsDMARDs, but the lower limit of the 95% CI was close to unity.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiological ProductsSkin NeoplasmsAbataceptHumansIncidenceRandomized Controlled Trials as TopicAbataceptAntirheumatic AgentsBiological Productsabataceptarthritis, rheumatoidbiological therapyepidemiology

Identifiers

PMID37932010
PMCPMC10850629
OpenAlexW4388425491

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.