Abatacept and the risk of malignancy: a meta-analysis across disease indications
Benjamin P Zuckerman1, Mark Gibson1, Ritika Roy2
1Centre for Rheumatic Diseases, King's College London, London, UK.
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.
Prospero Registration Number:
CRD42023382314.
Insights
Abatacept use showed no increased cancer risk compared to placebo or TNF inhibitors in clinical trials. However, observational studies indicated a higher malignancy incidence with abatacept versus other biologic drugs.
Area of Science:
- Rheumatology
- Oncology
- Pharmacovigilance
Background:
- Abatacept is a biologic therapy used for autoimmune conditions like rheumatoid arthritis.
- Understanding the potential cancer risk associated with abatacept is crucial for patient safety.
Purpose of the Study:
- To evaluate the association between abatacept and the risk of developing malignancies, excluding non-melanoma skin cancers.
- To compare cancer incidence in patients treated with abatacept versus placebo and other disease-modifying antirheumatic drugs (DMARDs).
Main Methods:
- Systematic literature searches identified randomized clinical trials (RCTs), long-term extension (LTE) studies, and observational cohorts up to April 2024.
- Network and pairwise meta-analyses were conducted to compare malignancy incidence rates.
- Studies compared abatacept against placebo, tumor necrosis factor inhibitors (TNFi), conventional synthetic DMARDs (csDMARDs), and other biologic/targeted synthetic DMARDs (b/tsDMARDs).
Main Results:
- In RCTs/LTEs, abatacept use was not significantly associated with a different incidence of malignancy compared to placebo (IRR 0.58) or TNFi (IRR 0.72).
- Observational data suggested a higher incidence of malignancy with abatacept compared to other b/tsDMARDs (IRR 1.21).
- No significant difference in malignancy incidence was observed between abatacept and csDMARDs in observational studies (IRR 0.97).
Conclusions:
- Abatacept is not associated with an increased risk of malignancy compared to placebo or TNFi in controlled trial settings.
- Observational data indicate a potential increased risk of malignancy when abatacept is compared to other b/tsDMARDs.
- Further pharmacovigilance is necessary to definitively assess the impact of abatacept on cancer risk.
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