Abatacept and the risk of malignancy: a meta-analysis across disease indications

Benjamin P. Zuckerman; Mark Gibson; Ritika Roy; Mark Hughes; Daksh Mehta; Zijing Yang; Maryam Adas; Kenrick Ng; Mark D. Russell; Andrew Cope; Sam Norton; James Galloway

doi:10.1093/rheumatology/keaf114

Abatacept and the risk of malignancy: a meta-analysis across disease indications

Benjamin P. Zuckerman^*
, Mark Gibson
, Ritika Roy
, Mark Hughes
, Daksh Mehta
, Zijing Yang
, Maryam Adas
, Kenrick Ng
, Mark D. Russell
, Andrew Cope
, Sam Norton
, James Galloway

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

28 Downloads (Pure)

Abstract

Objectives: To estimate the association between abatacept use and the incidence of malignancy excluding non-melanomatous skin cancers (NMSCs). Methods: Systematic database searches were performed, to April 2024, to identify phase II/III/IV randomized clinical trials (RCTs), long-term extension (LTE) and observational cohort studies of abatacept in people with rheumatoid arthritis and psoriatic arthritis. Network and pairwise meta-analyses were performed to estimate incidence rate ratios (IRRs) for malignancy excluding NMSC, comparing abatacept with placebo and tumour necrosis factor inhibitors (TNFi) in RCT/LTE studies. Pairwise meta-analyses evaluated the same outcome in observational studies, comparing abatacept with conventional synthetic DMARDs (csDMARDs) and biologic/targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs). Results: In 18 eligible RCTs and 10 LTE studies, there were 15 535 person-years of exposure to abatacept, 1495 to placebo and 733 to TNFi. In network meta-analyses of combined RCT/LTE data, the incidence of all malignancies excluding NMSCs was not significantly different between abatacept and placebo (IRR 0.58; 95% CI 0.32–1.09) or TNFi (IRR 0.72; 95% 0.27–1.87). In observational data, the incidence of malignancy was higher with abatacept, relative to other b/tsDMARDs (IRR 1.21; 95% CI 1.15–1.28), but not significantly different compared with csDMARDs (IRR 0.97; 95% CI 0.90–1.06). Conclusions: Abatacept was associated with a higher incidence of malignancy compared with other b/tsDMARDs in observational studies, but not when compared with placebo or TNFi in RCT/LTE data. Further pharmacovigilance data is essential to help elucidate whether abatacept modifies cancer risk.

Original language	English
Article number	keaf114
Pages (from-to)	3280-3287
Number of pages	8
Journal	Rheumatology
Volume	64
Issue number	6
Early online date	24 Feb 2025
DOIs	https://doi.org/10.1093/rheumatology/keaf114
Publication status	Published - 1 Jun 2025

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Abatacept and the risk of _ZUCKERMAN_Publishedlonline24February2025_GOLD_VoR (CC BY)Final published version, 852 KBLicence: CC BY

Cite this

@article{188345aa44fe45eaa4f5542fbd793c21,

title = "Abatacept and the risk of malignancy: a meta-analysis across disease indications",

abstract = "Objectives: To estimate the association between abatacept use and the incidence of malignancy excluding non-melanomatous skin cancers (NMSCs). Methods: Systematic database searches were performed, to April 2024, to identify phase II/III/IV randomized clinical trials (RCTs), long-term extension (LTE) and observational cohort studies of abatacept in people with rheumatoid arthritis and psoriatic arthritis. Network and pairwise meta-analyses were performed to estimate incidence rate ratios (IRRs) for malignancy excluding NMSC, comparing abatacept with placebo and tumour necrosis factor inhibitors (TNFi) in RCT/LTE studies. Pairwise meta-analyses evaluated the same outcome in observational studies, comparing abatacept with conventional synthetic DMARDs (csDMARDs) and biologic/targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs). Results: In 18 eligible RCTs and 10 LTE studies, there were 15 535 person-years of exposure to abatacept, 1495 to placebo and 733 to TNFi. In network meta-analyses of combined RCT/LTE data, the incidence of all malignancies excluding NMSCs was not significantly different between abatacept and placebo (IRR 0.58; 95\% CI 0.32–1.09) or TNFi (IRR 0.72; 95\% 0.27–1.87). In observational data, the incidence of malignancy was higher with abatacept, relative to other b/tsDMARDs (IRR 1.21; 95\% CI 1.15–1.28), but not significantly different compared with csDMARDs (IRR 0.97; 95\% CI 0.90–1.06). Conclusions: Abatacept was associated with a higher incidence of malignancy compared with other b/tsDMARDs in observational studies, but not when compared with placebo or TNFi in RCT/LTE data. Further pharmacovigilance data is essential to help elucidate whether abatacept modifies cancer risk.",

author = "Zuckerman, \{Benjamin P.\} and Mark Gibson and Ritika Roy and Mark Hughes and Daksh Mehta and Zijing Yang and Maryam Adas and Kenrick Ng and Russell, \{Mark D.\} and Andrew Cope and Sam Norton and James Galloway",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025. Published by Oxford University Press on behalf of the British Society for Rheumatology.",

year = "2025",

month = jun,

day = "1",

doi = "10.1093/rheumatology/keaf114",

language = "English",

volume = "64",

pages = "3280--3287",

journal = "Rheumatology",

issn = "1462-0324",

publisher = "OXFORD UNIV PRESS",

number = "6",

}

TY - JOUR

T1 - Abatacept and the risk of malignancy

T2 - a meta-analysis across disease indications

AU - Zuckerman, Benjamin P.

AU - Gibson, Mark

AU - Roy, Ritika

AU - Hughes, Mark

AU - Mehta, Daksh

AU - Yang, Zijing

AU - Adas, Maryam

AU - Ng, Kenrick

AU - Russell, Mark D.

AU - Cope, Andrew

AU - Norton, Sam

AU - Galloway, James

PY - 2025/6/1

Y1 - 2025/6/1

N2 - Objectives: To estimate the association between abatacept use and the incidence of malignancy excluding non-melanomatous skin cancers (NMSCs). Methods: Systematic database searches were performed, to April 2024, to identify phase II/III/IV randomized clinical trials (RCTs), long-term extension (LTE) and observational cohort studies of abatacept in people with rheumatoid arthritis and psoriatic arthritis. Network and pairwise meta-analyses were performed to estimate incidence rate ratios (IRRs) for malignancy excluding NMSC, comparing abatacept with placebo and tumour necrosis factor inhibitors (TNFi) in RCT/LTE studies. Pairwise meta-analyses evaluated the same outcome in observational studies, comparing abatacept with conventional synthetic DMARDs (csDMARDs) and biologic/targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs). Results: In 18 eligible RCTs and 10 LTE studies, there were 15 535 person-years of exposure to abatacept, 1495 to placebo and 733 to TNFi. In network meta-analyses of combined RCT/LTE data, the incidence of all malignancies excluding NMSCs was not significantly different between abatacept and placebo (IRR 0.58; 95% CI 0.32–1.09) or TNFi (IRR 0.72; 95% 0.27–1.87). In observational data, the incidence of malignancy was higher with abatacept, relative to other b/tsDMARDs (IRR 1.21; 95% CI 1.15–1.28), but not significantly different compared with csDMARDs (IRR 0.97; 95% CI 0.90–1.06). Conclusions: Abatacept was associated with a higher incidence of malignancy compared with other b/tsDMARDs in observational studies, but not when compared with placebo or TNFi in RCT/LTE data. Further pharmacovigilance data is essential to help elucidate whether abatacept modifies cancer risk.

AB - Objectives: To estimate the association between abatacept use and the incidence of malignancy excluding non-melanomatous skin cancers (NMSCs). Methods: Systematic database searches were performed, to April 2024, to identify phase II/III/IV randomized clinical trials (RCTs), long-term extension (LTE) and observational cohort studies of abatacept in people with rheumatoid arthritis and psoriatic arthritis. Network and pairwise meta-analyses were performed to estimate incidence rate ratios (IRRs) for malignancy excluding NMSC, comparing abatacept with placebo and tumour necrosis factor inhibitors (TNFi) in RCT/LTE studies. Pairwise meta-analyses evaluated the same outcome in observational studies, comparing abatacept with conventional synthetic DMARDs (csDMARDs) and biologic/targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs). Results: In 18 eligible RCTs and 10 LTE studies, there were 15 535 person-years of exposure to abatacept, 1495 to placebo and 733 to TNFi. In network meta-analyses of combined RCT/LTE data, the incidence of all malignancies excluding NMSCs was not significantly different between abatacept and placebo (IRR 0.58; 95% CI 0.32–1.09) or TNFi (IRR 0.72; 95% 0.27–1.87). In observational data, the incidence of malignancy was higher with abatacept, relative to other b/tsDMARDs (IRR 1.21; 95% CI 1.15–1.28), but not significantly different compared with csDMARDs (IRR 0.97; 95% CI 0.90–1.06). Conclusions: Abatacept was associated with a higher incidence of malignancy compared with other b/tsDMARDs in observational studies, but not when compared with placebo or TNFi in RCT/LTE data. Further pharmacovigilance data is essential to help elucidate whether abatacept modifies cancer risk.

UR - https://www.scopus.com/pages/publications/105006741322

U2 - 10.1093/rheumatology/keaf114

DO - 10.1093/rheumatology/keaf114

M3 - Article

C2 - 39992258

SN - 1462-0324

VL - 64

SP - 3280

EP - 3287

JO - Rheumatology

JF - Rheumatology

IS - 6

M1 - keaf114

ER -

Abatacept and the risk of malignancy: a meta-analysis across disease indications

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